86. 肺動脈性肺高血圧症 ［臨床試験数：505，薬物数：433（DrugBank：113），標的遺伝子数：91，標的パスウェイ数：178］
Searched query = "Pulmonary arterial hypertension", "Eisenmenger Syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03833323 | August 1, 2020 | 22 October 2019 | Implantable System for Remodulin Post-Approval Study | Implantable System for Remodulin Post-Approval Study | Pulmonary Arterial Hypertension | Combination Product: Implantable System for Remodulin (treprostinil) | Medtronic Cardiac Rhythm and Heart Failure | United Therapeutics | Not recruiting | 22 Years | N/A | All | 50 | Phase 3 | |
| 2 | JPRN-JapicCTI-194971 | 16/12/2019 | 7 October 2019 | Clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed-dose combination therapy in subjects with pulmonary arterial hypertension (PAH) | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, groupsequential,adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination (FDC) therapy | pulmonary arterial hypertension | Intervention name : ACT-064992D INN of the intervention : - Dosage And administration of the intervention : Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments. Control intervention name : Macitentan INN of the control intervention : - Dosage And administration of the control intervention : Film-coated tablet with 10 mg macitentan, to be administered orally once daily. Control intervention name : Tadalafil INN of the control intervention : - Dosage And administration of the control intervention : Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : FDC therapy + Placebo macitentan + Placebo tadalafil , Macitentan mono-therapy + Placebo tadalafil + Placebo FDC, Tadalafil mono-therapy + Placebo macitentan + Placebo FDC | Janssen Pharmaceutical K.K. | Not Recruiting | 18 | 75 | BOTH | 170 | Phase 3 | Japan, South America, Europe | |
| 3 | NCT04084678 | December 15, 2019 | 30 September 2019 | A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH | A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Ralinepag to Evaluate Safety and Effects on Exercise Capacity Assessed by CPET in Subjects With WHO Group 1 Pulmonary Hypertension Who Recently Initiated Therapy | PAH;Pulmonary Hypertension;Hypertension;Connective Tissue Disease;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease;Pulmonary Arterial Hypertension | Drug: Ralinepag;Drug: Placebo | United Therapeutics | Not recruiting | 18 Years | N/A | All | 193 | Phase 3 | ||
| 4 | NCT04125745 | October 30, 2019 | 22 October 2019 | Oral CXA-10 in Pulmonary Arterial Hypertension | Phase 2 Open-Label Study of Safety and Efficacy Trial of CXA-10 in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: CXA-10 | University of Pittsburgh | National Heart, Lung, and Blood Institute (NHLBI);Complexa, Inc. | Not recruiting | 18 Years | 80 Years | All | 30 | Phase 2 | |
| 5 | NCT03683186 | September 23, 2019 | 28 October 2019 | A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH) | PAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease | Drug: Ralinepag | United Therapeutics | Recruiting | 18 Years | 75 Years | All | 1000 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;China;Croatia;Denmark;France;Greece;Italy;Korea, Republic of;Poland;Romania;Spain;Sweden;Taiwan;Ukraine;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03950739 | September 17, 2019 | 4 November 2019 | Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using Tyvaso | An Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using Tyvaso | Pulmonary Arterial Hypertension | Drug: Treprostinil Inhalation Powder | United Therapeutics | Recruiting | 18 Years | N/A | All | 45 | Phase 1 | United States | |
| 7 | NCT03782818 | September 2019 | 24 June 2019 | Olaparib for PAH: a Multicenter Clinical Trial | Olaparib for Pulmonary Arterial Hypertension: a Multicenter Clinical Trial | Pulmonary Arterial Hypertension | Drug: Olaparib | Laval University | Not recruiting | 18 Years | 75 Years | All | 20 | Phase 1 | Canada | |
| 8 | NCT03904693 | August 30, 2019 | 30 September 2019 | Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination (FDC) Therapy | Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) | Drug: FDC macitentan/tadalafil;Drug: Macitentan 10 mg;Drug: Tadalafil 40 mg;Drug: Placebo FDC;Drug: Placebo macitentan;Drug: Placebo tadalafil | Actelion | Covance;Almac Clinical Technologies;WorldCare Clinical;Frontier Science Foundation | Recruiting | 18 Years | 75 Years | All | 170 | Phase 3 | United States;Hungary;Taiwan |
| 9 | NCT03655704 | August 22, 2019 | 9 September 2019 | Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study | Apabetalone for Pulmonary Arterial Hypertension: a Pilot Study | Pulmonary Arterial Hypertension | Drug: Apabetalone | Steeve Provencher | Recruiting | 18 Years | 75 Years | All | 10 | Early Phase 1 | Canada | |
| 10 | NCT04053543 | August 9, 2019 | 7 October 2019 | CXA-10 Study in Subjects With Pulmonary Arterial Hypertension | A Phase 2, Multi-Center, Open-Label Study to Evaluate Long-term Safety and Efficacy of CXA-10 in Subjects With Pulmonary Arterial Hypertension on Stable Background Therapy: Extension to Study CXA-10-301 | PAH | Drug: CXA-10 | Complexa, Inc. | Medpace, Inc.;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Recruiting | 18 Years | N/A | All | 96 | Phase 2 | United States;United Kingdom |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT03924154 | August 1, 2019 | 4 November 2019 | A Study of RVT-1201 in Patients With Pulmonary Arterial Hypertension (ELEVATE 1) | A Phase 2a, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of RVT-1201 in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: RVT-1201;Drug: Placebo | Altavant Sciences GmbH | Altavant Sciences, Inc.;PPD | Recruiting | 18 Years | 75 Years | All | 36 | Phase 2 | United States;Canada |
| 12 | NCT03926793 | August 2019 | 26 August 2019 | Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial Hypertension | A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: GB002;Drug: Placebo;Device: Generic Dry Powder Inhaler | GB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | Recruiting | 18 Years | 75 Years | All | 24 | Phase 1 | United States;United Kingdom | |
| 13 | NCT03863990 | July 26, 2019 | 4 November 2019 | Study Performed at Various Medical Centers to Learn More About Survival and Expected Course of Pulmonary Arterial Hypertension, a Type of High Blood Pressure in the Lungs Related to the Narrowing of the Small Blood Vessels in the Lungs | Prognostic Factors and Survival in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: PAH medication | Bayer | Not recruiting | 18 Years | N/A | All | 110 | Phase 2 | Argentina | |
| 14 | NCT03992755 | July 18, 2019 | 30 September 2019 | Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of Treprostinil | A Global, Open-Label Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients | Primary Pulmonary Hypertension | Drug: LIQ861 Inhaled Treprostinil | Liquidia Technologies, Inc. | Nuventra, Inc. | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | United States |
| 15 | NCT03884465 | May 30, 2019 | 1 April 2019 | Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of Treprostinil | A Two Part, Phase 2 Open-label, Multi-Centre, Dose Escalation Hemodynamic Study to Evaluate Dose-Response and Safety of Inhaled LIQ861 (Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Subjects | Pulmonary Arterial Hypertension | Drug: Inhaled dry powder treprostinil (LIQ861) | Liquidia Technologies, Inc. | FGK Clinical Research GmbH | Not recruiting | 18 Years | N/A | All | 32 | Phase 2 | France;Germany |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT03554291 | May 1, 2019 | 24 June 2019 | Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension | Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary Hypertension | Pulmonary Arterial Hypertension;Right Heart Failure | Drug: Famotidine 20 MG;Other: Placebo | University of Washington | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 18 Years | 80 Years | All | 80 | Phase 2 | United States |
| 17 | NCT03738150 | May 1, 2019 | 11 November 2019 | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension | A Phase 2a Single-Arm, Open-Label, Multicenter Exploratory Study to Assess the Effects of Sotatercept (ACE-011) for the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Biological: Sotatercept | Acceleron Pharma, Inc. | Recruiting | 18 Years | N/A | All | 25 | Phase 2 | United States | |
| 18 | NCT03835676 | May 1, 2019 | 26 August 2019 | Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension | Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Treprostinil | Magdi H. Yacoub | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | Egypt | |
| 19 | NCT03795428 | April 10, 2019 | 23 April 2019 | Long-Term Extension Study of PB1046 in PAH Subjects Having Completed Studies PB1046-PT-CL-0004 or PB1046-PT-CL-0005 | A Long-Term Extension Study of PB1046 Injection in Pulmonary Arterial Hypertension Subjects Having Completed Studies PB1046-PT-CL-0004 or PB1046-PT-CL-0005 | Pulmonary Arterial Hypertension | Drug: PB1046 Injection | PhaseBio Pharmaceuticals Inc. | Recruiting | 18 Years | 79 Years | All | 64 | Phase 2 | United States | |
| 20 | JPRN-UMIN000035389 | 2019/04/01 | 23 April 2019 | Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension | Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension - SETOUCHI PH study | Pulmonary arterial hypertension | Dose: macitentan 10 mg/day+riociguat 3 mg/day. Max dose of riociguat is 7.5 mg/day.Intervention period: 8 month Dose: macitentan 10 mg/day+selexipag 0.4 mg/day. Max dose of selexipag is 3.2 mg/day. Intervention period: 8 month | Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science | Not Recruiting | 20years-old | Not applicable | Male and Female | 76 | Not selected | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT04062565 | March 25, 2019 | 2 September 2019 | Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH | A Prospective Trial to Evaluate Up-front Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Patients With Advanced Pulmonary Arterial Hypertension (IIR-3810) | Pulmonary Arterial Hypertension | Drug: Treprostinil Injectable Product;Drug: Riociguat Pill | University of Arizona | Recruiting | 18 Years | N/A | All | 20 | Phase 3 | United States | |
| 22 | NCT03522935 | March 18, 2019 | 15 April 2019 | Subcutaneous Elafin in Healthy Subjects | Safety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal Subjects | Pulmonary Arterial Hypertension | Drug: Elafin;Drug: Placebo | Roham T. Zamanian | Duke University;SRI International | Recruiting | 18 Years | 55 Years | All | 30 | Phase 1 | United States |
| 23 | JPRN-JapicCTI-194651 | 12/3/2019 | 16 July 2019 | MD-711 Phase 2/3 Study in PAH | MD-711 Phase 2/3 Study in Pulmonary Arterial Hypertension | Pulmonary arterial hypertension | Intervention name : MD-711 INN of the intervention : treprostinil Dosage And administration of the intervention : Inhaled admistration Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | Mochida Pharmaceutical Co., Ltd. | Not Recruiting | 18 | 75 | BOTH | 15 | Phase 2-3 | Japan | |
| 24 | NCT03789643 | March 2019 | 13 May 2019 | Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial Hypertension | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of JTT-251 Administered for 24 Weeks to Participants With Pulmonary Arterial Hypertension (RELIEF-PAH) | Pulmonary Arterial Hypertension | Drug: JTT-251;Drug: Placebo | Akros Pharma Inc. | Not recruiting | 18 Years | 80 Years | All | 0 | Phase 2 | ||
| 25 | EUCTR2018-001189-40-FR | 15/02/2019 | 30 April 2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0 Level: LLT Classification code 10077731 Term: Pulmonary hypertension WHO functional class I System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Arena Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2018-001189-40-SE | 11/02/2019 | 30 April 2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0 Level: LLT Classification code 10077731 Term: Pulmonary hypertension WHO functional class I System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Arena Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden | |||
| 27 | NCT03754660 | January 21, 2019 | 11 November 2019 | This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | A Non-randomized Two Part Multi-Center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel Group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592 | Hypertension, Pulmonary | Drug: BAY1237592;Drug: PH-monotherapy;Drug: PH-combination therapy;Procedure: NO gas | Bayer | Recruiting | 18 Years | 80 Years | All | 60 | Phase 1 | Germany | |
| 28 | NCT03744637 | January 18, 2019 | 22 October 2019 | A Study of Single Doses of MK -5475 on Pulmonary Vascular Resistance (MK-5475-002) | A Study to Assess the Effect of Single Doses of MK -5475 on Pulmonary Vascular Resistance in Patients With Moderate to Severe Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: MK-5475;Drug: Placebo | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | 70 Years | All | 28 | Phase 1 | Moldova, Republic of | |
| 29 | EUCTR2018-002796-18-ES | 17/01/2019 | 28 February 2019 | To study the safety and effectiveness of the maximum tolerated dose of zamicastat, found in BIA-51058-201, in the treatment of long-term PAH. | An open-label, multicentre study to evaluate the safety and efficacy of zamicastat as adjunctive therapy in long-term treatment of pulmonary arterial hypertension (PAH) disease | Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA-5-1058 Pharmaceutical Form: Tablet INN or Proposed INN: ZAMICASTAT CAS Number: 1080028-80-3 Current Sponsor code: BIA 5-1058 Other descriptive name: BIA 5-1058 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Bial - Portela & Ca, S.A. | Authorised | Female: yes Male: yes | 40 | Phase 2 | Portugal;Spain;Ukraine;Austria;United Kingdom | |||
| 30 | EUCTR2018-001187-33-HU | 14/01/2019 | 28 February 2019 | A study evaluating the efficacy and safety of ralinepag in treatment of patients with pulmonary hypertension. | A StuDy eVAluatiNg the EffiCacy and Safety of RalinEpag To Improve Treatment OUTCOMES in PAH Patients - ADVANCE-outcomes | pulmonary arterial hypertension (PAH) MedDRA version: 20.0 Level: LLT Classification code 10077731 Term: Pulmonary hypertension WHO functional class I System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Other descriptive name: NA Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Other descriptive name: NA Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Other descriptive name: NA Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Arena Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 700 | Phase 3 | United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Germany;Japan;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | EUCTR2018-001189-40-HU | 14/01/2019 | 28 February 2019 | An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertension | A StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extension | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0 Level: LLT Classification code 10077731 Term: Pulmonary hypertension WHO functional class I System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Ralinepag Product Code: APD811 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Arena Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Taiwan;Greece;Thailand;Ukraine;Chile;Israel;Switzerland;France;Australia;Denmark;China;Korea, Republic of;Turkey;United Kingdom;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Belgium;Singapore;Croatia;Bulgaria;Japan;Sweden | |||
| 32 | NCT03648385 | January 9, 2019 | 4 November 2019 | Effects of DHEA in Pulmonary Hypertension | Effects of DHEA in Pulmonary Hypertension | Pulmonary Arterial Hypertension | Drug: DHEA tablet;Other: Placebo | Rhode Island Hospital | Recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States | |
| 33 | NCT03657095 | December 10, 2018 | 11 November 2019 | BPS-314d-MR-PAH-303 (BEAT OLE) | An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension Patients | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium 314d Modified Release tablets | Lung Biotechnology PBC | Not recruiting | 18 Years | 85 Years | All | 112 | Phase 3 | United States;Israel | |
| 34 | EUCTR2018-002448-10-PT | 26/11/2018 | 4 December 2018 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 Pharmaceutical Form: Tablet INN or Proposed INN: ZAMICASTAT CAS Number: 1080028-80-3 Current Sponsor code: BIA 5-1058 Other descriptive name: BIA 5-1058 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Bial - Portela & Ca, S.A. | Authorised | Female: yes Male: yes | 40 | Phase 2 | France;Portugal;Belgium;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom | |||
| 35 | EUCTR2018-002448-10-AT | 31/10/2018 | 12 November 2018 | Study to find the most promising therapeutic dosage of zamicastat for the treatment of PAH disease. | An open-label, multicentre study to evaluate pharmacokinetics, safety and efficacy of zamicastat as adjunctive therapy in pulmonary arterial hypertension (PAH) - Pharmacokinetics, safety and efficacy of BIA 5-1058 in PAH | Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Zamicastat Product Code: BIA 5-1058 Pharmaceutical Form: Tablet INN or Proposed INN: ZAMICASTAT CAS Number: 1080028-80-3 Current Sponsor code: BIA 5-1058 Other descriptive name: BIA 5-1058 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Bial - Portela & Ca, S.A. | Authorised | Female: yes Male: yes | 40 | Phase 2 | Ukraine;Austria | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT03251872 | October 25, 2018 | 24 June 2019 | Olaparib for PAH: a Pilot Study | Olaparib for Pulmonary Arterial Hypertension: a Pilot Clinical Study | Pulmonary Arterial Hypertension | Drug: Olaparib | Laval University | Recruiting | 18 Years | 75 Years | All | 6 | Early Phase 1 | Canada | |
| 37 | NCT03528902 | October 1, 2018 | 22 October 2018 | Tamoxifen Therapy to Treat Pulmonary Arterial Hypertension | Tamoxifen Therapy to Treat Pulmonary Arterial Hypertension | Hypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary Hypertension;Primary Pulmonary Hypertension;Lung Diseases;Tamoxifen;Estrogen Receptor Antagonist;Hormone Antagonists;Estrogens | Drug: Tamoxifen;Drug: Placebo Oral Tablet | Vanderbilt University Medical Center | Recruiting | 18 Years | N/A | All | 24 | Phase 2 | United States | |
| 38 | NCT03497689 | September 21, 2018 | 4 November 2019 | EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension | EXPEDITE: A 16-Week, Multicenter, Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Intravenous/Subcutaneous Treprostinil; Oral Treprostinil | United Therapeutics | Recruiting | 17 Years | 85 Years | All | 30 | Phase 4 | United States | |
| 39 | NCT03626688 | August 30, 2018 | 11 November 2019 | A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients | A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH | PAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease | Drug: Ralinepag;Drug: Placebo | United Therapeutics | Recruiting | 18 Years | 75 Years | All | 700 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;China;Croatia;Denmark;France;Greece;Italy;Korea, Republic of;Poland;Romania;Spain;Sweden;Taiwan;Ukraine;United Kingdom | |
| 40 | NCT03617458 | August 23, 2018 | 23 April 2019 | Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension | Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension | Pulmonary Artery Hypertension | Drug: Metformin;Drug: Placebo;Device: mHealth Intervention;Device: Usual Care | Vanderbilt University Medical Center | Mayo Clinic;The Cleveland Clinic | Recruiting | 18 Years | N/A | All | 160 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT03449524 | August 1, 2018 | 4 November 2019 | PRIMEx - A Study of 2 Doses of Oral CXA-10 in Pulmonary Arterial Hypertension (PAH) | Phase 2 Multicenter, Double-Blind, Placebo Controlled, Efficacy, Safety, and Pharmacokinetic Study of 2 Doses of CXA-10 on Stable Background Therapy in Subjects With Pulmonary Arterial Hypertension | PAH | Drug: 75mg CXA-10;Drug: 150mg CXA-10;Other: Placebo | Complexa, Inc. | Medpace, Inc.;Philips Healthcare;Cardiovascular Clinical Science Foundation;MicroConstants;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) | Recruiting | 18 Years | 80 Years | All | 96 | Phase 2 | United States;United Kingdom |
| 42 | NCT03492177 | July 25, 2018 | 16 September 2019 | A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension | A Prospective, Multicenter, Open-label, Single-arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: selexipag (Uptravi) | Actelion | Recruiting | 2 Years | 18 Years | All | 55 | Phase 2 | United States;Belarus;France;Germany;Hungary;Israel;Malaysia;Poland;Russian Federation;Serbia;Taiwan;Ukraine;United Kingdom | |
| 43 | NCT03556020 | July 15, 2018 | 28 October 2019 | Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC PB1046 in Subjects With Symptomatic PAH | A Randomized, Double-Blind, Parallel Group, Phase 2 Study to Assess the Safety, Tolerability, and Efficacy of Once Weekly Subcutaneous (SC) Injections of a Sustained-Release Vasoactive Intestinal Peptide (VIP) Analogue, PB1046, in Adult Subjects With Symptomatic Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: PB1046 | PhaseBio Pharmaceuticals Inc. | Recruiting | 18 Years | 79 Years | All | 63 | Phase 2 | United States | |
| 44 | NCT03496207 | June 27, 2018 | 9 September 2019 | A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (PAH) | A Phase 2, Double-Blind, Placebo-Controlled, Randomized Study to Compare the Efficacy and Safety of Sotatercept (ACE-011) Versus Placebo When Added to Standard of Care for the Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Placebo;Drug: Sotatercept | Acceleron Pharma, Inc. | Not recruiting | 18 Years | N/A | All | 100 | Phase 2 | United States;Australia;Brazil;France;Germany;Israel;Spain;United Kingdom | |
| 45 | NCT03683082 | June 5, 2018 | 1 October 2018 | Oxygen Treatment and Pulmonary Arterial Hypertension | Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients | Pulmonary Arterial Hypertension | Drug: Oxygen supplementation;Drug: Sham O2 (medical air) | George Papanicolaou Hospital | Recruiting | 18 Years | 80 Years | All | 10 | N/A | Greece | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT03166306 | May 1, 2018 | 23 July 2018 | Angiogenic Imaging in Pulmonary Arterial Hypertension | Angiogenic Imaging in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Exercise Associated Pulmonary Arterial Hypertension | Diagnostic Test: PET-CT Imaging with [89Zr]-bevacizumab | Brigham and Women's Hospital | Recruiting | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | United States | |
| 47 | NCT03489005 | April 9, 2018 | 11 November 2019 | Effect of BIA 5 1058 on Cardiac Repolarization | A Randomized, Double-blind, Placebo-controlled and Open-label, Active Controlled, 4 Period Crossover Trial to Evaluate the Effect of BIA 5 1058 on Cardiac Repolarization in Healthy Adult Males and Females Under Fed Conditions | Cardiovascular Disease;Pulmonary Arterial Hypertension;Heart Failure | Drug: BIA 5-1058;Drug: Placebo Oral Tablet;Drug: Moxifloxacin 400 mg | Bial - Portela C S.A. | Covance | Not recruiting | 18 Years | 55 Years | All | 49 | Phase 1 | United Kingdom |
| 48 | NCT03422328 | April 4, 2018 | 4 November 2019 | A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Arterial Hypertension Who Were Previously Treated With Macitentan in Clinical Studies. | mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies (UMBRELLA) | Pulmonary Arterial Hypertension | Drug: macitentan | Actelion | Recruiting | 18 Years | 80 Years | All | 94 | Phase 3 | Belarus;France;Poland;Ukraine | |
| 49 | NCT03344159 | April 1, 2018 | 29 April 2019 | Spironolactone Therapy in Chronic Stable Right HF Trial | Spironolactone Therapy in Chronic Stable Right HF Trial | Chronic Right-Sided Heart Failure;Pulmonary Arterial Hypertension;Pulmonary Hypertension, Primary, 2;Pulmonary Hypertension, Primary, 3;Pulmonary Hypertension, Primary, 4;Cardiomyopathy Right Ventricular | Drug: Spironolactone;Drug: Placebo;Radiation: PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82;Diagnostic Test: Cardiac MRI (Gadolinium enhanced) | Ottawa Heart Institute Research Corporation | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | Canada | |
| 50 | EUCTR2017-003934-10-FR | 19/03/2018 | 28 February 2019 | A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary arterial hypertension and who were previously treated with macitentan in clinical studies. | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | Actelion Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 94 | Phase 3 | France | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT03464864 | March 9, 2018 | 12 November 2018 | Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers | A Phase 1, Single-center, Open-label, Dose-Rising Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder (TrIP) in Healthy Normal Volunteers | Pulmonary Arterial Hypertension | Drug: Treprostinil Inhalation Powder | Mannkind Corporation | Not recruiting | 18 Years | 55 Years | All | 36 | Phase 1 | United States | |
| 52 | NCT03362047 | March 1, 2018 | 11 June 2018 | (RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment) | Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen | Pulmonary Arterial Hypertension (PAH) | Drug: Riciguat Group;Drug: Macitentan Group | University of Giessen | Philipps University Marburg Medical Center | Recruiting | 18 Years | 85 Years | All | 30 | Phase 2 | Germany |
| 53 | NCT03177603 | February 21, 2018 | 15 July 2019 | A Dose-escalation Study in Subjects With Pulmonary Arterial Hypertension (PAH) | An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: GSK2586881 | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | All | 23 | Phase 2 | United States;Germany;Spain | |
| 54 | NCT02939599 | February 1, 2018 | 9 September 2019 | Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients | Long-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: QCC374 | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 5 | Phase 2 | United States;Germany;United Kingdom | |
| 55 | NCT03293407 | February 1, 2018 | 4 November 2019 | Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension | Ventavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Iloprost (Ventavis, BAYQ6256);Device: Breelib nebulizer | Bayer | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | Germany | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT03399604 | January 2, 2018 | 30 September 2019 | Investigation of the Safety and Pharmacology of Dry Powder Inhalation of Treprostinil | A Phase 3 Open-label, Multicenter Study to Evaluate the Long-term Safety and Tolerability of Inhaled LIQ861(Treprostinil) in Pulmonary Arterial Hypertension (WHO Group 1) Patients | Primary Pulmonary Hypertension | Drug: LIQ861 Inhaled Treprostinil | Liquidia Technologies, Inc. | Nuventra, Inc. | Not recruiting | 18 Years | N/A | All | 121 | Phase 3 | United States |
| 57 | EUCTR2017-000137-31-NL | 19/12/2017 | 8 January 2018 | Treatment of Pulmonary Hypertension with 6 Mercaptopurine | Pulmonary Hypertension REversal in Clusters of Patients With Identical Pathobiological Substrates. 6-Mercaptopurine Proof-of-Concept Trial - PRECISE-MP | Pulmonary arterial hypertension MedDRA version: 20.0 Level: HLGT Classification code 10037454 Term: Pulmonary vascular disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: HLT Classification code 10037401 Term: Pulmonary hypertensions System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: Puri-Nethol Pharmaceutical Form: Tablet | VU University Medical Center | Authorised | Female: yes Male: yes | 50 | Phase 2 | Netherlands | |||
| 58 | NCT03187678 | December 4, 2017 | 3 June 2019 | Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension | A Multicenter, Open-label, Single-sequence Cross-over Study to Assess Safety, Tolerability, and Pharmacokinetics of Intravenous Selexipag in Subjects With Stable Pulmonary Arterial Hypertension Switching From an Oral Stable Dose of Selexipag | Pulmonary Arterial Hypertension | Drug: i.v. selexipag;Drug: oral selexipag (Uptravi) | Actelion | Not recruiting | 18 Years | 75 Years | All | 20 | Phase 3 | United States;Germany | |
| 59 | NCT03364244 | November 30, 2017 | 11 March 2019 | Revavtio Special Investigation for Long-term Use in Pediatric Patients | REVATIO SPECIAL INVESTIGATION - INVESTIGATION FOR LONG-TERM USE OF REVATIO IN PEDIATRIC PATIENTS - | Pulmonary Arterial Hypertension | Drug: Sildenafil | Pfizer | Recruiting | N/A | 14 Years | All | 190 | Phase 2 | Japan | |
| 60 | NCT02932410 | November 28, 2017 | 16 September 2019 | A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) | A Multicenter, Open-label, Randomized, Event-driven Study to Assess Efficacy, Safety and Pharmacokinetics of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Other: Standard-of-care;Drug: Macitentan | Actelion | Recruiting | 2 Years | 17 Years | All | 300 | Phase 3 | United States;Australia;Austria;Canada;China;Colombia;France;Hungary;Israel;Korea, Republic of;Mexico;Philippines;Poland;Portugal;Russian Federation;South Africa;Spain;Thailand;Ukraine;Vietnam;Argentina;Bulgaria | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT03078907 | November 8, 2017 | 16 September 2019 | Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension. | A Multi-center, Double-blind, Placebo-controlled Phase 4 Study in Patients With Pulmonary Arterial Hypertension to Assess the Effect of Selexipag on Daily Life Physical Activity and Patient's Self-reported Symptoms and Their Impacts | Pulmonary Arterial Hypertension | Drug: Selexipag;Drug: Placebo | Actelion | Not recruiting | 18 Years | 75 Years | All | 108 | Phase 4 | United States;Austria;France;Germany;Ireland;Norway;Portugal;Sweden;Switzerland;United Kingdom | |
| 62 | NCT03315507 | October 20, 2017 | 22 October 2019 | A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAH | An Open-Label, Dose Titration Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046, A Sustained-Release Analogue of Vasoactive Intestinal Peptide, In Adult Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: PB1046 Subcutaneous Injection | PhaseBio Pharmaceuticals Inc. | Not recruiting | 18 Years | N/A | All | 3 | Phase 1 | United States | |
| 63 | EUCTR2016-001411-20-DE | 17/10/2017 | 26 November 2018 | Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patients | Long-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAH | Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QCC374 0.015 mg Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: TBD Current Sponsor code: QCC374 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.015- Product Code: QCC374 0.06 mg Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: TBD Current Sponsor code: QCC374 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.06- | Novartis Pharma AG | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | United States;Taiwan;Germany;United Kingdom;Korea, Republic of | |||
| 64 | NCT03270332 | October 12, 2017 | 11 November 2019 | Effect of Inhaled Albuterol in Pulmonary Hypertension | Effect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept Study | Pulmonary Hypertension | Drug: albuterol first then placebo;Drug: placebo first then albuterol | University of Miami | Recruiting | 18 Years | N/A | All | 6 | Early Phase 1 | United States | |
| 65 | NCT03229499 | October 2, 2017 | 14 January 2019 | Pulmonary Hypertension and Anastrozole Trial | Pulmonary Hypertension and Anastrozole Trial (PHANTOM) | Pulmonary Arterial Hypertension | Drug: Anastrozole;Drug: Placebo Oral Tablet | University of Pennsylvania | National Heart, Lung, and Blood Institute (NHLBI);Johns Hopkins University;University of Colorado, Denver;Rhode Island Hospital;Stanford University;Vanderbilt University;Washington University School of Medicine | Recruiting | 18 Years | N/A | All | 84 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | NCT03145298 | October 1, 2017 | 25 February 2019 | ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApy | A Phase I Study of the Safety and Feasibility of Central Intravenous Delivery of Allogeneic Human Cardiosphere-Derived Stem Cells in Patients With Pulmonary Arterial Hypertension ALPHA Trial | Pulmonary Arterial Hypertension (PAH) | Biological: Allogeneic Human Cardiosphere-Derived Stem Cells;Biological: Placebo | Cedars-Sinai Medical Center | California Institute for Regenerative Medicine (CIRM) | Recruiting | 18 Years | 75 Years | All | 26 | Phase 1 | United States |
| 67 | NCT02999906 | October 2017 | 16 December 2017 | Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Compare the Efficacy and Safety of Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Oral Treprostinil;Drug: Placebo | United Therapeutics | Not recruiting | 18 Years | 79 Years | All | 0 | Phase 3 | ||
| 68 | NCT03001414 | September 28, 2017 | 23 April 2019 | Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCs | A Multicentre, Phase 2 Clinical Trial to Establish the Efficacy and Safety of Repeat Dosing of Autologous Endothelial Progenitor Cells (EPCs) Transfected With Human Endothelial NO-synthase (eNOS) in Patients With Pulmonary Arterial Hypertension (PAH) on Top of Conventional Treatments | Hypertension,Pulmonary | Biological: Placebo followed by Autologous EPCs transfected with human eNOS;Biological: Autologous EPCs transfected with human eNOS followed by Placebo;Biological: Autologous EPCs transfected with human eNOS | Northern Therapeutics | Ottawa Hospital Research Institute | Recruiting | 18 Years | 80 Years | All | 45 | Phase 2 | Canada |
| 69 | NCT02927366 | September 19, 2017 | 1 April 2019 | Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH Patients | A Randomized, Parallel-group, Placebo-controlled Subject and Investigator Blinded Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of QCC374 in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Placebo Matching;Drug: QCC374 | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 8 | Phase 2 | United States;Germany;Korea, Republic of;United Kingdom;Taiwan | |
| 70 | EUCTR2017-000216-42-IE | 12/09/2017 | 29 January 2018 | Daily life physical activity and disease symptoms assessed in patients with pulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 3b study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Selexipag Current Sponsor code: ACT-293987 Other descriptive name: SELEXIPAG Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 100 | Phase 4 | Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2017-000212-41-DE | 01/09/2017 | 27 August 2018 | Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH) | An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts | Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10077739 Term: Pulmonary arterial hypertension WHO functional class I System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10077729 Term: Pulmonary arterial hypertension WHO functional class III System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10077740 Term: Pulmonary arterial hypertension WHO functional class II System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GSK2586881 Product Code: GSK2586881 Pharmaceutical Form: Solution for injection INN or Proposed INN: GSK2586881 Current Sponsor code: GSK2586881 Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- | GlaxoSmithKline Research & Development Ltd | Authorised | Female: yes Male: yes | 24 | Phase 2 | United States;Spain;Germany | |||
| 72 | EUCTR2017-000216-42-AT | 29/08/2017 | 28 February 2019 | Daily life physical activity and disease symptoms assessed in patients with pulmonary arterial hypertension (PAH) treated with selexipag | A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE | Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Selexipag Current Sponsor code: ACT-293987 Other descriptive name: SELEXIPAG Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 100 | Phase 4 | Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden | |||
| 73 | EUCTR2017-000212-41-ES | 10/08/2017 | 21 August 2017 | Study to test a new drug to treat patients with Pulmonary Arterial Hypertension (PAH). | An Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2586881 in Participants with Pulmonary Arterial Hypertension. - PH 2a, SD, DE, safety, PK/PD study of GSK2586881 in Pulmonary Arterial Hypertension pts | Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10077739 Term: Pulmonary arterial hypertension WHO functional class I System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10077729 Term: Pulmonary arterial hypertension WHO functional class III System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10077740 Term: Pulmonary arterial hypertension WHO functional class II System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: GSK2586881 Product Code: GSK2586881 Pharmaceutical Form: Solution for injection INN or Proposed INN: GSK2586881 Current Sponsor code: GSK2586881 Other descriptive name: Recombinant Human Angiotensin-converting enzyme 2 (ACE2), APN01 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- | GlaxoSmithKline, S.A. | Authorised | Female: yes Male: yes | 24 | Phase 2 | United States;Spain | |||
| 74 | NCT03045029 | July 18, 2017 | 20 May 2019 | ADAPT - A Patient Registry of the Real-world Use of Orenitram® | ADAPT - A Patient Registry of the Real-world Use of Orenitram® | Pulmonary Arterial Hypertension | Drug: Oral treprostinil | United Therapeutics | Recruiting | 18 Years | N/A | All | 300 | Phase 2 | United States | |
| 75 | NCT02800941 | July 5, 2017 | 18 December 2018 | Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension | Bleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study. | Pulmonary Arterial Hypertension | Drug: Oral anticoagulant treatment | Centre Hospitalier Universitaire de Saint Etienne | Recruiting | 18 Years | N/A | All | 203 | Phase 2 | France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | JPRN-UMIN000027284 | 2017/07/01 | 2 April 2019 | The effect of iloprost on pulmonary hypertension and exercuse capacity | Pulmonary arterial hypertension | inhale of iloprost | The University of Tokushima Graduate School of Health Biosciences | Not Recruiting | 20years-old | 90years-old | Male and Female | 20 | Not selected | Japan | ||
| 77 | NCT03273387 | June 1, 2017 | 16 December 2017 | The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension in National Cardiovascular Center Harapan Kita Hospital | The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension Patients in National Cardiovascular Center Harapan Kita Hospital Indonesia | Precapillary Pulmonary Hypertension | Drug: Trimetazidine;Drug: Placebo oral capsule | Indonesia University | Recruiting | 18 Years | 65 Years | All | 25 | Phase 2/Phase 3 | Indonesia | |
| 78 | NCT02882126 | June 2017 | 16 December 2017 | An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial Hypertension | An Open-Label Extension Trial to Evaluate the Safety of Continued Therapy With Subcutaneous Remodulin® in Subjects With Pulmonary Arterial Hypertension Who Completed Study CVT-CV-003 | Pulmonary Arterial Hypertension | Drug: Subcutaneous Treprostinil | United Therapeutics | CVie Therapeutics Co. Ltd. | Not recruiting | 18 Years | N/A | All | 0 | Phase 4 | China |
| 79 | EUCTR2016-004035-21-DE | 23/05/2017 | 30 April 2019 | A study to evaluate whether it is safe for patients with pulmonary arterial hypertension to temporarily change from selexipag tablets (Uptravi®) to selexipag given directly into a vein (intravenous selexipag) | A multicenter, open-label, single-sequence cross-over study to assess safety, tolerability, and pharmacokinetics of intravenous selexipag in subjects with stable pulmonary arterial hypertension switching from an oral stable dose of selexipag | Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Selexipag Current Sponsor code: ACT-293987 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 1800- | Actelion Pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Germany | |||
| 80 | NCT03401476 | May 8, 2017 | 29 January 2018 | Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension | Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Morphine Sulfate | John Granton | Recruiting | 18 Years | N/A | All | 15 | Phase 2 | Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | NCT03365479 | May 1, 2017 | 5 November 2018 | Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension | Acute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial Hypertension | Pulmonary Hypertension;Pulmonary Arterial Hypertension | Drug: Iloprost | University of Giessen | Not recruiting | 18 Years | N/A | All | 30 | N/A | Germany | |
| 82 | NCT03016468 | May 2017 | 16 December 2017 | Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH | A Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Parenteral Remodulin (treprostinil) injection;Drug: Oral Treprostinil | United Therapeutics | Not recruiting | 18 Years | 75 Years | All | 0 | Phase 2 | ||
| 83 | NCT02911844 | April 10, 2017 | 4 March 2019 | Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension | Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Fulvestrant | University of Pennsylvania | Not recruiting | 18 Years | N/A | Female | 5 | Phase 2 | United States | |
| 84 | NCT02587325 | April 1, 2017 | 18 March 2019 | ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial Hypertension | A Phase 1 Clinical Trial of ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: ABI-009, nab-rapamycin, albumin-bound rapamycin | Aadi, LLC | Recruiting | 18 Years | N/A | All | 25 | Phase 1 | United States | |
| 85 | NCT03431649 | April 1, 2017 | 26 February 2018 | Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children | Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect | Pediatric Pulmonary Hypertension | Drug: Beraprost Sodium;Drug: Sildenafil Citrate | Dr. Soetomo General Hospital | Not recruiting | 1 Year | 17 Years | All | 40 | Phase 4 | Indonesia | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | NCT02893995 | February 2017 | 16 December 2017 | Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial Hypertension | A 16-Week, Open-Label, Multi-Center, Parallel, Randomized Controlled Study to Compare the Safety, Tolerability, Pharmacokinetics and Efficacy of Slow and Rapid Dose Titration Regimens of Subcutaneous Remodulin Therapy in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Slow Dose Titration Group of Subcutaneous Treprostinil;Drug: Rapid Dose Titration Group of Subcutaneous Treprostinil | United Therapeutics | CVie Therapeutics Co. Ltd. | Not recruiting | 18 Years | N/A | All | 0 | Phase 4 | China |
| 87 | EUCTR2016-001062-28-HU | 25/01/2017 | 30 April 2018 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Dispersible tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Dispersible tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Dispersible tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- | ACTELION Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of | |||
| 88 | NCT02891850 | January 11, 2017 | 22 October 2019 | Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy | A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal | Pulmonary Arterial Hypertension | Drug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: Tadalafil | Bayer | Not recruiting | 18 Years | 75 Years | All | 223 | Phase 4 | United States;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;Australia;Switzerland | |
| 89 | JPRN-UMIN000025176 | 2017/01/01 | 2 April 2019 | Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension | Medicine transition from beraprost to selexipag In accordance with the Japanese package insert (http://www.info.pmda.go.jp/go/pack/2190037F1020_1_02/), selexipag is initiated at a dose of 0.2mg twice daily and is increased in twice-daily increments of 0.2mg until unmanageable adverse effects associated with prostacyclin use, such as headache or jaw pain, developed. The maximum dose allowed is 1.6mg twice daily. | Hamamatsu University School of Medicine | Recruiting | 16years-old | Not applicable | Male and Female | 33 | Not selected | Japan | ||
| 90 | NCT02682511 | January 2017 | 26 August 2019 | Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension | A Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Ifetroban in Patients With Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension (SSc-PAH) | Scleroderma, Diffuse;Scleroderma, Systemic;Scleroderma, Limited;Sclerosis, Progressive Systemic;Skin Diseases;Connective Tissue Diseases;Pathologic Processes;Autoimmune Diseases | Drug: Oral Ifetroban;Drug: Oral Placebo | Cumberland Pharmaceuticals | Recruiting | 18 Years | 80 Years | All | 34 | Phase 2 | United States;India | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | EUCTR2010-024585-22-DE | 01/12/2016 | 26 March 2018 | What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? | What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? - Ferinject® for iron deficiency in IPAH patients | Idiopathic or familial pulmonary arterial hypertension MedDRA version: 19.0 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Solution for infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Imperial College Academic Healthsciences Centre | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Germany;United Kingdom | |||
| 92 | NCT02736149 | December 2016 | 29 July 2019 | Open-Label Extension Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) | A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety and Efficacy of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) | Pulmonary Arterial Hypertension | Drug: ubenimex | Eiger BioPharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 51 | Phase 2 | United States;Canada | |
| 93 | NCT02981082 | December 2016 | 25 February 2019 | Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension | A Double-blinded, Placebo-controlled Pilot Study of Dimethyl Fumarate (DMF) in Pulmonary Arterial Hypertension (PAH) Associated With Systemic Sclerosis (SSc-PAH): The Effect of DMF on Clinical Disease and Biomarkers of Oxidative Stress. | Systemic Sclerosis;Pulmonary; Hypertension | Drug: Dimethyl Fumarate (DMF);Drug: Placebo Oral Tablet | Robert Lafyatis | Biogen | Recruiting | 18 Years | 80 Years | All | 34 | Phase 1 | United States |
| 94 | NCT03053739 | December 2016 | 16 December 2017 | To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis | Randomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic Sclerosis | Associated Pulmonary Arterial Hypertension | Drug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and Placebo | Postgraduate Institute of Medical Education and Research | Recruiting | 18 Years | N/A | All | 50 | Phase 4 | India | |
| 95 | EUCTR2016-003495-53-NL | 29/11/2016 | 9 January 2017 | Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defect | Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease - SELECT trial | Pulmonary arterial hypertension related to congenital heart disease.;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Selexipag Product Name: Selexipag Pharmaceutical Form: Film-coated tablet | Academic Medical Center - Cardiology | Authorised | Female: yes Male: yes | Phase 3 | Netherlands | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | NCT02657356 | October 4, 2016 | 7 October 2019 | Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYST | A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Drug: Placebo capsules;Drug: Bardoxolone methyl capsules | Reata Pharmaceuticals, Inc. | Recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;Czechia;Germany;Israel;Japan;Mexico;Netherlands;Philippines;Spain;United Kingdom;Czech Republic | |
| 97 | NCT02826252 | September 15, 2016 | 16 December 2017 | Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20) | VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 µg/mL (V10) to 20 µg/mL (V20) | Hypertension, Pulmonary | Drug: Iloprost,(Ventavis, BAYQ6256);Device: I-Neb AAD system | Bayer | Not recruiting | 18 Years | N/A | All | 64 | N/A | Germany | |
| 98 | JPRN-UMIN000025158 | 2016/09/01 | 7 October 2019 | A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension - A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Drug: Bardoxolone Methyl Bardoxolone methyl dose escalated to a maximum of 10 mg. Dosing period is up to 6 months. Drug: Placebo Oral Capsule Capsule containing an inert placebo is administrated up to 6 months. | Reata Pharmaceuticals, Inc. | Recruiting | 18years-old | 75years-old | Male and Female | 20 | Phase 3 | Japan,North America,South America,Australia,Europe | |
| 99 | NCT02825160 | August 1, 2016 | 4 November 2019 | Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH) | Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Ventavis (Iloprost, BAYQ6256) | Bayer | Recruiting | N/A | N/A | All | 270 | Phase 2 | Japan | |
| 100 | EUCTR2015-005223-90-GB | 12/07/2016 | 4 September 2017 | This is a multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy, tolerability and safety of pulsed inhaled nitric oxide 75mcg/kg IBW/hr, 12 hours per day or longer for 18 weeks in symptomatic subjects with pulmonary arterial hypertension. (Part 1), followed by an open-label extension (Part 2) which provides active therapy to all subjects completing the first 18 weeks. | A PHASE 3, PLACEBO CONTROLLED, DOUBLE-BLIND, RANDOMIZED, CLINICAL STUDY TO DETERMINE EFFICACY, SAFETY AND TOLERABILITY OF PULSED, INHALED NITRIC OXIDE (iNO) VERSUS PLACEBO IN SYMPTOMATIC SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH): INOvation-1 (Part 1 and Part 2) | Pulmonary Arterial Hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: inhaled nitric oxide & INOpulse delivery Product Code: iNO Pharmaceutical Form: Medicinal gas, compressed INN or Proposed INN: NITRIC OXIDE CAS Number: 10102-43-9 Other descriptive name: inhaled NO with pulsed delivery Concentration unit: PPM part per million Concentration type: equal Concentration number: 4880- Pharmaceutical form of the placebo: Medicinal gas, compressed Route of administration of the placebo: Inhalation use | Bellerophon Pulse Technologies LLC | Authorised | Female: yes Male: yes | 188 | Phase 3 | Serbia;Portugal;United States;Spain;Ukraine;Austria;Israel;Colombia;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Croatia;Australia;Netherlands;Germany;Korea, Republic of | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | NCT02782052 | July 2016 | 22 January 2018 | Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial Hypertension | Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Nebulized Placebo;Drug: Nebulized combination ipratropium bromide with salbutamol;Drug: Nebulized ipratropium bromide | Assistance Publique - Hôpitaux de Paris | Not recruiting | 18 Years | N/A | All | 18 | Phase 3 | ||
| 102 | NCT02899533 | July 2016 | 4 March 2019 | [18F]FES PET/CT in PAH | [18F]Fluoroestradiol (FES) PET/CT Imaging To Evaluate In Vivo ER In Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: [18F] FES | University of Pennsylvania | Not recruiting | 18 Years | N/A | Female | 5 | Phase 1 | United States | |
| 103 | NCT02759419 | June 16, 2016 | 4 November 2019 | A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension. | An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial. | Hypertension, Pulmonary | Drug: Adempas (Riociguat, BAY63-2521) | Bayer | Recruiting | 18 Years | N/A | All | 25 | Phase 4 | France;Italy;Korea, Republic of;Poland;Thailand | |
| 104 | NCT02885012 | June 2016 | 23 April 2019 | Crossover Study From Macitentan or Bosentan Over to Ambrisentan | A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Ambrisentan | Medical University of South Carolina | Ochsner Health System | Not recruiting | 18 Years | 80 Years | All | 3 | Phase 4 | United States |
| 105 | NCT02558231 | May 1, 2016 | 16 September 2019 | The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension | The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study | Pulmonary Arterial Hypertension | Drug: Macitentan;Drug: Tadalafil;Drug: Selexipag | Actelion | Not recruiting | 18 Years | 75 Years | All | 247 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Norway | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | NCT02705807 | May 2016 | 16 December 2017 | Evaluation of a New Thermostable Formulation of FLOLAN in Japanese Subjects | An Open Label, Single-arm Study Evaluating a New Thermostable Formulation of FLOLAN™ in Japanese Subjects With Pulmonary Arterial Hypertension (PAH) | Cardiovascular Disease | Drug: FLOLAN injection with currently marketed diluent;Drug: FLOLAN injection with reformulated diluent | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | All | 10 | Phase 4 | Japan | |
| 107 | NCT03809156 | April 26, 2016 | 28 January 2019 | Upfront Combination Pulmonary Arterial Hypertension Therapy | Upfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot Study | Pulmonary Hypertension | Drug: Riociguat Oral Product | University of Calgary | Bayer | Recruiting | 18 Years | N/A | All | 20 | Phase 4 | Canada |
| 108 | NCT02664558 | April 2016 | 26 November 2018 | A Study of Ubenimex in Patients With Pulmonary Arterial Hypertension (WHO Group 1) | A Phase 2, Randomized, Double-BLInd, Placebo- Controlled Study of UBEnimex in Patients With Pulmonary ARTerial HYpertension (WHO Group 1) (LIBERTY) | Pulmonary Arterial Hypertension | Drug: ubenimex;Other: placebo | Eiger BioPharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 61 | Phase 2 | United States;Canada | |
| 109 | NCT02725372 | April 2016 | 26 August 2019 | Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAH | A Phase 3, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Efficacy, Safety, and Tolerability of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo in Symptomatic Subjects With PAH (Part 1 and Part 2) | Pulmonary Arterial Hypertension | Drug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr;Drug: Placebo | Bellerophon Pulse Technologies | Worldwide Clinical Trials | Not recruiting | 18 Years | 85 Years | All | 162 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czechia;France;Germany;Israel;Italy;Netherlands;Portugal;Serbia;Spain;Ukraine;United Kingdom |
| 110 | NCT02734953 | April 2016 | 16 December 2017 | Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH | Effects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Nitric Oxide | Allegheny Singer Research Institute | Not recruiting | 18 Years | 80 Years | All | 10 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | NCT03057028 | April 2016 | 15 April 2019 | Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension | Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Anakinra | Virginia Commonwealth University | Not recruiting | 18 Years | N/A | All | 7 | Phase 1 | United States | |
| 112 | EUCTR2015-003438-28-DE | 04/03/2016 | 30 April 2019 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Selexipag Current Sponsor code: ACT-293987 Other descriptive name: SELEXIPAG Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Macitentan Current Sponsor code: ACT-064992 Other descriptive name: MACITENTAN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trade Name: Adcirca Product Name: Adcirca Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Actelion Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden | |||
| 113 | NCT02652429 | March 2016 | 16 December 2017 | Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH | An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAH | Pulmonary Arterial Hypertension | Drug: Inhaled Nitric Oxide | Bellerophon Pulse Technologies | Not recruiting | N/A | N/A | All | 22 | Phase 3 | United States;Canada | |
| 114 | NCT02507011 | January 31, 2016 | 22 July 2019 | Beta-blockers in Pulmonary Arterial Hypertension | Beta-blockers in Pulmonary Arterial Hypertension - A Phase 2 Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy, and Safety of Carvedilol for Right Ventricular Dysfunction in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Carvedilol;Drug: Placebo | University of Minnesota - Clinical and Translational Science Institute | Recruiting | 18 Years | N/A | All | 26 | Phase 2 | United States | |
| 115 | EUCTR2015-002835-17-DE | 18/01/2016 | 8 January 2018 | RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatment | Investigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions - RIGHT HEART III | Pulmonary arterial Hypertension (PAH) MedDRA version: 20.0 Level: LLT Classification code 10037403 Term: Pulmonary hypertension NOS System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10077729 Term: Pulmonary arterial hypertension WHO functional class III System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0 Level: LLT Classification code 10077740 Term: Pulmonary arterial hypertension WHO functional class II System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Adempas® Pharmaceutical Form: Film-coated tablet INN or Proposed INN: RIOCIGUAT CAS Number: 625115-55-1 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 7,5- Trade Name: Opsumit® Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | Justus Liebig Universität Gießen | Authorised | Female: yes Male: yes | 30 | Phase 2 | Germany | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 116 | NCT02676947 | January 2016 | 11 June 2018 | A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension | A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Tocilizumab | Papworth Hospital NHS Foundation Trust | Roche Pharma AG;National Institute for Health Research, United Kingdom | Not recruiting | 18 Years | 70 Years | All | 29 | Phase 2 | United Kingdom |
| 117 | EUCTR2012-004411-31-GB | 25/11/2015 | 28 February 2019 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 20.0 Level: LLT Classification code 10058554 Term: Eisenmenger's syndrome System Organ Class: 100000164933 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: macitentan CAS Number: 441798-33-0 Other descriptive name: MACITENTAN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | Actelion Pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany | |||
| 118 | NCT02551653 | November 17, 2015 | 27 August 2018 | Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients | A Microdose Study to Evaluate the Biodistribution of [11C]-GSK2256098 in the Lungs and Heart of Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) Patients Using Positron Emission Tomography (PET) | Hypertension, Pulmonary | Drug: [11C]-GSK2256098 500 MBq | GlaxoSmithKline | Not recruiting | 40 Years | 70 Years | All | 10 | Phase 1 | United Kingdom | |
| 119 | NCT02471183 | November 4, 2015 | 16 December 2017 | Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial Hypertension | Multicenter, Open-label, Single-group Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Adult Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Selexipag | Actelion | Not recruiting | 18 Years | 75 Years | All | 30 | Phase 3 | United States | |
| 120 | NCT02746237 | November 2015 | 12 September 2016 | Single and Multiple Ascending Doses Clinical Pharmacology Study With KAR5585 | A Randomized, Double-blind, Placebo-controlled, Phase 1, First-in-human, Single-center, Safety, Tolerability, Ventricular Repolarization and Pharmacokinetic Study of Single and Multiple Ascending Doses of KAR5585 in Healthy Subjects | Pulmonary Arterial Hypertension | Drug: KAR5585 Capsules;Drug: Placebo Capsules | Karos Pharmaceuticals | Not recruiting | 18 Years | 65 Years | Both | 120 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 121 | EUCTR2015-002799-26-GB | 27/10/2015 | 28 November 2016 | A therapeutic trial of blockade of interleukin-6 using the drug Tocilizumab in pulmonary arterial hypertension | TRANSFORM-UK: A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension - An open label study of Tocilizumab in PAH | Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: RoActemra Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Tocilizumab CAS Number: 375823-41-9 Current Sponsor code: n/a Other descriptive name: n/a Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | Papworth Hospital NHS Foundation Trust | Authorised | Female: yes Male: yes | 26 | Phase 2 | United Kingdom | |||
| 122 | EUCTR2015-000709-38-AT | 20/10/2015 | 5 September 2016 | Effects of the drug Benzbromaron on the pulmonary vessels | Acute Effects of Benzbromaron on the pulmonary circulation | Pulmonary arterial hypertension MedDRA version: 18.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Benzbromaron AL Product Name: Benzbromaron Pharmaceutical Form: Film-coated tablet INN or Proposed INN: BENZBROMARONE CAS Number: 3562-84-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Medical University of Graz | Not Recruiting | Female: yes Male: yes | Phase 2 | Austria | ||||
| 123 | NCT02576002 | October 2015 | 14 March 2016 | Epidemiology and Treatment Patterns of Paediatric PAH (Pulmonary Arterial Hypertension) | Study to Estimate the Incidence and Prevalence and Treatment Patterns of Pediatric Pulmonary Hypertension in the US | Hypertension, Pulmonary | Drug: Assigned pulmonary hypertension medication | Bayer | Not recruiting | N/A | 18 Years | Both | 2691 | N/A | United States | |
| 124 | NCT02790450 | October 2015 | 9 January 2017 | Acute Effects of Benzbromaron on the Pulmonary Circulation | Acute Effects of Benzbromaron on the Pulmonary Circulation | Idiopathic Pulmonary Arterial Hypertension | Drug: Benzbromarone | Medical University of Graz | Ludwig Boltzmann Institute for Lung Vascular Research | Not recruiting | 18 Years | 90 Years | Both | 10 | Phase 2 | Austria |
| 125 | NCT02545465 | September 15, 2015 | 16 December 2017 | A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice | Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | Not recruiting | N/A | N/A | All | 125 | N/A | Belgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 126 | NCT02968901 | September 1, 2015 | 22 October 2019 | Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA) | Prospective, Multicenter, Open-label Study Evaluating the Effects of First-line Oral Combination Therapy of Macitentan and Tadalafil in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (OPTIMA). | Pulmonary Arterial Hypertension | Drug: macitentan;Drug: tadalafil | Actelion | Not recruiting | 18 Years | 75 Years | All | 46 | Phase 4 | France | |
| 127 | NCT02253394 | September 2015 | 28 January 2019 | The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study | The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study) | Pulmonary Arterial Hypertension | Drug: Ambrisentan plus Spironolactone;Drug: Ambrisentan plus Placebo | Brigham and Women's Hospital | Gilead Sciences | Not recruiting | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 128 | EUCTR2014-003952-29-HU | 25/08/2015 | 8 May 2017 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Hypertension, Pulmonary ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.0- Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 Pharmaceutical Form: Granules for oral solution INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 0.3- | Bayer AG | Authorised | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan | |||
| 129 | NCT02279745 | July 2015 | 26 August 2019 | Long Term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension | An Open-Label Extension Study of Ralinepag in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Ralinepag | United Therapeutics | Not recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Slovakia;Spain | |
| 130 | NCT02428985 | June 29, 2015 | 22 October 2019 | Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH) | Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Riociguat (ADEMPAS, BAY63-2521) | Bayer | Recruiting | N/A | N/A | All | 600 | Phase 1/Phase 2 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 131 | NCT02310672 | June 1, 2015 | 14 October 2019 | REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension | A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | Not recruiting | 18 Years | 64 Years | All | 89 | Phase 4 | United States;Australia;France;Germany;Hong Kong;Israel;Italy;Malaysia;Netherlands;Russian Federation;Singapore;United Kingdom | |
| 132 | NCT02436512 | June 2015 | 14 September 2015 | Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide | A Phase 3 Open-label Multi-Center, Two-Part Single-arm Study to Evaluate the Acute Vasodilation Response of Inhaled Nitric Oxide as a Predictor of Successful Wean From Parental Prostacyclins in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Inhaled Nitric Oxide | Geno LLC | Not recruiting | 18 Years | 70 Years | Both | 0 | Phase 3 | United States | |
| 133 | EUCTR2014-004066-20-GB | 14/05/2015 | 28 February 2019 | A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs. | A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right ventricular remodeling in pulmonary arterIal hypertension | Pulmonary Arterial Hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | Actelion Pharmaceuticals Ltd. | Authorised | Female: yes Male: yes | 100 | Phase 4 | France;United States;Hong Kong;Malaysia;Singapore;Australia;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom | |||
| 134 | EUCTR2014-000667-40-CZ | 23/04/2015 | 28 February 2019 | A study to investigate the safety of APD811 (study drug) and to determine the most effective dose of APD811 in patients with pulmonary arterial hypertension. | A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension MedDRA version: 18.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: APD811 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Other descriptive name: AR392830 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.01- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: APD811 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Other descriptive name: AR392830 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.02- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: APD811 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Other descriptive name: AR392830 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.03- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: APD811 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ralinepag CAS Number: 1187856-49-0 Current Sponsor code: APD811 Other descriptive name: AR392830 Concentration unit: mg milligram(s) Concentration type: equal | Arena Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria | |||
| 135 | NCT03195543 | March 12, 2015 | 1 April 2019 | Assessment of Blood Coagulation Disorders in Patients With Pulmonary Hypertension | Assessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension. | Pulmonary Artery Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Diagnostic Test: Platelet function analyzer-100;Diagnostic Test: Light transmission aggregometry;Diagnostic Test: Rotational thromboelastometry;Diagnostic Test: Endogenous thrombin potential | National and Kapodistrian University of Athens | Recruiting | 18 Years | N/A | All | 60 | N/A | Greece | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 136 | ChiCTR-OON-17013521 | 2015-02-01 | 27 November 2017 | Transition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective study | Transition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective study | pulmonary arterial hypertension | ambrisentan group:oral ambrisentan;bosentan group:oral bosentan; | Shanghai Pulmonary Hospital | Not Recruiting | Male | ambrisentan group:12;bosentan group:8; | Other | China | |||
| 137 | JPRN-JapicCTI-142722 | 01/1/2015 | 23 April 2019 | ACT-385781A extension study for PAH pediatric patients | Open-label, long-term, efficacy, safety, and tolerability extension study using ACT-385781A in the treatment of Japanese children with pulmonary arterial hypertension who completed the AC-066A308 study. | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : epoprostenol Dosage And administration of the intervention : continuous intravenous infusion | Actelion Pharmaceuticals Japan Ltd. | 14 | BOTH | 3 | Phase 3 | ||||
| 138 | NCT02309463 | January 2015 | 11 April 2016 | Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance & 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension | A Prospective Multicenter Study to Assess the Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance and 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension Newly Initiating Endothelin Receptor Antagonist Therapy | Pulmonary Arterial Hypertension | Drug: Endothelin receptor antagonist therapy | Actelion | Not recruiting | 18 Years | N/A | Both | 0 | N/A | ||
| 139 | NCT02276872 | December 2014 | 16 December 2017 | Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years | A Multicenter, Open-Label, 24-Week, Uncontrolled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil Extended Release Tablets Following Transition From Remodulin or Inhaled Prostacyclin Therapy or as Add-on to Current PAH Therapy in De Novo Prostacyclin Pediatric Subjects Aged 7 to 17 Years With Pulmonary Arterial Hypertension | PAH | Drug: oral treprostinil | United Therapeutics | Not recruiting | 7 Years | 17 Years | All | 40 | Phase 2 | United States | |
| 140 | NCT02279160 | December 2014 | 18 December 2018 | Safety and Efficacy of APD811 in Pulmonary Arterial Hypertension | A Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: APD811;Drug: Placebo | Arena Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Spain;Czech Republic | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 141 | NCT02290613 | December 2014 | 16 December 2017 | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated With Systemic Sclerosis (SSc-APAH) A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial EDITA | Systemic Sclerosis;Pulmonary Hypertension | Drug: Ambrisentan;Drug: Placebo | Heidelberg University | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 38 | Phase 2 | Germany |
| 142 | NCT02284737 | November 28, 2014 | 20 May 2019 | A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAH | A Prospective, Multi-center, Randomized Control Trial to Investigate the Efficacy of Pulmonary Artery Denervation to Improved Functional Capacity and Hemodynamics in Patients With Pulmonary Artery Hypertension | Pulmonary Arterial Hypertension | Procedure: PADN;Procedure: sham PADN;Drug: Sildenafil | Nanjing First Hospital, Nanjing Medical University | Recruiting | 18 Years | N/A | All | 270 | Phase 4 | China | |
| 143 | NCT02234141 | November 2014 | 9 January 2017 | Selonsertib in Adults With Pulmonary Arterial Hypertension | A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Selonsertib;Drug: Placebo | Gilead Sciences | Not recruiting | 18 Years | 75 Years | Both | 151 | Phase 2 | United States;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom | |
| 144 | EUCTR2014-001882-28-DE | 13/10/2014 | 8 January 2018 | Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertension | Early Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITA | Systemic sclerosis-patients (SSc) with borderline pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Volibris Product Name: Ambrisentan Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Thoraxklinik-Heidelberg gGmbH | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | Germany | |||
| 145 | NCT02191137 | September 23, 2014 | 16 December 2017 | Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION) | A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | Not recruiting | 18 Years | 80 Years | All | 75 | Phase 4 | United States;Puerto Rico | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 146 | NCT02060487 | September 22, 2014 | 4 November 2019 | Effects of Oral Sildenafil on Mortality in Adults With PAH | A MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) | Pulmonary Arterial Hypertension | Drug: sildenafil citrate | Pfizer | Recruiting | 18 Years | 74 Years | All | 429 | Phase 4 | United States;Australia;Belgium;Bosnia and Herzegovina;Croatia;Czechia;Germany;Greece;Hong Kong;Israel;Latvia;Malaysia;Mexico;Poland;Romania;Russian Federation;Serbia;Singapore;South Africa;Spain;Thailand;Turkey;Ukraine;Austria;Czech Republic;Netherlands;Portugal | |
| 147 | JPRN-UMIN000016320 | 2014/09/18 | 2 April 2019 | Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue disease | Pulmonary arterial hypertension associated with connective tissue disease | Weekly rituximab (375mg/m2) infusion for 4 weeks | The University of Tokyo Hospital | Not Recruiting | 20years-old | 80years-old | Male and Female | 6 | Not selected | Japan | ||
| 148 | EUCTR2014-000091-25-GB | 01/09/2014 | 23 March 2015 | A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome | A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome - Iloprost in patients with Eisenmenger Syndrome | Pulmonary Arterial Hypertension Eisenmenger syndrome MedDRA version: 17.0 Level: LLT Classification code 10037405 Term: Pulmonary hypertension primary System Organ Class: 100000004855 MedDRA version: 17.0 Level: LLT Classification code 10037406 Term: Pulmonary hypertension secondary System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Iloprost Product Name: Ventavis Pharmaceutical Form: Inhalation solution INN or Proposed INN: Iloprost Concentration unit: µg/ml microgram(s)/millilitre Concentration type: up to Concentration number: 5-10 Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use | Royal Brompton and Harefield NHS Foundation Trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 149 | JPRN-JapicCTI-142721 | 01/9/2014 | 2 April 2019 | ACT-385781A for PAH pediatric patients | Prospectiove, single-arm, Open-label, multi-center study to assess the efficacy, safety, and tolerability of ACT-385781A in Japanese children with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : epoprostenol Dosage And administration of the intervention : continuous intravenous infusion Control intervention name : null | Actelion Pharmaceuticals Japan Ltd. | 14 | BOTH | 3 | Phase 3 | ||||
| 150 | ChiCTR-TRC-14004894 | 2014-07-01 | 18 April 2017 | Clinical research on treatment of pulmonary arterial hypertension associated with connective tissue disease by Mycophenolate mofetil | Clinical research on treatment of pulmonary arterial hypertension associated with connective tissue | pulmonary arterial hypertension associated with connective tissue disease | A:Glucocorticoid plus sildenafil;B:Glucocorticoid plus sildenafil; | Beijing Chaoyang Hospital affiliated to Capital Medical University | Recruiting | 18 | 80 | Male | A:8;B:8; | Other | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 151 | NCT02112487 | June 23, 2014 | 30 September 2019 | Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH | An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™ | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | Not recruiting | 18 Years | 80 Years | All | 88 | Phase 3 | France;Italy;Spain | |
| 152 | NCT02108743 | June 2014 | 18 January 2016 | Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension | Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension. | Drug: Albuterol.;Drug: Normal saline placebo | American Medical Association Foundation | Not recruiting | 18 Years | 75 Years | Both | 0 | Phase 2 | United States | |
| 153 | NCT02763735 | June 2014 | 29 July 2019 | Right Ventricular Metabolism in Pulmonary Arterial Hypertension | Metabolic Intervention in the Right Ventricle in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Healthy | Drug: 11C acetate | Vanderbilt University | Not recruiting | 18 Years | N/A | All | 34 | N/A | United States | |
| 154 | NCT02036970 | May 2014 | 14 January 2019 | Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIAT | A Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension;Interstitial Lung Disease;Idiopathic Interstitial Pneumonia;Idiopathic Pulmonary Fibrosis;Sarcoidosis;Respiratory Bronchiolitis Associated Interstitial Lung Disease;Desquamative Interstitial Pneumonia;Cryptogenic Organizing Pneumonia;Acute Interstitial Pneumonitis;Idiopathic Lymphoid Interstitial Pneumonia;Idiopathic Pleuroparenchymal Fibroelastosis | Drug: Bardoxolone methyl;Drug: Placebo | Reata Pharmaceuticals, Inc. | Not recruiting | 18 Years | 75 Years | All | 166 | Phase 2 | United Kingdom;Spain;United States;Germany | |
| 155 | NCT02120339 | May 2014 | 22 July 2019 | Carvedilol PAH A Pilot Study of Efficacy and Safety | Beta Blockers in Pulmonary Arterial Hypertension (PAH) A Pilot Study of Efficacy and Safety | Pulmonary Hypertension;Cardiac MRI <40 | Drug: Carvedilol | University of Minnesota - Clinical and Translational Science Institute | Not recruiting | 18 Years | 99 Years | All | 5 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 156 | NCT02126943 | April 30, 2014 | 4 November 2019 | OPsumit USers Registry | US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice | Pulmonary Arterial Hypertension | Drug: Opsumit (macitentan) | Actelion | Recruiting | N/A | N/A | All | 5000 | Phase 2/Phase 3 | United States;Puerto Rico | |
| 157 | NCT02304198 | April 2014 | 25 April 2016 | Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAH | A Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) | Pulmonary Arterial Hypertension | Drug: Udenafil | Dong-A ST Co., Ltd. | Not recruiting | 18 Years | N/A | Both | 59 | Phase 2/Phase 3 | Korea, Republic of | |
| 158 | NCT02032836 | March 10, 2014 | 1 October 2018 | Comparative PK PD Study in PAH Patients (Fox vs. I-Neb) | A Multi-center, Open-label, Randomized Cross-over Study to Compare the Acute Tolerability and Pharmacokinetics of BAYQ6256 (Iloprost; Ventavis) Inhalation Using the I-Neb Nebulizer and the FOX Nebulizer in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: lloprost(Ventavis,BAYQ6252, 20 µg/mL);Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL) | Bayer | Not recruiting | 18 Years | N/A | All | 27 | Phase 1/Phase 2 | Germany;Austria | |
| 159 | NCT02081690 | March 2014 | 14 March 2016 | A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain | A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™ | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | Not recruiting | 18 Years | 80 Years | Both | 160 | Phase 3 | France;Italy;Spain | |
| 160 | EUCTR2013-003462-14-ES | 20/02/2014 | 12 October 2015 | Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT. | A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT? - ORCHESTRA | Pulmonary arterial hypertension Hipertensión arterial pulmonar MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | ACTELION Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 160 | Phase 3b | Spain | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 161 | EUCTR2013-003489-15-ES | 20/02/2014 | 15 October 2018 | An extension of the ORCHESTRA (AC-055-310) study Extension del estudio ORCHESTRA (AC-055-310) | An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext. | Pulmonary arterial hypertension MedDRA version: 16.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | ACTELION Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Italy | |||
| 162 | NCT01824290 | February 5, 2014 | 23 April 2019 | A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH) | A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Tadalafil;Drug: Placebo | Eli Lilly and Company | Not recruiting | 6 Months | 18 Years | All | 34 | Phase 3 | United States;Austria;Belgium;Brazil;France;Germany;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Turkey;Canada;Romania;Switzerland | |
| 163 | NCT01897740 | January 24, 2014 | 15 April 2019 | Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With Sildenafil | A LOCAL, SINGLE-CENTRE, EXTENSION, OPEN LABEL ACCESS STUDY, TO PROVIDE SILDENAFIL THERAPY FOR SUBJECTS WHO COMPLETED A1481156 STUDY AND ARE JUDGED BY THE INVESTIGATOR TO DERIVE CLINICAL BENEFIT FROM CONTINUED TREATMENT WITH SILDENAFIL, PRIOR TO REIMBURSEMENT AND AVAILABILITY FOR SUBJECTS IN RUSSIAN FEDERATION | Pulmonary Arterial Hypertension | Drug: sildenafil | Pfizer | Not recruiting | 10 Years | 30 Years | All | Phase 1/Phase 2 | Russian Federation | ||
| 164 | NCT02042014 | January 22, 2014 | 15 July 2019 | Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan | An Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in Japan and Are Judged by the Investigator to Benefit From Continued QTI571 Treatment | Severe Pulmonary Arterial Hypertension | Drug: QTI571 | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 8 | Phase 3 | Japan | |
| 165 | NCT01712620 | January 10, 2014 | 24 June 2019 | Spironolactone for Pulmonary Arterial Hypertension | A Pilot Study of the Effect of Spironolactone Therapy on Exercise Capacity and Endothelial Dysfunction in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Spironolactone;Drug: Placebo | National Institutes of Health Clinical Center (CC) | National Heart, Lung, and Blood Institute (NHLBI);National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);University of Pennsylvania;University of Maryland;Washington Hospital Center;New England Medical Center, Tufts University School of Medicine | Recruiting | 18 Years | 99 Years | All | 70 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 166 | EUCTR2011-002707-16-ES | 09/01/2014 | 27 January 2014 | sildenafil in the postoperative period of cardiac surgery in children. | SILDENAFIL IN THE POST-CARDIAC SURGERY IN CHILDREN: IVORY STUDY - IVORY | Postoperative pulmonary artery hypertension MedDRA version: 16.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension System Organ Class: 100000004855 ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Trade Name: revatio oral Pharmaceutical Form: Tablet INN or Proposed INN: SILDENAFIL CITRATE CAS Number: 171599-83-0 Other descriptive name: SILDENAFIL CITRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Trade Name: Revatio inyectable Pharmaceutical Form: Solution for injection INN or Proposed INN: SILDENAFIL CITRATE CAS Number: 171599-83-0 Other descriptive name: SILDENAFIL CITRATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.8- | Fundacion para la investigación Biomédica del hospital Gregorio Marañón | Authorised | Female: yes Male: yes | Spain | |||||
| 167 | EUCTR2013-002783-12-DE | 07/01/2014 | 20 August 2018 | No | A multi-center, open-label, randomized cross-over study to compare the acute tolerability and pharmacokinetics of BAY Q 6256 (iloprost; Ventavis) inhalation using the I-Neb nebulizer and the FOX nebulizer in patients with pulmonary arterial hypertension - Administration von Iloprost aerosol comparing two nebulizers: Fox and I-Neb | Patients with Pulmonary arterial hypertension, WHO class III, who have been on therpay with Ventavis 10 for at least 4 weeks MedDRA version: 16.1 Level: LLT Classification code 10036727 Term: Primary pulmonary hypertension System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Ventavis 10 Product Name: Ventavis 10 Product Code: Bay Q 6256 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: ILOPROST CAS Number: 78919-13-8 Current Sponsor code: Bay q 6256 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 10- Trade Name: Ilomedin 20 [20 µg / ml] Product Name: Ilomedin 20 Product Code: Bay q 6256 Pharmaceutical Form: Concentrate for solution for injection/infusion INN or Proposed INN: ILOPROST CAS Number: 78919-13-8 Current Sponsor code: Bay q 6256 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 20- | Bayer HealthCare AG | Not Recruiting | Female: yes Male: yes | 24 | Phase 1;Phase 2 | Austria;Germany | |||
| 168 | EUCTR2013-001759-10-DE | 03/01/2014 | 2 October 2017 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 Pharmaceutical Form: Tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 Pharmaceutical Form: Tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 Pharmaceutical Form: Tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 Pharmaceutical Form: Tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.0- Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 Pharmaceutical Form: Tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- | Bayer AG | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland | |||
| 169 | JPRN-JapicCTI-142462 | 01/1/2014 | 23 April 2019 | An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in the extension study (A2301E1) in Japan and are judged by the investigator to benefit from continued QTI571 treatment | An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in the extension study (A2301E1) in Japan and are judged by the investigator to benefit from continued QTI571 treatment | pulmonary arterial hypertension | Intervention name : QTI571 INN of the intervention : imatinib Dosage And administration of the intervention : QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day | Novartis Pharma K.K. | BOTH | Phase 3 | ||||||
| 170 | EUCTR2013-003462-14-IT | 10/12/2013 | 5 March 2018 | Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT. | A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA | Pulmonary arterial hypertension MedDRA version: 16.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | ACTELION Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Italy | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 171 | EUCTR2013-003489-15-IT | 10/12/2013 | 5 March 2018 | An extension of the ORCHESTRA (AC-055-310) study | An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext. | Pulmonary arterial hypertension MedDRA version: 16.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | ACTELION Pharmaceuticals Ltd. | Authorised | Female: yes Male: yes | 160 | Phase 3 | Spain;Italy | |||
| 172 | NCT02023450 | December 2013 | 19 February 2015 | Testing of HIV Protease Inhibitors to Suppress Inflammation and Improve Cardio Pulmonary Hemodynamics in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: saquinavir and ritonavir | The Third Xiangya Hospital of Central South University | Xiangya Hospital of Central South University | Recruiting | 18 Years | 60 Years | Both | 20 | Phase 0 | China | |
| 173 | EUCTR2013-001100-10-ES | 12/11/2013 | 9 December 2013 | This study is to allow continued access to QTI571 for patients who received QTI571 for pulmonary arterial hypertension in one of the long-term extension studies (A2301E1, A2102E1 and E2203) and have been judged by the investigator to benefit from continued QTI571 treatment. | An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment | Pulmonary Arterial Hypertension MedDRA version: 16.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: GLIVEC 100 mg comprimidos recubiertos con película Product Name: Imatinib mesilate Product Code: QTI571 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IMATINIB MESILATE CAS Number: 220127-57-1 Current Sponsor code: QTI571 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Novartis Farmacéutica, S.A. | Not Recruiting | Female: yes Male: yes | 81 | United States;Spain;Australia;Switzerland | ||||
| 174 | NCT01926509 | November 2013 | 2 May 2016 | Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-005) | A 28-Day Multiple-Dose Titration Study to Assess the Effects of MK-8892 on Safety, Tolerability and Pharmacokinetics in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: MK-8892;Drug: Placebo for MK-8892 | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 70 Years | Both | 23 | Phase 1 | Bulgaria;Germany;Moldova, Republic of | |
| 175 | NCT01934647 | November 2013 | 1 February 2016 | Acute Dosing of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-003) | A Non-randomized, Single-Panel, Open-Label Trial to Study the Safety, Tolerability and Pharmacodynamics of MK-8892 Acute Dosing in Subjects With Moderate to Severe Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: MK-8892 | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 70 Years | Both | 20 | Phase 1 | Germany | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 176 | NCT01966302 | November 2013 | 15 July 2019 | Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH) | Compassionate Use of Beraprost Sodium 314d Modified Release (BPS-314d-MR) for Three Patients With Pulmonary Arterial Hypertension (PAH). | Pulmonary Arterial Hypertension | Drug: BPS-314d-MR | Los Angeles Biomedical Research Institute | Lung Biotechnology PBC | Not recruiting | 18 Years | 75 Years | All | 3 | Phase 2 | United States |
| 177 | NCT02000856 | November 2013 | 11 June 2018 | BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension | BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Dietary Supplement: Beetroot juice | Uppsala University | Karolinska Institutet | Not recruiting | 18 Years | N/A | All | 15 | N/A | Sweden |
| 178 | NCT03638908 | November 2013 | 27 August 2018 | Fluoxetine in Pulmonary Arterial Hypertension (PAH) Trial | A Phase 2, Open-label, Clinical Trial of Fluoxetine, a Selective Serotonin Reuptake Inhibitor, in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Fluoxetine | University of Texas Southwestern Medical Center | Not recruiting | 16 Years | 80 Years | All | 8 | Phase 2 | United States | |
| 179 | NCT01827059 | October 2013 | 16 December 2017 | Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasE | A Randomized Placebo Controlled Trial to Analyze Changes in Pulmonary Arterial Pressures at Peak Exercise in Congenital Heart Disease Patients With Exercise-induced Pulmonary Arterial Hypertension Before and After Treatment With Bosentan, Compared to Placebo | Pulmonary Arterial Hypertension;Congenital Heart Disease | Drug: Bosentan;Drug: Placebo | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Not recruiting | 18 Years | N/A | All | 12 | Phase 2 | Netherlands | |
| 180 | NCT01894035 | September 23, 2013 | 11 June 2018 | Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation | Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost. | Pulmonary Hypertension | Drug: Iloprost (Ventavis, BAYQ 6256) | Bayer | Not recruiting | 18 Years | N/A | All | 13 | N/A | Portugal | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 181 | NCT01781052 | September 11, 2013 | 16 December 2017 | Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients | DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients | Pulmonary Arterial Hypertension | Drug: Ventavis (Iloprost, BAYQ6256) | Bayer | Not recruiting | 18 Years | N/A | All | 17 | N/A | France | |
| 182 | NCT01739400 | September 10, 2013 | 27 August 2018 | Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome | Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome | Pulmonary Arterial Hypertension | Drug: Macitentan 10 mg tablet, once daily. | Actelion | Not recruiting | 12 Years | N/A | All | 217 | Phase 3 | United States;Austria;Bulgaria;Chile;China;France;Germany;Greece;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;United Kingdom;Vietnam;Belgium;Canada;Czech Republic;Hungary;India;Israel;Italy;Netherlands;South Africa;Taiwan;Turkey | |
| 183 | NCT01950585 | September 6, 2013 | 4 November 2019 | Hydroxyurea in Pulmonary Arterial Hypertension | Hydroxyurea in Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Hydroxyurea | National Heart, Lung, and Blood Institute (NHLBI) | The Cleveland Clinic | Not recruiting | 18 Years | 110 Years | All | 0 | Early Phase 1 | United States |
| 184 | NCT01847014 | September 2013 | 20 June 2016 | Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument | AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | Not recruiting | 18 Years | 80 Years | Both | 4 | Phase 3 | United States | |
| 185 | NCT01953965 | September 2013 | 8 August 2016 | Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. | 11C-acetate/18Fluorodeoxyglucose-FDG PET/Cardiac MRI in Pulmonary Hypertension | Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Drug: 11C-acetate;Drug: [18F]Fluoro-2-deoxy-2-D-glucose;Drug: MultiHance | Brigham and Women's Hospital | University of Pennsylvania;University of Maryland;Yale University | Not recruiting | 18 Years | 72 Years | Both | 4 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 186 | JPRN-JapicCTI-132155 | 01/8/2013 | 23 April 2019 | Bosentan extension study for PAH pediatric patients | Open-label, long-term, efficacy, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of Japanese children with pulmonary arterial hypertension who completed the previous study. | Pulmonary arterial hypertension (PAH) | Intervention name : Ro 47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d. | Actelion Pharmaceuticals Japan Ltd. | 14 | BOTH | 5 | Phase 3 | ||||
| 187 | NCT01934582 | August 2013 | 19 October 2017 | A Pharmacokinetic Substudy of the TDE-PH-304 Protocol | A Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 Protocol | Pulmonary Arterial Hypertension | Drug: UT-15C SR;Drug: treprostinil diethanolamine | United Therapeutics | Not recruiting | 12 Years | 75 Years | All | 13 | Phase 3 | United States | |
| 188 | NCT01880866 | July 2013 | 19 February 2015 | (-)-Epicatechin and Pulmonary Arterial Hypertension | An Open Label Pilot Study of Purified (-)-Epicatechin to Improve Hemodynamics in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: (-)-Epicatechin | University of California, San Francisco | Not recruiting | 18 Years | N/A | Both | 0 | Phase 1 | United States | |
| 189 | NCT01743001 | May 21, 2013 | 5 March 2018 | Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome | Pulmonary Arterial Hypertension | Drug: Macitentan 10 mg;Drug: Placebo | Actelion | Not recruiting | 12 Years | N/A | All | 226 | Phase 3 | United States;Austria;Bulgaria;Chile;China;France;Germany;Greece;Israel;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Turkey;United Kingdom;Vietnam;Belgium;Canada;Czech Republic;Hungary;India;Italy;Netherlands;South Africa;Taiwan | |
| 190 | JPRN-JapicCTI-132154 | 01/5/2013 | 2 April 2019 | Bosentan for PAH pediatric patients | Open-label, multicenter study to assess the efficacy, safety, tolerability, and pharmacokinetics of bosentan in Japanese children with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : Ro47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d. Control intervention name : null | Actelion Pharmaceuticals Japan Ltd. | 14 | BOTH | 5 | Phase 3 | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 191 | NCT01637675 | May 2013 | 19 February 2015 | Efficacy and Safety Study of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension | Clinical Study of Effects of Sodium Tanshinone IIA Sulfonate on Pulmonary Hypertension | Pulmonary Hypertension;Pulmonary Arterial Hypertension;Cardiovascular Diseases;Lung Diseases;Tanshinone IIA Sulfonate | Drug: 20 mg sildenafil citrate by mouth;Drug: sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth | The First Affiliated Hospital of Guangzhou Medical University | Jiangsu Carefree Pharmaceutical Co., LTD;The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School;Guangdong General Hospital;Sir run run shaw hospital Zhejiang University School of Medicine, Hangzhou, China;The First Affiliated Hospital of Zhengzhou University;Dongguan People's Hospital;Second Affiliated Hospital of Xi'an Jiaotong University;Beijing Chao Yang Hospital;Beijing Anzhen Hospital;Qingdao University | Recruiting | 15 Years | 70 Years | Both | 90 | Phase 2/Phase 3 | China |
| 192 | NCT01908699 | May 2013 | 13 May 2019 | Beraprost-314d Added-on to Tyvaso® (BEAT) | A Multicenter, Double-blind, Randomized, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of Oral BPS-314d-MR added-on to Treprostinil, Inhaled (Tyvaso®) in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium 314d Modified Release Tablets;Drug: Placebo | Lung Biotechnology PBC | Not recruiting | 18 Years | 80 Years | All | 240 | Phase 3 | United States;Israel | |
| 193 | NCT03236818 | May 2013 | 16 December 2017 | Goal Oriented Strategy to Preserve Ejection Fraction Trial | Raising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction Trial | Pulmonary Arterial Hypertension | Drug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan) | VU University Medical Center | Not recruiting | 18 Years | 80 Years | All | 30 | Phase 4 | Netherlands | |
| 194 | JPRN-JapicCTI-132142 | 01/4/2013 | 23 April 2019 | ACT-385781A PAH Post-marketing study | A Post-marketing, Open-label-study ACT-385781A in patients with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : Epoprostenol Dosage And administration of the intervention : A commercially available epoprostenol sodium preparation will be switched to the study drug at the same dose | Actelion Pharmaceuticals Japan Ltd. | 20 | BOTH | 5 | Phase 4 | ||||
| 195 | NCT01795950 | April 2013 | 23 February 2016 | Safety Study of PLX-PAD Cells to Treat Pulmonary Arterial Hypertension (PAH) | A Phase I Safety and Pharmacodynamic Study of Intravenous Infusion of PLX-PAD Cells in Patients With PAH | Pulmonary Arterial Hypertension | Drug: PLX-PAD | United Therapeutics | Not recruiting | 18 Years | 75 Years | Both | 6 | Phase 1 | Australia | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 196 | NCT01841762 | April 2013 | 20 June 2016 | Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | Not recruiting | 18 Years | N/A | Both | 284 | Phase 3 | United States | |
| 197 | NCT01864863 | April 2013 | 31 October 2016 | To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers | An Open-label, Randomized, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics of Traclear 62.5 mg 2 Tablets and HGP1206 125mg 1 Tablet in Healthy Male Volunteers | Pulmonary Arterial Hypertension | Drug: HGP1206;Drug: Traclear | Hanmi Pharmaceutical Company Limited | Not recruiting | 20 Years | 55 Years | Male | 28 | Phase 1 | Korea, Republic of | |
| 198 | EUCTR2011-002018-35-IT | 08/03/2013 | 19 October 2015 | SPHERIC-1OE: study of the duration of 12 months for the observation of the use of sildenafil for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease in patients enrolled in the previous study titled SPHERIC-1 | SPHERIC-1OE (Sildenafil and Pulmonary HypERtension In COPD – Open Extension) - A multicenter, longitudinal, 12 months open-label study, for the observation of the use of sildenafil in the treatment of patients with pulmonary hypertension associated to chronic obstructive lung disease enrolled in SPHERIC-1 study - SPHERIC-1 OPEN EXTENSION | Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease enrolled in the study SPHERIC-1 MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SILDENAFIL CITRATE CAS Number: 171599-83-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | ASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 199 | NCT01725269 | March 2013 | 19 February 2015 | Long-term Study of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension Who Completed AIR001-CS05 | A Phase 2, Multicenter, Open-Label Study to Evaluate the Intermediate/Long Term Safety and Efficacy of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: AIR001 | Aires Pharmaceuticals, Inc. | Not recruiting | 18 Years | 75 Years | Both | 17 | Phase 2 | United States;Australia;Hungary | |
| 200 | NCT01798849 | March 2013 | 24 August 2015 | A Rising Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics of MK-8892 (MK-8892-001) | A Single Rising Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8892 | Pulmonary Arterial Hypertension | Drug: MK-8892;Drug: Placebo for MK-8892 | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 60 Years | Male | 24 | Phase 1 | Belgium | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 201 | EUCTR2012-003335-33-GB | 27/02/2013 | 30 April 2019 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 18.1 Level: LLT Classification code 10058554 Term: Eisenmenger's syndrome System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: macitentan CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany | |||
| 202 | EUCTR2012-004411-31-IT | 01/02/2013 | 31 January 2017 | Long-term study to evaluate if macitentan is safe, tolerable and efficient to be used for treatment of Eisenmenger Syndrome. | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome. - MAESTRO-OL | Eisenmenger Syndrome MedDRA version: 14.1 Level: PT Classification code 10058554 Term: Eisenmenger's syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Macitentan Product Code: ACT-064992 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Macitentan CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Other descriptive name: Macitentan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | ACTELION PHARMACEUTICALS LTD. | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Austria;Russian Federation;Chile;Israel;Italy;Vietnam;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Romania;Bulgaria;South Africa;Germany;China | |||
| 203 | NCT01847352 | February 2013 | 17 May 2016 | Iron Status and Hypoxic Pulmonary Vascular Responses | Effect of Endogenous Iron Status on Hypoxic Pulmonary Vascular Responses and Their Attenuation by Intravenous Iron | Lung Hypoxia;Pulmonary Arterial Hypertension;Iron Deficiency | Drug: Intravenous administration of ferric carboxymaltose;Other: Subacute hypoxic exposures | University of Oxford | National Institute for Health Research, United Kingdom;British Heart Foundation | Not recruiting | 18 Years | N/A | Both | 31 | N/A | United Kingdom |
| 204 | EUCTR2012-000153-31-HU | 22/01/2013 | 10 March 2014 | A Phase 2, Multi-Center, unblinded study to evaluate the intermediate/long term safety and effectiveness of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | A Phase 2, Multi-Center, Open-Label study to evaluate the intermediate/long term safety and efficacy of AIR001 in subjects with WHO Group I Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AIR001 Inhalation Solution Product Code: AIR001 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: sodium nitrite CAS Number: 7632-00-0 Current Sponsor code: AIR001 Other descriptive name: SODIUM NITRITE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 80- | Aires Pharmaceuticals, Inc | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;United States;Serbia;Czech Republic;Hungary;Poland;Australia;Germany;Italy | |||
| 205 | EUCTR2012-000166-37-HU | 22/01/2013 | 10 March 2014 | A Phase 2, Multi-Centre, unblinded, parallel dose, safety and effectiveness study of AIR001 in subjects with high blood pressure in the blood vessels in the lungs | A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: AIR001 Inhalation Solution Product Code: AIR001 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: sodium nitrite CAS Number: 7632-00-0 Current Sponsor code: AIR001 Other descriptive name: SODIUM NITRITE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 80- | Aires Pharmaceuticals Inc | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;United States;Serbia;Czech Republic;Hungary;Poland;Australia;Germany;Italy | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 206 | NCT01808313 | December 1, 2012 | 16 December 2017 | Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH) | An Open Label Phase IIIb Study to Evaluate Efficacy and Safety of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH) | Vascular Disease | Drug: ambrisentan | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | All | 134 | Phase 3 | China | |
| 207 | NCT01586156 | December 2012 | 16 December 2017 | PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol) | Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure | Pulmonary Hypertension | Drug: Carvedilol;Drug: placebo | The Cleveland Clinic | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI) | Not recruiting | 18 Years | 65 Years | All | 30 | N/A | United States |
| 208 | NCT01517854 | November 14, 2012 | 7 October 2019 | Revatio Portal-Pulmonary Arterial Hypertension Trial | Revatio Portal-Pulmonary Arterial Hypertension Trial (RePo1 Trial): A Randomized, Double-blinded, Placebo-controlled, Multi-center Study to Evaluate the Effects of Sildenafil Citrate (Revatio) 20 mg TID on Patients With Portal Pulmonary Arterial Hypertension (PPAH) | Portopulmonary Hypertension | Drug: Sildenafil;Drug: Placebo | University Health Network, Toronto | Not recruiting | 18 Years | 75 Years | All | 12 | Phase 2 | Canada | |
| 209 | EUCTR2012-000097-26-GB | 06/11/2012 | 28 February 2019 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receiving background oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: 830354-48-8 Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.125- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: 830354-48-8 Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: 830354-48-8 Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | |||
| 210 | EUCTR2012-000098-21-GB | 06/11/2012 | 30 April 2019 | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension | An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310 | Pulmonary Arterial Hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: 830354-48-8 Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.125- Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: 830354-48-8 Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: 830354-48-8 Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: 830354-48-8 Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet | United Therapeutics Corporation | Authorised | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 211 | NCT01582438 | November 2012 | 16 December 2017 | An Open Label Access Study For Subjects Who Completed A1481156 | A Local, Multicentre, Open Label Access Study, To Provide Sildenafil Therapy For Subjects Who Completed A1481156 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil For Subjects In India | Pulmonary Arterial Hypertension | Drug: Access program - sildenafil citrate, Viagra, Revatio | Pfizer | Not recruiting | 12 Years | 30 Years | All | N/A | India | ||
| 212 | NCT01725256 | November 2012 | 19 February 2015 | A Phase 2 Study to Determine the Safety and Efficacy of AIR001 in Subjects With Pulmonary Arterial Hypertension (PAH) | A Phase 2, Multi-Center, Open-label, Randomized, Parallel-Dose Study to Determine the Safety and Efficacy of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: AIR001 (sodium nitrite inhalation solution) | Aires Pharmaceuticals, Inc. | Not recruiting | 18 Years | 75 Years | Both | 29 | Phase 2 | United States;Australia;Hungary | |
| 213 | NCT01545336 | October 2012 | 19 October 2017 | Anastrozole in Patients With Pulmonary Arterial Hypertension | A Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Anastrozole;Drug: Placebo | University of Pennsylvania | Not recruiting | 18 Years | N/A | All | 18 | Phase 2 | United States | |
| 214 | EUCTR2012-000097-26-DE | 17/09/2012 | 28 February 2019 | International, multicenter, randomized (1:1 oral treprostinil (UT-15C): placebo), double-blind, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) who are receivingbackground oral monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects with Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy. | Pulmonary Arterial Hypertension MedDRA version: 20.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: 830354-48-8 Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.125- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: 830354-48-8 Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine CAS Number: 830354-48-8 Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: treprostinil diethanolamine | United Therapeutics Corporation | Not Recruiting | Female: yes Male: yes | 850 | Phase 3 | United States;Taiwan;Greece;Austria;Israel;Chile;Italy;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Australia;Denmark;Netherlands;Germany;China;Korea, Republic of;Sweden | |||
| 215 | JPRN-JapicCTI-121986 | 01/9/2012 | 23 April 2019 | Macitentan PAH | A multicenter, open-label, phase II/III study to asseses the efficacy, safety and Pharmacokinetics(PK) of macitentan (ACT-064992) in patients with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-064992 INN of the intervention : macitentan Dosage And administration of the intervention : macitentan tablet 10 mg once daily | Nippon Shinyaku co.,LTD./Actelion Pharmaceuticals Japan Ltd. | 16 | BOTH | 22 | Phase 2-3 | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 216 | NCT01649739 | September 2012 | 19 February 2015 | Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled Iloprost | Pulmonary Arterial Hypertension | Drug: Levitra | Rabin Medical Center | Not recruiting | 18 Years | 70 Years | Both | 20 | Phase 4 | Israel | ||
| 217 | NCT01712997 | September 2012 | 19 February 2015 | Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients | Phase ? Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients | Pulmonary Arterial Hypertension | Drug: Iloprost;Drug: Bosentan | Fourth Military Medical University | Recruiting | 10 Years | 80 Years | Both | 90 | Phase 3 | China | |
| 218 | NCT01723371 | September 2012 | 18 January 2016 | Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children | Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children | Pulmonary Arterial Hypertension | Drug: Carvedilol | The Hospital for Sick Children | Not recruiting | 8 Years | 17 Years | Both | 0 | Phase 1/Phase 2 | Canada | |
| 219 | NCT02169752 | September 2012 | 3 September 2018 | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension | Pre-Pulmonary Atrial Hypertension | Drug: Ambrisentan | National Jewish Health | Not recruiting | 18 Years | 80 Years | All | 7 | N/A | United States | |
| 220 | NCT01642407 | August 24, 2012 | 1 October 2018 | Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial Hypertension | A Phase 3, Multi-center, Open-label Study To Investigate Safety, Efficacy, And Tolerability Of Sildenafil Citrate In Pediatric Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Hypertension, Pulmonary | Drug: Sildenafil | Pfizer | Not recruiting | 1 Year | 17 Years | All | 6 | Phase 4 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 221 | NCT01683981 | August 2012 | 19 February 2015 | Exercise Capacity and Quality of Life in Patients With PPH Receiving Short Term Oral L-Citrulline Malate | Exercise Capacity and Quality of Life in Patients With Idiopathic Pulmonary Hypertension and Eisenmenger Syndrome Receiving Short Term Oral L-Citrulline Malate | Idiopathic Pulmonary Arterial Hypertension;Eisenmenger Syndrome | Drug: L-Citrulline Malate | Masih Daneshvari Hospital | Recruiting | 15 Years | 70 Years | Both | 25 | Phase 0 | Iran, Islamic Republic of | |
| 222 | EUCTR2012-001675-37-DE | 24/07/2012 | 7 October 2014 | A Study to Investigate the Effects of Lisuride in addition to Conventional Treatment in Patients with Pulmonary Arterial Hypertension | A Prospective, Open-label, Exploratory Study to Investigate the Safety, Efficacy, and Haemodynamics of Lisuride Subcutaneous Infusion as Add-on to Conventional Treatment in Patients with Pulmonary Arterial Hypertension - Lis-Safe | Pulmonary Arterial Hypertension MedDRA version: 16.0 Level: LLT Classification code 10036727 Term: Primary pulmonary hypertension System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Lisuride Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Lisuride CAS Number: 18016-80-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | Sinoxa Pharma GmbH | Not Recruiting | Female: yes Male: yes | 12 | Austria;Germany | ||||
| 223 | NCT01484431 | July 17, 2012 | 14 October 2019 | A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension | A Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Tadalafil- Tablet or Oral suspension | Eli Lilly and Company | Not recruiting | 6 Months | 17 Years | All | 20 | Phase 1/Phase 2 | United States;Canada;France;Poland;Spain;United Kingdom | |
| 224 | EUCTR2011-004612-31-PT | 06/07/2012 | 2 June 2014 | A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time. | A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1 Level: LLT Classification code 10064908 Term: Associated with (APAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10064909 Term: Idiopathic (IPAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10064910 Term: Familial (FPAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan Pharmaceutical Form: Dispersible tablet INN or Proposed INN: bosentan CAS Number: 157212-55-0 Current Sponsor code: ACT-050088 Other descriptive name: BOSENTAN MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32- | Actelion pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | 105 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China | ||||
| 225 | NCT01523548 | July 2012 | 16 December 2017 | Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension | Carbon Monoxide Therapy for Severe Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Carbon Monoxide | University of Illinois at Chicago | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI) | Not recruiting | 18 Years | N/A | All | 0 | Phase 1/Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 226 | NCT01645826 | July 2012 | 3 December 2018 | Efficacy Study of Cardizem in Pulmonary Arterial Hypertension | Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension. | Idiopathic Pulmonary Arterial Hypertension;Primary Pulmonary Hypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary Hypertension | Drug: Diltiazem Hydrochloride;Drug: Sugar Pill | University of South Florida | Not recruiting | 18 Years | N/A | All | 0 | N/A | United States | |
| 227 | NCT01647945 | July 2012 | 19 October 2017 | FK506 (Tacrolimus) in Pulmonary Arterial Hypertension | Single-Center Randomized Controlled Phase II Study of Safety and Efficacy of FK-506 (Tacrolimus) in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Placebo;Drug: FK506 level < 2 ng/ml;Drug: FK506 level 2-3 ng/ml;Drug: FK506 level 3-5 ng/ml | Edda Spiekerkoetter | Stanford University | Not recruiting | 18 Years | 70 Years | All | 23 | Phase 2 | United States |
| 228 | NCT01560624 | June 26, 2012 | 13 May 2019 | Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral Monotherapy | A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Clinical Worsening Study of UT-15C in Subjects With Pulmonary Arterial Hypertension Receiving Background Oral Monotherapy | Pulmonary Arterial Hypertension | Drug: Treprostinil Diolamine;Drug: Placebo | United Therapeutics | Not recruiting | 18 Years | 75 Years | All | 690 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom | |
| 229 | NCT01469169 | June 19, 2012 | 16 December 2017 | Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation Study | A Multi-center, Non-randomized, Open Label, Single-arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of BAY q 6256 (Iloprost) Inhalation in Patients With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Iloprost (Ventavis inhaled, BAYQ6256) | Bayer | Not recruiting | 18 Years | 75 Years | All | 27 | Phase 3 | Japan | |
| 230 | NCT01557647 | June 2012 | 19 February 2015 | Safety and Efficacy of Inhaled Treprostinil in Patients With PAH | Inhaled Treprostinil for the Treatment of Pulmonary Arterial Hypertension: A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil. | Pulmonary Arterial Hypertension | Drug: Inhaled treprostinil;Drug: Placebo | United Therapeutics | Not recruiting | 18 Years | 75 Years | Both | 0 | Phase 3 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 231 | NCT01557660 | June 2012 | 19 February 2015 | Inhaled Treprostinil for PAH: Open-label Extension | Inhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center Study | Pulmonary Arterial Hypertension | Drug: inhaled treprostinil | United Therapeutics | Not recruiting | 18 Years | N/A | Both | 0 | Phase 3 | ||
| 232 | NCT01560637 | May 2012 | 2 September 2019 | An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension | Open-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310 | Pulmonary Arterial Hypertension | Drug: UT-15C (treprostinil diethanolamine) | United Therapeutics | Recruiting | 18 Years | 75 Years | All | 850 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Chile;China;Denmark;France;Germany;Greece;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Singapore;Sweden;Taiwan;United Kingdom | |
| 233 | NCT01457781 | April 2012 | 23 July 2018 | Inhaled Nitric Oxide/INOpulse DS for Pulmonary Arterial Hypertension (PAH) | A Phase 2, Placebo Controlled, Double-Blind, Randomized, Clinical Study to Determine Safety, Tolerability and Efficacy of Pulsed, Inhaled Nitric Oxide (iNO) Versus Placebo as Add-On Therapy in Symptomatic Subjects With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: Nitric Oxide;Other: Placebo | Bellerophon Pulse Technologies | Not recruiting | 16 Years | 80 Years | All | 80 | Phase 2 | United States;Canada | |
| 234 | NCT01588405 | April 2012 | 19 October 2017 | Remodulin® to Oral Treprostinil Transition | A Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: UT-15C SR | United Therapeutics | Not recruiting | 15 Years | 80 Years | All | 33 | Phase 2 | United States | |
| 235 | NCT01615627 | April 2012 | 19 February 2015 | Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain | Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site Pain | Pulmonary Arterial Hypertension | Drug: HypotonicTreprostinil Solution;Drug: Eutonic Treprostinil Solution | Jewish General Hospital | Not recruiting | 18 Years | N/A | Both | 12 | Phase 4 | Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 236 | NCT02847260 | April 2012 | 16 December 2017 | Safety and Tolerability of Rapid Dose Titration of Subcutaneous Remodulin® Therapy in PAH Subjects (RAPID) | A 16 Week, Open Label, Multi-centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Remodulin | United Therapeutics | Not recruiting | 18 Years | N/A | All | 39 | Phase 4 | ||
| 237 | EUCTR2011-004631-31-DE | 13/03/2012 | 10 July 2015 | 16 week study is to assess the safety, tolerability and the effects on the body of a rapid dosing regimen using subcutaneous Remodulin® | A 16 Week, Open Label, Multi-Centre, Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of a Rapid Dose Titration Regimen of Subcutaneous Remodulin® Therapy in Subjects with Pulmonary Arterial Hypertension - RAPID study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Remodulin® (treprostinil) 1 mg/ml solution for infusion Pharmaceutical Form: Solution for infusion INN or Proposed INN: Treprostinil CAS Number: 289480-64-4 Current Sponsor code: Remodulin® Other descriptive name: TREPROSTINIL SODIUM, UT-15 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- Trade Name: Remodulin® (treprostinil) 2.5 mg/ml solution for infusion Pharmaceutical Form: Solution for infusion INN or Proposed INN: Treprostinil CAS Number: 289480-64-4 Current Sponsor code: Remodulin® Other descriptive name: TREPROSTINIL SODIUM, UT-15 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5- Trade Name: Remodulin® (treprostinil) 5 mg/ml solution for infusion Pharmaceutical Form: Solution for infusion INN or Proposed INN: Treprostinil CAS Number: 289480-64-4 Current Sponsor code: Remodulin® Other descriptive name: TREPROSTINIL SODIUM, UT-15 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Trade Name: Remodulin® (treprostinil) 10 mg/ml solution for infusion Pharmaceutical Form: Solution for infusion INN or Proposed INN: Treprostinil CAS Number: 289480-64-4 Current Sponsor code: Remodulin® Other descriptive name: TREPROSTINIL SODIUM, UT-15 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | United Therapeutics Corp. | Not Recruiting | Female: yes Male: yes | 50 | Germany | ||||
| 238 | NCT01590108 | March 2012 | 29 April 2019 | The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy Subjects | The Apelin-APJ System in Idiopathic Pulmonary Arterial Hypertension and Healthy Volunteers; Tissue Location and Cardiopulmonary Response. | Idiopathic Pulmonary Arterial Hypertension | Drug: (Pyr1)apelin-13;Drug: Saline | Imperial College London | Not recruiting | 18 Years | 90 Years | Male | 12 | Phase 1 | United Kingdom | |
| 239 | EUCTR2011-001873-24-ES | 13/01/2012 | 26 June 2012 | A study in children with Pulmonary Arterial Hypertension to assess the safety of Tadalafil as the dose increases, as well as how the drug works in the body | A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension MedDRA version: 14.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cialis 2.5 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Current Sponsor code: LY450190 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Trade Name: Cialis 5 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Current Sponsor code: LY450190 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Cialis 10 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Current Sponsor code: LY450190 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trade Name: Cialis 20 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Current Sponsor code: LY450190 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Product Name: LY450190 Product Code: LY450190 Pharmaceutical Form: Oral suspension INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Other descriptive name: LY450190 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.0- | Eli Lilly and Company | Authorised | Female: yes Male: yes | 24 | United Kingdom;Canada;France;Spain;United States;Poland | ||||
| 240 | NCT01433328 | January 2012 | 19 February 2015 | Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain | Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain | Pulmonary Arterial Hypertension | Drug: Lidocaine;Drug: Placebo | Jewish General Hospital | Not recruiting | 18 Years | N/A | Both | 4 | Phase 4 | Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 241 | NCT01446848 | January 2012 | 19 February 2015 | Oral Iron Supplementation in Pulmonary Hypertension | Oral Iron Supplementation in Pulmonary Hypertension | Pulmonary Arterial Hypertension | Dietary Supplement: iron supplement | The Cleveland Clinic | Not recruiting | 21 Years | N/A | Both | 6 | N/A | United States | |
| 242 | NCT01457170 | January 2012 | 19 February 2015 | Effects of Apelin on the Lung Circulation in Pulmonary Hypertension | Investigating the Acute Pulmonary Vascular Haemodynamic Effects of Apelin in Pulmonary Hypertension | Pulmonary Arterial Hypertension;Heart Failure | Drug: Apelin;Drug: Saline (Placebo) | Golden Jubilee National Hospital | NHS Lothian;Imperial College Healthcare NHS Trust | Recruiting | 18 Years | N/A | Both | 63 | N/A | United Kingdom |
| 243 | NCT02661802 | January 2012 | 1 February 2016 | Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome | Acute Effects of 40% Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger Syndrome | Eisenmenger Complex;Hypertension, Pulmonary | Other: Oxygen Supplementation | Federal University of São Paulo | Not recruiting | 18 Years | 60 Years | Both | 30 | N/A | ||
| 244 | EUCTR2012-002354-23-GB | 2 October 2017 | A clinical trial looking at the use and safety of tadalafil for the treatment of pulmonary arterial hypertension in children. | A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension MedDRA version: 15.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cialis 2.5 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Current Sponsor code: LY450190 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Cialis 5 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Current Sponsor code: LY450190 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Cialis 10 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Current Sponsor code: LY450190 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Cialis 20 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Current Sponsor code: LY450190 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Tadalafil oral suspension Product Code: LY450190 Pharmaceutical Form: Oral suspension INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Current Sponsor code: LY450190 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use | Eli Lilly and Company | Not Available | Female: yes Male: yes | 134 | Phase 3 | United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan | ||||
| 245 | EUCTR2007-003694-27-GB | 17/11/2011 | 6 January 2015 | Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension | SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label) Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL | symptomatic pulmonary arterial hypertension MedDRA version: 17.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Tablet INN or Proposed INN: macitentan CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | Actelion Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 525 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 246 | EUCTR2011-002943-92-NL | 07/11/2011 | 3 December 2012 | Study of a new thermostable formulation of Flolan™ to treat Pulmonary Arterial Hypertension (PAH) | A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN™ in Subjects with Pulmonary Arterial Hypertension (PAH) | pulmonary arterial hypertension (PAH) MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: FLOLAN™ and Glycine Diluent Product Name: FLOLAN™ and Glycine Diluent Product Code: 4AU76 Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion INN or Proposed INN: EPOPROSTENOL CAS Number: 61849-14-7 Current Sponsor code: 4AU76 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Trade Name: FLOLAN TM and Glycine Diluent Product Name: FLOLAN™ and Glycine Diluent Product Code: 4AU76 Pharmaceutical Form: Powder and solvent for concentrate for solution for infusion INN or Proposed INN: EPOPROSTENOL CAS Number: 61849-14-7 Current Sponsor code: 4AU76 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- | GlaxoSmithKline Research and Development Limited | Not Recruiting | Female: yes Male: yes | 20 | Netherlands;Canada;United States | ||||
| 247 | NCT01462565 | November 1, 2011 | 16 December 2017 | Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH) | A Single-arm, Open Label Study Evaluating the Impact on Lifestyle of a New Thermo Stable Formulation of FLOLAN® in Subjects With Pulmonary Arterial Hypertension (PAH). (FLOLAN® is a Registered Trademark of the GlaxoSmithKline Group of Companies.) | Hypertension, Pulmonary | Drug: current marketed FLOLAN (epoprostenol sodium);Drug: new thermo stable formulation of epoprostenol sodium | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | All | 16 | Phase 4 | United States;Canada;Netherlands | |
| 248 | NCT01431326 | November 2011 | 15 April 2019 | Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care | Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care | Adenovirus;Anesthesia;Anxiety;Anxiolysis;Autism;Autistic Disorder;Bacterial Meningitis;Bacterial Septicemia;Benzodiazepine;Bipolar Disorder;Bone and Joint Infections;Central Nervous System Infections;Convulsions;Cytomegalovirus Retinitis;Early-onset Schizophrenia Spectrum Disorders;Epilepsy;General Anesthesia;Gynecologic Infections;Herpes Simplex Virus;Infantile Hemangioma;Infection;Inflammation;Inflammatory Conditions;Intra-abdominal Infections;Lower Respiratory Tract Infections;Migraines;Pain;Pneumonia;Schizophrenia;Sedation;Seizures;Skeletal Muscle Spasms;Skin and Skin-structure Infections;Treatment-resistant Schizophrenia;Urinary Tract Infections;Withdrawal;Sepsis;Gram-negative Infection;Bradycardia;Cardiac Arrest;Cardiac Arrhythmia;Staphylococcal Infections;Nosocomial Pneumonia;Neuromuscular Blockade;Methicillin Resistant Staphylococcus Aureus;Endocarditis;Neutropenia;Headache;Fibrinolytic Bleeding;Pulmonary Arterial Hypertension;CMV Retinitis;Hypertension;Chronic Kidney Diseases;Hyperaldosteronism;Hypokalemia;Heart Failure;Hemophilia;Heavy Menstrual Bleeding;Insomnia | Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care: | Daniel Benjamin | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);The EMMES Corporation | Recruiting | N/A | 21 Years | All | 10000 | Phase 2 | United States;Australia;Canada;Israel;Singapore;United Kingdom |
| 249 | NCT01458236 | November 2011 | 19 February 2015 | A Multinational, Multicenter, Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor | A Multinational, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of BPS-314d-MR in Subjects With Pulmonary Arterial Hypertension Currently Receiving Treatment With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium 314d Modified Release Tablets;Drug: Placebo | Lung Biotechnology Inc. | Not recruiting | 18 Years | 80 Years | Both | 0 | Phase 3 | ||
| 250 | EUCTR2011-001893-24-DE | 13/10/2011 | 5 August 2013 | To determine oral bioavailability of the oral liquid formulation and potential food effects. | Relative bioavailability and food effect study of two oral liquid formulations in comparison to a 1mg tablet of riociguat to characterize its pharmacokinetic properties in healthy male and female adult subjects in a randomized, open label, 5 fold crossover design | Children with PH due to • Pulmonary arterial hypertension (PAH) • persistent pulmonary hypertension of the newborn (PPHN) MedDRA version: 14.0 Level: LLT Classification code 10037405 Term: Pulmonary hypertension primary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0 Level: LLT Classification code 10036727 Term: Primary pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0 Level: LLT Classification code 10053592 Term: Newborn persistent pulmonary hypertension System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: BAY 63-2521 0.3 % Product Code: BAY 63-2521 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Concentration unit: % percent Concentration type: equal Concentration number: 0.3- Product Name: BAY 63-2521 0.06 % Product Code: BAY 63-2521 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Concentration unit: % percent Concentration type: equal Concentration number: 0.06- Product Name: BAY 63-2521 IR tablets 1 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- | Bayer HealthCare AG | Not Recruiting | Female: yes Male: yes | 30 | Germany | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 251 | NCT01447628 | October 2011 | 24 June 2019 | IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients | What is the Effect of Intravenous Iron Supplementation on Cardiopulmonary Haemodynamics, Exercise Capacity and Quality of Life in Patients With IPAH and Iron Deficiency? | Pulmonary Arterial Hypertension;Iron Deficiency | Drug: Saline;Drug: Ferinject or CosmoFer | Imperial College London | Fu Wai Hospital, Beijing, China | Not recruiting | 16 Years | 75 Years | All | 40 | Phase 2 | China;Germany;United Kingdom |
| 252 | NCT01468545 | October 2011 | 19 February 2015 | Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT System | Prospective, Non-interventional, Multi-centre Study. The Observation Period for Each Subject Covers 1 Year of Treatment. One Initial Visit and 4 Follow-up Visits Every 3 Months and One Extra Educational Reinforcement at Baseline and at 6 Months Will be Given to a Group of Patients. | Pulmonary Arterial Hypertension | Other: Iloprost (Ventavis inhaled, BAYQ6256) | Bayer | Dra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain) | Not recruiting | 18 Years | N/A | Both | 38 | N/A | Spain |
| 253 | NCT01477333 | October 2011 | 16 December 2017 | Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso® | An Evaluation of the Safety and Efficacy of the Addition of UT-15C SR to Pulmonary Arterial Hypertension Patients Currently Receiving Tyvaso® | Pulmonary Arterial Hypertension | Drug: UT-15C SR;Drug: Tyvaso Inhalation Solution | United Therapeutics | Not recruiting | 18 Years | 75 Years | All | 18 | Phase 2 | United States | |
| 254 | NCT01548950 | September 2011 | 29 June 2015 | Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension | Combined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD) | Congenital Heart Disease;Pulmonary Arterial Hypertension | Drug: Sildenafil singly or in association with Bosentan | University of Sao Paulo General Hospital | Instituto do Coracao;Fundação de Amparo à Pesquisa do Estado de São Paulo | Recruiting | 2 Months | N/A | Both | 50 | N/A | Brazil |
| 255 | JPRN-JapicCTI-122017 | 01/8/2011 | 23 April 2019 | ACT-385781A PAH | Open-label study ACT-385781A in patients with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-385781A INN of the intervention : epoprostenol Dosage And administration of the intervention : Continuous intravenous infusion | Actelion Pharmaceuticals Japan Ltd. | 20 | BOTH | 10 | Phase 3 | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 256 | JPRN-UMIN000005973 | 2011/08/01 | 23 April 2019 | Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics | Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics - Tadalafil study for pediatric PAH | pediatric pulmonary arterial hypertension | single oral administration of tadalafil 1mg/kg | National Cerebral and Cardiovascular Center | Not Recruiting | Not applicable | 18years-old | Male and Female | 10 | Not applicable | Japan | |
| 257 | NCT01393795 | August 2011 | 19 February 2015 | Qutenza®-Remodulin® in Pulmonary Arterial Hypertension Patients | A Double-blind, Randomized, Crossover Clinical Study to Assess the Efficacy of Qutenza® for the Reduction of Site Pain Caused by Continuous Subcutaneous Infusion of Remodulin®, in Pulmonary Arterial Hypertension Patients | Pulmonary Hypertension;Pain | Drug: Qutenza;Drug: Tegaderm | Imperial College London | United Therapeutics | Not recruiting | 18 Years | N/A | Both | 11 | Phase 2 | United Kingdom |
| 258 | NCT01553721 | August 2011 | 25 April 2016 | Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) | A Placebo-controlled, Double-blind, Phase II Clinical Study to Evaluate the Efficacy and Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH) | Pulmonary Arterial Hypertension | Drug: udenafil;Drug: placebo | Dong-A ST Co., Ltd. | Not recruiting | 18 Years | N/A | Both | 63 | Phase 2 | Korea, Republic of | |
| 259 | NCT01757808 | August 2011 | 16 December 2017 | A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension | A Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Ranolazine;Drug: Placebo | University of Chicago | Not recruiting | 18 Years | 72 Years | All | 12 | Phase 1 | United States | |
| 260 | NCT01365585 | July 2011 | 16 December 2017 | Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial Hypertension | Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: sildenafil citrate | Pfizer | Not recruiting | 18 Years | N/A | All | 227 | N/A | Germany;Ireland | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 261 | NCT01409122 | July 2011 | 19 February 2015 | Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy Subjects | A Phase 1, Placebo Controlled, Blinded, Multiple Dose Escalation Study of AIR001 (Sodium Nitrite Inhalation Solution) in Healthy Subjects, an Assessment of the Tolerability in Combination With Oral Sildenafil, and an Open-Label Study of Multiple Dose AIR001 in Patients With Pulmonary Arterial Hypertension | Pulmonary Hypertension;Pulmonary Arterial Hypertension | Drug: 15 mg sodium nitrite inhalation solution;Drug: 90 mg sodium nitrite inhalation solution;Drug: 45 mg sodium nitrite inhalation solution;Drug: 120 mg sodium nitrite inhalation solution;Drug: 25% MTD sodium nitrite inhalation solution | Aires Pharmaceuticals, Inc. | Not recruiting | 18 Years | 56 Years | Both | 42 | Phase 1 | United States | |
| 262 | NCT01468571 | July 2011 | 25 May 2015 | Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension | Effects of Spironolactone on Collagen Metabolism in Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Spironolactone;Drug: Placebo | Baylor College of Medicine | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 18 Years | N/A | Both | 50 | Phase 4 | United States |
| 263 | EUCTR2011-001312-59-GB | 24/06/2011 | 28 August 2012 | A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension | A double-blinded, randomized, crossover clinical study to assess the efficacy of Qutenza (capsaicin 8% patches) for the reduction of site pain caused by continuous subcutaneous infusion of Remodulin (treprostinil sodium), in Pulmonary Arterial Hypertension Patients - Efficacy of capsaicin 8% patches in Pulmonary Arterial Hypertension | Pulmonary arterial hypertension (PAH) is a rare life-threatening disease characterised by high blood pressure in the arteries to the lungs, rapidly evolving in a clinical syndrome of dyspnoea and fatigue and eventually leading to right ventricular failure and death. MedDRA version: 13.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Qutenza Product Name: Qutenza Pharmaceutical Form: Transdermal patch INN or Proposed INN: Capsaicin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 179- Pharmaceutical form of the placebo: Transdermal patch Route of administration of the placebo: Cutaneous use Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Cutaneous use | Imperial College London | Not Recruiting | Female: yes Male: yes | 0 | United Kingdom | ||||
| 264 | NCT01086540 | June 24, 2011 | 26 August 2019 | Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | Systemic Sclerosis-Associated PAH | Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Not recruiting | 18 Years | 75 Years | All | 58 | Phase 2 | United States |
| 265 | NCT01389206 | June 1, 2011 | 27 August 2018 | Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program | Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program | Pulmonary Arterial Hypertension | Drug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi | Actelion | Canadian Heart Research Centre | Not recruiting | 18 Years | N/A | All | 797 | Phase 1 | United States;Puerto Rico |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 266 | NCT01470144 | June 1, 2011 | 16 December 2017 | Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension | An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Epoprostenol | Actelion | Chiltern International Ltd.;Effi-stat | Not recruiting | N/A | N/A | All | 41 | Phase 3 | Belgium;Canada;France;Italy;Netherlands;Spain |
| 267 | NCT01319045 | June 2011 | 19 October 2017 | Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart Disease | Pulmonary Arterial Hypertension;Congenital Heart Disease;Eisenmenger's Syndrome | Drug: Iloprost | University of California, Los Angeles | Actelion | Not recruiting | 18 Years | N/A | All | 5 | N/A | United States | |
| 268 | NCT01330108 | May 2011 | 19 October 2017 | Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension | Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension | Pulmonary Arterial Hypertension | Drug: ambrisentan | University of Alabama at Birmingham | Not recruiting | 19 Years | N/A | All | 32 | Phase 4 | United States | |
| 269 | NCT01352026 | May 2011 | 19 February 2015 | Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Metformin | Nantes University Hospital | Not recruiting | 18 Years | 80 Years | Both | 0 | Phase 2 | France | ||
| 270 | EUCTR2010-021825-11-NL | 28/04/2011 | 21 October 2013 | A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a day | An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1 Level: LLT Classification code 10064908 Term: Associated with (APAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10064909 Term: Idiopathic (IPAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10064910 Term: Familial (FPAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan Pharmaceutical Form: Dispersible tablet INN or Proposed INN: BOSENTAN MONOHYDRATE CAS Number: 157212-55-0 Other descriptive name: Ro-47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32- | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 64 | Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Germany;Netherlands;China | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 271 | NCT01392469 | April 20, 2011 | 25 June 2018 | Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Patients | A Non-randomized, Multiple Dose, Three Treatment Period, Open-label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) Patients | Pulmonary Arterial Hypertension | Drug: Imatinib | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 21 | Phase 3 | United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey | |
| 272 | EUCTR2010-021960-14-DE | 08/04/2011 | 12 May 2014 | An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension | An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Glivec® Product Code: QTI571 Pharmaceutical Form: Tablet INN or Proposed INN: IMATINIB MESILATE CAS Number: 220127-57-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Glivec® Product Code: QTI571 Pharmaceutical Form: Tablet INN or Proposed INN: IMATINIB MESILATE CAS Number: 220127-57-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Novartis Pharma AG | Not Recruiting | Female: yes Male: yes | 20 | Germany;Italy | ||||
| 273 | EUCTR2010-021793-12-DE | 04/04/2011 | 2 March 2015 | A 1 year follow-up research project for children with pulmonary arterial hypertension (PAH) that participated in the FUTURE 3 core study. This is to find out how well bosentan is tolerated and safe when taken either two or three times a day | A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension | Pulmonary arterial hypertension (PAH) in children MedDRA version: 16.1 Level: LLT Classification code 10064910 Term: Familial (FPAH) System Organ Class: 100000004855 MedDRA version: 16.1 Level: LLT Classification code 10064909 Term: Idiopathic (IPAH) System Organ Class: 100000004855 MedDRA version: 16.1 Level: LLT Classification code 10064908 Term: Associated with (APAH) System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan Pharmaceutical Form: Dispersible tablet INN or Proposed INN: BOSENTAN MONOHYDRATE CAS Number: 157212-55-0 Other descriptive name: Ro-47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32- | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 64 | China;Netherlands;Germany;South Africa;Australia;Poland;Mexico;Czech Republic;Hungary;France;India;Italy;Russian Federation;Israel;Ukraine;Spain;Serbia;Belarus;United States | ||||
| 274 | JPRN-UMIN000005438 | 2011/04/01 | 2 April 2019 | prospective intervention study of prevention of infections by chlorhexidine-impregnated sponge dressings for patients with tunneled central venous catheters | patients with pulmonary arterial hypertension | Use of chlorhexidine-impregnated sponge dressing during former 6 months Use of chlorhexidine-impregnated sponge dressing during latter 6 months | Department of cardiology, Keio University School of Medicine | Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | ||
| 275 | JPRN-UMIN000005464 | 2011/04/01 | 2 April 2019 | Drug interactions and effects of combination therapy for pulmonary arterial hypertension | pulmonary arterial hypertension | phase 1: sildenafil (60mg/day) and bosentan (250mg/day) for 4 or 5 weeks phase 2: sildenafil(60mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks phase 3: tadalafil (40mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks | Hamamatsu University School of Medicine | University of Shizuoka | Recruiting | 20years-old | Not applicable | Male and Female | 15 | Not applicable | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 276 | EUCTR2010-024585-22-GB | 25/03/2011 | 4 August 2015 | What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? | What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? - Ferinject® for iron deficiency in IPAH patients | Idiopathic or familial pulmonary arterial hypertension MedDRA version: 18.0 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Ferinject Product Name: Ferinject Pharmaceutical Form: Solution for infusion INN or Proposed INN: Ferric carboxymaltose Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Route of administration of the placebo: Intravenous use | Imperial College Academic Healthsciences Centre | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 277 | NCT01223352 | March 8, 2011 | 16 December 2017 | Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension | An Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: bosentan | Actelion | Not recruiting | 3 Months | 12 Years | All | 64 | Phase 3 | United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic | |
| 278 | JPRN-JapicCTI-111532 | 01/3/2011 | 23 April 2019 | NS-304 PAH | The clinical study to assess the efficacy, safety and pharmacokinetics of NS-304 in patients with pulmonary arterial hypertension (PAH) | Pulmonary arterial hypertension (PAH) | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration | NIPPON SHINYAKU CO., LTD. / Actelion Pharmaceuticals Japan Ltd. | 18 | BOTH | 30 | Phase 2 | ||||
| 279 | NCT01265888 | March 2011 | 26 September 2016 | Study in Subjects With PAH and PH Secondary to IPF Using Inhaled GeNOsyl. | A Phase 2, Open-Label, Dose-Escalation Study in Subjects With Pulmonary Arterial Hypertension, (PAH, WHO Group 1) and Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis, (PH-IPF WHO Group 3) Using Inhaled GeNOsyl. | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis | Drug: Inhaled Nitric Oxide | Geno LLC | Not recruiting | 18 Years | 80 Years | Both | 31 | Phase 2 | United States | |
| 280 | NCT01302444 | March 2011 | 19 October 2017 | Treprostinil Combined With Tadalafil for Pulmonary Hypertension | Randomized Placebo Controlled Trial of Treprostinil Infusion Combined With Oral Tadalafil or Placebo in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Tadalafil;Drug: Placebo | Rhode Island Hospital | United Therapeutics | Not recruiting | 18 Years | 80 Years | All | 1 | Phase 4 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 281 | NCT01431716 | March 2011 | 19 October 2017 | Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension | A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: EFI/ACT-385781A | Actelion | Not recruiting | 18 Years | N/A | All | 42 | Phase 3 | Belgium;Canada;France;Italy;Netherlands;Spain | |
| 282 | ChiCTR-ONC-11001799 | 2011-02-17 | 18 April 2017 | A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease | A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease | pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease | All groups:Bosentan therapy ; | Beijing Anzhen Hospital | Not Recruiting | 0 | 18 | Both | All groups:50; | Post-market | China | |
| 283 | NCT01246037 | February 2011 | 19 February 2015 | Beta-blockers in i-PAH | Beta-blocker Therapy in Idiopathic Pulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Drug: Bisoprolol | VU University Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development | Not recruiting | 18 Years | N/A | Both | 30 | Phase 1/Phase 2 | Netherlands |
| 284 | EUCTR2010-021344-17-IT | 28/01/2011 | 18 March 2013 | A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND | A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND | Pulmonary arterial hypertension (PAH) MedDRA version: 9.1 Level: LLT Classification code 10064911 | Trade Name: GLIVEC Pharmaceutical Form: Tablet INN or Proposed INN: IMATINIB MESYLATE CAS Number: 220127-57-1 Current Sponsor code: QTI571 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: REVATIO Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sildenafil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Trade Name: TRACLEER Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Bosentan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 62.5- | NOVARTIS FARMA | Not Recruiting | Female: yes Male: yes | 24 | Italy | ||||
| 285 | EUCTR2010-020424-21-NL | 10/01/2011 | 19 March 2012 | Betablocker Therapy in Pulmonary Arterial Hypertension | Betablocker Therapy in Pulmonary Arterial Hypertension | Idiopathic pulmonal arterial hypertension MedDRA version: 12.1 Level: LLT Classification code 10020787 Term: Hypertension pulmonary | Product Name: Bisoprolol Product Code: C07AB07 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | VU medical center | Authorised | Female: yes Male: yes | Netherlands | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 286 | NCT01332331 | January 4, 2011 | 15 July 2019 | Efficacy and Safety of Ambrisentan in Children 8-18yrs | A Randomized, Open Label Study Comparing Safety and Efficacy Parameters for a High and a Low Dose of Ambrisentan (Adjusted for Body Weight) for the Treatment of Pulmonary Arterial Hypertension in Paediatric Patients Aged 8 Years up to 18 Years | Hypertension, Pulmonary | Drug: Ambrisentan - low dose;Drug: Ambrisentan - high dose | GlaxoSmithKline | Not recruiting | 8 Years | 18 Years | All | 41 | Phase 2 | United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Greece;Mexico;Netherlands | |
| 287 | JPRN-UMIN000004369 | 2011/01/01 | 2 April 2019 | Application of Exercise Echocardiography and Treatment by Bosentan in Latent Pulmonary Arterial Hypertension Associated with Connective Tissue Disease | Connective Tissue Disease | Bosentan | Tokushima University | Not Recruiting | 18years-old | 85years-old | Male and Female | 20 | Not selected | Japan | ||
| 288 | NCT01028651 | January 2011 | 16 December 2017 | A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension | An Open-Label Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension | Portopulmonary Hypertension;Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: Treprostinil | United Therapeutics | University of California, Los Angeles;Brigham and Women's Hospital;University of Texas;Emory University | Not recruiting | N/A | N/A | All | 13 | N/A | United States |
| 289 | NCT01251848 | January 2011 | 16 March 2015 | Drug Interaction Between Ritonavir And Sitaxsentan | A Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy Subjects | Pulmonary Arterial Hypertension | Drug: Sitaxentan;Drug: Ritonavir;Drug: Sitaxsentan | Pfizer | Not recruiting | 21 Years | 55 Years | Both | 0 | Phase 1 | ||
| 290 | NCT01288651 | January 2011 | 19 February 2015 | Iron Deficiency In Pulmonary Hypertension | Intravenous Iron Treatment In Iron Deficient Patients With Idiopathic Pulmonary Arterial Hypertension | Idiopathic Pulmonary Arterial Hypertension | Drug: Ferricarboxymaltose | VU University Medical Center | Vifor Pharma | Recruiting | 18 Years | N/A | Both | 30 | Phase 4 | Netherlands |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 291 | EUCTR2011-004106-16-NL | 2 October 2017 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1 Level: LLT Classification code 10064908 Term: Associated with (APAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10064909 Term: Idiopathic (IPAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10064910 Term: Familial (FPAH) System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Tracleer Product Name: bosentan Pharmaceutical Form: Dispersible tablet INN or Proposed INN: bosentan CAS Number: 157212-55-0 Current Sponsor code: ACT-050088 Other descriptive name: BOSENTAN MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32- Pharmaceutical form of the placebo: Dispersible tablet Route of administration of the placebo: Oral use | Actelion pharmaceuticals Ltd | Not Available | Female: yes Male: yes | 105 | Phase 3 | Portugal;Serbia;United States;Philippines;Guatemala;Ukraine;Russian Federation;Chile;Colombia;India;Vietnam;France;Mexico;Argentina;Croatia;Peru;South Africa;Bulgaria;Netherlands;China | ||||
| 292 | NCT01406327 | December 14, 2010 | 17 September 2018 | Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension) | Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension) | Hypertension, Pulmonary | Drug: Ambrisentan | GlaxoSmithKline | Not recruiting | N/A | N/A | All | 900 | Phase 4 | ||
| 293 | EUCTR2010-023233-30-NL | 13/12/2010 | 19 March 2012 | ‘Intravenous iron treatment in iron deficient patients with pulmonary arterial hypertension' - Treating iron deficiency in PAH | ‘Intravenous iron treatment in iron deficient patients with pulmonary arterial hypertension' - Treating iron deficiency in PAH | Objective: To evaluate the effects of intravenous iron suppletion in iron deficient IPAH patients. Study design: Intervention study Study population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency Intervention: Patients receive a weekly iron bolus infusion until iron levels are restored (correction phase). Then a maintenance dose is given once per month (maintenance phase) until the endpoint after 20 weeks. MedDRA version: 12.1 Level: LLT Classification code 10064909 Term: Idiopathic (IPAH) | Trade Name: Ferinject Product Name: Ferric carboxymaltose Product Code: RVG 33865 Pharmaceutical Form: Solution for injection | VU university medical center | Authorised | Female: yes Male: yes | 30 | Netherlands | ||||
| 294 | JPRN-JapicCTI-101370 | 10/12/2010 | 2 April 2019 | Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients | A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Intervention name : Sitaxentan sodium INN of the intervention : Sitaxentan Dosage And administration of the intervention : 100 mg, once daily Control intervention name : null | Pfizer Japan Inc. | 16 | 80 | BOTH | 35 | Phase 3 | |||
| 295 | NCT01251835 | December 2010 | 16 March 2015 | Effect Of Rifampin On Pharmacokinetics Of Sitaxsentan | A Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy Subjects | Pulmonary Arterial Hypertension | Drug: Sitaxsentan alone;Drug: Sitaxsentan;Drug: Rifampin | Pfizer | Not recruiting | 21 Years | 55 Years | Both | 0 | Phase 1 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 296 | NCT01266265 | December 2010 | 19 October 2017 | Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH Therapies | A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution | Pulmonary Arterial Hypertension | Drug: inhaled prostacyclin;Drug: prostacyclin;Drug: subcutaneous and intravenous prostacyclin;Drug: oral ERA;Drug: oral PDE5 inhibitors | United Therapeutics | Not recruiting | N/A | N/A | All | 1333 | N/A | United States | |
| 297 | EUCTR2010-021572-29-GR | 23/11/2010 | 21 August 2012 | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired | An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired | Pulmonary Arterial Hypertension MedDRA version: 12.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension MedDRA version: 12.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension MedDRA version: 12.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AMBRISENTAN CAS Number: 0 Current Sponsor code: GSK1325760 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- INN or Proposed INN: AMBRISENTAN CAS Number: 0 Current Sponsor code: GSK1325760 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Name: ambrisentan Product Code: GSK1325760 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ambrisentan Current Sponsor code: GSK1325760 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- | GlaxoSmithKline Research & Development, Ltd | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Germany;Netherlands;Spain;Italy;Greece | ||||
| 298 | NCT01210443 | November 2010 | 19 October 2017 | Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients | A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Sitaxentan | Pfizer | Not recruiting | 16 Years | 80 Years | All | 2 | Phase 3 | Japan | |
| 299 | NCT01244620 | November 2010 | 19 October 2017 | A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple Doses | A Phase 1, Open Label, Randomized, Four Period, Crossover, Multiple Dose Study To Assess The Pharmacokinetic Interaction Between Sitaxsentan and Tadalafil and The Effect Of Sildenafil On Sitaxsentan PK In Healthy Subjects | Pulmonary Arterial Hypertension | Drug: sitaxentan;Drug: tadalafil;Drug: sitaxsentan;Drug: sildenafil | Pfizer | Not recruiting | 21 Years | 55 Years | All | 16 | Phase 1 | Singapore | |
| 300 | NCT01260454 | November 2010 | 19 October 2017 | The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site Pain | The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain | Pulmonary Hypertension;Pulmonary Arterial Hypertension | Drug: Qutenza (8% capsaicin) | University of Rochester | United Therapeutics | Not recruiting | 15 Years | 80 Years | All | 6 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 301 | EUCTR2007-003975-38-AT | 03/10/2010 | 19 March 2012 | Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH | Proof of Concept Study to Investigate the Efficacy, Haemodynamics and Tolerability of Terguride vs. Placebo in Patients with Pulmonary Arterial Hypertension. Double-blind, randomized, prospective Phase II proof of concept study for 12 weeks of constant treatment with Terguride or placebo - TERPAH | Pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10036727 Term: Primary pulmonary hypertension | Product Name: Terguride 0.5 mg tablet Pharmaceutical Form: Tablet INN or Proposed INN: Terguride CAS Number: 37686-84-3 Other descriptive name: Transdihydrolisuride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0,5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Ergonex Pharma GmbH | Not Recruiting | Female: yes Male: yes | 99 | Phase 2 | Czech Republic;Germany;Netherlands;Austria | |||
| 302 | JPRN-UMIN000012669 | 2010/10/01 | 2 April 2019 | Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management- | pulmonary hypertension | Sildenafil will be administered via a nasogastric tube or orally at a dose of 0.5 mg/kg. If the investigator note there is no effect of sildenafil on any parameters and clinical conditions, a repeat dose of sildenafil (0.5 or 1.0 mg/kg) can be given 4 hours after the initial administration by the investigators judgment. Sildenafil will be gradually weaned off for 5 to 7 days. | Osaka Medical College | Not Recruiting | Not applicable | 24months-old | Male and Female | 20 | Not applicable | Japan | ||
| 303 | NCT01178073 | October 1, 2010 | 16 December 2017 | A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: ambrisentan;Drug: tadalafil | GlaxoSmithKline | Gilead Sciences | Not recruiting | 18 Years | 75 Years | All | 610 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Greece;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom |
| 304 | NCT01054105 | October 2010 | 23 February 2016 | Effect of BMPR-2 Gene Mutations on Hemodynamic Response by Iloprost Inhalation in Pulmonary Arterial Hypertension | The Prevalence of BMPR-2 Gene Mutations in Korean Patients With Pulmonary Arterial Hypertension (PAH) and the Effects of Gene Mutations on Hemodynamic Response by Drug Therapy | Pulmonary Arterial Hypertension | Drug: Iloprost | Gachon University Gil Medical Center | Seoul National University Hospital;Seoul National University Bundang Hospital;The Catholic University of Korea;Bayer | Recruiting | 20 Years | 80 Years | Both | 48 | Phase 4 | Korea, Republic of |
| 305 | NCT01092559 | October 2010 | 19 October 2017 | Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide | An Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery System | Pulmonary Arterial Hypertension | Drug: Nitric Oxide generated by the GeNO nitrosyl delivery system | Geno LLC | Not recruiting | 18 Years | N/A | All | 10 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 306 | NCT01094067 | September 1, 2010 | 16 July 2018 | Tezosentan in Patients With Pulmonary Arterial Hypertension | Multi-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Demonstrate That a Single Infusion of Tezosentan Has Minimal Effect on Blood Pressure in Patients With Pulmonary Arterial Hypertension, Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or a Combination of Both. | Pulmonary Arterial Hypertension | Drug: ACT-050089;Other: Placebo | Idorsia Pharmaceuticals Ltd. | Not recruiting | 18 Years | N/A | All | 2 | Phase 2 | United States;France;Japan | |
| 307 | NCT01165047 | September 2010 | 19 October 2017 | Nitric Oxide, GeNO Nitrosyl Delivery System | An Open Label, Non-Randomized Pilot Study to Evaluate the Safety and Performance of the GeNO Nitrosyl Delivery System in Subjects Being Evaluated for Orthotopic Heart Transplantation (OHT), or Left Ventricular Assist Device (LVAD) Implantation | Pulmonary Arterial Hypertension | Drug: Nitric Oxide | Aurora Health Care | Not recruiting | 18 Years | N/A | All | 10 | Phase 2 | United States | |
| 308 | EUCTR2010-019883-36-HU | 31/08/2010 | 10 July 2012 | A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH) | A 24 week, randomized, double blind, multicenter, placebo-controlled efficacy, safety, tolerability and PK trial of Nilotinib (Tasigna®, AMN107) in Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension (PAH) Class II or III patients remaining symptomatic despite at least one PAH-specific therapy. MedDRA version: 12.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Tasigna® Product Name: Tasigna Product Code: AMN107 Pharmaceutical Form: Capsule, hard INN or Proposed INN: nilotinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: nilotinib Product Code: AMN107 Pharmaceutical Form: Capsule, hard INN or Proposed INN: nilotinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Nilotinib Product Code: AMN107 Pharmaceutical Form: Capsule, hard INN or Proposed INN: nilotinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Novartis Pharma AG | Not Recruiting | Female: yes Male: yes | 66 | Germany;Hungary | ||||
| 309 | EUCTR2009-011150-17-NL | 26/08/2010 | 21 August 2012 | Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | Pulmonary arterial hypotension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Virus Diseases [C02] | Trade Name: Volibris Product Name: ambrisentan 5 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AMBRISENTAN CAS Number: 177036-94-1 Current Sponsor code: GSK1325760 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Cialis Product Name: tadalafil 20 mg film-coated tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TADALAFIL CAS Number: 171596-29-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | GlaxoSmithKline R&D Ltd | Authorised | Female: yes Male: yes | 545 | Germany;United Kingdom;Netherlands;France;Spain;Italy;Japan;Greece;Austria;Sweden | ||||
| 310 | JPRN-JapicCTI-101369 | 20/8/2010 | 2 April 2019 | A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients | A Phase 3, Multi-Center, Open Label Study to Investigate Safety and efficacy of Sitaxentan THERAPY in japanese Subjects with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Intervention name : Sitaxentan sodium INN of the intervention : Sitaxentan Dosage And administration of the intervention : 100 mg, once daily Control intervention name : null | Pfizer Japan Inc. | 16 | 80 | BOTH | 35 | Phase 3 | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 311 | NCT01355380 | August 5, 2010 | 16 December 2017 | Efficacy of Ventavis Used in Real-life Setting. | The Efficacy of Inhaled Iloprost in Patients Treated Within the Pulmonary Arterial Hypertension Therapeutic Programme. | Pulmonary Arterial Hypertension | Drug: Inhaled iloprost (Ventavis, BAYQ6256) | Bayer | Not recruiting | 18 Years | N/A | All | 55 | N/A | Poland | |
| 312 | NCT01077297 | August 2010 | 16 July 2018 | Tezosentan in Pulmonary Arterial Hypertension | Multicenter, Open-label, Non-comparative, Proof-of-concept, Phase 2a Study to Evaluate the Effect of a Single Infusion of Tezosentan on Pulmonary Vascular Resistance in Patients With Stable, Chronic Pulmonary Arterial Hypertension, Currently Not Treated With Endothelin Receptor Antagonists, Phosphodiesterase-5 Inhibitors or Prostacyclines | Pulmonary Arterial Hypertension | Drug: Tezosentan | Idorsia Pharmaceuticals Ltd. | Not recruiting | 18 Years | N/A | All | 3 | Phase 2 | United States;France;Switzerland | |
| 313 | NCT01172496 | August 2010 | 19 February 2015 | A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy Volunteers | A Comparative Bioavailability Study of UT-15C SR (Treprostinil Diethanolamine, Sustained Release) Oral Tablets and UT-15C (Treprostinil Diethanolamine) Administered as an Oral Solution in Healthy Volunteers | Pulmonary Arterial Hypertension | Drug: treprostinil diethanolamine | United Therapeutics | Not recruiting | 18 Years | 55 Years | Both | 24 | Phase 1 | United States | |
| 314 | NCT01204853 | August 2010 | 19 October 2017 | A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients | A Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Sitaxentan | Pfizer | Not recruiting | 16 Years | 80 Years | All | 2 | Phase 3 | Japan | |
| 315 | NCT01268553 | August 2010 | 16 December 2017 | Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin Medication | Transition From Parenteral Prostanoids to Inhaled Treprostinil | Pulmonary Arterial Hypertension | Drug: Treprostinil | Los Angeles Biomedical Research Institute | United Therapeutics | Not recruiting | 18 Years | 80 Years | All | 6 | Phase 4 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 316 | EUCTR2010-018863-40-DE | 16/07/2010 | 27 January 2014 | Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters | An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS | Pulmonary arterial hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAY 63-2521 IR tablets 1.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAY 63-2521 IR tablets 2.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAY 63-2521 IR tablets 0.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet | Bayer HealthCare AG | Not Recruiting | Female: yes Male: yes | 18 | Italy;United Kingdom;Germany;Austria;Poland;Spain;Czech Republic | ||||
| 317 | EUCTR2010-019547-19-GR | 16/07/2010 | 21 August 2012 | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. | Pulmonary Arterial Hypertension MedDRA version: 12.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension MedDRA version: 12.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension MedDRA version: 12.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension MedDRA version: 12.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension MedDRA version: 12.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Volibris Product Name: ambrisentan Product Code: GSK1325760 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AMBRISENTAN CAS Number: 0 Current Sponsor code: GSK1325760 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- INN or Proposed INN: AMBRISENTAN CAS Number: 0 Current Sponsor code: GSK1325760 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Name: ambrisentan Product Code: GSK1325760 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ambrisentan Current Sponsor code: GSK1325760 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- | GlaxoSmithKline Research & Development, Ltd | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Germany;Netherlands;France;Spain;Italy;Greece | ||||
| 318 | EUCTR2010-018320-10-BE | 02/07/2010 | 17 August 2015 | An extension of study AC-066A301 to investigate safety and tolerability of the study medication (epoprostenol for injection) | An open-label extension of study AC-066A301 investigating the safety and tolerability of ACT-385781A in patients with pulmonary arterial hypertension (PAH) - EPITOME-2 Extension | Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: EPOPROSTENOL SODIUM CAS Number: 61849-14-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Trade Name: Epoprostenol for injection Product Name: Epoprostenol for injection Product Code: ACT-385781A Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: EPOPROSTENOL SODIUM CAS Number: 61849-14-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- | ACTELION Pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | 40 | France;Canada;Spain;Belgium;Netherlands;Italy | ||||
| 319 | NCT00796510 | July 2010 | 19 October 2017 | Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety | A Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Monotherapy Sitaxsentan Sodium And Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: Sitaxsentan;Drug: Sitaxsentan and Sildenafil | Pfizer | Not recruiting | 16 Years | 80 Years | All | 3 | Phase 3 | United States;Romania;Ukraine;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;India;Mexico;Peru;Philippines;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand | |
| 320 | NCT01153386 | July 2010 | 19 February 2015 | Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil Diethanolamine | An Evaluation of the Pharmacokinetic Linearity and Comparative Bioavailability of a Single Oral Dose of 0.5 mg, 1 mg and 2.5 mg UT-15C (Treprostinil Diethanolamine) SR Tablets in Healthy Volunteers in the Fed State | Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine | United Therapeutics | Not recruiting | 18 Years | 55 Years | Both | 36 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 321 | NCT01165476 | July 2010 | 19 February 2015 | Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent Facilities | An Evaluation of the Comparative Bioavailability of a Single Oral Dose of 1mg UT-15C (Treprostinil Diethanolamine) SR Tablets Manufactured by Two Independent Facilities Administered to Healthy Volunteers in the Fed State | Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine | United Therapeutics | Not recruiting | 18 Years | 55 Years | Both | 64 | Phase 1 | United States | |
| 322 | NCT01305252 | July 2010 | 16 December 2017 | A 48-week Study of the Effect of Dual Therapy (Inhaled Treprostinil and Tadafafil) Versus Monotherapy (Tadalafil). | CombinatiON Up-FRON t Therapy for PAH - A Phase 4, Randomized, Multicenter Study of Inhaled Treprostinil in Treatment naïve Pulmonary Arterial Hypertension Patients Starting on Tadalafil | Hypertension, Pulmonary | Drug: treprostinil inhalations;Drug: tadalafil | Stanford University | Northwestern University | Not recruiting | 18 Years | 69 Years | All | 21 | Phase 4 | United States |
| 323 | NCT01317134 | July 2010 | 8 February 2016 | Endothelial Function in Patients With Pulmonary Arterial Hypertension | Serological and Non-invasive Evaluation of Endothelial Function in Patients With Pulmonary Arterial Hypertension | Hypertension, Pulmonary;Pulmonary Arterial Hypertension;Pathophysiology;Genetics | Device: EndoPAT measurement;Biological: Blood Test | Universitätsklinikum Hamburg-Eppendorf | Pfizer;Actelion | Not recruiting | 18 Years | N/A | Both | 90 | N/A | Germany |
| 324 | EUCTR2008-004533-21-NL | 25/06/2010 | 19 March 2012 | The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patients | The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patients | To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation. MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: Tracleer Product Code: 66215-101 Pharmaceutical Form: Coated tablet INN or Proposed INN: BOSENTAN CAS Number: 147536978 Current Sponsor code: 03602 Other descriptive name: Tracleer Concentration unit: mg milligram(s) Concentration type: range Concentration number: 62,5-250 | ICIN | Authorised | Female: yes Male: yes | 50 | Netherlands | ||||
| 325 | EUCTR2010-020917-97-IT | 23/06/2010 | 14 October 2013 | SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD. - SPHERIC-1 | SPHERIC-1 (Sildenafil in the Chronic Obstructive Pulmonary Disease associated to Chronic Pulmonary Hypertension. Sixteen weeks long, multicentre, randomized, double blind study, in comparison with placebo, for the evaluation of sildenafil in the treatment of patients affected by pulmonary hypertension associated to COPD. - SPHERIC-1 | Moderate to severe pulmonary hypertension associated to moderate to mild COPD. MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sildenafil Concentration unit: mg milligram(s) Concentration number: 20- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | ASSOCIAZIONE ITALIANA PNEUMOLOGI OSPEDALIERI | Not Recruiting | Female: yes Male: yes | Italy | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 326 | NCT00964678 | June 2010 | 16 December 2017 | Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension | Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Carvedilol | Virginia Commonwealth University | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 10 | Phase 1/Phase 2 | United States |
| 327 | NCT01174173 | June 2010 | 11 June 2018 | Ranolazine and Pulmonary Hypertension | Effects of Ranolazine in Patients With Angina Due to Right Ventricular Ischemia in Pulmonary Arterial Hypertension | Angina;Pulmonary Arterial Hypertension | Drug: Ranolazine | Northwestern University | Gilead Sciences | Not recruiting | 18 Years | 80 Years | All | 11 | Phase 3 | United States |
| 328 | EUCTR2010-018322-40-FR | 20/05/2010 | 26 June 2012 | A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 | A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension - EPITOME-2 | Pulmonary Arterial Hypertension MedDRA version: 12.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Epoprostenol-Actelion Product Name: Epoprostenol-Actelion Product Code: ACT-385781A Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: EPOPROSTENOL SODIUM CAS Number: 61849-14-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- | ACTELION Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 20 | Phase 3b | Netherlands;Belgium;France;Spain;Italy | |||
| 329 | NCT01105117 | May 2010 | 19 October 2017 | Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401 | An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan® | Actelion | Not recruiting | 18 Years | 65 Years | All | 2 | Phase 4 | United States | |
| 330 | NCT01131845 | May 2010 | 19 February 2015 | The Effect of Renal Impairment on the Pharmacokinetics of Oral Treprostinil | An Evaluation of the Pharmacokinetics and Safety of a Single Dose of UT-15C SR (Treprostinil Diethanolamine) in Subjects With Renal Impairment. | Pulmonary Arterial Hypertension;Renal Dysfunction | Drug: UT-15C SR (treprostinil diethanolamine) | United Therapeutics | Not recruiting | 18 Years | 79 Years | Both | 16 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 331 | EUCTR2009-018167-26-AT | 15/04/2010 | 2 June 2014 | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension | Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 12.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Glivec® Product Code: QTI571 Pharmaceutical Form: Tablet INN or Proposed INN: IMATINIB MESYLATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 140 | France;Belgium;Spain;Austria;Germany;Italy;United Kingdom | ||||
| 332 | NCT00995566 | April 2010 | 19 October 2017 | A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin | Thelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed Thelin | Pulmonary Arterial Hypertension | Drug: Sitaxentan sodium | Pfizer | Not recruiting | 18 Years | N/A | All | 54 | N/A | Belgium;France;Germany;Sweden | |
| 333 | NCT01083524 | March 2010 | 19 February 2015 | Dichloroacetate (DCA) for the Treatment of Pulmonary Arterial Hypertension | A Phase I, Open-Label, Two Centre Study to Evaluate Dichloroacetate(DCA) in Advanced Pulmonary Arterial Hypertension. | Pulmonary Hypertension (Idiopathic, Familial or Anorexigen-associated) | Drug: Dichloroacetate Sodium | University of Alberta | Imperial College London | Not recruiting | 18 Years | N/A | Both | 30 | Phase 1 | Canada;United Kingdom |
| 334 | NCT01105091 | March 2010 | 19 October 2017 | Epoprostenol for Injection in Pulmonary Arterial Hypertension | A Phase IV, Open-label, Randomized, Multicenter Study of the Safety, Tolerability,and Pharmacokinetics of ACT- 385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan® | Actelion | Not recruiting | 18 Years | 65 Years | All | 30 | Phase 4 | United States | |
| 335 | EUCTR2009-014992-31-BE | 22/02/2010 | 6 October 2015 | Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertension | Long-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OL | The intended indication is Pulmonary Arterial Hypertension MedDRA version: 18.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: selexipag Product Code: ACT-293987 Pharmaceutical Form: Tablet INN or Proposed INN: Selexipag Current Sponsor code: ACT-293987 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- | Actelion Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 1150 | Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 336 | EUCTR2009-014246-29-IE | 01/02/2010 | 18 September 2012 | A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) | A 12-week, double-blind, international, multicenter, dose-response study of the safety and efficacy of Beraprost Sodium Modified Release (BPS-MR) in patients with pulmonary arterial hypertension (PAH) | Pulmonary Arterial Hypertension MedDRA version: 12.0 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Beraprost Sodium CAS Number: 88475-69-8 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Modified-release tablet Route of administration of the placebo: Oral use | Lung Rx | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Germany;Belgium;Ireland | ||||
| 337 | EUCTR2009-014453-32-IE | 01/02/2010 | 6 January 2015 | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Beraprost Sodium CAS Number: 88475-69-8 Current Sponsor code: BPS-MR Other descriptive name: TRK-100STP Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 60- | Lung LLC Inc | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Belgium;Ireland;Germany | ||||
| 338 | EUCTR2008-005885-30-CZ | 12/01/2010 | 19 March 2012 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | Pulmonary arterial hypertension MedDRA version: 9.1 Level: HLT Classification code 10037401 Term: Pulmonary hypertensions | Trade Name: Thelin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SITAXSENTAN SODIUM CAS Number: 210421-64-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Pfizer Ltd | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Bulgaria | |||
| 339 | EUCTR2008-005886-78-CZ | 12/01/2010 | 12 December 2016 | A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | A PHASE 3, MULTI-CENTER, OPEN LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF MONOTHERAPY SITAXSENTAN SODIUM AND COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION | PULMONARY ARTERIAL HYPERTENSION MedDRA version: 9.1 Level: HLT Classification code 10037401 Term: Pulmonary hypertensions | Trade Name: Thelin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sitaxsentan Sodium CAS Number: 210421-64-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Revatio Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sildenafil citrate CAS Number: 139755-83-2 Current Sponsor code: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Pfizer Ltd. | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Bulgaria | |||
| 340 | EUCTR2008-005887-14-CZ | 12/01/2010 | 19 March 2012 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 | A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, EFFICACY AND SAFETY STUDY OF MONOTHERAPY SITAXSENTAN SODIUM VERSUS COMBINATION THERAPY WITH SITAXSENTAN SODIUM AND SILDENAFIL CITRATE IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSION WHO HAVE COMPLETED STUDY B1321001 | Pulmonary Arterial Hypertension MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Thelin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sitaxsentan Sodium CAS Number: 210421-64-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Revatio Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sildenafil Citrate CAS Number: 139755-83-2 Current Sponsor code: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Pfizer Ltd. | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Czech Republic;Bulgaria | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 341 | EUCTR2009-014453-32-BE | 11/01/2010 | 21 August 2017 | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patients | Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Beraprost Sodium CAS Number: 88475-69-8 Current Sponsor code: BPS-MR Other descriptive name: TRK-100STP Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 60- | Lung LLC | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | United States;Czech Republic;Belgium;Ireland;Romania;Germany | |||
| 342 | NCT01042158 | January 2010 | 16 December 2017 | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis | Pulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary Hypertension | Drug: tadalafil and ambrisentan upfront combination therapy | Johns Hopkins University | National Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford University | Not recruiting | 18 Years | N/A | All | 25 | Phase 4 | United States |
| 343 | NCT01066845 | January 2010 | 2 November 2015 | Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension | Safety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in Japan | Pulmonary Arterial Hypertension | Drug: tadalafil | Eli Lilly and Company | Not recruiting | 15 Years | N/A | Both | 1809 | N/A | ||
| 344 | NCT01148836 | January 2010 | 19 October 2017 | Coenzyme Q-10 and Pulmonary Arterial Hypertension | Coenzyme Q-10 in the Treatment of Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Dietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects;Dietary Supplement: Coenzyme Q-10 in Normal Control subjects | The Cleveland Clinic | Not recruiting | 18 Years | 55 Years | All | 18 | N/A | United States | |
| 345 | EUCTR2009-014490-41-DK | 08/12/2009 | 5 August 2014 | Study to evaluate if selexipag is safe and efficacious for the treatment of pulmonary arterial hypertension. | A multicenter, double-blind, placebo-controlled Phase 3 study assessing the safety and efficacy of selexipag on morbidity and mortality in patients with pulmonary arterial hypertension - GRIPHON | The intended indication is Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: ACT-293987 Product Code: ACT-293987 Pharmaceutical Form: Tablet INN or Proposed INN: Selexipag Current Sponsor code: ACT-293987 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | 1150 | Phase 3 | Serbia;United States;Belarus;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Germany;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 346 | NCT01112306 | December 1, 2009 | 16 September 2019 | ACT-293987 in Pulmonary Arterial Hypertension | Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of Selexipag (ACT-293987) in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: ACT-293987 | Actelion | Not recruiting | 18 Years | N/A | All | 670 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Czech Republic | |
| 347 | NCT01106014 | December 2009 | 19 October 2017 | Selexipag (ACT-293987) in Pulmonary Arterial Hypertension | A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Selexipag;Drug: Placebo | Actelion | Not recruiting | 18 Years | 75 Years | All | 1156 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Colombia;Czech Republic;Denmark;France;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom | |
| 348 | NCT01445873 | December 2009 | 19 October 2017 | Pilot Chart Review Study Of Sitaxentan Sodium (Thelin) In Patients With Pulmonary Arterial Hypertension (PAH) | Non-Interventional (NI) Drug Study Protocol: Three-Country Pilot Study For Retrospective Chart Review Of Effectiveness Of Thelin® (Sitaxsentan) In Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Sitaxentan sodium | Pfizer | Not recruiting | 18 Years | N/A | All | 36 | N/A | ||
| 349 | NCT00990314 | November 30, 2009 | 30 September 2019 | Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients | An Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) Patients | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Lung Biotechnology PBC | Not recruiting | 18 Years | 75 Years | All | 31 | Phase 2 | United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic | |
| 350 | EUCTR2008-003572-21-SE | 19/11/2009 | 19 March 2012 | A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OF PF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHIC AND FAMILIAL PULMONARY ARTERIAL HYPERTENSION | A PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OF PF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHIC AND FAMILIAL PULMONARY ARTERIAL HYPERTENSION | Pulmonary arterial hypertension. MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Product Name: PF-00489791 Pharmaceutical Form: Film-coated tablet CAS Number: 853003-48-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: PF-00489791 Pharmaceutical Form: Film-coated tablet CAS Number: 853003-48-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: PF-00489791 Pharmaceutical Form: Film-coated tablet CAS Number: 853003-48-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Revatio Pharmaceutical Form: Film-coated tablet Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Pfizer Ltd,Ramsgate Road,Sandwich,Kent CT13 9NJ | Not Recruiting | Female: yes Male: yes | 79 | Phase 2A | Germany;Belgium;Spain;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 351 | NCT00989963 | November 2009 | 19 February 2015 | Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH) | A 12-week, Double-blind, International, Multicenter, Dose-response Study of the Safety and Efficacy of Beraprost Sodium Modified Release (BPS-MR) in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Lung Biotechnology Inc. | Not recruiting | 18 Years | 75 Years | Both | 36 | Phase 2 | United States;Belgium;Czech Republic;Germany;Ireland;Romania | |
| 352 | EUCTR2009-012450-20-FR | 15/10/2009 | 19 March 2012 | Multicenter, open-label, non-comparative, proof-of-concept, phase 2a study to evaluate the effect of a single infusion of tezosentan on pulmonary vascular resistance in patients with stable, chronic pulmonary arterial hypertension, currently not treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or prostacyclines | Multicenter, open-label, non-comparative, proof-of-concept, phase 2a study to evaluate the effect of a single infusion of tezosentan on pulmonary vascular resistance in patients with stable, chronic pulmonary arterial hypertension, currently not treated with endothelin receptor antagonists, phosphodiesterase-5 inhibitors or prostacyclines | Pulmonary arterial hypertension MedDRA version: 12.0 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Product Name: Tezosentan Product Code: ACT-050089 (Ro 61-0612) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tezosentan CAS Number: 180384-58-0 Current Sponsor code: ACT-050089 (Ro 61-0612) Other descriptive name: Tezosentan Concentration unit: % (V/V) percent volume/volume Concentration type: equal Concentration number: 1- | Actelion Pharmaceuticals Ltd. | Authorised | Female: yes Male: yes | 13 | Phase 2a | France | |||
| 353 | NCT00866983 | October 2009 | 19 February 2015 | Local Open-Label Access Study For Patients Who Completed A1481244 Study In Brazil | A Local, Multi-Centre, Extension, Open Label Access Study, To Provide Sildenafil Therapy For Patients Who Completed A1481244 Study And Are Judged By The Investigator To Derive Clinical Benefit From Continued Treatment With Sildenafil , Prior To Reimbursement And Availability For Patients In Brazil. | Pulmonary Arterial Hypertension | Drug: sildenafil (Revatio) 20 mg TID | Pfizer | Not recruiting | 18 Years | N/A | Both | Phase 4 | Brazil | ||
| 354 | EUCTR2009-009366-13-GB | 02/09/2009 | 28 August 2012 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C2 | Pulmonary Arterial Hypertension MedDRA version: 14.0 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: treprostinil diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: treprostinil diethanolamine Product Code: UT-15C Pharmaceutical Form: Coated tablet INN or Proposed INN: treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.125- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | United Therapeutics Corporation | Not Recruiting | Female: yes Male: yes | 300 | Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||||
| 355 | JPRN-JapicCTI-121998 | 01/9/2009 | 23 April 2019 | Bosentan PAH (WHO-FC II) | Open label multicenter study to assess the efficacy, safety, and tolerability of bosentan in Japanese patients with pulmonary arterial hypertension (PAH) in WHO functional class II. | Pulmonary arterial hypertension (PAH) | Intervention name : Ro47-0203 INN of the intervention : Bosentan Dosage And administration of the intervention : Oral administration, Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients, Target dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg) | Actelion Pharmaceuticals Japan Ltd. | 18 | 74 | BOTH | 16 | Phase 3 | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 356 | NCT00902174 | September 2009 | 19 October 2017 | Imatinib (QTI571) in Pulmonary Arterial Hypertension | A 24-week Randomized Placebo-controlled, Double-blind Multi-center Clinical Trial Evaluating the Efficacy and Safety of Oral QTI571 as an add-on Therapy in the Treatment of Severe Pulmonary Arterial Hypertension: Imatinib in Pulmonary Arterial Hypertension, a Randomized, Efficacy Study (IMPRES) | Pulmonary Arterial Hypertension | Drug: imatinib mesylate;Drug: Placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 202 | Phase 3 | United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Switzerland;United Kingdom | |
| 357 | NCT00942708 | September 2009 | 29 June 2015 | Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension | Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Fluoxetine | University of Texas Southwestern Medical Center | Not recruiting | 16 Years | 75 Years | Both | 6 | Phase 2 | United States | |
| 358 | NCT00963001 | September 2009 | 19 February 2015 | Effect of Food on the Pharmacokinetics of Oral Treprostinil | Effect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy Volunteers | Hypertension, Pulmonary;Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine;Other: Standardized meals | United Therapeutics | Not recruiting | 18 Years | 55 Years | Both | 32 | Phase 1 | United States | |
| 359 | NCT00963027 | September 2009 | 19 February 2015 | Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil | An Evaluation of Single Dose UT-15C SR (Treprostinil Diethanolamine) Pharmacokinetics Following Repeated Dosing With the Proton Pump Inhibitor Esomeprazole in Healthy Adult Volunteers | Hypertension, Pulmonary;Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine;Drug: Esomeprazole | United Therapeutics | Not recruiting | 18 Years | 55 Years | Both | 30 | Phase 1 | United States | |
| 360 | EUCTR2009-012057-38-DE | 13/08/2009 | 28 August 2012 | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES | Pulmonary arterial hypertension (PAH) patients who have a PVR =800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Glivec® 100 mg Filmtabletten Product Code: QTI571 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Imatinib mesilate CAS Number: 220127-57-1 Current Sponsor code: QTI571 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 361 | EUCTR2008-006833-29-IE | 29/06/2009 | 6 January 2015 | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients | Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Beraprost Sodium CAS Number: 88475-69-8 Current Sponsor code: BPS-MR Other descriptive name: TRK-100STP Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 60- | Lung LLC | Not Recruiting | Female: yes Male: yes | 19 | Belgium;Ireland | ||||
| 362 | EUCTR2009-010703-80-DE | 11/06/2009 | 24 July 2012 | A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 | Indication: Symptomatic Pulmonary Arterial Hypertension MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Ventavis Product Name: Iloprost Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Iloprost CAS Number: 78919-13-8 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: -10 Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Actelion Pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | 63 | Germany;Austria | |||||
| 363 | EUCTR2009-011013-24-AT | 03/06/2009 | 19 March 2012 | A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Extension | A Multicenter, Double-blind, Randomized Study comparing the Safety and Tolerability of Iloprost inhalation solution delivered by I-neb utilizing Power disc-15 and Power disc-6 in Patients with Symptomatic Pulmonary Arterial Hypertension - PROWESS 15 Extension | Indication: Symptomatic Pulmonary Arterial Hypertension MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Ventavis Product Name: Iloprost Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Iloprost CAS Number: 78919-13-8 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: -10 | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 63 | Austria | ||||
| 364 | NCT00887978 | June 2009 | 19 October 2017 | Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: UT-15C SR;Drug: Placebo | United Therapeutics | Not recruiting | 18 Years | 75 Years | All | 310 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Portugal;Spain;Sweden;United Kingdom;Ireland;Norway | |
| 365 | ChiCTR-TCC-12002776 | 2009-05-01 | 18 April 2017 | BEraproST combined therapy with Sildenafil for pulmonary arterial hypertension | BEraproST combined therapy with Sildenafil for pulmonary arterial hypertension | Pulmonary arterial hypertension | Group B :beraprost combined with sildenafil ;A:Sildenafil citrate ; | Shanghai Pulmonary Hospital | Not Recruiting | 18 | 65 | Both | Group B :30;A:30; | Pilot study | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 366 | NCT00796666 | May 2009 | 19 October 2017 | Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil | A Phase 3, Multi-Center, Randomized, Double-Blind, Efficacy And Safety Study Of Monotherapy Sitaxsentan Sodium Versus Combination Therapy With Sitaxsentan Sodium And Sildenafil Citrate In Subjects With Pulmonary Arterial Hypertension Who Have Completed Study B1321001 (NCT00795639) | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: Sitaxsentan;Drug: Sitaxsentan and Sildenafil | Pfizer | Not recruiting | 16 Years | 80 Years | All | 131 | Phase 3 | United States;Argentina;Bulgaria;Chile;China;Colombia;Czech Republic;India;Malaysia;Mexico;Peru;Romania;Russian Federation;Serbia;South Africa;Thailand;Turkey;Ukraine;Costa Rica;Dominican Republic;Philippines;Saudi Arabia;Slovakia | |
| 367 | NCT00864201 | April 2009 | 19 February 2015 | A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease | A Pilot Study to Evaluate the Effect of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue Disease | Hypertension, Pulmonary;Connective Tissue Disease | Drug: bosentan | Hamilton Health Sciences Corporation | Actelion | Not recruiting | 18 Years | N/A | Both | 10 | Phase 3 | Canada |
| 368 | NCT01391104 | April 2009 | 19 February 2015 | Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension | Reproducibility and Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Sildenafil;Drug: Sugar Pill | Laval University | Not recruiting | 18 Years | 80 Years | Both | 22 | N/A | Canada | |
| 369 | NCT00878943 | March 31, 2009 | 8 January 2018 | Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study | A Local, Multi-centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 Study In India Or Ongoing In A1481269 Study Who Continue To Receive Benefit From Sildenafil Therapy. | Pulmonary Arterial Hypertension | Drug: Sildenafil citrate | Pfizer | Not recruiting | 18 Years | N/A | All | N/A | India | ||
| 370 | NCT00863681 | March 12, 2009 | 30 September 2019 | BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension | Long-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Riociguat (BAY63-2521) | Bayer | Not recruiting | 18 Years | 80 Years | All | 396 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Singapore;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Czech Republic;Ireland;Israel;Netherlands;New Zealand;Slovakia;Spain | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 371 | NCT00902603 | March 2009 | 20 April 2015 | Ventavis® Registry Protocol | Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Commercial Ventavis® (iloprost) | Actelion | Not recruiting | 19 Years | N/A | Both | 148 | N/A | United States | |
| 372 | EUCTR2008-003290-41-BE | 04/02/2009 | 14 October 2013 | A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients | A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patients | Pulmonary Arterial Hypertension MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Product Name: Beraprost Sodium Modified Release Product Code: BPS-MR Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Beraprost Sodium CAS Number: 88475-69-8 Current Sponsor code: BPS-MR Other descriptive name: TRK-100STP Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 60- | Lung Rx | Not Recruiting | Female: yes Male: yes | 20 | Belgium;Ireland | ||||
| 373 | JPRN-UMIN000001709 | 2009/02/01 | 2 April 2019 | Multikinase Inhibitor (Tyrosine and Serine/Threonine Kinase Inhibitor) for the Treatment of Severe Pulmonary Arterial Hypertension | pulmonary arterial hypertension | administration of sorafenib, which is the multikinase inhibitor (tyrosine and serine/threonine kinase inhibitor) | Medical Education Center, School of Medicine, Keio University | Not Recruiting | 20years-old | Not applicable | Male and Female | 10 | Not selected | Japan | ||
| 374 | NCT00792571 | February 2009 | 19 February 2015 | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients | An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients. | Pulmonary Arterial Hypertension | Drug: Beraprost Sodium Modified Release | Lung Biotechnology Inc. | Not recruiting | 18 Years | 75 Years | Both | 18 | Phase 2 | United States;Belgium;Ireland | |
| 375 | NCT00781885 | January 2009 | 19 February 2015 | A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients | A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH Patients | Pulmonary Arterial Hypertension | Drug: Beraprost sodium modified release | Lung Biotechnology Inc. | Not recruiting | 18 Years | 75 Years | Both | 19 | Phase 2 | United States;Belgium;Ireland | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 376 | NCT00811486 | January 2009 | 19 February 2015 | Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure | Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure | Right Heart Failure;Pulmonary Hypertension | Drug: Spironolactone and conivaptan | University of Colorado, Denver | Not recruiting | 18 Years | 75 Years | Both | 0 | N/A | United States | |
| 377 | NCT00832507 | January 2009 | 19 February 2015 | Study of Cicletanine for Pulmonary Arterial Hypertension (PAH) | A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-ranging Study of Cicletanine in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Cicletanine;Drug: Cicletanine Placebo | Gilead Sciences | Not recruiting | 16 Years | 70 Years | Both | 162 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Germany;Israel;Mexico;Spain;United Kingdom | |
| 378 | NCT01100736 | January 2009 | 3 August 2015 | Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3) | Characterisation of the Role of ETA and ETB Receptors in Regulating Plasma ET-1 and the Vasodilator Response to ET-3 in Man | Pulmonary Arterial Hypertension;Vasodilation;Vasoconstriction | Drug: Bosentan;Drug: Sitaxsentan;Drug: Placebo;Biological: Endothelin-3 | University of Edinburgh | Encysive Pharmaceuticals | Not recruiting | 18 Years | 70 Years | Both | 10 | Phase 0 | United Kingdom |
| 379 | JPRN-UMIN000001578 | 2008/12/01 | 2 April 2019 | Tyrosine Kinase Inhibitor for the Treatment of Severe Pulmonary Arterial Hypertension | pulmonary arterial hypertension | administration of tyrosine kinase inhibitor (imatinib) | Medical Education Center | 20years-old | Not applicable | Male and Female | 10 | Not selected | Japan | |||
| 380 | NCT00760916 | December 2008 | 19 February 2015 | FREEDOM DR: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor or as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH) | FREEDOM DR: An International, Multi-Center, 12-Week, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study Followed by a 12-Week Open-Label Extension Study to Assess the Efficacy, Safety, and Dose Response of UT-15C SR in Subjects With Pulmonary Hypertension | Pulmonary Hypertension | Drug: UT-15C 1 mg;Drug: UT-15C 0.25 mg;Drug: UT-15C 5 mg;Drug: Placebo | United Therapeutics | Not recruiting | 18 Years | 70 Years | Both | 0 | Phase 3 | United States;Australia;Mexico | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 381 | NCT00780728 | December 2008 | 19 February 2015 | Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial Hypertension | Addition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Sildenafil | University Health Network, Toronto | Not recruiting | 18 Years | N/A | Both | Phase 3 | Canada | ||
| 382 | NCT00795639 | December 2008 | 19 October 2017 | Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil (SR-PAAS) | A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Safety And Efficacy Study Of Sitaxsentan Sodium In Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: Sitaxsentan;Drug: Placebo | Pfizer | Not recruiting | 16 Years | 80 Years | All | 183 | Phase 3 | United States;Argentina;Bulgaria;Chile;China;Colombia;Costa Rica;Czech Republic;Dominican Republic;Guatemala;India;Malaysia;Mexico;Peru;Philippines;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;South Africa;Thailand;Turkey;Ukraine;Egypt;Jordan;Lebanon;United Arab Emirates | |
| 383 | NCT00814645 | December 2008 | 19 February 2015 | Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy Volunteers | A Placebo-Controlled, Phase 1b, Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution (AIR001 INHALATION SOLUTION) in Normal, Healthy Volunteers | Pulmonary Arterial Hypertension | Drug: Sodium Nitrite Inhalation Solution;Drug: Placebo and AIR001 Inhalation Solution (Expansion arm) | Aires Pharmaceuticals, Inc. | Not recruiting | 18 Years | 55 Years | Both | 25 | Phase 1 | United States | |
| 384 | EUCTR2008-003482-68-DE | 26/11/2008 | 3 December 2012 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | Bayer HealthCare AG | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||||
| 385 | EUCTR2008-003610-94-DE | 26/11/2008 | 4 February 2013 | Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 15.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Product Name: BAY 63-2521 tablets 2.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) | Bayer HealthCare AG | Authorised | Female: yes Male: yes | 462 | United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 386 | EUCTR2007-003694-27-DE | 28/10/2008 | 26 October 2015 | Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension | SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label) Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL | symptomatic pulmonary arterial hypertension MedDRA version: 17.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 Pharmaceutical Form: Tablet INN or Proposed INN: macitentan CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | Actelion Pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | 700 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||||
| 387 | NCT00667823 | October 17, 2008 | 16 September 2019 | Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension | Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | Not recruiting | 12 Years | N/A | All | 550 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Croatia;Czech Republic;Denmark;Finland;Japan;Korea, Republic of;Norway;Portugal;Spain | |
| 388 | NCT00800592 | October 2008 | 16 December 2017 | Sildenafil IV Bolus Study | An Open Single Dose Study To Assess The Safety, Tolerability And Pharmacokinetics Of An Intravenous Bolus Dose (10 Mg) Of Sildenafil In Patients With Pulmonary Arterial Hypertension (PAH). | Hypertension, Pulmonary | Drug: sildenafil | Pfizer | Not recruiting | 18 Years | N/A | All | 12 | Phase 1 | Belgium | |
| 389 | JPRN-UMIN000001350 | 2008/09/01 | 2 April 2019 | Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseases | Pulmonary arterial hypertension (PAH) associated with connective tissue disease | Beraprost sodium Beraprost sodium and Sildenafil citrate | Keio University | Not Recruiting | 18years-old | 80years-old | Male and Female | 70 | Not selected | Japan | ||
| 390 | NCT00709098 | September 2008 | 19 October 2017 | Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial Hypertension | A Multicenter, Double-blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: iloprost | Actelion | Not recruiting | 18 Years | N/A | All | 49 | Phase 3 | United States;Austria;Germany | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 391 | NCT00741819 | September 2008 | 19 October 2017 | Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects | An Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension. | Pulmonary Arterial Hypertension | Drug: Inhaled treprostinil | United Therapeutics | Not recruiting | 18 Years | 75 Years | All | 73 | Phase 4 | United States | |
| 392 | NCT00825266 | September 2008 | 16 December 2017 | Insulin Resistance in Pulmonary Arterial Hypertension | The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: bosentan;Drug: Pioglitazone | Stanford University | Not recruiting | 18 Years | 75 Years | All | 2 | Phase 2 | United States | |
| 393 | NCT01338636 | September 2008 | 16 December 2017 | An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Participants With Exercise-Induced Pulmonary Arterial Hypertension (PAH) | An Open-Label Uncontrolled Study of the Safety and Efficacy of Ambrisentan in Patients With Exercise Induced Pulmonary Arterial Hypertension | Exercise-induced Pulmonary Arterial Hypertension | Drug: Ambrisentan | Brigham and Women's Hospital | Gilead Sciences | Not recruiting | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 394 | NCT00705588 | August 2008 | 19 February 2015 | Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids. | Pulmonary Arterial Hypertension | Drug: Tadalafil;Drug: Vardenafil | Rabin Medical Center | Not recruiting | 18 Years | N/A | Both | 30 | Phase 4 | Israel | ||
| 395 | NCT00742014 | August 2008 | 19 February 2015 | The Assessment of Right Ventricular Contractility in Response to Sildenafil | The Assessment of Right Ventricular Contractility in Response to Sildenafil in Pediatric Patients With Pulmonary Arterial Hypertension | Hypertension | Drug: Sildenafil | The Hospital for Sick Children | Not recruiting | 1 Year | 18 Years | Both | 10 | Phase 3 | Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 396 | NCT00705133 | July 2008 | 11 June 2018 | Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial Hypertension | Using Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung Disease | Pulmonary Arterial Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary Fibrosis | Drug: Treprostinil | Rajan Saggar | United Therapeutics | Not recruiting | N/A | N/A | All | 15 | Phase 2 | United States |
| 397 | NCT00709956 | July 2008 | 19 October 2017 | Iloprost Power 15 in Pulmonary Arterial Hypertension | A Multicenter, Double-blind, Randomized, Placebo-controlled, Crossover Study to Assess the Effects of a Single Dose of Iloprost Power 15 on Exercise Capacity in Patients With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: iloprost (5 µg);Drug: placebo | Actelion | Not recruiting | 18 Years | N/A | All | 64 | Phase 3 | United States;Austria;Germany | |
| 398 | NCT00718952 | July 2008 | 19 February 2015 | The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial Hypertension | Multi-centre, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Treatment of Pulmonary Arterial Hypertension With Vardenafil in China | Pulmonary Hypertension | Drug: Vardenafil;Drug: Placebo | Tongji University | Not recruiting | 12 Years | 65 Years | Both | 60 | Phase 3 | China | |
| 399 | NCT00723554 | July 2008 | 19 October 2017 | Iloprost Power Disc-15 in Pulmonary Arterial Hypertension | A Phase IIIb, Multicenter, Open-label Study of Patients With Pulmonary Arterial Hypertension Treated With Iloprost(Inhalation)Evaluating Safety and Inhalation Times When Converting From Power Disc-6 (PD-6) to Power Disc-15 (PD-15) With the I-neb® AAD® | Pulmonary Arterial Hypertension | Drug: Iloprost PD-6;Drug: Iloprost PD-15 | Actelion | Not recruiting | 18 Years | 85 Years | All | 63 | Phase 3 | United States | |
| 400 | EUCTR2007-001643-21-GB | 26/06/2008 | 19 March 2012 | Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension | Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension | Pulmonary hypertension in patients with interstitial lung disease. MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: Tracleer Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Bosentan CAS Number: 147536-97-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 62.5-125 Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Royal Brompton and Harefield NHS Trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 401 | EUCTR2007-003621-24-FR | 29/05/2008 | 19 March 2012 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: Aviptadil CAS Number: 40077-57-4 Other descriptive name: VIP Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Powder for nebuliser solution Route of administration of the placebo: Inhalation use | MondoGEN AG | Authorised | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | ||||
| 402 | EUCTR2007-002440-14-GB | 15/05/2008 | 7 January 2013 | A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN | A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN | To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Product Name: ACT-064992 Product Code: ACT-064992 Pharmaceutical Form: Tablet CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: -3 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: ACT-064992 Product Code: ACT-064992 Pharmaceutical Form: Tablet CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Other descriptive name: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: -10 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd. | Authorised | Female: yes Male: yes | 700 | Phase 3 | Portugal;France;Finland;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 403 | EUCTR2007-003328-39-BE | 25/04/2008 | 19 March 2012 | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | A multi-centre, multinational, open-label single-dose acute hemodynamic study followed by a multi-centre, multinational, randomized, double-blind, parallel-group, placebo controlled study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy (proof-of-concept) of ACT-293987 (NS-304) in the treatment of pulmonary arterial hypertension in subjects aged 18 years and over | pulmonary arterial hypertension (PAH) (idiopathic PAH, familial PAH, and PAH associated with collagen disease, corrected congenital vitium or anorexigen use) MedDRA version: 9.1 Level: LLT Classification code 10065151 Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10065152 Term: Familial pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10065150 Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Product Code: ACT-293987 (NS-304) Pharmaceutical Form: Tablet INN or Proposed INN: 2-(4-[5,6-diphenylpyrazin-2-yl)(isopropyl)amino]butoxy)-N-(methylsulfonyl)actamide Current Sponsor code: ACT-293987 (NS-304) Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | 44 | Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria | ||||
| 404 | EUCTR2006-006748-76-NL | 23/04/2008 | 19 March 2012 | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | A MULTINATIONAL, MULTICENTRE, RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO ASSESS THE EFFICACY AND SAFETY OF 1 MG, 5MG AND 20 MG TID OF ORAL SILDENAFIL IN THE TREATMENT OF SUBJECTS AGED 18 YEARS AND OVER WITH PULMONARY ARTERIAL HYPERTENSION (PAH) - N/A | Pulmonary arterial hypertension (PAH). MedDRA version: 8.1 Level: LLT Classification code 10037400 Term: Pulmonary hypertension | Trade Name: Revatio Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Trade Name: Revatio Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Revatio Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil citrate Other descriptive name: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- | Pfizer Ltd. Ramsgate Road, Sandwich, Kent, UK | Not Recruiting | Female: yes Male: yes | 284 | United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia | ||||
| 405 | NCT00430716 | April 2008 | 19 October 2017 | To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension. | A Multinational, Multicentre, Randomized, Parallel Group, Double-Blind Study To Assess The Efficacy and Safety Of 1 mg, 5 mg and 20 mg TID of Oral Sildenafil in the Treatment of Subjects Aged 18 Years and Over With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Sildenafil citrate | Pfizer | Not recruiting | 18 Years | N/A | All | 130 | Phase 4 | United States;Belgium;Brazil;Bulgaria;China;Greece;India;Italy;Latvia;Malaysia;Netherlands;Philippines;Poland;Romania;Russian Federation;Thailand;United Kingdom;Denmark;Panama | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 406 | NCT00581607 | April 2008 | 19 February 2015 | Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension | Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary Hypertension | Sarcoidosis;Pulmonary Arterial Hypertension | Drug: Bosentan;Drug: Placebo | University of Cincinnati | Actelion | Not recruiting | 18 Years | N/A | Both | 43 | Phase 2/Phase 3 | United States |
| 407 | NCT00617305 | April 2008 | 19 October 2017 | Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1) | An Open-label, Multicenter Study of Ambrisentan and a Phosphodiesterase Type-5 Inhibitor Combination Therapy in Subjects With Pulmonary Arterial Hypertension Who Have Demonstrated a Sub-Optimal Response to a Phosphodiesterase Type-5 Inhibitor | Pulmonary Arterial Hypertension | Drug: Ambrisentan;Drug: Placebo;Drug: Sildenafil;Drug: Tadalafil | Gilead Sciences | Not recruiting | 16 Years | 75 Years | All | 38 | Phase 4 | United States | |
| 408 | EUCTR2007-002803-42-AT | 05/03/2008 | 8 April 2013 | Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial | Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trial | Pulmonary arterial hypertension (PAH) is associated with poor prognosis.The most common cause of death is right heart failure. The fact that right heart failure is associated with low systemic perfusion pressures limits the systemic use of potent vasodilators in this patient population. As a consequence, no therapeutic recommendations exist for patients experiencing right heart failure in the course of PAH. | Trade Name: Ventavis(Iloprost) Product Name: Ventavis(Iloprost) Pharmaceutical Form: Nebuliser solution | Univ.Clinic of Internal Medicine II, Department of Cardiology, Medical University of Vienna, Austria | Not Recruiting | Female: yes Male: yes | 8 | Austria | ||||
| 409 | NCT00435331 | March 2008 | 19 February 2015 | 6R-BH4 Pulmonary Arterial Hypertension Study | A Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Efficacy of 6R-BH4 in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: sapropterin dihydrochloride (6R-BH4) | Vanderbilt University | National Institutes of Health (NIH);BioMarin Pharmaceutical | Not recruiting | 18 Years | N/A | Both | 14 | Phase 1 | United States |
| 410 | NCT00643604 | March 2008 | 19 October 2017 | Rapid Switch From Flolan to Remodulin in the Outpatient Clinic | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment Satisfaction | Hypertension, Pulmonary | Drug: treprostinil sodium | United Therapeutics | Not recruiting | 18 Years | 70 Years | All | 7 | Phase 4 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 411 | NCT00554619 | February 2008 | 19 October 2017 | A Study to Evaluate GSK1325760A - a Long-Term Extension Study | Study AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study - | Pulmonary Arterial Hypertension;Hypertension, Pulmonary | Drug: GSK1325760A | GlaxoSmithKline | Not recruiting | N/A | N/A | All | 21 | Phase 3 | Japan | |
| 412 | NCT01200732 | February 2008 | 19 February 2015 | Phosphodiesterase-5 Inhibitor in Eisenmenger Syndrome | Clinical Efficacy of Phosphodiesterase-5 Inhibitor Tadalafil in Eisenmenger Syndrome - A Randomised, Placebo Controlled, Double Blind, Crossover Study | Eisenmenger Syndrome | Drug: Tadalafil, placebo | Govind Ballabh Pant Hospital | Not recruiting | 18 Years | N/A | Both | 28 | Phase 2 | India | |
| 413 | NCT00909337 | January 2008 | 19 February 2015 | Early Therapy of Pulmonary Arterial Hypertension | Early Therapy of Pulmonary Arterial Hypertension | Pulmonary Hypertension;Systemic Sclerosis | Drug: Bosentan | Medical University of Graz | Actelion | Not recruiting | 18 Years | 90 Years | Both | 10 | N/A | Austria |
| 414 | EUCTR2007-001645-17-GB | 04/12/2007 | 19 March 2012 | Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung Disease | Prevention of Established Pulmonary Hypertension in High Risk patients with Fibrotic Lung Disease – a double-blinded, randomised, placebo controlled trial with endothelin-1 receptor antagonist therapy - Prevention of Pulmonary Hypertension in Interstitial Lung Disease | Pulmonary hypertension in patients with interstitial lung disease. Specifically this trial looks at patients who have mild pulmonary hypertension, or are in an at-risk group to developing pulmonary hypertension, in the context of their interstitial lung disease. The interstitial lung diseases addressed include idiopathic pulmonary fibrosis and non-specific interstitial pneumonitis. MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: Tracleer Pharmaceutical Form: Film-coated tablet Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Royal Brompton and Harefield NHS Trust | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
| 415 | EUCTR2007-002774-64-DE | 04/12/2007 | 31 July 2012 | Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - Sildenafil | Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - Sildenafil | Patients with pre-existing congenital heart disease may develop Eisenmenger physiology (EP), characterized by development of pulmonary arterial hypertension and intracardiac right to left shunt. This Patients suffer from cyanosis and reduced quality of life. While EP has been regarded as not amenable to conventional treatments, new oral drugs as Sildenafil have been used successfully to improve primary arterial hypertension. Thus may be an important treatment option for patients with EP, too. | Trade Name: Revatio Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SILDENAFIL CAS Number: 139755832 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Deutsches Herzzentrum Berlin, Kompetenznetz Angeborene Herzfehler | Not Recruiting | Female: yes Male: yes | 80 | Germany | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 416 | NCT00586794 | December 2007 | 19 February 2015 | Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients | Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger Patients | Pulmonary Arterial Hypertension (PAH) | Drug: Sildenafil;Drug: Placebo | Competence Network for Congenital Heart Defects | German Federal Ministry of Education and Research | Not recruiting | 14 Years | N/A | Both | 24 | Phase 3 | Germany |
| 417 | NCT00625469 | October 2007 | 11 June 2018 | Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan | Treatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot Study | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis | Drug: bosentan | Rajan Saggar | Actelion | Not recruiting | N/A | N/A | All | 0 | Phase 4 | United States |
| 418 | NCT00540436 | August 2007 | 19 October 2017 | Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension | Study AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A - | Hypertension, Pulmonary | Drug: GSK1325760A | GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 25 | Phase 2 | Japan | |
| 419 | EUCTR2005-005068-97-SE | 18/06/2007 | 6 January 2015 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA: a.Idiopathic (IPAH) b.Familial (FPAH) c.Associated with (APAH): i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair iii.Drugs and toxins MedDRA version: 9.1 Level: LLT Classification code 10064908 Term: Associated with (APAH) MedDRA version: 9.1 Level: LLT Classification code 10064909 Term: Idiopathic (IPAH) MedDRA version: 9.1 Level: LLT Classification code 10064910 Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: Ro-47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 62.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: Ro-47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | |||
| 420 | EUCTR2006-004705-26-GB | 10/05/2007 | 19 March 2012 | Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology | Safety and Tolerability of Sildenafil in Patients with Eisenmenger Physiology | Eisenmenger Syndrome (pulmonary hypertension due to congenital heart disease) MedDRA version: 8.1 Level: LLT Classification code 10058554 Term: Eisenmenger's syndrome | Trade Name: Revatio ® 20 mg film-coated tablets Product Name: Sildenafil Pharmaceutical Form: Tablet INN or Proposed INN: Sildenafil (REVATIO) CAS Number: 139755832 Current Sponsor code: cro529 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Imperial College London | Authorised | Female: yes Male: yes | United Kingdom | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 421 | NCT00454207 | April 2007 | 19 October 2017 | Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension | A Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: sildenafil citrate (UK-92,480) | Pfizer | Not recruiting | 16 Years | N/A | All | 44 | Phase 3 | Japan | |
| 422 | NCT00433329 | March 2007 | 19 October 2017 | Combination Therapy in Pulmonary Arterial Hypertension | COMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac Remodeling | Pulmonary Arterial Hypertension | Drug: Bosentan;Drug: Sildenafil | Actelion | Not recruiting | 12 Years | N/A | All | 100 | Phase 4 | United States | |
| 423 | NCT00452218 | March 2007 | 5 September 2016 | Sorafenib Study: Dosing in Patients With Pulmonary Arterial Hypertension (PAH) | Sorafenib Study: Dosing in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Sorafenib | University of Chicago | Bayer | Not recruiting | 18 Years | N/A | Both | 12 | Phase 1 | United States |
| 424 | NCT00458042 | March 2007 | 19 February 2015 | Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction | Transitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction | Hypertension, Pulmonary | Drug: treprostinil sodium | United Therapeutics | Not recruiting | 18 Years | 65 Years | Both | 10 | Phase 4 | United States | |
| 425 | EUCTR2006-000801-50-AT | 19/02/2007 | 19 March 2012 | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects with Pulmonary Arterial Hypertension - FREEDOM-M | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with: 1) Appetite suppressant/toxin use, or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or 3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: Treprostinil Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: Treprostinil Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: Treprostinil Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: Treprostinil Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.125- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | United Therapeutics Corporation | Not Recruiting | Female: yes Male: yes | 150 | Netherlands;Belgium;France;Italy;Austria | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 426 | EUCTR2006-000800-17-IE | 15/02/2007 | 19 March 2012 | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | A 16-Week International, Multicenter, Double-Blind, Randomized, Placebo Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination with an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects with Pulmonary Arterial Hypertension - FREEDOM-C | Idiopathic or Familial pulmonary arterial hypertension (PAH), including PAH associated with: 1) Appetite suppressant use, or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years), or 3) Collagen Vascular Disease (CVD), or 4) Human Immunodeficiency virus (HIV) MedDRA version: 8.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension | Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: Treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: Treprostinil Diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: Treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | United Therapeutics Corporation | Not Recruiting | Female: yes Male: yes | 300 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | ||||
| 427 | EUCTR2006-000804-18-IE | 15/02/2007 | 22 July 2013 | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXT | Idiopathic or familial pulmonary arterial hypertension (PAH), including PAH associated with : 1) Appetite suppressant use or 2) Repaired congenital systemic-to-pulmonary shunts (repaired = 5 years) or 3) Collagen Vascular Disease (CVD) or 4) Human Immunodeficiency Virus (HIV) MedDRA version: 8.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension | Product Name: Treprostinil diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: Treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Product Name: Treprostinil diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: Treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Name: Treprostinil diethanolamine Product Code: UT-15C SR Pharmaceutical Form: Coated tablet INN or Proposed INN: Treprostinil diethanolamine Current Sponsor code: UT-15C SR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | United Therapeutics Corporation | Not Recruiting | Female: yes Male: yes | 450 | Portugal;France;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||||
| 428 | NCT00439946 | February 2007 | 19 October 2017 | Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) Using the Crono Five Ambulatory Infusion Pump in Patients With Stable Pulmonary Arterial Hypertension (PAH): Safety, Efficacy and Treatment Satisfaction | Pulmonary Arterial Hypertension | Drug: treprostinil;Device: Crono Five ambulatory pump | United Therapeutics | Not recruiting | 18 Years | 65 Years | All | 8 | Phase 4 | United States | |
| 429 | NCT00625079 | February 2007 | 11 June 2018 | Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With Sildenafil | Randomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot Study | Pulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary Hypertension | Drug: sildenafil | University of California, Los Angeles | Pfizer | Not recruiting | N/A | N/A | All | 0 | Phase 4 | United States |
| 430 | JPRN-C000000340 | 2007/01/01 | 2 April 2019 | Effects of phosphodiesterase V (sildenafil) on pulmonary arterial hypertension | Pulmonary arterial hypertension | Treatment with sildenafil 25mg three times daily for 24 weeks Treatment with prior therapy without sildenafil for 24 weeks | Division of cardiovascular internal medicine, The University of Tokyo Hospital | Not Recruiting | 18years-old | 80years-old | Male and Female | 20 | Phase 2,3 | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 431 | EUCTR2006-002235-25-GB | 14/12/2006 | 19 March 2012 | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A | Pulmonary Arterial Hypertension MedDRA version: 9.0 Level: LLT Classification code 10064911 | Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil (as citrate) CAS Number: N/A Other descriptive name: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Revatio Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil (as citrate) CAS Number: N/A Other descriptive name: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil (as citrate) CAS Number: N/A Other descriptive name: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Sildenafil Citrate Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil (as citrate) CAS Number: N/A Other descriptive name: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom | Authorised | Female: yes Male: yes | 200 | Finland;United Kingdom | ||||
| 432 | NCT00403650 | November 2006 | 19 February 2015 | Inhaled Iloprost for Sarcoidosis-associated Pulmonary Hypertension | Inhaled Iloprost for Sarcoidosis Associated Pulmonary Hypertension | Sarcoidosis;Pulmonary Arterial Hypertension | Drug: Iloprost | University of Cincinnati | Not recruiting | 18 Years | 90 Years | Both | 20 | Phase 4 | United States | |
| 433 | EUCTR2006-003520-10-DE | 20/10/2006 | 28 November 2016 | Long-term study to collect additional information to evaluate the saftey and tolerability of BAY 63-2521 in different doses | A multicenter, non-randomized, non-blinded, non-controlled study to investigate the impact of multiple doses of BAY 63 2521 on safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with pulmonary hypertension in a 12 week 3 times a day individual dose titration scheme | Subjects with PH due to • Pulmonary arterial hypertension (PAH) [Venice protocol] or • Chronic thrombembolic PH (CTEPH) MedDRA version: 19.0 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Product Name: BAY 63-2521 Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Product Name: BAY 63-2521 Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Product Name: BAY 63-2521 Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Product Name: BAY 63-2521 Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.0- | Bayer HealthCare AG | Not Recruiting | Female: yes Male: yes | 0 | Phase 1;Phase 2 | Germany | |||
| 434 | EUCTR2006-002081-19-NL | 16/10/2006 | 19 March 2012 | The Effects of EGFR Inhibition on Pulmonary Arterial Hypertension Associated with Systemic Sclerosis A phase II open-label safety and efficacy study. - EGFR Inhibition in SSc-PAH | The Effects of EGFR Inhibition on Pulmonary Arterial Hypertension Associated with Systemic Sclerosis A phase II open-label safety and efficacy study. - EGFR Inhibition in SSc-PAH | Pulmonary arterial hypertension associated with systemic sclerosis | Trade Name: Erbitux Product Name: Cetuximab Product Code: C225 Pharmaceutical Form: Intravenous infusion | VU University Medical Centre | Authorised | Female: yes Male: yes | 20 | Phase 2 | Netherlands | |||
| 435 | NCT00325403 | October 2006 | 19 October 2017 | FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH) | A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Oral treprostinil (UT-15C) Sustained Release Tablets;Other: Placebo | United Therapeutics | Not recruiting | 12 Years | 75 Years | All | 349 | Phase 3 | United States;Austria;Belgium;Canada;China;France;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 436 | NCT00325442 | October 2006 | 16 December 2017 | FREEDOM-C: Oral Treprostinil in Combination With an Endothelin Receptor Antagonist (ERA) and/or a Phosphodiesterase-5 (PDE-5) Inhibitor for the Treatment of Pulmonary Arterial Hypertension (PAH) | A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Combination With an Endothelin Receptor Antagonist and/or a Phosphodiesterase-5 Inhibitor in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Oral treprostinil (UT-15C) sustained release tablets;Drug: Placebo | United Therapeutics | Not recruiting | 12 Years | 70 Years | All | 354 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Spain;United Kingdom | |
| 437 | NCT00323024 | September 2006 | 19 February 2015 | Dose Determination Safety and Activity Study of Inhaled NX1011 to Treat Pulmonary Arterial Hypertension | An Open-Label, Dose-Determination Safety, Tolerability, and Activity Study of Inhaled NX1011 in Patients With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: NX1011 | NITROX, LLC | Not recruiting | 18 Years | 75 Years | Both | 72 | Phase 2 | United States | |
| 438 | NCT00373360 | September 2006 | 19 October 2017 | Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to Remodulin | Rapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment Satisfaction | Pulmonary Hypertension | Drug: treprostinil sodium | United Therapeutics | Not recruiting | 18 Years | 70 Years | All | 10 | Phase 4 | United States | |
| 439 | NCT00384865 | September 2006 | 16 December 2017 | A Study of Aspirin and Simvastatin in Pulmonary Arterial Hypertension | A Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Simvastatin;Drug: Aspirin;Drug: Placebo | University of Pennsylvania | National Heart, Lung, and Blood Institute (NHLBI) | Not recruiting | 18 Years | N/A | All | 64 | Phase 2 | United States |
| 440 | NCT00453414 | July 2006 | 19 February 2015 | Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension | Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Iloprost Inhalation Solution (Ventavis) | Actelion | Not recruiting | 3 Years | 18 Years | Both | 0 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 441 | NCT01062282 | July 2006 | 19 February 2015 | Hypertension Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension (VENIS) | VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Iloprost (Ventavis BAYQ6256) | Bayer | Not recruiting | 18 Years | N/A | Both | 41 | N/A | Korea, Republic of | |
| 442 | EUCTR2005-006192-13-GB | 22/06/2006 | 19 March 2012 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF INHALED ILOPROST IN PATIENTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) RECEIVING ORAL SILDENAFIL - VISION | Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1 Level: LLT Classification code 10037400 Term: Pulmonary hypertension | Trade Name: Ventavis Product Name: Iloprost (Ventavis®) Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: Iloprost CAS Number: 78919-13-8 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use | Actelion Pharmaceuticals US, Inc. | Not Recruiting | Female: yes Male: yes | 180 | Portugal;Germany;United Kingdom;Spain;Italy;Austria | ||||
| 443 | EUCTR2006-001464-23-CZ | 08/06/2006 | 12 May 2014 | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A | Pulmonary Arterial Hypertension MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sildenafil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJ | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;Italy;United Kingdom | ||||
| 444 | NCT00946114 | June 2006 | 19 October 2017 | To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks | A Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For One Hundred Twelve Weeks / Prior To Reimbursement And Availability For Patients In Poland. | Pulmonary Hypertension | Drug: sildenafil | Pfizer | Not recruiting | 18 Years | N/A | All | 32 | N/A | Poland | |
| 445 | NCT00303459 | May 2006 | 19 October 2017 | Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH) | Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study | Pulmonary Arterial Hypertension | Drug: bosentan;Drug: placebo | Actelion | Not recruiting | 12 Years | N/A | All | 334 | Phase 4 | United States;Brazil;Czech Republic;Denmark;Germany;Greece;Portugal;Saudi Arabia;Slovakia;Spain;Sweden;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 446 | NCT00469027 | May 2006 | 24 October 2016 | Pulmonary Hypertension: Assessment of Cell Therapy | Phase I Trial to Establish Safety of Autologous Progenitor Cell-based Gene Therapy Delivery of heNOS in Patients With Severe Pulmonary Arterial Hypertension(PAH)Refractory to Conventional Treatment | Hypertension, Pulmonary | Biological: eNOS transfected EPCs will be delivered via a PA line | Northern Therapeutics | St. Michael's Hospital, Toronto;Sir Mortimer B. Davis - Jewish General Hospital;St. Michael's Hospital, Toronto;Sir Mortimer B. Davis - Jewish General Hospital | Not recruiting | 18 Years | 80 Years | Both | 7 | Phase 1 | Canada |
| 447 | NCT00595049 | May 2006 | 11 May 2015 | Pulmonary Artery Remodelling With Bosentan | Open Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH). | Hypertension, Pulmonary | Drug: bosentan | Actelion | Not recruiting | 18 Years | N/A | Both | 11 | Phase 4 | Australia;United States | |
| 448 | NCT01027949 | May 2006 | 14 October 2019 | An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension | An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Treprostinil diethanolamine | United Therapeutics | Not recruiting | 12 Years | N/A | All | 900 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;India;Ireland;Israel;Italy;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Spain;Sweden;United Kingdom;Czech Republic | |
| 449 | EUCTR2005-002692-33-GB | 10/04/2006 | 18 April 2012 | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGY | Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. | Product Name: Cialis Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Tadalafil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5 or 10 or 20- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Lilly ICOS LLC | Authorised | Female: yes Male: yes | 400 | Phase 3 | Germany;United Kingdom;Spain;Ireland;Italy | |||
| 450 | EUCTR2005-002844-24-GB | 10/04/2006 | 14 August 2012 | A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX | A Double-Blind, Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients with Pulmonary Arterial Hypertension - LVGX | Pulmonary arterial hypertension (PAH) is a chronic and progressive disease characterised by elevation of pulmonary artery pressure and pulmonary vascular resistance, leading to right heart failure and death. | Product Name: Cialis Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Tadalafil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20 - | Lilly ICOS LLC | Authorised | Female: yes Male: yes | 350 | Germany;United Kingdom;Spain;Ireland;Italy | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 451 | NCT01721564 | April 2006 | 19 October 2017 | Bosentan and Pulmonary Endothelial Function | Pulmonary Artery Remodelling With Bosentan | Pulmonary Arterial Hypertension | Drug: Bosentan | Prof David S Celermajer | Not recruiting | 18 Years | 80 Years | All | 8 | N/A | ||
| 452 | EUCTR2005-005066-37-GB | 15/03/2006 | 19 March 2012 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 | Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxins Patients are already on prescribed bosentan therapy for at least 12 weeks. | Trade Name: viagra Product Name: sildenafil Product Code: N/A Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Sildenafil citrate CAS Number: 171599-83-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- | Actelion Pharmaceuticals Ltd. | Authorised | Female: yes Male: yes | 44 | Phase 2 | Germany;United Kingdom;Italy | |||
| 453 | EUCTR2006-000021-57-DK | 10/03/2006 | 19 March 2012 | Bosentan and Sildenfil for patients with Eisenmenger syndrome | Bosentan and Sildenfil for patients with Eisenmenger syndrome | Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome). | Trade Name: Tracleer Product Name: Tracleer Pharmaceutical Form: Tablet Other descriptive name: Bosentan monohydrat Trade Name: VIAGRA Product Name: Viagra Pharmaceutical Form: Tablet Other descriptive name: sildenafil Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Rigshospitalet | Not Recruiting | Female: yes Male: yes | 20 | Denmark | ||||
| 454 | NCT00303004 | March 2006 | 19 February 2015 | Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome | Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers Syndrome | Eisenmenger Syndrome | Drug: Bosentan and Sildenafil | Rigshospitalet, Denmark | Not recruiting | 18 Years | N/A | Both | 20 | Phase 3 | Denmark | |
| 455 | NCT00310830 | March 2006 | 19 February 2015 | Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients With Pulmonary Arterial Hypertension (PAH) | Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell Disease | Pulmonary Hypertension | Drug: Bosentan | Actelion | Not recruiting | 12 Years | N/A | Both | 14 | Phase 3 | United States;France;Netherlands;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 456 | NCT00302211 | February 2006 | 19 October 2017 | The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension | A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral Sildenafil | Pulmonary Hypertension | Drug: Iloprost Inhalation Solution (Ventavis);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: Bosentan | Actelion | Not recruiting | 12 Years | 85 Years | All | 67 | Phase 3 | United States | |
| 457 | EUCTR2005-005569-12-GB | 26/01/2006 | 10 July 2015 | A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension. | A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension. | pulmonary arterial hypertension | Trade Name: Glivec Product Name: Glivec Product Code: STI571 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Imatinib Current Sponsor code: STI571 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: STI571 Pharmaceutical Form: Coated tablet INN or Proposed INN: Imatinib Current Sponsor code: STI571 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 60 | Austria;Germany;United Kingdom | ||||
| 458 | NCT00549302 | December 2005 | 19 October 2017 | Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the Lungs | An Extension Study to Evaluate the Long-Term Safety and Efficacy of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment of Patients With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: tadalafil | Eli Lilly and Company | ICOS Corporation | Not recruiting | 12 Years | N/A | All | 357 | Phase 3 | United States;Belgium;Canada;France;Germany;Ireland;Italy;Japan;Spain;United Kingdom |
| 459 | EUCTR2005-001193-28-AT | 08/11/2005 | 22 April 2013 | ARIES-320/321-E “A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321 - 320/321-E | ARIES-320/321-E “A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321 - 320/321-E | Pulmonary Arterial Hypertension | Product Name: Ambrisentan Product Code: BSF 208075 Pharmaceutical Form: Tablet INN or Proposed INN: Ambrisentan CAS Number: 177036-94-1 Current Sponsor code: BSF 208075 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Product Name: Ambrisentan Product Code: BSF 208075 Pharmaceutical Form: Tablet INN or Proposed INN: Ambrisentan CAS Number: 177036-94-1 Current Sponsor code: BSF 208075 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Product Name: Ambrisentan Product Code: BSF 208075 Pharmaceutical Form: Tablet INN or Proposed INN: Ambrisentan CAS Number: 177036-94-1 Current Sponsor code: BSF 208075 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.0- Product Name: Ambrisentan Product Code: BSF 208075 Pharmaceutical Form: Tablet INN or Proposed INN: Ambrisentan CAS Number: 177036-94-1 Current Sponsor code: BSF 208075 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10.0- | Myogen, Inc | Not Recruiting | Female: yes Male: yes | 372 | Austria | ||||
| 460 | EUCTR2005-001967-70-GB | 13/10/2005 | 24 April 2012 | An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2 | An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2 | Idiopathic or familial pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Tablet INN or Proposed INN: bosentan monohydrate CAS Number: 147536-97-8 Current Sponsor code: Ro 47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32- | Actelion Pharmaceuticals Ltd. | Authorised | Female: yes Male: yes | 30 | Germany;United Kingdom;Italy | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 461 | EUCTR2005-001564-31-DE | 07/10/2005 | 19 March 2012 | A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA | A phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects with Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities - NA | Pulmonary Arterial Hypertension MedDRA version: 7.0 Level: low Classification code 10037400 | Product Name: Ambrisentan Product Code: BSF 208075 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ambrisentan Current Sponsor code: BSF 208075 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Product Name: Ambrisentan Product Code: BSF 208075 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ambrisentan Current Sponsor code: BSF 208075 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.0- Product Name: Ambrisentan Product Code: BSF 208075 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ambrisentan Current Sponsor code: BSF 208075 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10.0- | Myogen Inc. | Authorised | Female: yes Male: yes | 30 | Phase 2 | Germany | |||
| 462 | NCT00240656 | October 2005 | 19 February 2015 | Spironolactone Combined With Captopril and Carvedilol for the Treatment of Pulmonary Arterial Hypertension | Official Title: Spironolactone Combined With Captopril and Carvedilol for the Treatment of Patients With Pulmonary Arterial Hypertension Associated With Congenital Heart Disease—Focus on Pulmonary Artery Remodeling | Hypertension, Pulmonary | Drug: spironolactone captopril carvedilol | Hebei Medical University | Not recruiting | N/A | 80 Years | Both | Phase 1 | China | ||
| 463 | EUCTR2005-000812-29-HU | 21/09/2005 | 28 August 2012 | Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1 | Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1 | Pulmonary Arterial Hypertension MedDRA version: 7.0 Level: low Classification code 10037400 | Product Name: Ambrisentan Product Code: BSF 208075 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ambrisentan CAS Number: 177036-94-1 Current Sponsor code: BSF 208075 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Ambrisentan Product Code: BSF 208075 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ambrisentan CAS Number: 177036-94-1 Current Sponsor code: BSF 208075 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.0- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Ambrisentan Product Code: BSF 208075 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ambrisentan CAS Number: 177036-94-1 Current Sponsor code: BSF 208075 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10.0- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Myogen, Inc. | Authorised | Female: yes Male: yes | 186 | Phase 3 | Hungary;Germany;Belgium;Spain;Italy | |||
| 464 | NCT00125918 | August 2005 | 19 February 2015 | PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial Hypertension | PHIRST-1: Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Phosphodiesterase Type 5 (PDE5) Inhibitor Tadalafil in the Treatment in Patients With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: tadalafil;Drug: placebo | Eli Lilly and Company | ICOS Corporation | Not recruiting | 12 Years | N/A | Both | 406 | Phase 3 | United States;France;Italy;Japan;Belgium;Canada;Germany;Ireland;Spain;United Kingdom |
| 465 | NCT00593905 | July 2005 | 19 February 2015 | Pharmacogenomics in Pulmonary Arterial Hypertension | Pharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific Genes | Pulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group I | Drug: Sitaxsentan;Drug: Bosentan, Ambrisentan | West Penn Allegheny Health System | National Institutes of Health (NIH);Baylor College of Medicine;Emory University;University of Chicago;Johns Hopkins University;Tufts Medical Center;Sir Mortimer B. Davis - Jewish General Hospital;London Health Sciences Centre;University of Maryland;University of California, San Francisco;University of Calgary;Chest Medical Associates;Columbia University;Lung Diagnostics, Ltd.;Duke University;University of California, Los Angeles;Latter Day Saints Hospital;Louisiana State University Health Sciences Center in New Orleans;Massachusetts General Hospital;Mayo Clinic;Medical College of Wisconsin;Southeastern Lung Care;Suncoast Lung Center;Children's Hospital Colorado;University Hospital Case Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh;University of Southern California;The University of Texas, Galveston;Vanderbilt University;Wayne State University;Ohio State University;University of Alabama at Birmingham;Washington University School of Medicine;Sentara Norfolk General Hospital;University of Texas Southwestern Medical Center;Bay Area Chest Physicians | Recruiting | N/A | N/A | Both | 1300 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 466 | EUCTR2004-003236-59-GB | 30/06/2005 | 24 July 2012 | Double blind placebo controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. - | NYHA Class III and IV patients with severe Pulmonary Arterial Hypertension (PAH) | Product Name: Treprostinil Sodium Solution for Inhalation Product Code: N/A Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: N/A CAS Number: 81846-19-7 Current Sponsor code: Treprostinil solution for inhalation Other descriptive name: Treprostinil, UT-15, LRX-15, 15AU81, BW A15AU, U-62, 840 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.6- Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use | United Therapeutics Corporation | Authorised | Female: yes Male: yes | 220 | Germany;United Kingdom;Spain;Ireland;Italy | |||||
| 467 | EUCTR2004-005157-63-GB | 15/06/2005 | 1 May 2012 | An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1 | An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1 | Idiopathic or familial PAH | Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Dispersible tablet INN or Proposed INN: bosentan monohydrate CAS Number: 147536-97-8 Current Sponsor code: Ro 47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32- | Actelion Pharmaceuticals Ltd. | Authorised | Female: yes Male: yes | 33 | United Kingdom;Italy | ||||
| 468 | NCT03055221 | June 10, 2005 | 16 December 2017 | TRUST-2: Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) | TRUST-2: An Open-label Continuation Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Intravenous Treprostinil | United Therapeutics | Not recruiting | 16 Years | 75 Years | All | 20 | Phase 4 | ||
| 469 | NCT00147199 | June 2005 | 19 October 2017 | Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH) | TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Inhaled treprostinil;Drug: Placebo inhalation solution | United Therapeutics | Not recruiting | 18 Years | 75 Years | All | 235 | Phase 3 | United States;Austria;Belgium;France;Germany;Ireland;Israel;Italy;Spain;United Kingdom | |
| 470 | EUCTR2005-000963-25-SE | 30/05/2005 | 17 June 2013 | Oral Revatio in Pediatric PAH- Long term follow on study to A1481131 | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | Pulmonary Arterial Hypertension MedDRA version: 14.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil (as citrate) CAS Number: N/A Other descriptive name: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trade Name: Revatio Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil (as citrate) CAS Number: N/A Other descriptive name: UK-92,480 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK | Not Recruiting | Female: yes Male: yes | 200 | Taiwan;Finland;Thailand;Costa Rica;Guatemala;Chile;Russian Federation;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Brazil;Malaysia;Poland;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 471 | EUCTR2004-004391-36-HU | 23/05/2005 | 19 March 2012 | A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension | A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension | Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible. | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 147536-97-8 Current Sponsor code: Ro 47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 62.5 and-125 | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: no Male: yes | 23 | Hungary;Czech Republic | ||||
| 472 | NCT00423592 | May 2005 | 19 October 2017 | Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension | A Phase 2, Open-label, Multicenter Study Evaluating Ambrisentan in Subjects With Pulmonary Arterial Hypertension Who Have Previously Discontinued Endothelin Receptor Antagonist Therapy Due to Serum Aminotransferase Abnormalities | Pulmonary Hypertension | Drug: ambrisentan | Gilead Sciences | Not recruiting | 12 Years | 75 Years | All | 36 | Phase 2 | ||
| 473 | NCT00494533 | March 2005 | 19 February 2015 | Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial Hypertension | Treprostinil for Untreated Symptomatic PAH Trial: A 12-Week Multicenter Randomized Double-Blind Placebo-Controlled Trial of the Safety and Efficacy of Intravenous Remodulin® in Patients in India With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Remodulin (treprostinil sodium) | United Therapeutics | Asian Clinical Trials | Not recruiting | 16 Years | 75 Years | Both | 45 | Phase 4 | India |
| 474 | EUCTR2005-005068-97-DE | 26 January 2015 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA: a.Idiopathic (IPAH) b.Familial (FPAH) c.Associated with (APAH): i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair iii.Drugs and toxins MedDRA version: 9.1 Level: LLT Classification code 10064908 Term: Associated with (APAH) MedDRA version: 9.1 Level: LLT Classification code 10064909 Term: Idiopathic (IPAH) MedDRA version: 9.1 Level: LLT Classification code 10064910 Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: Ro-47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 62.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: Ro-47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Viagra Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil (as citrate) CAS Number: 139755-83-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Viagra Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil (as citrate) CAS Number: 139755-83-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Viagra Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil CAS Number: 139755-83-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Revatio Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sildenafil (as citrate) CAS Number: 139755-83-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||||
| 475 | EUCTR2004-000478-30-AT | 08/12/2004 | 22 April 2013 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: Ro47-0203/029 Other descriptive name: ------------ Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 62.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: R047-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 170 | Czech Republic;Spain;Denmark;Austria;Italy;United Kingdom;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 476 | EUCTR2004-000478-30-SE | 28/10/2004 | 19 March 2012 | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY | Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated. MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: Ro47-0203/029 Other descriptive name: ------------ Concentration unit: mg milligram(s) Concentration type: equal Concentration number: -62.5 Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: Ro47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: -125 Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 170 | United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden | ||||
| 477 | EUCTR2004-000745-37-ES | 11/10/2004 | 19 March 2012 | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension | Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension | Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosis | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 147536-97-8 Current Sponsor code: Ro47-0203/029 Other descriptive name: ------------ Concentration unit: % percent Concentration type: range Concentration number: 98.0-102.0 | Actelion Pharmaceuticals Ltd. | Authorised | Female: yes Male: yes | 50 | United Kingdom;Spain;Italy | ||||
| 478 | NCT00120380 | September 2004 | 19 February 2015 | Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH) | Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension | Hypertension | Drug: Aerosolized iloprost;Drug: Placebo | Hannover Medical School | Not recruiting | 18 Years | 75 Years | Both | 40 | Phase 4 | Germany | |
| 479 | NCT00626028 | September 2004 | 19 October 2017 | Comparison of Inhaled Nitric Oxide and Oxygen in Patient Reactivity During Acute Pulmonary Vasodilator Testing | Comparison of Supplemental Oxygen and Nitric Oxide for Inhalation in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator Testing | Idiopathic Pulmonary Arterial Hypertension;Congenital Heart Disease With Pulmonary Hypertension;Cardiomyopathy | Drug: Nitric Oxide for inhalation;Drug: Oxygen;Drug: Nitric Oxide plus Oxygen | Mallinckrodt | Not recruiting | N/A | 18 Years | All | 136 | Phase 3 | United States;France;Netherlands;Spain;United Kingdom | |
| 480 | NCT00266162 | August 2004 | 19 February 2015 | Bosentan in Treatment of Pulmonary Arterial Hypertension | Therapy of Pulmonary Arterial Hypertension (PAH) With Bosentan in Patients With Eisenmenger Syndrome | Eisenmenger Syndrome | Drug: Bosentan administration | Competence Network for Congenital Heart Defects | German Federal Ministry of Education and Research;Actelion | Not recruiting | 18 Years | N/A | Both | 60 | Phase 4 | Germany |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 481 | NCT00086463 | June 2004 | 19 February 2015 | Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH) | A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH | Pulmonary Arterial Hypertension;Ayerza Syndrome;Pulmonary Hypertension | Drug: Iloprost or placebo | Actelion | Not recruiting | 12 Years | 75 Years | Both | 60 | Phase 2 | United States | |
| 482 | NCT00091715 | April 2004 | 19 February 2015 | Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: bosentan;Drug: placebo | Actelion | Not recruiting | 12 Years | N/A | Both | 185 | Phase 3 | United States;Australia;Austria;Belgium;Canada;China;Czech Republic;France;Germany;Italy;Netherlands;Spain;Switzerland;United Kingdom | |
| 483 | NCT00578786 | February 2004 | 19 October 2017 | A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202) | A Long Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 (NCT00423748) or AMB-321 (NCT00423202) | Pulmonary Arterial Hypertension | Drug: ambrisentan | Gilead Sciences | Not recruiting | 18 Years | N/A | All | 383 | Phase 3 | Argentina;Brazil;Chile;Mexico | |
| 484 | NCT00091598 | January 2004 | 19 February 2015 | ARIES - Ambrisentan in Patients With Moderate to Severe Pulmonary Arterial Hypertension (PAH) | ARIES 1 and ARIES 2: Ambrisentan in PAH - A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Ambrisentan | Gilead Sciences | Not recruiting | 18 Years | N/A | Both | 372 | Phase 3 | United States;Australia;Canada | |
| 485 | NCT00159874 | January 2004 | 19 October 2017 | A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131 | Pulmonary Arterial Hypertension | Drug: Sildenafil citrate | Pfizer | Not recruiting | 1 Year | 17 Years | All | 234 | Phase 3 | United States;Brazil;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;Sweden;Taiwan;Canada;Costa Rica;Panama;Singapore | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 486 | NCT00367770 | January 2004 | 19 October 2017 | BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | Pulmonary Arterial Hypertension | Drug: Tracleer® | Actelion | Not recruiting | 12 Years | N/A | All | 37 | Phase 4 | United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom | |
| 487 | NCT00423202 | December 2003 | 19 February 2015 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. | Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. | Pulmonary Arterial Hypertension | Drug: ambrisentan | Gilead Sciences | Not recruiting | 18 Years | N/A | Both | 186 | Phase 3 | ||
| 488 | NCT00423748 | December 2003 | 19 February 2015 | Study to Assess Safety and Efficacy of Ambrisentan in Subjects With Pulmonary Arterial Hypertension. | Ambrisentan in PAH - A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: ambrisentan | Gilead Sciences | Not recruiting | 18 Years | N/A | Both | 186 | Phase 3 | ||
| 489 | NCT00317486 | September 2003 | 19 February 2015 | Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Tracleer (Bosentan) on Oxygen Saturation and Cardiac Hemodynamics in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | Pulmonary Arterial Hypertension Related to Eisenmenger Physiology | Drug: bosentan | Actelion | Not recruiting | 12 Years | N/A | Both | 54 | Phase 4 | United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom | |
| 490 | NCT00159913 | August 2003 | 19 October 2017 | A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension. | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension. | Pulmonary Arterial Hypertension, Children | Drug: Sildenafil citrate;Drug: Placebo | Pfizer | Not recruiting | 1 Year | 17 Years | All | 235 | Phase 3 | United States;Brazil;Canada;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Peru;Poland;Russian Federation;Sweden;Taiwan;Australia;Costa Rica;Panama;Singapore | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 491 | NCT00483626 | August 2003 | 19 February 2015 | Hemodynamic Response After Six Months of Sildenafil | Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil Treatment | Pulmonary Arterial Hypertension | Drug: oral sildenafil | University of Chile | Recruiting | 16 Years | 75 Years | Both | 27 | Phase 4 | Chile | |
| 492 | NCT00082186 | July 2003 | 19 February 2015 | The Effect of Tracleer® on Male Fertility | TRACLEER® (Bosentan) Pulmonary Arterial Hypertension A Multicenter, Open-label, Single-arm Safety Study to Investigate the Effects of Chronic TRACLEER® Treatment on Testicular Function in Male Patients With Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: bosentan | Actelion | Not recruiting | 18 Years | 65 Years | Male | 22 | Phase 4 | United States;Australia;Brazil;Czech Republic;Hungary | |
| 493 | NCT00159861 | July 2003 | 19 October 2017 | The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAH | A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension. | Pulmonary Hypertension | Drug: Sildenafil citrate | Pfizer | Not recruiting | 16 Years | N/A | All | 267 | Phase 3 | United States;Belgium;Canada;Czech Republic;Denmark;France;Israel;Italy;Netherlands;Spain;United Kingdom | |
| 494 | NCT00080457 | May 2003 | 19 February 2015 | Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial Hypertension | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: sitaxsentan sodium | Encysive Pharmaceuticals | Not recruiting | 12 Years | 75 Years | Both | 240 | Phase 3 | United States | |
| 495 | NCT00424021 | April 2003 | 19 October 2017 | Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial Hypertension | An Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220 | Pulmonary Hypertension | Drug: ambrisentan | Gilead Sciences | Not recruiting | 18 Years | N/A | All | 54 | Phase 2 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 496 | NCT00811018 | March 2003 | 19 October 2017 | A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension | A Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Sitaxsentan | Pfizer | Not recruiting | 12 Years | 75 Years | All | 1192 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Spain;United Kingdom | |
| 497 | NCT00159887 | December 2002 | 19 February 2015 | Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension | A Multi-Centre, Multinational, Long-Term Extension Study, to Assess the Safety and Toleration of Subject Optimised Treatment Regimens of Oral Sildenafil Citrate for Pulmonary Arterial Hypertension in Subjects Who Have Completed Study A1481140. | Pulmonary Hypertension | Drug: Sildenafil citrate | Pfizer | Not recruiting | 18 Years | N/A | Both | 260 | Phase 3 | United States;Australia;Belgium;Brazil;Czech Republic;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Singapore;South Africa;Spain;Sweden;United Kingdom | |
| 498 | NCT00058929 | October 2002 | 19 February 2015 | A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension | A Multicenter, Randomized, Parallel Placebo-Controlled Study of the Safety and Efficacy of Subcutaneous Remodulin® Therapy After Transition From Flolan® in Patients With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension;Pulmonary Hypertension | Drug: treprostinil sodium | United Therapeutics | Not recruiting | 18 Years | 75 Years | Both | 39 | Phase 4 | United States | |
| 499 | NCT00644605 | October 2002 | 4 May 2015 | A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial Hypertension | A Multinational, Multi-centre, Randomised, Double-blind, Double-dummy, Placebo-controlled Study to Assess the Efficacy and Safety of 20, 40, and 80mg TID Sildenafil in the Treatment of Pulmonary Arterial Hypertension in Subjects Aged 18 Years and Over | Hypertension, Pulmonary | Drug: sildenafil;Drug: placebo | Pfizer | Not recruiting | 18 Years | N/A | Both | 275 | Phase 3 | United States;Australia;Belgium;Brazil;Czech Republic;Denmark;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Singapore;South Africa;Spain;Sweden;United Kingdom | |
| 500 | NCT00046319 | September 2002 | 19 February 2015 | Study of BSF 208075 Evaluating Exercise Capacity in Patients With Pulmonary Arterial Hypertension | A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Patients With Moderate to Severe Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: BSF 208075 | Gilead Sciences | Not recruiting | 18 Years | N/A | Both | 60 | Phase 2 | United States;Australia;Belgium;France;Germany;Italy | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 501 | NCT00105209 | April 2002 | 19 February 2015 | A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension | A Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Drug: Aspirin;Drug: clopidogrel | Kawut, Steven, MD | National Heart, Lung, and Blood Institute (NHLBI);Columbia University | Not recruiting | 18 Years | N/A | Both | 20 | Phase 2 | United States |
| 502 | NCT00034307 | February 2002 | 19 February 2015 | Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension | A Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: sitaxsentan sodium | ICOS-Texas Biotechnology | ICOS Corporation;Texas Biotechnology Corporation | Not recruiting | 16 Years | 75 Years | Both | 180 | Phase 2/Phase 3 | United States;Canada |
| 503 | NCT02784808 | January 2000 | 20 June 2016 | Retrospective Analysis of Pulmonary Arterial Hypertension (PAH) and Related Complications in Juvenile Idiopathic Arthritis (JIA) Participants Treated With Biologic and Non-biologic Disease-modifying Anti-rheumatic Drugs (DMARDs) | Juvenile Idiopathic Arthritis | Drug: Biological DMARDs;Drug: Non-Biologic DMARDs | Hoffmann-La Roche | Not recruiting | N/A | 18 Years | Both | 4557 | N/A | |||
| 504 | JPRN-UMIN000020386 | 1999/04/01 | 2 April 2019 | Acute Vasoreactivity Testing with Nicardipine in Patients with Pulmonary Arterial Hypertension | plumonary arterial hypertension | Nicardipine was administered by short-time continuous infusion (1 microg/kg/min for 5 min and 2 microg/kg/min for 5 min) followed by bolus injection (5 microg/kg). Hemodynamic responses were continuously measured using a right heart catheter.Hemodynamic responses were continuously measured before, during and after administration of nicardipine using an RHC. SaO2 (saturation of arterial blood) and SPAO2 (saturation of pulmonary arterial blood) were measured to calculate cardiac output every 5 minutes. | Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences | National Hospital Organization, Okayama Medical Center | Not Recruiting | Not applicable | Not applicable | Male and Female | 100 | Not applicable | Japan | |
| 505 | JPRN-JapicCTI-132356 | 16 July 2019 | A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension | A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial Hypertension | Hypertension, Pulmonary | Intervention name : Tadalafil, Placebo Dosage And administration of the intervention : Tadalafil doses may range from 5 mg to 40 mg depending on body weight cohorts. | Eli Lilly Japan K.K. | Recruiting | BOTH | Phase 3 |