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 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:84,標的パスウェイ数:58] 

Searched query = "Pulmonary arterial hypertension", "Eisenmenger Syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03833323August 1, 202022 October 2019Implantable System for Remodulin Post-Approval StudyImplantable System for Remodulin Post-Approval StudyPulmonary Arterial HypertensionCombination Product: Implantable System for Remodulin (treprostinil)Medtronic Cardiac Rhythm and Heart FailureUnited TherapeuticsNot recruiting22 YearsN/AAll50Phase 3
2JPRN-JapicCTI-19497116/12/20197 October 2019Clinical 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) therapypulmonary arterial hypertensionIntervention 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 Recruiting1875BOTH170Phase 3Japan, South America, Europe
3NCT04084678December 15, 201930 September 2019A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PHA 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 TherapyPAH;Pulmonary Hypertension;Hypertension;Connective Tissue Disease;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract Disease;Pulmonary Arterial HypertensionDrug: Ralinepag;Drug: PlaceboUnited TherapeuticsNot recruiting18 YearsN/AAll193Phase 3
4NCT04125745October 30, 201922 October 2019Oral CXA-10 in Pulmonary Arterial HypertensionPhase 2 Open-Label Study of Safety and Efficacy Trial of CXA-10 in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: CXA-10University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI);Complexa, Inc.Not recruiting18 Years80 YearsAll30Phase 2
5NCT03683186September 23, 201928 October 2019A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label ExtensionA 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 DiseaseDrug: RalinepagUnited TherapeuticsRecruiting18 Years75 YearsAll1000Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;China;Croatia;Denmark;France;Greece;Italy;Korea, Republic of;Poland;Romania;Spain;Sweden;Taiwan;Ukraine;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03950739September 17, 20194 November 2019Open-label, Clinical Study to Evaluate the Safety and Tolerability of TreT in Subjects With PAH Currently Using TyvasoAn Open-label, Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder (TreT) in Subjects With Pulmonary Arterial Hypertension Currently Using TyvasoPulmonary Arterial HypertensionDrug: Treprostinil Inhalation PowderUnited TherapeuticsRecruiting18 YearsN/AAll45Phase 1United States
7NCT03782818September 201924 June 2019Olaparib for PAH: a Multicenter Clinical TrialOlaparib for Pulmonary Arterial Hypertension: a Multicenter Clinical TrialPulmonary Arterial HypertensionDrug: OlaparibLaval UniversityNot recruiting18 Years75 YearsAll20Phase 1Canada
8NCT03904693August 30, 201930 September 2019Clinical 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) TherapyPulmonary 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 tadalafilActelionCovance;Almac Clinical Technologies;WorldCare Clinical;Frontier Science FoundationRecruiting18 Years75 YearsAll170Phase 3United States;Hungary;Taiwan
9NCT03655704August 22, 20199 September 2019Apabetalone for Pulmonary Arterial Hypertension: a Pilot StudyApabetalone for Pulmonary Arterial Hypertension: a Pilot StudyPulmonary Arterial HypertensionDrug: ApabetaloneSteeve ProvencherRecruiting18 Years75 YearsAll10Early Phase 1Canada
10NCT04053543August 9, 20197 October 2019CXA-10 Study in Subjects With Pulmonary Arterial HypertensionA 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-10-301PAHDrug: CXA-10Complexa, Inc.Medpace, Inc.;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Recruiting18 YearsN/AAll96Phase 2United States;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03924154August 1, 20194 November 2019A 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 HypertensionPulmonary Arterial HypertensionDrug: RVT-1201;Drug: PlaceboAltavant Sciences GmbHAltavant Sciences, Inc.;PPDRecruiting18 Years75 YearsAll36Phase 2United States;Canada
12NCT03926793August 201926 August 2019Clinical Study of Inhaled GB002 for Treatment of WHO Group I Pulmonary Arterial HypertensionA 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 HypertensionDrug: GB002;Drug: Placebo;Device: Generic Dry Powder InhalerGB002, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Recruiting18 Years75 YearsAll24Phase 1United States;United Kingdom
13NCT03863990July 26, 20194 November 2019Study 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 LungsPrognostic Factors and Survival in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: PAH medicationBayerNot recruiting18 YearsN/AAll110Phase 2Argentina
14NCT03992755July 18, 201930 September 2019Extension Study for Participants in LIQ861 Trials to Evaluate the Long-term Safety of Dry Powder Inhalation of TreprostinilA 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) PatientsPrimary Pulmonary HypertensionDrug: LIQ861 Inhaled TreprostinilLiquidia Technologies, Inc.Nuventra, Inc.Recruiting18 YearsN/AAll150Phase 3United States
15NCT03884465May 30, 20191 April 2019Hemodynamic Evaluation of Dose-response and Safety of Dry Powder Inhalation of TreprostinilA 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) SubjectsPulmonary Arterial HypertensionDrug: Inhaled dry powder treprostinil (LIQ861)Liquidia Technologies, Inc.FGK Clinical Research GmbHNot recruiting18 YearsN/AAll32Phase 2France;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03554291May 1, 201924 June 2019Repurposing a Histamine Antagonist to Benefit Patients With Pulmonary HypertensionRepurposing a Histamine Antagonist to Benefit Patients With Pulmonary HypertensionPulmonary Arterial Hypertension;Right Heart FailureDrug: Famotidine 20 MG;Other: PlaceboUniversity of WashingtonNational Heart, Lung, and Blood Institute (NHLBI)Recruiting18 Years80 YearsAll80Phase 2United States
17NCT03738150May 1, 201911 November 2019A Study of Sotatercept for the Treatment of Pulmonary Arterial HypertensionA Phase 2a Single-Arm, Open-Label, Multicenter Exploratory Study to Assess the Effects of Sotatercept (ACE-011) for the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionBiological: SotaterceptAcceleron Pharma, Inc.Recruiting18 YearsN/AAll25Phase 2United States
18NCT03835676May 1, 201926 August 2019Effects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial HypertensionEffects of Treprostinil on Right Ventricular Structure and Function in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: TreprostinilMagdi H. YacoubRecruiting18 YearsN/AAll30Phase 4Egypt
19NCT03795428April 10, 201923 April 2019Long-Term Extension Study of PB1046 in PAH Subjects Having Completed Studies PB1046-PT-CL-0004 or PB1046-PT-CL-0005A Long-Term Extension Study of PB1046 Injection in Pulmonary Arterial Hypertension Subjects Having Completed Studies PB1046-PT-CL-0004 or PB1046-PT-CL-0005Pulmonary Arterial HypertensionDrug: PB1046 InjectionPhaseBio Pharmaceuticals Inc.Recruiting18 Years79 YearsAll64Phase 2United States
20JPRN-UMIN0000353892019/04/0123 April 2019Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertensionEffects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension - SETOUCHI PH studyPulmonary arterial hypertensionDose: 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 ScienceNot Recruiting20years-oldNot applicableMale and Female76Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04062565March 25, 20192 September 2019Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAHA 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 HypertensionDrug: Treprostinil Injectable Product;Drug: Riociguat PillUniversity of ArizonaRecruiting18 YearsN/AAll20Phase 3United States
22NCT03522935March 18, 201915 April 2019Subcutaneous Elafin in Healthy SubjectsSafety and Tolerability of Escalating Doses of Subcutaneous Elafin (Tiprelestat) Injection in Healthy Normal SubjectsPulmonary Arterial HypertensionDrug: Elafin;Drug: PlaceboRoham T. ZamanianDuke University;SRI InternationalRecruiting18 Years55 YearsAll30Phase 1United States
23JPRN-JapicCTI-19465112/3/201916 July 2019MD-711 Phase 2/3 Study in PAHMD-711 Phase 2/3 Study in Pulmonary Arterial HypertensionPulmonary arterial hypertensionIntervention 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 Recruiting1875BOTH15Phase 2-3Japan
24NCT03789643March 201913 May 2019Study to Evaluate Efficacy and Safety of JTT-251 in Participants With Pulmonary Arterial HypertensionA 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 HypertensionDrug: JTT-251;Drug: PlaceboAkros Pharma Inc.Not recruiting18 Years80 YearsAll0Phase 2
25EUCTR2018-001189-40-FR15/02/201930 April 2019An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extensionPulmonary 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
1000Phase 3United 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.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2018-001189-40-SE11/02/201930 April 2019An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extensionPulmonary 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
1000Phase 3United 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
27NCT03754660January 21, 201911 November 2019This 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 BAY1237592Hypertension, PulmonaryDrug: BAY1237592;Drug: PH-monotherapy;Drug: PH-combination therapy;Procedure: NO gasBayerRecruiting18 Years80 YearsAll60Phase 1Germany
28NCT03744637January 18, 201922 October 2019A 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 HypertensionPulmonary Arterial HypertensionDrug: MK-5475;Drug: PlaceboMerck Sharp & Dohme Corp.Recruiting18 Years70 YearsAll28Phase 1Moldova, Republic of
29EUCTR2018-002796-18-ES17/01/201928 February 2019To 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) diseasePulmonary 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
40Phase 2Portugal;Spain;Ukraine;Austria;United Kingdom
30EUCTR2018-001187-33-HU14/01/201928 February 2019A 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-outcomespulmonary 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
700Phase 3United 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.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2018-001189-40-HU14/01/201928 February 2019An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensionA StuDy EVAluatiNg the Long-Term EffiCacy and Safety of RalinEpag in Subjects with PAH via an Open-Label EXTENSION - ADVANCE-extensionPulmonary 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
1000Phase 3United 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
32NCT03648385January 9, 20194 November 2019Effects of DHEA in Pulmonary HypertensionEffects of DHEA in Pulmonary HypertensionPulmonary Arterial HypertensionDrug: DHEA tablet;Other: PlaceboRhode Island HospitalRecruiting18 YearsN/AAll24Phase 2United States
33NCT03657095December 10, 201811 November 2019BPS-314d-MR-PAH-303 (BEAT OLE)An Open-label Extension of BPS-314d-MR-PAH-302 in Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Beraprost Sodium 314d Modified Release tabletsLung Biotechnology PBCNot recruiting18 Years85 YearsAll112Phase 3United States;Israel
34EUCTR2018-002448-10-PT26/11/20184 December 2018Study 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 PAHPulmonary 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.AuthorisedFemale: yes
Male: yes
40Phase 2France;Portugal;Belgium;Spain;Ukraine;Austria;Netherlands;Germany;United Kingdom
35EUCTR2018-002448-10-AT31/10/201812 November 2018Study 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 PAHPulmonary 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.AuthorisedFemale: yes
Male: yes
40Phase 2Ukraine;Austria
No.TrialIDDate_
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36NCT03251872October 25, 201824 June 2019Olaparib for PAH: a Pilot StudyOlaparib for Pulmonary Arterial Hypertension: a Pilot Clinical StudyPulmonary Arterial HypertensionDrug: OlaparibLaval UniversityRecruiting18 Years75 YearsAll6Early Phase 1Canada
37NCT03528902October 1, 201822 October 2018Tamoxifen Therapy to Treat Pulmonary Arterial HypertensionTamoxifen Therapy to Treat Pulmonary Arterial HypertensionHypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary Hypertension;Primary Pulmonary Hypertension;Lung Diseases;Tamoxifen;Estrogen Receptor Antagonist;Hormone Antagonists;EstrogensDrug: Tamoxifen;Drug: Placebo Oral TabletVanderbilt University Medical CenterRecruiting18 YearsN/AAll24Phase 2United States
38NCT03497689September 21, 20184 November 2019EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial HypertensionEXPEDITE: A 16-Week, Multicenter, Open-label Study of Remodulin Induction Followed by Orenitram Optimization in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Intravenous/Subcutaneous Treprostinil; Oral TreprostinilUnited TherapeuticsRecruiting17 Years85 YearsAll30Phase 4United States
39NCT03626688August 30, 201811 November 2019A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH PatientsA 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 PAHPAH;Pulmonary Hypertension;Pulmonary Arterial Hypertension;Hypertension;Connective Tissue Diseases;Familial Primary Pulmonary Hypertension;Vascular Diseases;Cardiovascular Diseases;Hypertension, Pulmonary;Lung Diseases;Respiratory Tract DiseaseDrug: Ralinepag;Drug: PlaceboUnited TherapeuticsRecruiting18 Years75 YearsAll700Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Canada;China;Croatia;Denmark;France;Greece;Italy;Korea, Republic of;Poland;Romania;Spain;Sweden;Taiwan;Ukraine;United Kingdom
40NCT03617458August 23, 201823 April 2019Interventions Against Insulin Resistance in Pulmonary Arterial HypertensionInterventions Against Insulin Resistance in Pulmonary Arterial HypertensionPulmonary Artery HypertensionDrug: Metformin;Drug: Placebo;Device: mHealth Intervention;Device: Usual CareVanderbilt University Medical CenterMayo Clinic;The Cleveland ClinicRecruiting18 YearsN/AAll160Phase 2United States
No.TrialIDDate_
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41NCT03449524August 1, 20184 November 2019PRIMEx - 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 HypertensionPAHDrug: 75mg CXA-10;Drug: 150mg CXA-10;Other: PlaceboComplexa, Inc.Medpace, Inc.;Philips Healthcare;Cardiovascular Clinical Science Foundation;MicroConstants;Innovative Analytics;Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Recruiting18 Years80 YearsAll96Phase 2United States;United Kingdom
42NCT03492177July 25, 201816 September 2019A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial HypertensionA Prospective, Multicenter, Open-label, Single-arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: selexipag (Uptravi)ActelionRecruiting2 Years18 YearsAll55Phase 2United States;Belarus;France;Germany;Hungary;Israel;Malaysia;Poland;Russian Federation;Serbia;Taiwan;Ukraine;United Kingdom
43NCT03556020July 15, 201828 October 2019Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC PB1046 in Subjects With Symptomatic PAHA 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 HypertensionDrug: PB1046PhaseBio Pharmaceuticals Inc.Recruiting18 Years79 YearsAll63Phase 2United States
44NCT03496207June 27, 20189 September 2019A 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 HypertensionDrug: Placebo;Drug: SotaterceptAcceleron Pharma, Inc.Not recruiting18 YearsN/AAll100Phase 2United States;Australia;Brazil;France;Germany;Israel;Spain;United Kingdom
45NCT03683082June 5, 20181 October 2018Oxygen Treatment and Pulmonary Arterial HypertensionAcute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Oxygen supplementation;Drug: Sham O2 (medical air)George Papanicolaou HospitalRecruiting18 Years80 YearsAll10N/AGreece
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
46NCT03166306May 1, 201823 July 2018Angiogenic Imaging in Pulmonary Arterial HypertensionAngiogenic Imaging in Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Exercise Associated Pulmonary Arterial HypertensionDiagnostic Test: PET-CT Imaging with [89Zr]-bevacizumabBrigham and Women's HospitalRecruiting18 YearsN/AAll30Phase 1/Phase 2United States
47NCT03489005April 9, 201811 November 2019Effect of BIA 5 1058 on Cardiac RepolarizationA 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 ConditionsCardiovascular Disease;Pulmonary Arterial Hypertension;Heart FailureDrug: BIA 5-1058;Drug: Placebo Oral Tablet;Drug: Moxifloxacin 400 mgBial - Portela C S.A.CovanceNot recruiting18 Years55 YearsAll49Phase 1United Kingdom
48NCT03422328April 4, 20184 November 2019A 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 HypertensionDrug: macitentanActelionRecruiting18 Years80 YearsAll94Phase 3Belarus;France;Poland;Ukraine
49NCT03344159April 1, 201829 April 2019Spironolactone Therapy in Chronic Stable Right HF TrialSpironolactone Therapy in Chronic Stable Right HF TrialChronic Right-Sided Heart Failure;Pulmonary Arterial Hypertension;Pulmonary Hypertension, Primary, 2;Pulmonary Hypertension, Primary, 3;Pulmonary Hypertension, Primary, 4;Cardiomyopathy Right VentricularDrug: 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 CorporationRecruiting18 YearsN/AAll30Phase 4Canada
50EUCTR2017-003934-10-FR19/03/201828 February 2019A 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 - UMBRELLAPulmonary 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 LtdAuthorised Female: yes
Male: yes
94Phase 3France
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
51NCT03464864March 9, 201812 November 2018Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal VolunteersA 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 VolunteersPulmonary Arterial HypertensionDrug: Treprostinil Inhalation PowderMannkind CorporationNot recruiting18 Years55 YearsAll36Phase 1United States
52NCT03362047March 1, 201811 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 BedingungenPulmonary Arterial Hypertension (PAH)Drug: Riciguat Group;Drug: Macitentan GroupUniversity of GiessenPhilipps University Marburg Medical CenterRecruiting18 Years85 YearsAll30Phase 2Germany
53NCT03177603February 21, 201815 July 2019A 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 HypertensionHypertension, PulmonaryDrug: GSK2586881GlaxoSmithKlineNot recruiting18 Years75 YearsAll23Phase 2United States;Germany;Spain
54NCT02939599February 1, 20189 September 2019Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH PatientsLong-term, Open Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of QCC374 in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: QCC374Novartis PharmaceuticalsNot recruiting18 YearsN/AAll5Phase 2United States;Germany;United Kingdom
55NCT03293407February 1, 20184 November 2019Evaluation of Inhaled Iloprost Effects Using the Breelib Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial HypertensionVentavis® (Iloprost): Evaluation of Inhaled Iloprost Effects Using the Breelib™ Nebulizer, on Clinical Outcomes and Physical Activity of Patients With Advanced Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Iloprost (Ventavis, BAYQ6256);Device: Breelib nebulizerBayerRecruiting18 YearsN/AAll50Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
56NCT03399604January 2, 201830 September 2019Investigation of the Safety and Pharmacology of Dry Powder Inhalation of TreprostinilA 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) PatientsPrimary Pulmonary HypertensionDrug: LIQ861 Inhaled TreprostinilLiquidia Technologies, Inc.Nuventra, Inc.Not recruiting18 YearsN/AAll121Phase 3United States
57EUCTR2017-000137-31-NL19/12/20178 January 2018Treatment of Pulmonary Hypertension with 6 MercaptopurinePulmonary Hypertension REversal in Clusters of Patients With Identical Pathobiological Substrates. 6-Mercaptopurine Proof-of-Concept Trial - PRECISE-MPPulmonary 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 CenterAuthorisedFemale: yes
Male: yes
50Phase 2Netherlands
58NCT03187678December 4, 20173 June 2019Safety Study of the Switch From Oral Selexipag to Intravenous Selexipag in Subjects With Stable Pulmonary Arterial HypertensionA 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 SelexipagPulmonary Arterial HypertensionDrug: i.v. selexipag;Drug: oral selexipag (Uptravi)ActelionNot recruiting18 Years75 YearsAll20Phase 3United States;Germany
59NCT03364244November 30, 201711 March 2019Revavtio Special Investigation for Long-term Use in Pediatric PatientsREVATIO SPECIAL INVESTIGATION - INVESTIGATION FOR LONG-TERM USE OF REVATIO IN PEDIATRIC PATIENTS -Pulmonary Arterial HypertensionDrug: SildenafilPfizerRecruitingN/A14 YearsAll190Phase 2Japan
60NCT02932410November 28, 201716 September 2019A 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 HypertensionPulmonary Arterial HypertensionOther: Standard-of-care;Drug: MacitentanActelionRecruiting2 Years17 YearsAll300Phase 3United 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.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
61NCT03078907November 8, 201716 September 2019Effect 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 ImpactsPulmonary Arterial HypertensionDrug: Selexipag;Drug: PlaceboActelionNot recruiting18 Years75 YearsAll108Phase 4United States;Austria;France;Germany;Ireland;Norway;Portugal;Sweden;Switzerland;United Kingdom
62NCT03315507October 20, 201722 October 2019A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAHAn 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 HypertensionPulmonary Arterial HypertensionDrug: PB1046 Subcutaneous InjectionPhaseBio Pharmaceuticals Inc.Not recruiting18 YearsN/AAll3Phase 1United States
63EUCTR2016-001411-20-DE17/10/201726 November 2018Long-term extension study of the safety and pharmacokinetics of QCC374 in PAH patientsLong-term, open label, multicenter, extension study to evaluate the safety and tolerability of QCC374 in patients with PAHPulmonary 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 AGNot RecruitingFemale: yes
Male: yes
38Phase 2United States;Taiwan;Germany;United Kingdom;Korea, Republic of
64NCT03270332October 12, 201711 November 2019Effect of Inhaled Albuterol in Pulmonary HypertensionEffect of Inhaled Albuterol on Pulmonary Hemodynamics in Patients With Group 1 Pulmonary Arterial Hypertension on Oral Pulmonary Vasodilator Therapy: A Proof of Concept StudyPulmonary HypertensionDrug: albuterol first then placebo;Drug: placebo first then albuterolUniversity of MiamiRecruiting18 YearsN/AAll6Early Phase 1United States
65NCT03229499October 2, 201714 January 2019Pulmonary Hypertension and Anastrozole TrialPulmonary Hypertension and Anastrozole Trial (PHANTOM)Pulmonary Arterial HypertensionDrug: Anastrozole;Drug: Placebo Oral TabletUniversity of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI);Johns Hopkins University;University of Colorado, Denver;Rhode Island Hospital;Stanford University;Vanderbilt University;Washington University School of MedicineRecruiting18 YearsN/AAll84Phase 2United States
No.TrialIDDate_
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Last_Refreshed_
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PhaseCountries
66NCT03145298October 1, 201725 February 2019ALlogeneic Cardiosphere-derived Stem Cells (CDCs) for Pulmonary Hypertension therApyA 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 TrialPulmonary Arterial Hypertension (PAH)Biological: Allogeneic Human Cardiosphere-Derived Stem Cells;Biological: PlaceboCedars-Sinai Medical CenterCalifornia Institute for Regenerative Medicine (CIRM)Recruiting18 Years75 YearsAll26Phase 1United States
67NCT02999906October 201716 December 2017Study to Compare Triple Therapy (Oral Treprostinil, Ambrisentan, and Tadalafil) With Dual Therapy (Ambrisentan, Tadalafil, and Placebo) in Subjects With Pulmonary Arterial HypertensionA 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 HypertensionPulmonary Arterial HypertensionDrug: Oral Treprostinil;Drug: PlaceboUnited TherapeuticsNot recruiting18 Years79 YearsAll0Phase 3
68NCT03001414September 28, 201723 April 2019Study of Angiogenic Cell Therapy for Progressive Pulmonary Hypertension: Intervention With Repeat Dosing of eNOS-enhanced EPCsA 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 TreatmentsHypertension,PulmonaryBiological: 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 eNOSNorthern TherapeuticsOttawa Hospital Research InstituteRecruiting18 Years80 YearsAll45Phase 2Canada
69NCT02927366September 19, 20171 April 2019Safety, Pharmacokinetics and Efficacy Study of QCC374 in PAH PatientsA 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 HypertensionPulmonary Arterial HypertensionDrug: Placebo Matching;Drug: QCC374Novartis PharmaceuticalsNot recruiting18 YearsN/AAll8Phase 2United States;Germany;Korea, Republic of;United Kingdom;Taiwan
70EUCTR2017-000216-42-IE12/09/201729 January 2018Daily life physical activity and disease symptoms assessed in patients with pulmonary arterial hypertension (PAH) treated with selexipagA 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 - TRACEPulmonary 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 LtdAuthorisedFemale: yes
Male: yes
100Phase 4Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
No.TrialIDDate_
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71EUCTR2017-000212-41-DE01/09/201727 August 2018Study 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 ptsPulmonary 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 LtdAuthorisedFemale: yes
Male: yes
24Phase 2United States;Spain;Germany
72EUCTR2017-000216-42-AT29/08/201728 February 2019Daily life physical activity and disease symptoms assessed in patients with pulmonary arterial hypertension (PAH) treated with selexipagA 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 - TRACEPulmonary 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 LtdAuthorised Female: yes
Male: yes
100Phase 4Portugal;France;United States;Ireland;Austria;Norway;Netherlands;Germany;United Kingdom;Switzerland;Sweden
73EUCTR2017-000212-41-ES10/08/201721 August 2017Study 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 ptsPulmonary 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.AuthorisedFemale: yes
Male: yes
24Phase 2United States;Spain
74NCT03045029July 18, 201720 May 2019ADAPT - A Patient Registry of the Real-world Use of Orenitram®ADAPT - A Patient Registry of the Real-world Use of Orenitram®Pulmonary Arterial HypertensionDrug: Oral treprostinilUnited TherapeuticsRecruiting18 YearsN/AAll300Phase 2United States
75NCT02800941July 5, 201718 December 2018Bleeding Frequency Under Anticoagulant Treatment in Pulmonary HypertensionBleeding Frequency Under Anticoagulant Treatment in Pulmonary Hypertension : HEMA-HTP Multicentric Study.Pulmonary Arterial HypertensionDrug: Oral anticoagulant treatmentCentre Hospitalier Universitaire de Saint EtienneRecruiting18 YearsN/AAll203Phase 2France
No.TrialIDDate_
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76JPRN-UMIN0000272842017/07/012 April 2019The effect of iloprost on pulmonary hypertension and exercuse capacityPulmonary arterial hypertensioninhale of iloprostThe University of Tokushima Graduate School of Health BiosciencesNot Recruiting20years-old90years-oldMale and Female20Not selectedJapan
77NCT03273387June 1, 201716 December 2017The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension in National Cardiovascular Center Harapan Kita HospitalThe Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension Patients in National Cardiovascular Center Harapan Kita Hospital IndonesiaPrecapillary Pulmonary HypertensionDrug: Trimetazidine;Drug: Placebo oral capsuleIndonesia UniversityRecruiting18 Years65 YearsAll25Phase 2/Phase 3Indonesia
78NCT02882126June 201716 December 2017An Open Label Extension Study to Evaluate the Safety of Continued Therapy of Subcutanous Remodulin® in Pulmonary Arterial HypertensionAn 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-003Pulmonary Arterial HypertensionDrug: Subcutaneous TreprostinilUnited TherapeuticsCVie Therapeutics Co. Ltd.Not recruiting18 YearsN/AAll0Phase 4China
79EUCTR2016-004035-21-DE23/05/201730 April 2019A 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 selexipagPulmonary 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 LtdNot Recruiting Female: yes
Male: yes
20Phase 3United States;Germany
80NCT03401476May 8, 201729 January 2018Effect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial HypertensionEffect of Morphine on Dyspnea and 6-Minute Walk Distance in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Morphine SulfateJohn GrantonRecruiting18 YearsN/AAll15Phase 2Canada
No.TrialIDDate_
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81NCT03365479May 1, 20175 November 2018Acute Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial HypertensionAcute Hemodynamic Response of Iloprost Inhalation Using the Breelib Nebulizer in Pulmonary Arterial HypertensionPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: IloprostUniversity of GiessenNot recruiting18 YearsN/AAll30N/AGermany
82NCT03016468May 201716 December 2017Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAHA Multicenter, 16-Week, Open-label Study Evaluating the Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Parenteral Remodulin (treprostinil) injection;Drug: Oral TreprostinilUnited TherapeuticsNot recruiting18 Years75 YearsAll0Phase 2
83NCT02911844April 10, 20174 March 2019Estrogen Receptor Antagonist in Patients With Pulmonary Arterial HypertensionEstrogen Receptor Antagonist in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: FulvestrantUniversity of PennsylvaniaNot recruiting18 YearsN/AFemale5Phase 2United States
84NCT02587325April 1, 201718 March 2019ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial HypertensionA Phase 1 Clinical Trial of ABI-009, an mTOR Inhibitor, for Patients With Severe Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionDrug: ABI-009, nab-rapamycin, albumin-bound rapamycinAadi, LLCRecruiting18 YearsN/AAll25Phase 1United States
85NCT03431649April 1, 201726 February 2018Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in ChildrenEfficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart DefectPediatric Pulmonary HypertensionDrug: Beraprost Sodium;Drug: Sildenafil CitrateDr. Soetomo General HospitalNot recruiting1 Year17 YearsAll40Phase 4Indonesia
No.TrialIDDate_
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86NCT02893995February 201716 December 2017Safety, Tolerability, Pharmacokinetics and Efficacy of Two Different Rates of Subcutanous Remodulin® Dose Titration in Pulmonary Arterial HypertensionA 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 HypertensionPulmonary Arterial HypertensionDrug: Slow Dose Titration Group of Subcutaneous Treprostinil;Drug: Rapid Dose Titration Group of Subcutaneous TreprostinilUnited TherapeuticsCVie Therapeutics Co. Ltd.Not recruiting18 YearsN/AAll0Phase 4China
87EUCTR2016-001062-28-HU25/01/201730 April 2018A 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 WorldwidePulmonary 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 LtdAuthorisedFemale: yes
Male: yes
300Phase 3Portugal;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
88NCT02891850January 11, 201722 October 2019Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapyA 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 GoalPulmonary Arterial HypertensionDrug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: TadalafilBayerNot recruiting18 Years75 YearsAll223Phase 4United 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
89JPRN-UMIN0000251762017/01/012 April 2019Efficacy, tolerability, and safety of transition from beraprost to selexipag in patients with pulmonary arterial hypertension.Pulmonary arterial hypertensionMedicine 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 MedicineRecruiting16years-oldNot applicableMale and Female33Not selectedJapan
90NCT02682511January 201726 August 2019Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial HypertensionA 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 DiseasesDrug: Oral Ifetroban;Drug: Oral PlaceboCumberland PharmaceuticalsRecruiting18 Years80 YearsAll34Phase 2United States;India
No.TrialIDDate_
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91EUCTR2010-024585-22-DE01/12/201626 March 2018What 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 patientsIdiopathic 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 CentreNot RecruitingFemale: yes
Male: yes
60Phase 2Germany;United Kingdom
92NCT02736149December 201629 July 2019Open-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 HypertensionDrug: ubenimexEiger BioPharmaceuticalsNot recruiting18 Years75 YearsAll51Phase 2United States;Canada
93NCT02981082December 201625 February 2019Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial HypertensionA 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; HypertensionDrug: Dimethyl Fumarate (DMF);Drug: Placebo Oral TabletRobert LafyatisBiogenRecruiting18 Years80 YearsAll34Phase 1United States
94NCT03053739December 201616 December 2017To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisRandomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisAssociated Pulmonary Arterial HypertensionDrug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and PlaceboPostgraduate Institute of Medical Education and ResearchRecruiting18 YearsN/AAll50Phase 4India
95EUCTR2016-003495-53-NL29/11/20169 January 2017Study on the effect of the drug selexipag in adult patients with elevated pressure in the pulmonary arteries due to a cardiac birth defectProstacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease - SELECT trialPulmonary 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 - CardiologyAuthorisedFemale: yes
Male: yes
Phase 3Netherlands
No.TrialIDDate_
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96NCT02657356October 4, 20167 October 2019Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial Hypertension - CATALYSTA Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Connective Tissue Disease-associated Pulmonary Arterial HypertensionConnective Tissue Disease-Associated Pulmonary Arterial HypertensionDrug: Placebo capsules;Drug: Bardoxolone methyl capsulesReata Pharmaceuticals, Inc.Recruiting18 Years75 YearsAll200Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;Czechia;Germany;Israel;Japan;Mexico;Netherlands;Philippines;Spain;United Kingdom;Czech Republic
97NCT02826252September 15, 201616 December 2017Examination 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, PulmonaryDrug: Iloprost,(Ventavis, BAYQ6256);Device: I-Neb AAD systemBayerNot recruiting18 YearsN/AAll64N/AGermany
98JPRN-UMIN0000251582016/09/017 October 2019A Study of the Efficacy and Safety of Bardoxolone Methyl in Patients with Connective Tissue Disease-Associated Pulmonary Arterial HypertensionA 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 HypertensionConnective Tissue Disease-Associated Pulmonary Arterial HypertensionDrug: 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.Recruiting18years-old75years-oldMale and Female20Phase 3Japan,North America,South America,Australia,Europe
99NCT02825160August 1, 20164 November 2019Non-interventional, Postauthorization Safety Study of Ventavis for Pulmonary Arterial Hypertension (PAH)Drug Use Investigation of Ventavis for Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: Ventavis (Iloprost, BAYQ6256)BayerRecruitingN/AN/AAll270Phase 2Japan
100EUCTR2015-005223-90-GB12/07/20164 September 2017This 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 LLCAuthorisedFemale: yes
Male: yes
188Phase 3Serbia;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.TrialIDDate_
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101NCT02782052July 201622 January 2018Bronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial HypertensionBronchodilator's Effects on Exertional Dyspnoea in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Nebulized Placebo;Drug: Nebulized combination ipratropium bromide with salbutamol;Drug: Nebulized ipratropium bromideAssistance Publique - Hôpitaux de ParisNot recruiting18 YearsN/AAll18Phase 3
102NCT02899533July 20164 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 HypertensionDrug: [18F] FESUniversity of PennsylvaniaNot recruiting18 YearsN/AFemale5Phase 1United States
103NCT02759419June 16, 20164 November 2019A 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, PulmonaryDrug: Adempas (Riociguat, BAY63-2521)BayerRecruiting18 YearsN/AAll25Phase 4France;Italy;Korea, Republic of;Poland;Thailand
104NCT02885012June 201623 April 2019Crossover Study From Macitentan or Bosentan Over to AmbrisentanA 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 HypertensionDrug: AmbrisentanMedical University of South CarolinaOchsner Health SystemNot recruiting18 Years80 YearsAll3Phase 4United States
105NCT02558231May 1, 201616 September 2019The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial HypertensionThe 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 StudyPulmonary Arterial HypertensionDrug: Macitentan;Drug: Tadalafil;Drug: SelexipagActelionNot recruiting18 Years75 YearsAll247Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Norway
No.TrialIDDate_
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106NCT02705807May 201616 December 2017Evaluation of a New Thermostable Formulation of FLOLAN in Japanese SubjectsAn Open Label, Single-arm Study Evaluating a New Thermostable Formulation of FLOLAN™ in Japanese Subjects With Pulmonary Arterial Hypertension (PAH)Cardiovascular DiseaseDrug: FLOLAN injection with currently marketed diluent;Drug: FLOLAN injection with reformulated diluentGlaxoSmithKlineNot recruiting18 Years75 YearsAll10Phase 4Japan
107NCT03809156April 26, 201628 January 2019Upfront Combination Pulmonary Arterial Hypertension TherapyUpfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot StudyPulmonary HypertensionDrug: Riociguat Oral ProductUniversity of CalgaryBayerRecruiting18 YearsN/AAll20Phase 4Canada
108NCT02664558April 201626 November 2018A 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 HypertensionDrug: ubenimex;Other: placeboEiger BioPharmaceuticalsNot recruiting18 Years75 YearsAll61Phase 2United States;Canada
109NCT02725372April 201626 August 2019Clinical Study of Pulsed, Inhaled Nitric Oxide Versus Placebo in Symptomatic Subjects With PAHA 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 HypertensionDrug: Inhaled Nitric Oxide 75 mcg/kg IBW/hr;Drug: PlaceboBellerophon Pulse TechnologiesWorldwide Clinical TrialsNot recruiting18 Years85 YearsAll162Phase 3United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czechia;France;Germany;Israel;Italy;Netherlands;Portugal;Serbia;Spain;Ukraine;United Kingdom
110NCT02734953April 201616 December 2017Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAHEffects of iNO on Invasively Derived Pulmonary Vascular Parameters in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Nitric OxideAllegheny Singer Research InstituteNot recruiting18 Years80 YearsAll10Phase 2United States
No.TrialIDDate_
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111NCT03057028April 201615 April 2019Pilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial HypertensionPilot Study of the Safety and Efficacy of Anakinra in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: AnakinraVirginia Commonwealth UniversityNot recruiting18 YearsN/AAll7Phase 1United States
112EUCTR2015-003438-28-DE04/03/201630 April 2019The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertensionThe 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 PAHPulmonary 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 LtdAuthorised Female: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden
113NCT02652429March 201616 December 2017Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAHAn Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for PAHPulmonary Arterial HypertensionDrug: Inhaled Nitric OxideBellerophon Pulse TechnologiesNot recruitingN/AN/AAll22Phase 3United States;Canada
114NCT02507011January 31, 201622 July 2019Beta-blockers in Pulmonary Arterial HypertensionBeta-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 HypertensionPulmonary Arterial HypertensionDrug: Carvedilol;Drug: PlaceboUniversity of Minnesota - Clinical and Translational Science InstituteRecruiting18 YearsN/AAll26Phase 2United States
115EUCTR2015-002835-17-DE18/01/20168 January 2018RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatmentInvestigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions - RIGHT HEART IIIPulmonary 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 GießenAuthorisedFemale: yes
Male: yes
30Phase 2Germany
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PhaseCountries
116NCT02676947January 201611 June 2018A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial HypertensionA Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: TocilizumabPapworth Hospital NHS Foundation TrustRoche Pharma AG;National Institute for Health Research, United KingdomNot recruiting18 Years70 YearsAll29Phase 2United Kingdom
117EUCTR2012-004411-31-GB25/11/201528 February 2019Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong 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 LtdNot Recruiting Female: yes
Male: yes
220Phase 3Serbia;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
118NCT02551653November 17, 201527 August 2018Positron Emission Tomography (PET) Study to Evaluate Biodistribution of [11C]-GSK2256098 in Healthy Subjects and Idiopathic Pulmonary Arterial Hypertension (PAH) PatientsA 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, PulmonaryDrug: [11C]-GSK2256098 500 MBqGlaxoSmithKlineNot recruiting40 Years70 YearsAll10Phase 1United Kingdom
119NCT02471183November 4, 201516 December 2017Study to Assess the Tolerability and the Safety of the Transition From Inhaled Treprostinil to Oral Selexipag in Patients With Pulmonary Arterial HypertensionMulticenter, 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 HypertensionPulmonary Arterial HypertensionDrug: SelexipagActelionNot recruiting18 Years75 YearsAll30Phase 3United States
120NCT02746237November 201512 September 2016Single and Multiple Ascending Doses Clinical Pharmacology Study With KAR5585A 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 SubjectsPulmonary Arterial HypertensionDrug: KAR5585 Capsules;Drug: Placebo CapsulesKaros PharmaceuticalsNot recruiting18 Years65 YearsBoth120Phase 1United States
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
121EUCTR2015-002799-26-GB27/10/201528 November 2016A therapeutic trial of blockade of interleukin-6 using the drug Tocilizumab in pulmonary arterial hypertensionTRANSFORM-UK: A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension - An open label study of Tocilizumab in PAHPulmonary 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 TrustAuthorisedFemale: yes
Male: yes
26Phase 2United Kingdom
122EUCTR2015-000709-38-AT20/10/20155 September 2016Effects of the drug Benzbromaron on the pulmonary vesselsAcute Effects of Benzbromaron on the pulmonary circulationPulmonary 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 GrazNot RecruitingFemale: yes
Male: yes
Phase 2Austria
123NCT02576002October 201514 March 2016Epidemiology 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 USHypertension, PulmonaryDrug: Assigned pulmonary hypertension medicationBayerNot recruitingN/A18 YearsBoth2691N/AUnited States
124NCT02790450October 20159 January 2017Acute Effects of Benzbromaron on the Pulmonary CirculationAcute Effects of Benzbromaron on the Pulmonary CirculationIdiopathic Pulmonary Arterial HypertensionDrug: BenzbromaroneMedical University of GrazLudwig Boltzmann Institute for Lung Vascular ResearchNot recruiting18 Years90 YearsBoth10Phase 2Austria
125NCT02545465September 15, 201516 December 2017A 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 PracticeRetrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to AdempasHypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNot recruitingN/AN/AAll125N/ABelgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
126NCT02968901September 1, 201522 October 2019Clinical 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 HypertensionDrug: macitentan;Drug: tadalafilActelionNot recruiting18 Years75 YearsAll46Phase 4France
127NCT02253394September 201528 January 2019The Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension StudyThe Combination Ambrisentan Plus Spironolactone in Pulmonary Arterial Hypertension Study (The CAPS-PAH Study)Pulmonary Arterial HypertensionDrug: Ambrisentan plus Spironolactone;Drug: Ambrisentan plus PlaceboBrigham and Women's HospitalGilead SciencesNot recruiting18 YearsN/AAll30Phase 4United States
128EUCTR2014-003952-29-HU25/08/20158 May 2017Riociguat for treatment of PAH in children from 6 to less than 18 years oldOpen-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-CHILDHypertension, 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 AGAuthorisedFemale: yes
Male: yes
20Phase 3United States;Spain;Turkey;Colombia;United Kingdom;Italy;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan
129NCT02279745July 201526 August 2019Long Term Safety and Efficacy of Ralinepag in Pulmonary Arterial HypertensionAn Open-Label Extension Study of Ralinepag in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: RalinepagUnited TherapeuticsNot recruiting18 Years75 YearsAll60Phase 2United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Slovakia;Spain
130NCT02428985June 29, 201522 October 2019Prospective, 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, PulmonaryDrug: Riociguat (ADEMPAS, BAY63-2521)BayerRecruitingN/AN/AAll600Phase 1/Phase 2Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
131NCT02310672June 1, 201514 October 2019REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtensionA 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 ImagingPulmonary Arterial HypertensionDrug: MacitentanActelionNot recruiting18 Years64 YearsAll89Phase 4United States;Australia;France;Germany;Hong Kong;Israel;Italy;Malaysia;Netherlands;Russian Federation;Singapore;United Kingdom
132NCT02436512June 201514 September 2015Study to Assess Acute Vasodilation Response of Inhaled Nitric OxideA 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 HypertensionPulmonary Arterial HypertensionDrug: Inhaled Nitric OxideGeno LLCNot recruiting18 Years70 YearsBoth0Phase 3United States
133EUCTR2014-004066-20-GB14/05/201528 February 2019A 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 hypertensionPulmonary 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
100Phase 4France;United States;Hong Kong;Malaysia;Singapore;Australia;Russian Federation;Israel;Netherlands;Germany;Italy;United Kingdom
134EUCTR2014-000667-40-CZ23/04/201528 February 2019A 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 HypertensionPulmonary 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
60Phase 2Serbia;United States;Hungary;Czech Republic;Slovakia;Poland;Spain;Romania;Australia;Bulgaria
135NCT03195543March 12, 20151 April 2019Assessment of Blood Coagulation Disorders in Patients With Pulmonary HypertensionAssessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension.Pulmonary Artery Hypertension;Chronic Thromboembolic Pulmonary HypertensionDiagnostic Test: Platelet function analyzer-100;Diagnostic Test: Light transmission aggregometry;Diagnostic Test: Rotational thromboelastometry;Diagnostic Test: Endogenous thrombin potentialNational and Kapodistrian University of AthensRecruiting18 YearsN/AAll60N/AGreece
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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136ChiCTR-OON-170135212015-02-0127 November 2017Transition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective studyTransition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective studypulmonary arterial hypertensionambrisentan group:oral ambrisentan;bosentan group:oral bosentan;Shanghai Pulmonary HospitalNot RecruitingMaleambrisentan group:12;bosentan group:8;OtherChina
137JPRN-JapicCTI-14272201/1/201523 April 2019ACT-385781A extension study for PAH pediatric patientsOpen-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.14BOTH3Phase 3
138NCT02309463January 201511 April 2016Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance & 6-minute Walk Distance in Patients With Pulmonary Arterial HypertensionA 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 TherapyPulmonary Arterial HypertensionDrug: Endothelin receptor antagonist therapyActelionNot recruiting18 YearsN/ABoth0N/A
139NCT02276872December 201416 December 2017Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 YearsA 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 HypertensionPAHDrug: oral treprostinilUnited TherapeuticsNot recruiting7 Years17 YearsAll40Phase 2United States
140NCT02279160December 201418 December 2018Safety and Efficacy of APD811 in Pulmonary Arterial HypertensionA Randomized, Double-blind, Parallel-group, Placebo-controlled Phase 2 Trial of APD811, an Oral IP Receptor Agonist, in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: APD811;Drug: PlaceboArena PharmaceuticalsNot recruiting18 Years75 YearsAll60Phase 2United States;Australia;Bulgaria;Czechia;Hungary;Poland;Romania;Serbia;Spain;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
141NCT02290613December 201416 December 2017Early 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 EDITASystemic Sclerosis;Pulmonary HypertensionDrug: Ambrisentan;Drug: PlaceboHeidelberg UniversityGlaxoSmithKlineNot recruiting18 YearsN/AAll38Phase 2Germany
142NCT02284737November 28, 201420 May 2019A Study to Investigate the Efficacy of PADN to Improved Functional Capacity and Hemodynamics in Patients With PAHA 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 HypertensionPulmonary Arterial HypertensionProcedure: PADN;Procedure: sham PADN;Drug: SildenafilNanjing First Hospital, Nanjing Medical UniversityRecruiting18 YearsN/AAll270Phase 4China
143NCT02234141November 20149 January 2017Selonsertib in Adults With Pulmonary Arterial HypertensionA Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Selonsertib;Drug: PlaceboGilead SciencesNot recruiting18 Years75 YearsBoth151Phase 2United States;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
144EUCTR2014-001882-28-DE13/10/20148 January 2018Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertensionEarly Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITASystemic 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 gGmbHNot RecruitingFemale: yes
Male: yes
38Phase 2Germany
145NCT02191137September 23, 201416 December 2017Measuring 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 TreatmentHypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNot recruiting18 Years80 YearsAll75Phase 4United States;Puerto Rico
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
146NCT02060487September 22, 20144 November 2019Effects of Oral Sildenafil on Mortality in Adults With PAHA MULTINATIONAL, MULTICENTER STUDY TO ASSESS THE EFFECTS OF ORAL SILDENAFIL ON MORTALITY IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH)Pulmonary Arterial HypertensionDrug: sildenafil citratePfizerRecruiting18 Years74 YearsAll429Phase 4United 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
147JPRN-UMIN0000163202014/09/182 April 2019Clinical study to investigate the effects of anti-CD20 monoclonal antibody (Rituximab) in patients with refractory pulmonary arterial hypertension associated with connective tissue diseasePulmonary arterial hypertension associated with connective tissue diseaseWeekly rituximab (375mg/m2) infusion for 4 weeksThe University of Tokyo HospitalNot Recruiting20years-old80years-oldMale and Female6Not selectedJapan
148EUCTR2014-000091-25-GB01/09/201423 March 2015A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndromeA single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome - Iloprost in patients with Eisenmenger SyndromePulmonary 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 TrustAuthorisedFemale: yes
Male: yes
United Kingdom
149JPRN-JapicCTI-14272101/9/20142 April 2019ACT-385781A for PAH pediatric patientsProspectiove, 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.14BOTH3Phase 3
150ChiCTR-TRC-140048942014-07-0118 April 2017Clinical research on treatment of pulmonary arterial hypertension associated with connective tissue disease by Mycophenolate mofetilClinical research on treatment of pulmonary arterial hypertension associated with connective tissuepulmonary arterial hypertension associated with connective tissue diseaseA:Glucocorticoid plus sildenafil;B:Glucocorticoid plus sildenafil;Beijing Chaoyang Hospital affiliated to Capital Medical UniversityRecruiting1880MaleA:8;B:8;Other
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
151NCT02112487June 23, 201430 September 2019Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAHAn 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 HypertensionDrug: MacitentanActelionNot recruiting18 Years80 YearsAll88Phase 3France;Italy;Spain
152NCT02108743June 201418 January 2016Albuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial HypertensionAlbuterol and Dynamic Hyperinflation in Idiopathic Pulmonary Arterial HypertensionIdiopathic Pulmonary Arterial Hypertension.Drug: Albuterol.;Drug: Normal saline placeboAmerican Medical Association FoundationNot recruiting18 Years75 YearsBoth0Phase 2United States
153NCT02763735June 201429 July 2019Right Ventricular Metabolism in Pulmonary Arterial HypertensionMetabolic Intervention in the Right Ventricle in Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;HealthyDrug: 11C acetateVanderbilt UniversityNot recruiting18 YearsN/AAll34N/AUnited States
154NCT02036970May 201414 January 2019Bardoxolone Methyl Evaluation in Patients With Pulmonary Hypertension (PH) - LARIATA Dose-Ranging Study of the Efficacy and Safety of Bardoxolone Methyl in Patients With Pulmonary HypertensionPulmonary 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 FibroelastosisDrug: Bardoxolone methyl;Drug: PlaceboReata Pharmaceuticals, Inc.Not recruiting18 Years75 YearsAll166Phase 2United Kingdom;Spain;United States;Germany
155NCT02120339May 201422 July 2019Carvedilol PAH A Pilot Study of Efficacy and SafetyBeta Blockers in Pulmonary Arterial Hypertension (PAH) A Pilot Study of Efficacy and SafetyPulmonary Hypertension;Cardiac MRI <40Drug: CarvedilolUniversity of Minnesota - Clinical and Translational Science InstituteNot recruiting18 Years99 YearsAll5Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
156NCT02126943April 30, 20144 November 2019OPsumit USers RegistryUS-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical PracticePulmonary Arterial HypertensionDrug: Opsumit (macitentan)ActelionRecruitingN/AN/AAll5000Phase 2/Phase 3United States;Puerto Rico
157NCT02304198April 201425 April 2016Clinical Trial to Evaluate the Long-term Safety of Udenafil in Patient With PAHA Single-arm, Open-label, Extension Study to Evaluate the Long-term Safety of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)Pulmonary Arterial HypertensionDrug: UdenafilDong-A ST Co., Ltd.Not recruiting18 YearsN/ABoth59Phase 2/Phase 3Korea, Republic of
158NCT02032836March 10, 20141 October 2018Comparative 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 HypertensionPulmonary Arterial HypertensionDrug: lloprost(Ventavis,BAYQ6252, 20 µg/mL);Drug: lloprost(Ventavis,BAYQ6252, 10 µg/mL)BayerNot recruiting18 YearsN/AAll27Phase 1/Phase 2Germany;Austria
159NCT02081690March 201414 March 2016A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and SpainA 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 HypertensionDrug: MacitentanActelionNot recruiting18 Years80 YearsBoth160Phase 3France;Italy;Spain
160EUCTR2013-003462-14-ES20/02/201412 October 2015Study 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? - ORCHESTRAPulmonary 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 RecruitingFemale: yes
Male: yes
160Phase 3bSpain
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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161EUCTR2013-003489-15-ES20/02/201415 October 2018An 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 RecruitingFemale: yes
Male: yes
160Phase 3Spain;Italy
162NCT01824290February 5, 201423 April 2019A 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 HypertensionHypertension, PulmonaryDrug: Tadalafil;Drug: PlaceboEli Lilly and CompanyNot recruiting6 Months18 YearsAll34Phase 3United States;Austria;Belgium;Brazil;France;Germany;Israel;Italy;Japan;Mexico;Netherlands;Poland;Spain;Turkey;Canada;Romania;Switzerland
163NCT01897740January 24, 201415 April 2019Sildenafil Therapy For Subjects Who Derive Clinical Benefit From Continued Treatment With SildenafilA 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 FEDERATIONPulmonary Arterial HypertensionDrug: sildenafilPfizerNot recruiting10 Years30 YearsAllPhase 1/Phase 2Russian Federation
164NCT02042014January 22, 201415 July 2019Open-label, Multi-center Protocol to Provide QTI571 to PAH Patients Who Participated in the Extension Study (A2301E1) in JapanAn 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 TreatmentSevere Pulmonary Arterial HypertensionDrug: QTI571Novartis PharmaceuticalsNot recruiting18 YearsN/AAll8Phase 3Japan
165NCT01712620January 10, 201424 June 2019Spironolactone for Pulmonary Arterial HypertensionA Pilot Study of the Effect of Spironolactone Therapy on Exercise Capacity and Endothelial Dysfunction in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Spironolactone;Drug: PlaceboNational 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 MedicineRecruiting18 Years99 YearsAll70Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
166EUCTR2011-002707-16-ES09/01/201427 January 2014sildenafil in the postoperative period of cardiac surgery in children.SILDENAFIL IN THE POST-CARDIAC SURGERY IN CHILDREN: IVORY STUDY - IVORYPostoperative 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 MarañónAuthorisedFemale: yes
Male: yes
Spain
167EUCTR2013-002783-12-DE07/01/201420 August 2018NoA 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-NebPatients 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 AGNot RecruitingFemale: yes
Male: yes
24Phase 1;Phase 2Austria;Germany
168EUCTR2013-001759-10-DE03/01/20142 October 2017Open-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) - RESPITEHypertension, 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 AGNot RecruitingFemale: yes
Male: yes
70Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland
169JPRN-JapicCTI-14246201/1/201423 April 2019An 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 treatmentAn 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 treatmentpulmonary arterial hypertensionIntervention 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.BOTHPhase 3
170EUCTR2013-003462-14-IT10/12/20135 March 2018Study 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™ - ORCHESTRAPulmonary 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 RecruitingFemale: yes
Male: yes
160Phase 3Spain;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
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size
PhaseCountries
171EUCTR2013-003489-15-IT10/12/20135 March 2018An extension of the ORCHESTRA (AC-055-310) studyAn 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.AuthorisedFemale: yes
Male: yes
160Phase 3Spain;Italy
172NCT02023450December 201319 February 2015Testing of HIV Protease Inhibitors to Suppress Inflammation and Improve Cardio Pulmonary Hemodynamics in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: saquinavir and ritonavirThe Third Xiangya Hospital of Central South UniversityXiangya Hospital of Central South UniversityRecruiting18 Years60 YearsBoth20Phase 0China
173EUCTR2013-001100-10-ES12/11/20139 December 2013This 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 treatmentPulmonary 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 RecruitingFemale: yes
Male: yes
81United States;Spain;Australia;Switzerland
174NCT01926509November 20132 May 2016Study 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 HypertensionPulmonary Arterial HypertensionDrug: MK-8892;Drug: Placebo for MK-8892Merck Sharp & Dohme Corp.Not recruiting18 Years70 YearsBoth23Phase 1Bulgaria;Germany;Moldova, Republic of
175NCT01934647November 20131 February 2016Acute 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 HypertensionPulmonary Arterial HypertensionDrug: MK-8892Merck Sharp & Dohme Corp.Not recruiting18 Years70 YearsBoth20Phase 1Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
176NCT01966302November 201315 July 2019Compassionate 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 HypertensionDrug: BPS-314d-MRLos Angeles Biomedical Research InstituteLung Biotechnology PBCNot recruiting18 Years75 YearsAll3Phase 2United States
177NCT02000856November 201311 June 2018BEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial HypertensionBEET PAH: a Study to Assess the Effects of Beetroot Juice in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDietary Supplement: Beetroot juiceUppsala UniversityKarolinska InstitutetNot recruiting18 YearsN/AAll15N/ASweden
178NCT03638908November 201327 August 2018Fluoxetine in Pulmonary Arterial Hypertension (PAH) TrialA Phase 2, Open-label, Clinical Trial of Fluoxetine, a Selective Serotonin Reuptake Inhibitor, in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: FluoxetineUniversity of Texas Southwestern Medical CenterNot recruiting16 Years80 YearsAll8Phase 2United States
179NCT01827059October 201316 December 2017Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasEA 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 PlaceboPulmonary Arterial Hypertension;Congenital Heart DiseaseDrug: Bosentan;Drug: PlaceboAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Not recruiting18 YearsN/AAll12Phase 2Netherlands
180NCT01894035September 23, 201311 June 2018Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for InhalationStudy to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.Pulmonary HypertensionDrug: Iloprost (Ventavis, BAYQ 6256)BayerNot recruiting18 YearsN/AAll13N/APortugal
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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PhaseCountries
181NCT01781052September 11, 201316 December 2017Observational Description of Compliance for the Daily Ventavis Use Via the Insight Program in Class III Pulmonary Arterial Hypertension PatientsDAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Ventavis (Iloprost, BAYQ6256)BayerNot recruiting18 YearsN/AAll17N/AFrance
182NCT01739400September 10, 201327 August 2018Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger SyndromeLong 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 SyndromePulmonary Arterial HypertensionDrug: Macitentan 10 mg tablet, once daily.ActelionNot recruiting12 YearsN/AAll217Phase 3United 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
183NCT01950585September 6, 20134 November 2019Hydroxyurea in Pulmonary Arterial HypertensionHydroxyurea in Pulmonary Arterial HypertensionPulmonary HypertensionDrug: HydroxyureaNational Heart, Lung, and Blood Institute (NHLBI)The Cleveland ClinicNot recruiting18 Years110 YearsAll0Early Phase 1United States
184NCT01847014September 201320 June 2016Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT InstrumentAC-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 InstrumentPulmonary Arterial HypertensionDrug: MacitentanActelionNot recruiting18 Years80 YearsBoth4Phase 3United States
185NCT01953965September 20138 August 2016Look 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 HypertensionPulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary HypertensionDrug: 11C-acetate;Drug: [18F]Fluoro-2-deoxy-2-D-glucose;Drug: MultiHanceBrigham and Women's HospitalUniversity of Pennsylvania;University of Maryland;Yale UniversityNot recruiting18 Years72 YearsBoth4Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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size
PhaseCountries
186JPRN-JapicCTI-13215501/8/201323 April 2019Bosentan extension study for PAH pediatric patientsOpen-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.14BOTH5Phase 3
187NCT01934582August 201319 October 2017A Pharmacokinetic Substudy of the TDE-PH-304 ProtocolA Pharmacokinetic Substudy of Subjects Transitioning From Twice Daily to Three Times Daily Dosing of UT-15C SR (Treprostinil Diethanolamine) in the TDE-PH-304 ProtocolPulmonary Arterial HypertensionDrug: UT-15C SR;Drug: treprostinil diethanolamineUnited TherapeuticsNot recruiting12 Years75 YearsAll13Phase 3United States
188NCT01880866July 201319 February 2015(-)-Epicatechin and Pulmonary Arterial HypertensionAn Open Label Pilot Study of Purified (-)-Epicatechin to Improve Hemodynamics in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: (-)-EpicatechinUniversity of California, San FranciscoNot recruiting18 YearsN/ABoth0Phase 1United States
189NCT01743001May 21, 20135 March 2018Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger SyndromeA 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 SyndromePulmonary Arterial HypertensionDrug: Macitentan 10 mg;Drug: PlaceboActelionNot recruiting12 YearsN/AAll226Phase 3United 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
190JPRN-JapicCTI-13215401/5/20132 April 2019Bosentan for PAH pediatric patientsOpen-label, multicenter study to assess the efficacy, safety, tolerability, and pharmacokinetics of bosentan in Japanese children with pulmonary arterial hypertensionPulmonary 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.14BOTH5Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
191NCT01637675May 201319 February 2015Efficacy and Safety Study of Sodium Tanshinone IIA Sulfonate on Pulmonary HypertensionClinical Study of Effects of Sodium Tanshinone IIA Sulfonate on Pulmonary HypertensionPulmonary Hypertension;Pulmonary Arterial Hypertension;Cardiovascular Diseases;Lung Diseases;Tanshinone IIA SulfonateDrug: 20 mg sildenafil citrate by mouth;Drug: sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouthThe First Affiliated Hospital of Guangzhou Medical UniversityJiangsu 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 UniversityRecruiting15 Years70 YearsBoth90Phase 2/Phase 3China
192NCT01908699May 201313 May 2019Beraprost-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 HypertensionPulmonary Arterial HypertensionDrug: Beraprost Sodium 314d Modified Release Tablets;Drug: PlaceboLung Biotechnology PBCNot recruiting18 Years80 YearsAll240Phase 3United States;Israel
193NCT03236818May 201316 December 2017Goal Oriented Strategy to Preserve Ejection Fraction TrialRaising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction TrialPulmonary Arterial HypertensionDrug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)VU University Medical CenterNot recruiting18 Years80 YearsAll30Phase 4Netherlands
194JPRN-JapicCTI-13214201/4/201323 April 2019ACT-385781A PAH Post-marketing studyA Post-marketing, Open-label-study ACT-385781A in patients with pulmonary arterial hypertensionPulmonary 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.20BOTH5Phase 4
195NCT01795950April 201323 February 2016Safety 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 PAHPulmonary Arterial HypertensionDrug: PLX-PADUnited TherapeuticsNot recruiting18 Years75 YearsBoth6Phase 1Australia
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
196NCT01841762April 201320 June 2016Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT InstrumentA Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT InstrumentPulmonary Arterial HypertensionDrug: MacitentanActelionNot recruiting18 YearsN/ABoth284Phase 3United States
197NCT01864863April 201331 October 2016To Compare the Pharmacokinetics of Traclear 62.5 mg Tablets and HGP1206 125mg 1 Tablet in Healthy Male VolunteersAn 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 VolunteersPulmonary Arterial HypertensionDrug: HGP1206;Drug: TraclearHanmi Pharmaceutical Company LimitedNot recruiting20 Years55 YearsMale28Phase 1Korea, Republic of
198EUCTR2011-002018-35-IT08/03/201319 October 2015SPHERIC-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-1SPHERIC-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 EXTENSIONPatients 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 OSPEDALIERINot RecruitingFemale: yes
Male: yes
Italy
199NCT01725269March 201319 February 2015Long-term Study of AIR001 in Subjects With WHO Group 1 Pulmonary Arterial Hypertension Who Completed AIR001-CS05A 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 HypertensionPulmonary Arterial HypertensionDrug: AIR001Aires Pharmaceuticals, Inc.Not recruiting18 Years75 YearsBoth17Phase 2United States;Australia;Hungary
200NCT01798849March 201324 August 2015A 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-8892Pulmonary Arterial HypertensionDrug: MK-8892;Drug: Placebo for MK-8892Merck Sharp & Dohme Corp.Not recruiting18 Years60 YearsMale24Phase 1Belgium
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2012-003335-33-GB27/02/201330 April 2019Study 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 capacityEisenmenger 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
220Phase 3Serbia;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
202EUCTR2012-004411-31-IT01/02/201331 January 2017Long-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-OLEisenmenger 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 RecruitingFemale: yes
Male: yes
220Phase 3Portugal;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
203NCT01847352February 201317 May 2016Iron Status and Hypoxic Pulmonary Vascular ResponsesEffect of Endogenous Iron Status on Hypoxic Pulmonary Vascular Responses and Their Attenuation by Intravenous IronLung Hypoxia;Pulmonary Arterial Hypertension;Iron DeficiencyDrug: Intravenous administration of ferric carboxymaltose;Other: Subacute hypoxic exposuresUniversity of OxfordNational Institute for Health Research, United Kingdom;British Heart FoundationNot recruiting18 YearsN/ABoth31N/AUnited Kingdom
204EUCTR2012-000153-31-HU22/01/201310 March 2014A 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 lungsA 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 HypertensionPulmonary 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, IncNot RecruitingFemale: yes
Male: yes
90Phase 2France;United States;Serbia;Czech Republic;Hungary;Poland;Australia;Germany;Italy
205EUCTR2012-000166-37-HU22/01/201310 March 2014A 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 lungsA 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 HypertensionPulmonary 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 IncNot RecruitingFemale: yes
Male: yes
90Phase 2France;United States;Serbia;Czech Republic;Hungary;Poland;Australia;Germany;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
206NCT01808313December 1, 201216 December 2017Efficacy 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 DiseaseDrug: ambrisentanGlaxoSmithKlineNot recruiting18 Years75 YearsAll134Phase 3China
207NCT01586156December 201216 December 2017PAHTCH Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart Failure (Carvedilol)Pulmonary Arterial Hypertension Treatment With Carvedilol for Heart FailurePulmonary HypertensionDrug: Carvedilol;Drug: placeboThe Cleveland ClinicNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI)Not recruiting18 Years65 YearsAll30N/AUnited States
208NCT01517854November 14, 20127 October 2019Revatio Portal-Pulmonary Arterial Hypertension TrialRevatio 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 HypertensionDrug: Sildenafil;Drug: PlaceboUniversity Health Network, TorontoNot recruiting18 Years75 YearsAll12Phase 2Canada
209EUCTR2012-000097-26-GB06/11/201228 February 2019International, 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 monotherapyA 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 CorporationNot Recruiting Female: yes
Male: yes
850Phase 3United 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
210EUCTR2012-000098-21-GB06/11/201230 April 2019An Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial HypertensionAn Open Label Extension Study of UT-15C in subjects with Pulmonary Arterial Hypertension- A long term follow up to protocol TDE-PH-310Pulmonary 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 CorporationAuthorised Female: yes
Male: yes
850Phase 3United 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.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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agemin
Inclusion_
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PhaseCountries
211NCT01582438November 201216 December 2017An Open Label Access Study For Subjects Who Completed A1481156A 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 IndiaPulmonary Arterial HypertensionDrug: Access program - sildenafil citrate, Viagra, RevatioPfizerNot recruiting12 Years30 YearsAllN/AIndia
212NCT01725256November 201219 February 2015A 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 HypertensionDrug: AIR001 (sodium nitrite inhalation solution)Aires Pharmaceuticals, Inc.Not recruiting18 Years75 YearsBoth29Phase 2United States;Australia;Hungary
213NCT01545336October 201219 October 2017Anastrozole in Patients With Pulmonary Arterial HypertensionA Double-blind, Placebo-controlled Phase II Study of Anastrozole in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Anastrozole;Drug: PlaceboUniversity of PennsylvaniaNot recruiting18 YearsN/AAll18Phase 2United States
214EUCTR2012-000097-26-DE17/09/201228 February 2019International, 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 monotherapyA 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 CorporationNot Recruiting Female: yes
Male: yes
850Phase 3United 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
215JPRN-JapicCTI-12198601/9/201223 April 2019Macitentan PAHA multicenter, open-label, phase II/III study to asseses the efficacy, safety and Pharmacokinetics(PK) of macitentan (ACT-064992) in patients with pulmonary arterial hypertensionPulmonary 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.16BOTH22Phase 2-3
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
216NCT01649739September 201219 February 2015Vardenafil as add-on Therapy for Patients With Pulmonary Hypertension Treated With Inhaled IloprostPulmonary Arterial HypertensionDrug: LevitraRabin Medical CenterNot recruiting18 Years70 YearsBoth20Phase 4Israel
217NCT01712997September 201219 February 2015Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension PatientsPhase ? Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Iloprost;Drug: BosentanFourth Military Medical UniversityRecruiting10 Years80 YearsBoth90Phase 3China
218NCT01723371September 201218 January 2016Beta Blockers for Treatment of Pulmonary Arterial Hypertension in ChildrenBeta Blockers for Treatment of Pulmonary Arterial Hypertension in ChildrenPulmonary Arterial HypertensionDrug: CarvedilolThe Hospital for Sick ChildrenNot recruiting8 Years17 YearsBoth0Phase 1/Phase 2Canada
219NCT02169752September 20123 September 2018Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionAmbrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial HypertensionPre-Pulmonary Atrial HypertensionDrug: AmbrisentanNational Jewish HealthNot recruiting18 Years80 YearsAll7N/AUnited States
220NCT01642407August 24, 20121 October 2018Safety And Efficacy Of Sildenafil In Children With Pulmonary Arterial HypertensionA Phase 3, Multi-center, Open-label Study To Investigate Safety, Efficacy, And Tolerability Of Sildenafil Citrate In Pediatric Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Hypertension, PulmonaryDrug: SildenafilPfizerNot recruiting1 Year17 YearsAll6Phase 4Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
221NCT01683981August 201219 February 2015Exercise Capacity and Quality of Life in Patients With PPH Receiving Short Term Oral L-Citrulline MalateExercise Capacity and Quality of Life in Patients With Idiopathic Pulmonary Hypertension and Eisenmenger Syndrome Receiving Short Term Oral L-Citrulline MalateIdiopathic Pulmonary Arterial Hypertension;Eisenmenger SyndromeDrug: L-Citrulline MalateMasih Daneshvari HospitalRecruiting15 Years70 YearsBoth25Phase 0Iran, Islamic Republic of
222EUCTR2012-001675-37-DE24/07/20127 October 2014A Study to Investigate the Effects of Lisuride in addition to Conventional Treatment in Patients with Pulmonary Arterial HypertensionA 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-SafePulmonary 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 GmbHNot RecruitingFemale: yes
Male: yes
12Austria;Germany
223NCT01484431July 17, 201214 October 2019A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial HypertensionA Multiple Ascending Dose Study of Tadalafil to Assess the Pharmacokinetics and Safety in a Pediatric Population With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Tadalafil- Tablet or Oral suspensionEli Lilly and CompanyNot recruiting6 Months17 YearsAll20Phase 1/Phase 2United States;Canada;France;Poland;Spain;United Kingdom
224EUCTR2011-004612-31-PT06/07/20122 June 2014A 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 6Pulmonary 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 LtdNot RecruitingFemale: yes
Male: yes
105Portugal;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
225NCT01523548July 201216 December 2017Carbon Monoxide Therapy for Severe Pulmonary Arterial HypertensionCarbon Monoxide Therapy for Severe Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Carbon MonoxideUniversity of Illinois at ChicagoNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI)Not recruiting18 YearsN/AAll0Phase 1/Phase 2United States
No.TrialIDDate_
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size
PhaseCountries
226NCT01645826July 20123 December 2018Efficacy Study of Cardizem in Pulmonary Arterial HypertensionCalcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.Idiopathic Pulmonary Arterial Hypertension;Primary Pulmonary Hypertension;Pulmonary Arterial Hypertension;Familial Primary Pulmonary HypertensionDrug: Diltiazem Hydrochloride;Drug: Sugar PillUniversity of South FloridaNot recruiting18 YearsN/AAll0N/AUnited States
227NCT01647945July 201219 October 2017FK506 (Tacrolimus) in Pulmonary Arterial HypertensionSingle-Center Randomized Controlled Phase II Study of Safety and Efficacy of FK-506 (Tacrolimus) in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Placebo;Drug: FK506 level < 2 ng/ml;Drug: FK506 level 2-3 ng/ml;Drug: FK506 level 3-5 ng/mlEdda SpiekerkoetterStanford UniversityNot recruiting18 Years70 YearsAll23Phase 2United States
228NCT01560624June 26, 201213 May 2019Phase III Clinical Worsening Study of UT-15C in Subjects With PAH Receiving Background Oral MonotherapyA 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 MonotherapyPulmonary Arterial HypertensionDrug: Treprostinil Diolamine;Drug: PlaceboUnited TherapeuticsNot recruiting18 Years75 YearsAll690Phase 3United 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
229NCT01469169June 19, 201216 December 2017Inhaled Iloprost (Ventavis): Efficacy, Safety, and Pharmacokinetics (PK) Confirmation StudyA 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, PulmonaryDrug: Iloprost (Ventavis inhaled, BAYQ6256)BayerNot recruiting18 Years75 YearsAll27Phase 3Japan
230NCT01557647June 201219 February 2015Safety and Efficacy of Inhaled Treprostinil in Patients With PAHInhaled 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 HypertensionDrug: Inhaled treprostinil;Drug: PlaceboUnited TherapeuticsNot recruiting18 Years75 YearsBoth0Phase 3
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
231NCT01557660June 201219 February 2015Inhaled Treprostinil for PAH: Open-label ExtensionInhaled Treprostinil in Subjects With Pulmonary Arterial Hypertension: An Open-Label, Phase III, International, Multi-Center StudyPulmonary Arterial HypertensionDrug: inhaled treprostinilUnited TherapeuticsNot recruiting18 YearsN/ABoth0Phase 3
232NCT01560637May 20122 September 2019An Open-Label, Long-Term Study of Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionOpen-Label Extension Study of UT-15C in Subjects With Pulmonary Arterial Hypertension- A Long-Term Follow-Up to Protocol TDE-PH-310Pulmonary Arterial HypertensionDrug: UT-15C (treprostinil diethanolamine)United TherapeuticsRecruiting18 Years75 YearsAll850Phase 3United 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
233NCT01457781April 201223 July 2018Inhaled 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 HypertensionDrug: Nitric Oxide;Other: PlaceboBellerophon Pulse TechnologiesNot recruiting16 Years80 YearsAll80Phase 2United States;Canada
234NCT01588405April 201219 October 2017Remodulin® to Oral Treprostinil TransitionA Multicenter, Open-Label Study of the Safety and Tolerability of Transitioning From Remodulin® to Oral Treprostinil in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: UT-15C SRUnited TherapeuticsNot recruiting15 Years80 YearsAll33Phase 2United States
235NCT01615627April 201219 February 2015Hypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site PainHypotonic Treprostinil Subcutaneous Infusion for Control of Treprostinil Related Site PainPulmonary Arterial HypertensionDrug: HypotonicTreprostinil Solution;Drug: Eutonic Treprostinil SolutionJewish General HospitalNot recruiting18 YearsN/ABoth12Phase 4Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
236NCT02847260April 201216 December 2017Safety 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 HypertensionDrug: RemodulinUnited TherapeuticsNot recruiting18 YearsN/AAll39Phase 4
237EUCTR2011-004631-31-DE13/03/201210 July 201516 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 studyPulmonary 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 RecruitingFemale: yes
Male: yes
50Germany
238NCT01590108March 201229 April 2019The Study of Apelin-APJ System on Pulmonary Hypertension Patients and Healthy SubjectsThe Apelin-APJ System in Idiopathic Pulmonary Arterial Hypertension and Healthy Volunteers; Tissue Location and Cardiopulmonary Response.Idiopathic Pulmonary Arterial HypertensionDrug: (Pyr1)apelin-13;Drug: SalineImperial College LondonNot recruiting18 Years90 YearsMale12Phase 1United Kingdom
239EUCTR2011-001873-24-ES13/01/201226 June 2012A 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 bodyA multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial HypertensionPulmonary 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 CompanyAuthorisedFemale: yes
Male: yes
24United Kingdom;Canada;France;Spain;United States;Poland
240NCT01433328January 201219 February 2015Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site PainLidocaine Subcutaneous Infusion for Control of Treprostinil Related Site PainPulmonary Arterial HypertensionDrug: Lidocaine;Drug: PlaceboJewish General HospitalNot recruiting18 YearsN/ABoth4Phase 4Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Status
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PhaseCountries
241NCT01446848January 201219 February 2015Oral Iron Supplementation in Pulmonary HypertensionOral Iron Supplementation in Pulmonary HypertensionPulmonary Arterial HypertensionDietary Supplement: iron supplementThe Cleveland ClinicNot recruiting21 YearsN/ABoth6N/AUnited States
242NCT01457170January 201219 February 2015Effects of Apelin on the Lung Circulation in Pulmonary HypertensionInvestigating the Acute Pulmonary Vascular Haemodynamic Effects of Apelin in Pulmonary HypertensionPulmonary Arterial Hypertension;Heart FailureDrug: Apelin;Drug: Saline (Placebo)Golden Jubilee National HospitalNHS Lothian;Imperial College Healthcare NHS TrustRecruiting18 YearsN/ABoth63N/AUnited Kingdom
243NCT02661802January 20121 February 2016Effects Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger SyndromeAcute Effects of 40% Oxygen Supplementation Determined Better Exercise Capacity in Eisenmenger SyndromeEisenmenger Complex;Hypertension, PulmonaryOther: Oxygen SupplementationFederal University of São PauloNot recruiting18 Years60 YearsBoth30N/A
244EUCTR2012-002354-23-GB2 October 2017A 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 HypertensionPulmonary 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 CompanyNot AvailableFemale: yes
Male: yes
134Phase 3United States;Spain;Austria;United Kingdom;Switzerland;Italy;France;Mexico;Canada;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Japan
245EUCTR2007-003694-27-GB17/11/20116 January 2015Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial HypertensionSERAPHIN-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-OLsymptomatic 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 LtdAuthorisedFemale: yes
Male: yes
525Portugal;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.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
246EUCTR2011-002943-92-NL07/11/20113 December 2012Study 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 LimitedNot RecruitingFemale: yes
Male: yes
20Netherlands;Canada;United States
247NCT01462565November 1, 201116 December 2017Study 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, PulmonaryDrug: current marketed FLOLAN (epoprostenol sodium);Drug: new thermo stable formulation of epoprostenol sodiumGlaxoSmithKlineNot recruiting18 Years75 YearsAll16Phase 4United States;Canada;Netherlands
248NCT01431326November 201115 April 2019Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of CarePharmacokinetics of Understudied Drugs Administered to Children Per Standard of CareAdenovirus;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;InsomniaDrug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:Daniel BenjaminEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);The EMMES CorporationRecruitingN/A21 YearsAll10000Phase 2United States;Australia;Canada;Israel;Singapore;United Kingdom
249NCT01458236November 201119 February 2015A 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 InhibitorA 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 InhibitorPulmonary Arterial HypertensionDrug: Beraprost Sodium 314d Modified Release Tablets;Drug: PlaceboLung Biotechnology Inc.Not recruiting18 Years80 YearsBoth0Phase 3
250EUCTR2011-001893-24-DE13/10/20115 August 2013To 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 designChildren 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 AGNot RecruitingFemale: yes
Male: yes
30Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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agemin
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PhaseCountries
251NCT01447628October 201124 June 2019IV Iron Replacement for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) PatientsWhat 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 DeficiencyDrug: Saline;Drug: Ferinject or CosmoFerImperial College LondonFu Wai Hospital, Beijing, ChinaNot recruiting16 Years75 YearsAll40Phase 2China;Germany;United Kingdom
252NCT01468545October 201119 February 2015Educational Training Influence in Patients With PAH(Pulmonary Artery Hypertension) on Inhaled Ventavis Treatment Adherence Evaluated Trough INSIGHT SystemProspective, 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 HypertensionOther: Iloprost (Ventavis inhaled, BAYQ6256)BayerDra. Pilar Escribano Subías - Coordinator - HU 12 de Octubre - Madrid (Spain)Not recruiting18 YearsN/ABoth38N/ASpain
253NCT01477333October 201116 December 2017Addition 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 HypertensionDrug: UT-15C SR;Drug: Tyvaso Inhalation SolutionUnited TherapeuticsNot recruiting18 Years75 YearsAll18Phase 2United States
254NCT01548950September 201129 June 2015Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary HypertensionCombined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD)Congenital Heart Disease;Pulmonary Arterial HypertensionDrug: Sildenafil singly or in association with BosentanUniversity of Sao Paulo General HospitalInstituto do Coracao;Fundação de Amparo à Pesquisa do Estado de São PauloRecruiting2 MonthsN/ABoth50N/ABrazil
255JPRN-JapicCTI-12201701/8/201123 April 2019ACT-385781A PAHOpen-label study ACT-385781A in patients with pulmonary arterial hypertensionPulmonary 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.20BOTH10Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
256JPRN-UMIN0000059732011/08/0123 April 2019Tadalafil study for pediatric PAH on efficacy, safety and pharmacodynamicsTadalafil study for pediatric PAH on efficacy, safety and pharmacodynamics - Tadalafil study for pediatric PAHpediatric pulmonary arterial hypertensionsingle oral administration of tadalafil 1mg/kgNational Cerebral and Cardiovascular CenterNot RecruitingNot applicable18years-oldMale and Female10Not applicableJapan
257NCT01393795August 201119 February 2015Qutenza®-Remodulin® in Pulmonary Arterial Hypertension PatientsA 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 PatientsPulmonary Hypertension;PainDrug: Qutenza;Drug: TegadermImperial College LondonUnited TherapeuticsNot recruiting18 YearsN/ABoth11Phase 2United Kingdom
258NCT01553721August 201125 April 2016Efficacy 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 HypertensionDrug: udenafil;Drug: placeboDong-A ST Co., Ltd.Not recruiting18 YearsN/ABoth63Phase 2Korea, Republic of
259NCT01757808August 201116 December 2017A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial HypertensionA Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Ranolazine;Drug: PlaceboUniversity of ChicagoNot recruiting18 Years72 YearsAll12Phase 1United States
260NCT01365585July 201116 December 2017Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial HypertensionEvaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses =20mg TID For The Treatment Of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: sildenafil citratePfizerNot recruiting18 YearsN/AAll227N/AGermany;Ireland
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
261NCT01409122July 201119 February 2015Safety, Tolerability, and PK Parameters of Sodium Nitrite Inhalation Solution in Healthy SubjectsA 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 HypertensionPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: 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 solutionAires Pharmaceuticals, Inc.Not recruiting18 Years56 YearsBoth42Phase 1United States
262NCT01468571July 201125 May 2015Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial HypertensionEffects of Spironolactone on Collagen Metabolism in Pulmonary Arterial HypertensionPulmonary HypertensionDrug: Spironolactone;Drug: PlaceboBaylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)Recruiting18 YearsN/ABoth50Phase 4United States
263EUCTR2011-001312-59-GB24/06/201128 August 2012A 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 HypertensionA 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 HypertensionPulmonary 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 LondonNot RecruitingFemale: yes
Male: yes
0United Kingdom
264NCT01086540June 24, 201126 August 2019Rituximab 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 PAHBiological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophenNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceNot recruiting18 Years75 YearsAll58Phase 2United States
265NCT01389206June 1, 201127 August 2018Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial HypertensionDrug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or UptraviActelionCanadian Heart Research CentreNot recruiting18 YearsN/AAll797Phase 1United States;Puerto Rico
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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266NCT01470144June 1, 201116 December 2017Epoprostenol for Injection in Patients With Pulmonary Arterial HypertensionAn Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: EpoprostenolActelionChiltern International Ltd.;Effi-statNot recruitingN/AN/AAll41Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
267NCT01319045June 201119 October 2017Iloprost for the Treatment of Pulmonary Hypertension in Adults With Congenital Heart DiseasePulmonary Arterial Hypertension;Congenital Heart Disease;Eisenmenger's SyndromeDrug: IloprostUniversity of California, Los AngelesActelionNot recruiting18 YearsN/AAll5N/AUnited States
268NCT01330108May 201119 October 2017Safely Change From Bosentan to Ambrisentan in Pulmonary HypertensionSafely Change From Bosentan to Ambrisentan in Pulmonary HypertensionPulmonary Arterial HypertensionDrug: ambrisentanUniversity of Alabama at BirminghamNot recruiting19 YearsN/AAll32Phase 4United States
269NCT01352026May 201119 February 2015Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: MetforminNantes University HospitalNot recruiting18 Years80 YearsBoth0Phase 2France
270EUCTR2010-021825-11-NL28/04/201121 October 2013A 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 dayAn 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 3Pulmonary 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 RecruitingFemale: yes
Male: yes
64Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Germany;Netherlands;China
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
271NCT01392469April 20, 201125 June 2018Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension PatientsA 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) PatientsPulmonary Arterial HypertensionDrug: ImatinibNovartis PharmaceuticalsNot recruiting18 YearsN/AAll21Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey
272EUCTR2010-021960-14-DE08/04/201112 May 2014An 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 hypertensionAn 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 hypertensionPulmonary 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 AGNot RecruitingFemale: yes
Male: yes
20Germany;Italy
273EUCTR2010-021793-12-DE04/04/20112 March 2015A 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 dayA 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 extensionPulmonary 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 RecruitingFemale: yes
Male: yes
64China;Netherlands;Germany;South Africa;Australia;Poland;Mexico;Czech Republic;Hungary;France;India;Italy;Russian Federation;Israel;Ukraine;Spain;Serbia;Belarus;United States
274JPRN-UMIN0000054382011/04/012 April 2019prospective intervention study of prevention of infections by chlorhexidine-impregnated sponge dressings for patients with tunneled central venous catheterspatients with pulmonary arterial hypertensionUse 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 MedicineRecruiting20years-oldNot applicableMale and Female30Not selectedJapan
275JPRN-UMIN0000054642011/04/012 April 2019Drug interactions and effects of combination therapy for pulmonary arterial hypertensionpulmonary arterial hypertensionphase 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 MedicineUniversity of ShizuokaRecruiting20years-oldNot applicableMale and Female15Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
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276EUCTR2010-024585-22-GB25/03/20114 August 2015What 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 patientsIdiopathic 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 CentreAuthorisedFemale: yes
Male: yes
United Kingdom
277NCT01223352March 8, 201116 December 2017Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial HypertensionAn 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 HypertensionPulmonary Arterial HypertensionDrug: bosentanActelionNot recruiting3 Months12 YearsAll64Phase 3United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic
278JPRN-JapicCTI-11153201/3/201123 April 2019NS-304 PAHThe 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.18BOTH30Phase 2
279NCT01265888March 201126 September 2016Study 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 FibrosisDrug: Inhaled Nitric OxideGeno LLCNot recruiting18 Years80 YearsBoth31Phase 2United States
280NCT01302444March 201119 October 2017Treprostinil Combined With Tadalafil for Pulmonary HypertensionRandomized Placebo Controlled Trial of Treprostinil Infusion Combined With Oral Tadalafil or Placebo in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Tadalafil;Drug: PlaceboRhode Island HospitalUnited TherapeuticsNot recruiting18 Years80 YearsAll1Phase 4United States
No.TrialIDDate_
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Last_Refreshed_
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281NCT01431716March 201119 October 2017Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial HypertensionA 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 HypertensionPulmonary Arterial HypertensionDrug: EFI/ACT-385781AActelionNot recruiting18 YearsN/AAll42Phase 3Belgium;Canada;France;Italy;Netherlands;Spain
282ChiCTR-ONC-110017992011-02-1718 April 2017A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart diseaseA single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart diseasepediatric patients with severe pulmonary arterial hypertension due to congenital heart diseaseAll groups:Bosentan therapy ;Beijing Anzhen HospitalNot Recruiting018BothAll groups:50;Post-marketChina
283NCT01246037February 201119 February 2015Beta-blockers in i-PAHBeta-blocker Therapy in Idiopathic Pulmonary Arterial HypertensionIdiopathic Pulmonary Arterial HypertensionDrug: BisoprololVU University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentNot recruiting18 YearsN/ABoth30Phase 1/Phase 2Netherlands
284EUCTR2010-021344-17-IT28/01/201118 March 2013A 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. - NDA 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. - NDPulmonary 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 FARMANot RecruitingFemale: yes
Male: yes
24Italy
285EUCTR2010-020424-21-NL10/01/201119 March 2012Betablocker Therapy in Pulmonary Arterial HypertensionBetablocker Therapy in Pulmonary Arterial HypertensionIdiopathic 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 centerAuthorisedFemale: yes
Male: yes
Netherlands
No.TrialIDDate_
enrollement
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PhaseCountries
286NCT01332331January 4, 201115 July 2019Efficacy and Safety of Ambrisentan in Children 8-18yrsA 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 YearsHypertension, PulmonaryDrug: Ambrisentan - low dose;Drug: Ambrisentan - high doseGlaxoSmithKlineNot recruiting8 Years18 YearsAll41Phase 2United States;Argentina;France;Germany;Hungary;Italy;Japan;Russian Federation;Spain;Brazil;Canada;Greece;Mexico;Netherlands
287JPRN-UMIN0000043692011/01/012 April 2019Application of Exercise Echocardiography and Treatment by Bosentan in Latent Pulmonary Arterial Hypertension Associated with Connective Tissue DiseaseConnective Tissue DiseaseBosentanTokushima UniversityNot Recruiting18years-old85years-oldMale and Female20Not selectedJapan
288NCT01028651January 201116 December 2017A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary HypertensionAn Open-Label Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary HypertensionPortopulmonary Hypertension;Pulmonary Arterial Hypertension;Pulmonary HypertensionDrug: TreprostinilUnited TherapeuticsUniversity of California, Los Angeles;Brigham and Women's Hospital;University of Texas;Emory UniversityNot recruitingN/AN/AAll13N/AUnited States
289NCT01251848January 201116 March 2015Drug Interaction Between Ritonavir And SitaxsentanA Phase 1, Open Label, Randomized, Multiple Dose Study To Assess The Two-Way Drug Interaction Between Sitaxsentan And Low Dose Ritonavir In Healthy SubjectsPulmonary Arterial HypertensionDrug: Sitaxentan;Drug: Ritonavir;Drug: SitaxsentanPfizerNot recruiting21 Years55 YearsBoth0Phase 1
290NCT01288651January 201119 February 2015Iron Deficiency In Pulmonary HypertensionIntravenous Iron Treatment In Iron Deficient Patients With Idiopathic Pulmonary Arterial HypertensionIdiopathic Pulmonary Arterial HypertensionDrug: FerricarboxymaltoseVU University Medical CenterVifor PharmaRecruiting18 YearsN/ABoth30Phase 4Netherlands
No.TrialIDDate_
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Last_Refreshed_
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291EUCTR2011-004106-16-NL2 October 2017A 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 compoundA 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 5Pulmonary 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 LtdNot AvailableFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Guatemala;Ukraine;Russian Federation;Chile;Colombia;India;Vietnam;France;Mexico;Argentina;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
292NCT01406327December 14, 201017 September 2018Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Hypertension, PulmonaryDrug: AmbrisentanGlaxoSmithKlineNot recruitingN/AN/AAll900Phase 4
293EUCTR2010-023233-30-NL13/12/201019 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 PAHObjective: 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 centerAuthorisedFemale: yes
Male: yes
30Netherlands
294JPRN-JapicCTI-10137010/12/20102 April 2019Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension PatientsA Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionIntervention 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.1680BOTH35Phase 3
295NCT01251835December 201016 March 2015Effect Of Rifampin On Pharmacokinetics Of SitaxsentanA Phase 1, Open Label, Fixed Sequence Design, Multiple Dose Study To Assess The Effect Of Rifampin On The Pharmacokinetics Of Sitaxsentan In Healthy SubjectsPulmonary Arterial HypertensionDrug: Sitaxsentan alone;Drug: Sitaxsentan;Drug: RifampinPfizerNot recruiting21 Years55 YearsBoth0Phase 1
No.TrialIDDate_
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296NCT01266265December 201019 October 2017Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso® Compared to Other FDA Approved PAH TherapiesA Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation SolutionPulmonary Arterial HypertensionDrug: inhaled prostacyclin;Drug: prostacyclin;Drug: subcutaneous and intravenous prostacyclin;Drug: oral ERA;Drug: oral PDE5 inhibitorsUnited TherapeuticsNot recruitingN/AN/AAll1333N/AUnited States
297EUCTR2010-021572-29-GR23/11/201021 August 2012An 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 desiredAn 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 desiredPulmonary 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, LtdNot RecruitingFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
298NCT01210443November 201019 October 2017Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension PatientsA Phase 3, Multi-Center, Open Label Study To Evaluate The Long-Term Safety Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: SitaxentanPfizerNot recruiting16 Years80 YearsAll2Phase 3Japan
299NCT01244620November 201019 October 2017A Pharmacokinetic Drug-Drug Interaction (DDI) Study Between Sitaxsentan And Sildenafil, And Between Sitaxsentan And Tadalafil After Multiple DosesA 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 SubjectsPulmonary Arterial HypertensionDrug: sitaxentan;Drug: tadalafil;Drug: sitaxsentan;Drug: sildenafilPfizerNot recruiting21 Years55 YearsAll16Phase 1Singapore
300NCT01260454November 201019 October 2017The Qutenza Patch as Treatment for Disabling Treprostinil (Remodulin) Infusion Site PainThe Qutenza® Patch for Disabling Treprostinil Infusion Site PainPulmonary Hypertension;Pulmonary Arterial HypertensionDrug: Qutenza (8% capsaicin)University of RochesterUnited TherapeuticsNot recruiting15 Years80 YearsAll6Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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size
PhaseCountries
301EUCTR2007-003975-38-AT03/10/201019 March 2012Proof 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 - TERPAHProof 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 - TERPAHPulmonary 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 GmbHNot RecruitingFemale: yes
Male: yes
99Phase 2Czech Republic;Germany;Netherlands;Austria
302JPRN-UMIN0000126692010/10/012 April 2019Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH management-pulmonary hypertensionSildenafil 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 CollegeNot RecruitingNot applicable24months-oldMale and Female20Not applicableJapan
303NCT01178073October 1, 201016 December 2017A 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, PulmonaryDrug: ambrisentan;Drug: tadalafilGlaxoSmithKlineGilead SciencesNot recruiting18 Years75 YearsAll610Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Greece;Italy;Japan;Netherlands;Spain;Sweden;United Kingdom
304NCT01054105October 201023 February 2016Effect of BMPR-2 Gene Mutations on Hemodynamic Response by Iloprost Inhalation in Pulmonary Arterial HypertensionThe 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 TherapyPulmonary Arterial HypertensionDrug: IloprostGachon University Gil Medical CenterSeoul National University Hospital;Seoul National University Bundang Hospital;The Catholic University of Korea;BayerRecruiting20 Years80 YearsBoth48Phase 4Korea, Republic of
305NCT01092559October 201019 October 2017Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric OxideAn Open Label Pilot Study Evaluating Preliminary Safety and Performance of the GeNO Nitrosyl Delivery SystemPulmonary Arterial HypertensionDrug: Nitric Oxide generated by the GeNO nitrosyl delivery systemGeno LLCNot recruiting18 YearsN/AAll10Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
306NCT01094067September 1, 201016 July 2018Tezosentan in Patients With Pulmonary Arterial HypertensionMulti-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 HypertensionDrug: ACT-050089;Other: PlaceboIdorsia Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll2Phase 2United States;France;Japan
307NCT01165047September 201019 October 2017Nitric Oxide, GeNO Nitrosyl Delivery SystemAn 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) ImplantationPulmonary Arterial HypertensionDrug: Nitric OxideAurora Health CareNot recruiting18 YearsN/AAll10Phase 2United States
308EUCTR2010-019883-36-HU31/08/201010 July 2012A 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 AGNot RecruitingFemale: yes
Male: yes
66Germany;Hungary
309EUCTR2009-011150-17-NL26/08/201021 August 2012Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial HypertensionAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONPulmonary 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 LtdAuthorisedFemale: yes
Male: yes
545Germany;United Kingdom;Netherlands;France;Spain;Italy;Japan;Greece;Austria;Sweden
310JPRN-JapicCTI-10136920/8/20102 April 2019A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension PatientsA Phase 3, Multi-Center, Open Label Study to Investigate Safety and efficacy of Sitaxentan THERAPY in japanese Subjects with Pulmonary Arterial HypertensionPulmonary Arterial HypertensionIntervention 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.1680BOTH35Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
311NCT01355380August 5, 201016 December 2017Efficacy of Ventavis Used in Real-life Setting.The Efficacy of Inhaled Iloprost in Patients Treated Within the Pulmonary Arterial Hypertension Therapeutic Programme.Pulmonary Arterial HypertensionDrug: Inhaled iloprost (Ventavis, BAYQ6256)BayerNot recruiting18 YearsN/AAll55N/APoland
312NCT01077297August 201016 July 2018Tezosentan in Pulmonary Arterial HypertensionMulticenter, 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 ProstacyclinesPulmonary Arterial HypertensionDrug: TezosentanIdorsia Pharmaceuticals Ltd.Not recruiting18 YearsN/AAll3Phase 2United States;France;Switzerland
313NCT01172496August 201019 February 2015A Bioavailability Study Comparing Treprostinil Diethanolamine Oral Tablets and Oral Solution in Healthy VolunteersA 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 VolunteersPulmonary Arterial HypertensionDrug: treprostinil diethanolamineUnited TherapeuticsNot recruiting18 Years55 YearsBoth24Phase 1United States
314NCT01204853August 201019 October 2017A 12 Week Safety And Efficacy Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension PatientsA Phase 3, Multi-Center, Open Label Study To Evaluate The Safety And Efficacy Of Sitaxentan Sodium In Japanese Subjects With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: SitaxentanPfizerNot recruiting16 Years80 YearsAll2Phase 3Japan
315NCT01268553August 201016 December 2017Transition From Injectable Prostacyclin Medication to Inhaled Prostacyclin MedicationTransition From Parenteral Prostanoids to Inhaled TreprostinilPulmonary Arterial HypertensionDrug: TreprostinilLos Angeles Biomedical Research InstituteUnited TherapeuticsNot recruiting18 Years80 YearsAll6Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316EUCTR2010-018863-40-DE16/07/201027 January 2014Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn 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 PLUSPulmonary 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 AGNot RecruitingFemale: yes
Male: yes
18Italy;United Kingdom;Germany;Austria;Poland;Spain;Czech Republic
317EUCTR2010-019547-19-GR16/07/201021 August 2012A 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, LtdNot RecruitingFemale: yes
Male: yes
66Hungary;Germany;Netherlands;France;Spain;Italy;Greece
318EUCTR2010-018320-10-BE02/07/201017 August 2015An 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 ExtensionPulmonary 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 LtdNot RecruitingFemale: yes
Male: yes
40France;Canada;Spain;Belgium;Netherlands;Italy
319NCT00796510July 201019 October 2017Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term SafetyA 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 HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: Sitaxsentan and SildenafilPfizerNot recruiting16 Years80 YearsAll3Phase 3United 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
320NCT01153386July 201019 February 2015Pharmacokinetic Linearity and Comparative Bioavailability of Treprostinil DiethanolamineAn 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 StatePulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNot recruiting18 Years55 YearsBoth36Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
321NCT01165476July 201019 February 2015Comparative Bioavailability of Treprostinil Diethanolamine Manufactured by Two Independent FacilitiesAn 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 StatePulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNot recruiting18 Years55 YearsBoth64Phase 1United States
322NCT01305252July 201016 December 2017A 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 TadalafilHypertension, PulmonaryDrug: treprostinil inhalations;Drug: tadalafilStanford UniversityNorthwestern UniversityNot recruiting18 Years69 YearsAll21Phase 4United States
323NCT01317134July 20108 February 2016Endothelial Function in Patients With Pulmonary Arterial HypertensionSerological and Non-invasive Evaluation of Endothelial Function in Patients With Pulmonary Arterial HypertensionHypertension, Pulmonary;Pulmonary Arterial Hypertension;Pathophysiology;GeneticsDevice: EndoPAT measurement;Biological: Blood TestUniversitätsklinikum Hamburg-EppendorfPfizer;ActelionNot recruiting18 YearsN/ABoth90N/AGermany
324EUCTR2008-004533-21-NL25/06/201019 March 2012The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patientsThe role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patientsTo 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
ICINAuthorisedFemale: yes
Male: yes
50Netherlands
325EUCTR2010-020917-97-IT23/06/201014 October 2013SPHERIC-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-1SPHERIC-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-1Moderate 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 OSPEDALIERINot RecruitingFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
326NCT00964678June 201016 December 2017Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial HypertensionPilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: CarvedilolVirginia Commonwealth UniversityGlaxoSmithKlineNot recruiting18 YearsN/AAll10Phase 1/Phase 2United States
327NCT01174173June 201011 June 2018Ranolazine and Pulmonary HypertensionEffects of Ranolazine in Patients With Angina Due to Right Ventricular Ischemia in Pulmonary Arterial HypertensionAngina;Pulmonary Arterial HypertensionDrug: RanolazineNorthwestern UniversityGilead SciencesNot recruiting18 Years80 YearsAll11Phase 3United States
328EUCTR2010-018322-40-FR20/05/201026 June 2012A 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-2A 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-2Pulmonary 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 LtdAuthorisedFemale: yes
Male: yes
20Phase 3bNetherlands;Belgium;France;Spain;Italy
329NCT01105117May 201019 October 2017Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401An 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 HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNot recruiting18 Years65 YearsAll2Phase 4United States
330NCT01131845May 201019 February 2015The Effect of Renal Impairment on the Pharmacokinetics of Oral TreprostinilAn 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 DysfunctionDrug: UT-15C SR (treprostinil diethanolamine)United TherapeuticsNot recruiting18 Years79 YearsBoth16Phase 1United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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sponsor
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Inclusion_
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gender
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size
PhaseCountries
331EUCTR2009-018167-26-AT15/04/20102 June 2014An 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 ExtensionAn 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 ExtensionPulmonary 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 AGNot RecruitingFemale: yes
Male: yes
140France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
332NCT00995566April 201019 October 2017A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed ThelinThelin (Sitaxentan Sodium) Patient Safety Registry A Non-Interventional, Patient Registry For The Collection Of Pre-Defined Safety Data In Patients Prescribed ThelinPulmonary Arterial HypertensionDrug: Sitaxentan sodiumPfizerNot recruiting18 YearsN/AAll54N/ABelgium;France;Germany;Sweden
333NCT01083524March 201019 February 2015Dichloroacetate (DCA) for the Treatment of Pulmonary Arterial HypertensionA 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 SodiumUniversity of AlbertaImperial College LondonNot recruiting18 YearsN/ABoth30Phase 1Canada;United Kingdom
334NCT01105091March 201019 October 2017Epoprostenol for Injection in Pulmonary Arterial HypertensionA 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 HypertensionDrug: ACT-385781A (Actelion Epoprostenol);Drug: Flolan®ActelionNot recruiting18 Years65 YearsAll30Phase 4United States
335EUCTR2009-014992-31-BE22/02/20106 October 2015Study to evaluate if selexipag is safe for the treatment of pulmonary arterial hypertensionLong-term single-arm open-label study, to assess the safety and tolerability of selexipag in patients with pulmonary arterial hypertension - GRIPHON OLThe 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 LtdAuthorisedFemale: yes
Male: yes
1150Serbia;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.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336EUCTR2009-014246-29-IE01/02/201018 September 2012A 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 RxNot RecruitingFemale: yes
Male: yes
36Czech Republic;Germany;Belgium;Ireland
337EUCTR2009-014453-32-IE01/02/20106 January 2015An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patientsAn open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patientsPulmonary 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 IncNot RecruitingFemale: yes
Male: yes
36Czech Republic;Belgium;Ireland;Germany
338EUCTR2008-005885-30-CZ12/01/201019 March 2012A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONA PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, SAFETY AND EFFICACY STUDY OF SITAXSENTAN SODIUM IN SUBJECTS WITH PULMONARY ARTERIAL HYPERTENSIONPulmonary 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 LtdNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
339EUCTR2008-005886-78-CZ12/01/201012 December 2016A 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 HYPERTENSIONA 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 HYPERTENSIONPULMONARY 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 RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
340EUCTR2008-005887-14-CZ12/01/201019 March 2012A 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 B1321001A 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 B1321001Pulmonary 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 RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic;Bulgaria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2009-014453-32-BE11/01/201021 August 2017An open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patientsAn open-label extension of BPS-MR-PAH-203 in pulmonary arterial hypertension (PAH) patientsPulmonary 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 LLCNot RecruitingFemale: yes
Male: yes
36Phase 2United States;Czech Republic;Belgium;Ireland;Romania;Germany
342NCT01042158January 201016 December 2017A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisA Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic SclerosisPulmonary Arterial Hypertension;Systemic Sclerosis;Scleroderma Spectrum of Diseases;Connective Tissue Disease;Pulmonary HypertensionDrug: tadalafil and ambrisentan upfront combination therapyJohns Hopkins UniversityNational Institutes of Health (NIH);National Heart, Lung, and Blood Institute (NHLBI);Eli Lilly and Company;United Therapeutics;The Cleveland Clinic;University of Texas;Stanford UniversityNot recruiting18 YearsN/AAll25Phase 4United States
343NCT01066845January 20102 November 2015Post Marketing Observational Study in Patients With Pulmonary Arterial HypertensionSafety and Effectiveness of Adcirca (Tadalafil) in Japanese Patients With Pulmonary Arterial Hypertension: Open-label, Non-interventional Observational Study in JapanPulmonary Arterial HypertensionDrug: tadalafilEli Lilly and CompanyNot recruiting15 YearsN/ABoth1809N/A
344NCT01148836January 201019 October 2017Coenzyme Q-10 and Pulmonary Arterial HypertensionCoenzyme Q-10 in the Treatment of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDietary Supplement: Coenzyme Q-10 in Pulmonary Hypertension subjects;Dietary Supplement: Coenzyme Q-10 in Normal Control subjectsThe Cleveland ClinicNot recruiting18 Years55 YearsAll18N/AUnited States
345EUCTR2009-014490-41-DK08/12/20095 August 2014Study 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 - GRIPHONThe 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 LtdNot RecruitingFemale: yes
Male: yes
1150Phase 3Serbia;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.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346NCT01112306December 1, 200916 September 2019ACT-293987 in Pulmonary Arterial HypertensionLong-term Single-arm Open-label Study, to Assess the Safety and Tolerability of Selexipag (ACT-293987) in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: ACT-293987ActelionNot recruiting18 YearsN/AAll670Phase 3United 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
347NCT01106014December 200919 October 2017Selexipag (ACT-293987) in Pulmonary Arterial HypertensionA Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Selexipag;Drug: PlaceboActelionNot recruiting18 Years75 YearsAll1156Phase 3United 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
348NCT01445873December 200919 October 2017Pilot 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 HypertensionDrug: Sitaxentan sodiumPfizerNot recruiting18 YearsN/AAll36N/A
349NCT00990314November 30, 200930 September 2019Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-label Extension of BPS-MR-PAH-203 in Pulmonary Arterial Hypertension (PAH) PatientsPulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology PBCNot recruiting18 Years75 YearsAll31Phase 2United States;Belgium;Czechia;Germany;Ireland;Romania;Czech Republic
350EUCTR2008-003572-21-SE19/11/200919 March 2012A 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 HYPERTENSIONA 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 HYPERTENSIONPulmonary 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 9NJNot RecruitingFemale: yes
Male: yes
79Phase 2AGermany;Belgium;Spain;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351NCT00989963November 200919 February 2015Dose-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 HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology Inc.Not recruiting18 Years75 YearsBoth36Phase 2United States;Belgium;Czech Republic;Germany;Ireland;Romania
352EUCTR2009-012450-20-FR15/10/200919 March 2012Multicenter, 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 prostacyclinesMulticenter, 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 prostacyclinesPulmonary 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.AuthorisedFemale: yes
Male: yes
13Phase 2aFrance
353NCT00866983October 200919 February 2015Local Open-Label Access Study For Patients Who Completed A1481244 Study In BrazilA 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 HypertensionDrug: sildenafil (Revatio) 20 mg TIDPfizerNot recruiting18 YearsN/ABothPhase 4Brazil
354EUCTR2009-009366-13-GB02/09/200928 August 2012A 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-C2A 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-C2Pulmonary 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 CorporationNot RecruitingFemale: yes
Male: yes
300Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
355JPRN-JapicCTI-12199801/9/200923 April 2019Bosentan 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.1874BOTH16Phase 3
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
356NCT00902174September 200919 October 2017Imatinib (QTI571) in Pulmonary Arterial HypertensionA 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 HypertensionDrug: imatinib mesylate;Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 YearsN/AAll202Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Switzerland;United Kingdom
357NCT00942708September 200929 June 2015Safety and Efficacy of Fluoxetine in Pulmonary Arterial HypertensionSafety and Efficacy of Fluoxetine in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: FluoxetineUniversity of Texas Southwestern Medical CenterNot recruiting16 Years75 YearsBoth6Phase 2United States
358NCT00963001September 200919 February 2015Effect of Food on the Pharmacokinetics of Oral TreprostinilEffect of Different Meal Types on the Pharmacokinetics of a Single 1 mg Oral Dose of UT-15C (Treprostinil Diethanolamine) Sustained Release Tablets in Healthy VolunteersHypertension, Pulmonary;Pulmonary Arterial HypertensionDrug: Treprostinil diethanolamine;Other: Standardized mealsUnited TherapeuticsNot recruiting18 Years55 YearsBoth32Phase 1United States
359NCT00963027September 200919 February 2015Effect of Esomeprazole on the Pharmacokinetics of Oral TreprostinilAn Evaluation of Single Dose UT-15C SR (Treprostinil Diethanolamine) Pharmacokinetics Following Repeated Dosing With the Proton Pump Inhibitor Esomeprazole in Healthy Adult VolunteersHypertension, Pulmonary;Pulmonary Arterial HypertensionDrug: Treprostinil diethanolamine;Drug: EsomeprazoleUnited TherapeuticsNot recruiting18 Years55 YearsBoth30Phase 1United States
360EUCTR2009-012057-38-DE13/08/200928 August 2012A 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 - IMPRESA 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 - IMPRESPulmonary 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 AGNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361EUCTR2008-006833-29-IE29/06/20096 January 2015An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) PatientsPulmonary 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 LLCNot RecruitingFemale: yes
Male: yes
19Belgium;Ireland
362EUCTR2009-010703-80-DE11/06/200924 July 2012A 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 15Indication: 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 LtdNot RecruitingFemale: yes
Male: yes
63Germany;Austria
363EUCTR2009-011013-24-AT03/06/200919 March 2012A 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 ExtensionA 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 ExtensionIndication: 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 RecruitingFemale: yes
Male: yes
63Austria
364NCT00887978June 200919 October 2017Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial HypertensionA 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 HypertensionPulmonary HypertensionDrug: UT-15C SR;Drug: PlaceboUnited TherapeuticsNot recruiting18 Years75 YearsAll310Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Portugal;Spain;Sweden;United Kingdom;Ireland;Norway
365ChiCTR-TCC-120027762009-05-0118 April 2017BEraproST combined therapy with Sildenafil for pulmonary arterial hypertensionBEraproST combined therapy with Sildenafil for pulmonary arterial hypertensionPulmonary arterial hypertensionGroup B :beraprost combined with sildenafil ;A:Sildenafil citrate ;Shanghai Pulmonary HospitalNot Recruiting1865BothGroup B :30;A:30;Pilot studyChina
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
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agemin
Inclusion_
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gender
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size
PhaseCountries
366NCT00796666May 200919 October 2017Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding SildenafilA 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 HypertensionDrug: Sitaxsentan;Drug: Sitaxsentan and SildenafilPfizerNot recruiting16 Years80 YearsAll131Phase 3United 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
367NCT00864201April 200919 February 2015A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue DiseaseA Pilot Study to Evaluate the Effect of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue DiseaseHypertension, Pulmonary;Connective Tissue DiseaseDrug: bosentanHamilton Health Sciences CorporationActelionNot recruiting18 YearsN/ABoth10Phase 3Canada
368NCT01391104April 200919 February 2015Responsiveness of Exercise Tests in Pulmonary Arterial HypertensionReproducibility and Responsiveness of Exercise Tests in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Sildenafil;Drug: Sugar PillLaval UniversityNot recruiting18 Years80 YearsBoth22N/ACanada
369NCT00878943March 31, 20098 January 2018Open Label Access Study Of Sildenafil In Adult Patients With Pulmonary Arterial Hypertension Completing A1481244 StudyA 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 HypertensionDrug: Sildenafil citratePfizerNot recruiting18 YearsN/AAllN/AIndia
370NCT00863681March 12, 200930 September 2019BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial HypertensionLong-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, PulmonaryDrug: Riociguat (BAY63-2521)BayerNot recruiting18 Years80 YearsAll396Phase 3United 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.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371NCT00902603March 200920 April 2015Ventavis® Registry ProtocolRegistry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Commercial Ventavis® (iloprost)ActelionNot recruiting19 YearsN/ABoth148N/AUnited States
372EUCTR2008-003290-41-BE04/02/200914 October 2013A Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patientsA Multi-center, open-label, multiple dose, dose finding study exploring the safety and tolerability of Beraprost Sodium Modified Release in PAH patientsPulmonary 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 RxNot RecruitingFemale: yes
Male: yes
20Belgium;Ireland
373JPRN-UMIN0000017092009/02/012 April 2019Multikinase Inhibitor (Tyrosine and Serine/Threonine Kinase Inhibitor) for the Treatment of Severe Pulmonary Arterial Hypertensionpulmonary arterial hypertensionadministration of sorafenib, which is the multikinase inhibitor (tyrosine and serine/threonine kinase inhibitor)Medical Education Center, School of Medicine, Keio UniversityNot Recruiting20years-oldNot applicableMale and Female10Not selectedJapan
374NCT00792571February 200919 February 2015An Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) PatientsAn Open-Label Extension of BPS-MR-PAH-201 in Pulmonary Arterial Hypertension (PAH) Patients.Pulmonary Arterial HypertensionDrug: Beraprost Sodium Modified ReleaseLung Biotechnology Inc.Not recruiting18 Years75 YearsBoth18Phase 2United States;Belgium;Ireland
375NCT00781885January 200919 February 2015A Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH PatientsA Multi-Center, Open-Label, Multiple Dose, Dose Finding Study Exploring the Safety and Tolerability of Beraprost Sodium Modified Release in PAH PatientsPulmonary Arterial HypertensionDrug: Beraprost sodium modified releaseLung Biotechnology Inc.Not recruiting18 Years75 YearsBoth19Phase 2United States;Belgium;Ireland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376NCT00811486January 200919 February 2015Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular FailureBody Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular FailureRight Heart Failure;Pulmonary HypertensionDrug: Spironolactone and conivaptanUniversity of Colorado, DenverNot recruiting18 Years75 YearsBoth0N/AUnited States
377NCT00832507January 200919 February 2015Study 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 HypertensionPulmonary Arterial HypertensionDrug: Cicletanine;Drug: Cicletanine PlaceboGilead SciencesNot recruiting16 Years70 YearsBoth162Phase 2United States;Australia;Austria;Belgium;Canada;Germany;Israel;Mexico;Spain;United Kingdom
378NCT01100736January 20093 August 2015Role 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 ManPulmonary Arterial Hypertension;Vasodilation;VasoconstrictionDrug: Bosentan;Drug: Sitaxsentan;Drug: Placebo;Biological: Endothelin-3University of EdinburghEncysive PharmaceuticalsNot recruiting18 Years70 YearsBoth10Phase 0United Kingdom
379JPRN-UMIN0000015782008/12/012 April 2019Tyrosine Kinase Inhibitor for the Treatment of Severe Pulmonary Arterial Hypertensionpulmonary arterial hypertensionadministration of tyrosine kinase inhibitor (imatinib)Medical Education Center20years-oldNot applicableMale and Female10Not selectedJapan
380NCT00760916December 200819 February 2015FREEDOM 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 HypertensionPulmonary HypertensionDrug: UT-15C 1 mg;Drug: UT-15C 0.25 mg;Drug: UT-15C 5 mg;Drug: PlaceboUnited TherapeuticsNot recruiting18 Years70 YearsBoth0Phase 3United States;Australia;Mexico
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Status
Inclusion_
agemin
Inclusion_
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Inclusion_
gender
Target_
size
PhaseCountries
381NCT00780728December 200819 February 2015Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial HypertensionAddition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: SildenafilUniversity Health Network, TorontoNot recruiting18 YearsN/ABothPhase 3Canada
382NCT00795639December 200819 October 2017Sitaxsentan 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 HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: Sitaxsentan;Drug: PlaceboPfizerNot recruiting16 Years80 YearsAll183Phase 3United 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
383NCT00814645December 200819 February 2015Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution in Normal, Healthy VolunteersA Placebo-Controlled, Phase 1b, Dose-Finding, Safety, Pharmacodynamic Effect Study of Sodium Nitrite Inhalation Solution (AIR001 INHALATION SOLUTION) in Normal, Healthy VolunteersPulmonary Arterial HypertensionDrug: Sodium Nitrite Inhalation Solution;Drug: Placebo and AIR001 Inhalation Solution (Expansion arm)Aires Pharmaceuticals, Inc.Not recruiting18 Years55 YearsBoth25Phase 1United States
384EUCTR2008-003482-68-DE26/11/20083 December 2012Randomized, 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 StudyRandomized, 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 StudyPulmonary 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 AGNot RecruitingFemale: yes
Male: yes
462Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
385EUCTR2008-003610-94-DE26/11/20084 February 2013Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different dosesLong-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 studyPulmonary 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 AGAuthorisedFemale: yes
Male: yes
462United 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.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
386EUCTR2007-003694-27-DE28/10/200826 October 2015Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial HypertensionSERAPHIN-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-OLsymptomatic 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 LtdNot RecruitingFemale: yes
Male: yes
700Portugal;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
387NCT00667823October 17, 200816 September 2019Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial HypertensionLong-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 HypertensionPulmonary Arterial HypertensionDrug: MacitentanActelionNot recruiting12 YearsN/AAll550Phase 3United 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
388NCT00800592October 200816 December 2017Sildenafil IV Bolus StudyAn 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, PulmonaryDrug: sildenafilPfizerNot recruiting18 YearsN/AAll12Phase 1Belgium
389JPRN-UMIN0000013502008/09/012 April 2019Early intervention for mild or borderline pulmonary arterial hypertension (PAH) associated with connective tissue diseasesPulmonary arterial hypertension (PAH) associated with connective tissue diseaseBeraprost sodium
Beraprost sodium and Sildenafil citrate
Keio UniversityNot Recruiting18years-old80years-oldMale and Female70Not selectedJapan
390NCT00709098September 200819 October 2017Safety Study Extension of Iloprost Power 15 in Pulmonary Arterial HypertensionA 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 HypertensionPulmonary Arterial HypertensionDrug: iloprostActelionNot recruiting18 YearsN/AAll49Phase 3United States;Austria;Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
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size
PhaseCountries
391NCT00741819September 200819 October 2017Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) SubjectsAn 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 HypertensionDrug: Inhaled treprostinilUnited TherapeuticsNot recruiting18 Years75 YearsAll73Phase 4United States
392NCT00825266September 200816 December 2017Insulin Resistance in Pulmonary Arterial HypertensionThe Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: bosentan;Drug: PioglitazoneStanford UniversityNot recruiting18 Years75 YearsAll2Phase 2United States
393NCT01338636September 200816 December 2017An 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 HypertensionExercise-induced Pulmonary Arterial HypertensionDrug: AmbrisentanBrigham and Women's HospitalGilead SciencesNot recruiting18 YearsN/AAll30Phase 4United States
394NCT00705588August 200819 February 2015Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.Pulmonary Arterial HypertensionDrug: Tadalafil;Drug: VardenafilRabin Medical CenterNot recruiting18 YearsN/ABoth30Phase 4Israel
395NCT00742014August 200819 February 2015The Assessment of Right Ventricular Contractility in Response to SildenafilThe Assessment of Right Ventricular Contractility in Response to Sildenafil in Pediatric Patients With Pulmonary Arterial HypertensionHypertensionDrug: SildenafilThe Hospital for Sick ChildrenNot recruiting1 Year18 YearsBoth10Phase 3Canada
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
396NCT00705133July 200811 June 2018Treprostinil Therapy For Patients With Interstitial Lung Disease And Severe Pulmonary Arterial HypertensionUsing Either Intravenous (IV) or Subcutaneous (SQ) Treprostinil to Treat Pulmonary Hypertension Related to Underlying Interstitial Lung DiseasePulmonary Arterial Hypertension;Interstitial Lung Disease;Idiopathic Pulmonary FibrosisDrug: TreprostinilRajan SaggarUnited TherapeuticsNot recruitingN/AN/AAll15Phase 2United States
397NCT00709956July 200819 October 2017Iloprost Power 15 in Pulmonary Arterial HypertensionA 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 HypertensionPulmonary Arterial HypertensionDrug: iloprost (5 µg);Drug: placeboActelionNot recruiting18 YearsN/AAll64Phase 3United States;Austria;Germany
398NCT00718952July 200819 February 2015The Efficacy and Safety of Vardenafil in the Treatment of Pulmonary Arterial HypertensionMulti-centre, Prospective, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Treatment of Pulmonary Arterial Hypertension With Vardenafil in ChinaPulmonary HypertensionDrug: Vardenafil;Drug: PlaceboTongji UniversityNot recruiting12 Years65 YearsBoth60Phase 3China
399NCT00723554July 200819 October 2017Iloprost Power Disc-15 in Pulmonary Arterial HypertensionA 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 HypertensionDrug: Iloprost PD-6;Drug: Iloprost PD-15ActelionNot recruiting18 Years85 YearsAll63Phase 3United States
400EUCTR2007-001643-21-GB26/06/200819 March 2012Use 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 HypertensionUse 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 HypertensionPulmonary 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 TrustAuthorisedFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
401EUCTR2007-003621-24-FR29/05/200819 March 2012Double-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 AGAuthorisedFemale: yes
Male: yes
48Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria
402EUCTR2007-002440-14-GB15/05/20087 January 2013A 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 - SERAPHINA 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 - SERAPHINTo 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.AuthorisedFemale: yes
Male: yes
700Phase 3Portugal;France;Finland;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden
403EUCTR2007-003328-39-BE25/04/200819 March 2012A 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 overA 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 overpulmonary 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 LtdNot RecruitingFemale: yes
Male: yes
44Hungary;United Kingdom;Germany;Belgium;France;Italy;Austria
404EUCTR2006-006748-76-NL23/04/200819 March 2012A 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/AA 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/APulmonary 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, UKNot RecruitingFemale: yes
Male: yes
284United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;Italy;Greece;Latvia
405NCT00430716April 200819 October 2017To 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 HypertensionDrug: Sildenafil citratePfizerNot recruiting18 YearsN/AAll130Phase 4United States;Belgium;Brazil;Bulgaria;China;Greece;India;Italy;Latvia;Malaysia;Netherlands;Philippines;Poland;Romania;Russian Federation;Thailand;United Kingdom;Denmark;Panama
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
406NCT00581607April 200819 February 2015Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary HypertensionDouble Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary HypertensionSarcoidosis;Pulmonary Arterial HypertensionDrug: Bosentan;Drug: PlaceboUniversity of CincinnatiActelionNot recruiting18 YearsN/ABoth43Phase 2/Phase 3United States
407NCT00617305April 200819 October 2017Study 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 InhibitorPulmonary Arterial HypertensionDrug: Ambrisentan;Drug: Placebo;Drug: Sildenafil;Drug: TadalafilGilead SciencesNot recruiting16 Years75 YearsAll38Phase 4United States
408EUCTR2007-002803-42-AT05/03/20088 April 2013Inhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trialInhaled Iloprost for patients with pulmonary arterial hypertension and right heart failure:a pilot feasibility trialPulmonary 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, AustriaNot RecruitingFemale: yes
Male: yes
8Austria
409NCT00435331March 200819 February 20156R-BH4 Pulmonary Arterial Hypertension StudyA Phase 1, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety and Efficacy of 6R-BH4 in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: sapropterin dihydrochloride (6R-BH4)Vanderbilt UniversityNational Institutes of Health (NIH);BioMarin PharmaceuticalNot recruiting18 YearsN/ABoth14Phase 1United States
410NCT00643604March 200819 October 2017Rapid Switch From Flolan to Remodulin in the Outpatient ClinicRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension in the Outpatient Clinic: Safety, Efficacy and Treatment SatisfactionHypertension, PulmonaryDrug: treprostinil sodiumUnited TherapeuticsNot recruiting18 Years70 YearsAll7Phase 4United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
411NCT00554619February 200819 October 2017A Study to Evaluate GSK1325760A - a Long-Term Extension StudyStudy 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, PulmonaryDrug: GSK1325760AGlaxoSmithKlineNot recruitingN/AN/AAll21Phase 3Japan
412NCT01200732February 200819 February 2015Phosphodiesterase-5 Inhibitor in Eisenmenger SyndromeClinical Efficacy of Phosphodiesterase-5 Inhibitor Tadalafil in Eisenmenger Syndrome - A Randomised, Placebo Controlled, Double Blind, Crossover StudyEisenmenger SyndromeDrug: Tadalafil, placeboGovind Ballabh Pant HospitalNot recruiting18 YearsN/ABoth28Phase 2India
413NCT00909337January 200819 February 2015Early Therapy of Pulmonary Arterial HypertensionEarly Therapy of Pulmonary Arterial HypertensionPulmonary Hypertension;Systemic SclerosisDrug: BosentanMedical University of GrazActelionNot recruiting18 Years90 YearsBoth10N/AAustria
414EUCTR2007-001645-17-GB04/12/200719 March 2012Prevention 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 DiseasePrevention 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 DiseasePulmonary 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 TrustNot RecruitingFemale: yes
Male: yes
United Kingdom
415EUCTR2007-002774-64-DE04/12/200731 July 2012Therapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - SildenafilTherapy of PAH – Treatment with Sildenafil in Eisenmenger Patients - SildenafilPatients 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 HerzfehlerNot RecruitingFemale: yes
Male: yes
80Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
416NCT00586794December 200719 February 2015Therapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger PatientsTherapy of Pulmonary Arterial Hypertension (PAH) - Treatment With Sildenafil in Eisenmenger PatientsPulmonary Arterial Hypertension (PAH)Drug: Sildenafil;Drug: PlaceboCompetence Network for Congenital Heart DefectsGerman Federal Ministry of Education and ResearchNot recruiting14 YearsN/ABoth24Phase 3Germany
417NCT00625469October 200711 June 2018Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With BosentanTreatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary FibrosisDrug: bosentanRajan SaggarActelionNot recruitingN/AN/AAll0Phase 4United States
418NCT00540436August 200719 October 2017Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial HypertensionStudy 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, PulmonaryDrug: GSK1325760AGlaxoSmithKlineNot recruiting18 YearsN/AAll25Phase 2Japan
419EUCTR2005-005068-97-SE18/06/20076 January 2015Effects 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 2Effects 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 2Patients 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 RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
420EUCTR2006-004705-26-GB10/05/200719 March 2012Safety and Tolerability of Sildenafil in Patients with Eisenmenger PhysiologySafety and Tolerability of Sildenafil in Patients with Eisenmenger PhysiologyEisenmenger 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 LondonAuthorisedFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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sponsor
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PhaseCountries
421NCT00454207April 200719 October 2017Open Label Study of Sildenafil in Patients With Pulmonary Arterial HypertensionA Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: sildenafil citrate (UK-92,480)PfizerNot recruiting16 YearsN/AAll44Phase 3Japan
422NCT00433329March 200719 October 2017Combination Therapy in Pulmonary Arterial HypertensionCOMPASS 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 RemodelingPulmonary Arterial HypertensionDrug: Bosentan;Drug: SildenafilActelionNot recruiting12 YearsN/AAll100Phase 4United States
423NCT00452218March 20075 September 2016Sorafenib Study: Dosing in Patients With Pulmonary Arterial Hypertension (PAH)Sorafenib Study: Dosing in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: SorafenibUniversity of ChicagoBayerNot recruiting18 YearsN/ABoth12Phase 1United States
424NCT00458042March 200719 February 2015Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment SatisfactionTransitioning To Intravenous Remodulin® (Treprostinil Sodium) From Inhaled Iloprost (Ventavis®) in Patients With Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment SatisfactionHypertension, PulmonaryDrug: treprostinil sodiumUnited TherapeuticsNot recruiting18 Years65 YearsBoth10Phase 4United States
425EUCTR2006-000801-50-AT19/02/200719 March 2012A 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-MA 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-MIdiopathic 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 CorporationNot RecruitingFemale: yes
Male: yes
150Netherlands;Belgium;France;Italy;Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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PhaseCountries
426EUCTR2006-000800-17-IE15/02/200719 March 2012A 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-CA 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-CIdiopathic 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 CorporationNot RecruitingFemale: yes
Male: yes
300Germany;United Kingdom;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
427EUCTR2006-000804-18-IE15/02/200722 July 2013An Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTAn Open-Label Extension Trial of UT-15C SR in Subjects with Pulmonary Arterial Hypertension - FREEDOM-EXTIdiopathic 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 CorporationNot RecruitingFemale: yes
Male: yes
450Portugal;France;Spain;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
428NCT00439946February 200719 October 2017Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAHRapid 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 SatisfactionPulmonary Arterial HypertensionDrug: treprostinil;Device: Crono Five ambulatory pumpUnited TherapeuticsNot recruiting18 Years65 YearsAll8Phase 4United States
429NCT00625079February 200711 June 2018Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis And Treatment With SildenafilRandomized Placebo-Controlled Study of Sildenafil For The Treatment of Pulmonary Hypertension Secondary to Idiopathic Pulmonary Fibrosis: A Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary Fibrosis;Interstitial Lung Disease;Pulmonary HypertensionDrug: sildenafilUniversity of California, Los AngelesPfizerNot recruitingN/AN/AAll0Phase 4United States
430JPRN-C0000003402007/01/012 April 2019Effects of phosphodiesterase V (sildenafil) on pulmonary arterial hypertensionPulmonary arterial hypertensionTreatment 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 HospitalNot Recruiting18years-old80years-oldMale and Female20Phase 2,3Japan
No.TrialIDDate_
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Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
431EUCTR2006-002235-25-GB14/12/200619 March 2012A 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/AA 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/APulmonary 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 KingdomAuthorisedFemale: yes
Male: yes
200Finland;United Kingdom
432NCT00403650November 200619 February 2015Inhaled Iloprost for Sarcoidosis-associated Pulmonary HypertensionInhaled Iloprost for Sarcoidosis Associated Pulmonary HypertensionSarcoidosis;Pulmonary Arterial HypertensionDrug: IloprostUniversity of CincinnatiNot recruiting18 Years90 YearsBoth20Phase 4United States
433EUCTR2006-003520-10-DE20/10/200628 November 2016Long-term study to collect additional information to evaluate the saftey and tolerability of BAY 63-2521 in different dosesA 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 schemeSubjects 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 AGNot RecruitingFemale: yes
Male: yes
0Phase 1;Phase 2Germany
434EUCTR2006-002081-19-NL16/10/200619 March 2012The 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-PAHThe 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-PAHPulmonary arterial hypertension associated with systemic sclerosisTrade Name: Erbitux
Product Name: Cetuximab
Product Code: C225
Pharmaceutical Form: Intravenous infusion
VU University Medical CentreAuthorisedFemale: yes
Male: yes
20Phase 2Netherlands
435NCT00325403October 200619 October 2017FREEDOM - 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 HypertensionPulmonary HypertensionDrug: Oral treprostinil (UT-15C) Sustained Release Tablets;Other: PlaceboUnited TherapeuticsNot recruiting12 Years75 YearsAll349Phase 3United States;Austria;Belgium;Canada;China;France;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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sponsor
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PhaseCountries
436NCT00325442October 200616 December 2017FREEDOM-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 HypertensionPulmonary HypertensionDrug: Oral treprostinil (UT-15C) sustained release tablets;Drug: PlaceboUnited TherapeuticsNot recruiting12 Years70 YearsAll354Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
437NCT00323024September 200619 February 2015Dose Determination Safety and Activity Study of Inhaled NX1011 to Treat Pulmonary Arterial HypertensionAn Open-Label, Dose-Determination Safety, Tolerability, and Activity Study of Inhaled NX1011 in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: NX1011NITROX, LLCNot recruiting18 Years75 YearsBoth72Phase 2United States
438NCT00373360September 200619 October 2017Safety, Efficacy and Treatment Satisfaction in Patients With PAH Rapidly Switched From Epoprostenol to RemodulinRapid Switch From Intravenous Epoprostenol to Intravenous Remodulin® (Treprostinil Sodium) in Patients With Stable Pulmonary Arterial Hypertension: Safety, Efficacy and Treatment SatisfactionPulmonary HypertensionDrug: treprostinil sodiumUnited TherapeuticsNot recruiting18 Years70 YearsAll10Phase 4United States
439NCT00384865September 200616 December 2017A Study of Aspirin and Simvastatin in Pulmonary Arterial HypertensionA Clinical Trial of Aspirin and Simvastatin in Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Simvastatin;Drug: Aspirin;Drug: PlaceboUniversity of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI)Not recruiting18 YearsN/AAll64Phase 2United States
440NCT00453414July 200619 February 2015Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial HypertensionSafety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Iloprost Inhalation Solution (Ventavis)ActelionNot recruiting3 Years18 YearsBoth0Phase 2United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
441NCT01062282July 200619 February 2015Hypertension 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 HypertensionPulmonary HypertensionDrug: Iloprost (Ventavis BAYQ6256)BayerNot recruiting18 YearsN/ABoth41N/AKorea, Republic of
442EUCTR2005-006192-13-GB22/06/200619 March 2012A 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 - VISIONA 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 - VISIONPulmonary 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 RecruitingFemale: yes
Male: yes
180Portugal;Germany;United Kingdom;Spain;Italy;Austria
443EUCTR2006-001464-23-CZ08/06/200612 May 2014A 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/AA 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/APulmonary 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 9NJNot RecruitingFemale: yes
Male: yes
106Czech Republic;Greece;Germany;Italy;United Kingdom
444NCT00946114June 200619 October 2017To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 WeeksA 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 HypertensionDrug: sildenafilPfizerNot recruiting18 YearsN/AAll32N/APoland
445NCT00303459May 200619 October 2017Effects 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 StudyPulmonary Arterial HypertensionDrug: bosentan;Drug: placeboActelionNot recruiting12 YearsN/AAll334Phase 4United States;Brazil;Czech Republic;Denmark;Germany;Greece;Portugal;Saudi Arabia;Slovakia;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
446NCT00469027May 200624 October 2016Pulmonary Hypertension: Assessment of Cell TherapyPhase 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 TreatmentHypertension, PulmonaryBiological: eNOS transfected EPCs will be delivered via a PA lineNorthern TherapeuticsSt. Michael's Hospital, Toronto;Sir Mortimer B. Davis - Jewish General Hospital;St. Michael's Hospital, Toronto;Sir Mortimer B. Davis - Jewish General HospitalNot recruiting18 Years80 YearsBoth7Phase 1Canada
447NCT00595049May 200611 May 2015Pulmonary Artery Remodelling With BosentanOpen Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH).Hypertension, PulmonaryDrug: bosentanActelionNot recruiting18 YearsN/ABoth11Phase 4Australia;United States
448NCT01027949May 200614 October 2019An Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial HypertensionAn Open-Label Extension Trial of UT-15C SR in Subjects With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Treprostinil diethanolamineUnited TherapeuticsNot recruiting12 YearsN/AAll900Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;India;Ireland;Israel;Italy;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Spain;Sweden;United Kingdom;Czech Republic
449EUCTR2005-002692-33-GB10/04/200618 April 2012A 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 - LVGYA 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 - LVGYPulmonary 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 LLCAuthorisedFemale: yes
Male: yes
400Phase 3Germany;United Kingdom;Spain;Ireland;Italy
450EUCTR2005-002844-24-GB10/04/200614 August 2012A 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 - LVGXA 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 - LVGXPulmonary 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 LLCAuthorisedFemale: yes
Male: yes
350Germany;United Kingdom;Spain;Ireland;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
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PhaseCountries
451NCT01721564April 200619 October 2017Bosentan and Pulmonary Endothelial FunctionPulmonary Artery Remodelling With BosentanPulmonary Arterial HypertensionDrug: BosentanProf David S CelermajerNot recruiting18 Years80 YearsAll8N/A
452EUCTR2005-005066-37-GB15/03/200619 March 2012COMPASS-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-1COMPASS-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-1Symptomatic 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.AuthorisedFemale: yes
Male: yes
44Phase 2Germany;United Kingdom;Italy
453EUCTR2006-000021-57-DK10/03/200619 March 2012Bosentan and Sildenfil for patients with Eisenmenger syndromeBosentan and Sildenfil for patients with Eisenmenger syndromeEisenmengers 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
RigshospitaletNot RecruitingFemale: yes
Male: yes
20Denmark
454NCT00303004March 200619 February 2015Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers SyndromeCombination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers SyndromeEisenmenger SyndromeDrug: Bosentan and SildenafilRigshospitalet, DenmarkNot recruiting18 YearsN/ABoth20Phase 3Denmark
455NCT00310830March 200619 February 2015Efficacy 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 DiseasePulmonary HypertensionDrug: BosentanActelionNot recruiting12 YearsN/ABoth14Phase 3United States;France;Netherlands;United Kingdom
No.TrialIDDate_
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Last_Refreshed_
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456NCT00302211February 200619 October 2017The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial HypertensionA 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 SildenafilPulmonary HypertensionDrug: Iloprost Inhalation Solution (Ventavis);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: BosentanActelionNot recruiting12 Years85 YearsAll67Phase 3United States
457EUCTR2005-005569-12-GB26/01/200610 July 2015A 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 hypertensionTrade 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 AGNot RecruitingFemale: yes
Male: yes
60Austria;Germany;United Kingdom
458NCT00549302December 200519 October 2017Study the Safety and Effectiveness of Tadalafil on High Blood Pressure in the Blood Vessel Going From the Heart to the LungsAn 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 HypertensionHypertension, PulmonaryDrug: tadalafilEli Lilly and CompanyICOS CorporationNot recruiting12 YearsN/AAll357Phase 3United States;Belgium;Canada;France;Germany;Ireland;Italy;Japan;Spain;United Kingdom
459EUCTR2005-001193-28-AT08/11/200522 April 2013ARIES-320/321-E “A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321 - 320/321-EARIES-320/321-E “A Long-Term Study of Ambrisentan in Pulmonary Arterial Hypertension Subjects Having Completed AMB-320 or AMB-321 - 320/321-EPulmonary Arterial HypertensionProduct 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, IncNot RecruitingFemale: yes
Male: yes
372Austria
460EUCTR2005-001967-70-GB13/10/200524 April 2012An 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 2An 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 2Idiopathic or familial pulmonary arterial hypertensionTrade 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.AuthorisedFemale: yes
Male: yes
30Germany;United Kingdom;Italy
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461EUCTR2005-001564-31-DE07/10/200519 March 2012A 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 - NAA 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 - NAPulmonary 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.AuthorisedFemale: yes
Male: yes
30Phase 2Germany
462NCT00240656October 200519 February 2015Spironolactone Combined With Captopril and Carvedilol for the Treatment of Pulmonary Arterial HypertensionOfficial 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 RemodelingHypertension, PulmonaryDrug: spironolactone captopril carvedilolHebei Medical UniversityNot recruitingN/A80 YearsBothPhase 1China
463EUCTR2005-000812-29-HU21/09/200528 August 2012Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1Ambrisentan in PAH - A Phase III, Randomised, Double- Blind, Placebo- Controlled, Multicenter, Efficacy Study of Ambrisentan in Subjects with Pulmonary Arterial Hypertension - ARIES-1Pulmonary 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.AuthorisedFemale: yes
Male: yes
186Phase 3Hungary;Germany;Belgium;Spain;Italy
464NCT00125918August 200519 February 2015PHIRST-1: Tadalafil in the Treatment of Pulmonary Arterial HypertensionPHIRST-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 HypertensionPulmonary HypertensionDrug: tadalafil;Drug: placeboEli Lilly and CompanyICOS CorporationNot recruiting12 YearsN/ABoth406Phase 3United States;France;Italy;Japan;Belgium;Canada;Germany;Ireland;Spain;United Kingdom
465NCT00593905July 200519 February 2015Pharmacogenomics in Pulmonary Arterial HypertensionPharmacogenomics 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 GenesPulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group IDrug: Sitaxsentan;Drug: Bosentan, AmbrisentanWest Penn Allegheny Health SystemNational 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 PhysiciansRecruitingN/AN/ABoth1300N/AUnited States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
466EUCTR2004-003236-59-GB30/06/200524 July 2012Double 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 CorporationAuthorisedFemale: yes
Male: yes
220Germany;United Kingdom;Spain;Ireland;Italy
467EUCTR2004-005157-63-GB15/06/20051 May 2012An 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 1An 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 1Idiopathic or familial PAHProduct 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.AuthorisedFemale: yes
Male: yes
33United Kingdom;Italy
468NCT03055221June 10, 200516 December 2017TRUST-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 HypertensionDrug: Intravenous TreprostinilUnited TherapeuticsNot recruiting16 Years75 YearsAll20Phase 4
469NCT00147199June 200519 October 2017Clinical 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 HypertensionPulmonary HypertensionDrug: Inhaled treprostinil;Drug: Placebo inhalation solutionUnited TherapeuticsNot recruiting18 Years75 YearsAll235Phase 3United States;Austria;Belgium;France;Germany;Ireland;Israel;Italy;Spain;United Kingdom
470EUCTR2005-000963-25-SE30/05/200517 June 2013Oral Revatio in Pediatric PAH- Long term follow on study to A1481131A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/APulmonary 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, UKNot RecruitingFemale: yes
Male: yes
200Taiwan;Finland;Thailand;Costa Rica;Guatemala;Chile;Russian Federation;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Brazil;Malaysia;Poland;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
471EUCTR2004-004391-36-HU23/05/200519 March 2012A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertensionA multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertensionMany 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 RecruitingFemale: no
Male: yes
23Hungary;Czech Republic
472NCT00423592May 200519 October 2017Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial HypertensionA 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 AbnormalitiesPulmonary HypertensionDrug: ambrisentanGilead SciencesNot recruiting12 Years75 YearsAll36Phase 2
473NCT00494533March 200519 February 2015Study of Intravenous Remodulin in Patients in India With Pulmonary Arterial HypertensionTreprostinil 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 HypertensionPulmonary Arterial HypertensionDrug: Remodulin (treprostinil sodium)United TherapeuticsAsian Clinical TrialsNot recruiting16 Years75 YearsBoth45Phase 4India
474EUCTR2005-005068-97-DE26 January 2015Effects 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 2Effects 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 2Patients 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 RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
475EUCTR2004-000478-30-AT08/12/200422 April 2013Endothelin 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. - EARLYEndothelin 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. - EARLYPatients 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 RecruitingFemale: yes
Male: yes
170Czech Republic;Spain;Denmark;Austria;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
476EUCTR2004-000478-30-SE28/10/200419 March 2012Endothelin 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. - EARLYEndothelin 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. - EARLYPatients 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 RecruitingFemale: yes
Male: yes
170United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
477EUCTR2004-000745-37-ES11/10/200419 March 2012Uncontrolled 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 - ExtensionUncontrolled 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 - ExtensionPulmonary 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 prognosisTrade 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.AuthorisedFemale: yes
Male: yes
50United Kingdom;Spain;Italy
478NCT00120380September 200419 February 2015Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial HypertensionHypertensionDrug: Aerosolized iloprost;Drug: PlaceboHannover Medical SchoolNot recruiting18 Years75 YearsBoth40Phase 4Germany
479NCT00626028September 200419 October 2017Comparison of Inhaled Nitric Oxide and Oxygen in Patient Reactivity During Acute Pulmonary Vasodilator TestingComparison of Supplemental Oxygen and Nitric Oxide for Inhalation in the Evaluation of the Reactivity of the Pulmonary Vasculature During Acute Pulmonary Vasodilator TestingIdiopathic Pulmonary Arterial Hypertension;Congenital Heart Disease With Pulmonary Hypertension;CardiomyopathyDrug: Nitric Oxide for inhalation;Drug: Oxygen;Drug: Nitric Oxide plus OxygenMallinckrodtNot recruitingN/A18 YearsAll136Phase 3United States;France;Netherlands;Spain;United Kingdom
480NCT00266162August 200419 February 2015Bosentan in Treatment of Pulmonary Arterial HypertensionTherapy of Pulmonary Arterial Hypertension (PAH) With Bosentan in Patients With Eisenmenger SyndromeEisenmenger SyndromeDrug: Bosentan administrationCompetence Network for Congenital Heart DefectsGerman Federal Ministry of Education and Research;ActelionNot recruiting18 YearsN/ABoth60Phase 4Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
481NCT00086463June 200419 February 2015Trial 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 PAHPulmonary Arterial Hypertension;Ayerza Syndrome;Pulmonary HypertensionDrug: Iloprost or placeboActelionNot recruiting12 Years75 YearsBoth60Phase 2United States
482NCT00091715April 200419 February 2015Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class IIA 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 HypertensionDrug: bosentan;Drug: placeboActelionNot recruiting12 YearsN/ABoth185Phase 3United States;Australia;Austria;Belgium;Canada;China;Czech Republic;France;Germany;Italy;Netherlands;Spain;Switzerland;United Kingdom
483NCT00578786February 200419 October 2017A 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 HypertensionDrug: ambrisentanGilead SciencesNot recruiting18 YearsN/AAll383Phase 3Argentina;Brazil;Chile;Mexico
484NCT00091598January 200419 February 2015ARIES - 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 HypertensionPulmonary HypertensionDrug: AmbrisentanGilead SciencesNot recruiting18 YearsN/ABoth372Phase 3United States;Australia;Canada
485NCT00159874January 200419 October 2017A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In ChildrenA Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil Citrate In The Treatment Of Subjects Who Have Completed Study A1481131Pulmonary Arterial HypertensionDrug: Sildenafil citratePfizerNot recruiting1 Year17 YearsAll234Phase 3United States;Brazil;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;Sweden;Taiwan;Canada;Costa Rica;Panama;Singapore
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
486NCT00367770January 200419 October 2017BREATHE 5-OL: Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyA 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 PhysiologyPulmonary Arterial HypertensionDrug: Tracleer®ActelionNot recruiting12 YearsN/AAll37Phase 4United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
487NCT00423202December 200319 February 2015A 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 HypertensionDrug: ambrisentanGilead SciencesNot recruiting18 YearsN/ABoth186Phase 3
488NCT00423748December 200319 February 2015Study 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 HypertensionPulmonary Arterial HypertensionDrug: ambrisentanGilead SciencesNot recruiting18 YearsN/ABoth186Phase 3
489NCT00317486September 200319 February 2015Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyA 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 PhysiologyPulmonary Arterial Hypertension Related to Eisenmenger PhysiologyDrug: bosentanActelionNot recruiting12 YearsN/ABoth54Phase 4United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
490NCT00159913August 200319 October 2017A 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, ChildrenDrug: Sildenafil citrate;Drug: PlaceboPfizerNot recruiting1 Year17 YearsAll235Phase 3United States;Brazil;Canada;Chile;Colombia;Guatemala;Hungary;India;Italy;Japan;Malaysia;Mexico;Peru;Poland;Russian Federation;Sweden;Taiwan;Australia;Costa Rica;Panama;Singapore
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491NCT00483626August 200319 February 2015Hemodynamic Response After Six Months of SildenafilHemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil TreatmentPulmonary Arterial HypertensionDrug: oral sildenafilUniversity of ChileRecruiting16 Years75 YearsBoth27Phase 4Chile
492NCT00082186July 200319 February 2015The Effect of Tracleer® on Male FertilityTRACLEER® (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 HypertensionHypertension, PulmonaryDrug: bosentanActelionNot recruiting18 Years65 YearsMale22Phase 4United States;Australia;Brazil;Czech Republic;Hungary
493NCT00159861July 200319 October 2017The Efficacy and Safety of Sildenafil Citrate Used in Combination With Intravenous Epoprostenol in PAHA 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 HypertensionDrug: Sildenafil citratePfizerNot recruiting16 YearsN/AAll267Phase 3United States;Belgium;Canada;Czech Republic;Denmark;France;Israel;Italy;Netherlands;Spain;United Kingdom
494NCT00080457May 200319 February 2015Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial HypertensionA 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 HypertensionDrug: sitaxsentan sodiumEncysive PharmaceuticalsNot recruiting12 Years75 YearsBoth240Phase 3United States
495NCT00424021April 200319 October 2017Phase 2 Extension Study of Ambrisentan in Pulmonary Arterial HypertensionAn Open-Label, Long-Term Study of Ambrisentan in Pulmonary Hypertension Subjects Having Completed Myogen Study AMB-220Pulmonary HypertensionDrug: ambrisentanGilead SciencesNot recruiting18 YearsN/AAll54Phase 2
No.TrialIDDate_
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496NCT00811018March 200319 October 2017A Long-Term, Open-Label Study to Evaluate the Safety of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial HypertensionA Long-Term, Open-Label Study To Evaluate The Safety Of Sitaxsentan Sodium Treatment In Patients With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: SitaxsentanPfizerNot recruiting12 Years75 YearsAll1192Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Spain;United Kingdom
497NCT00159887December 200219 February 2015Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial HypertensionA 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 HypertensionDrug: Sildenafil citratePfizerNot recruiting18 YearsN/ABoth260Phase 3United 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
498NCT00058929October 200219 February 2015A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial HypertensionA Multicenter, Randomized, Parallel Placebo-Controlled Study of the Safety and Efficacy of Subcutaneous Remodulin® Therapy After Transition From Flolan® in Patients With Pulmonary Arterial HypertensionPulmonary Arterial Hypertension;Pulmonary HypertensionDrug: treprostinil sodiumUnited TherapeuticsNot recruiting18 Years75 YearsBoth39Phase 4United States
499NCT00644605October 20024 May 2015A Study to Assess the Efficacy and Safety of 20, 40, and 80mg of Sildenafil Three Times a Day in the Treatment of Pulmonary Arterial HypertensionA 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 OverHypertension, PulmonaryDrug: sildenafil;Drug: placeboPfizerNot recruiting18 YearsN/ABoth275Phase 3United 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
500NCT00046319September 200219 February 2015Study of BSF 208075 Evaluating Exercise Capacity in Patients With Pulmonary Arterial HypertensionA 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 HypertensionPulmonary HypertensionDrug: BSF 208075Gilead SciencesNot recruiting18 YearsN/ABoth60Phase 2United States;Australia;Belgium;France;Germany;Italy
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501NCT00105209April 200219 February 2015A Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial HypertensionA Double-Blind, Placebo-Controlled, Three Treatment Cross-Over Study of Aspirin and Clopidogrel in Patients With Idiopathic Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: Aspirin;Drug: clopidogrelKawut, Steven, MDNational Heart, Lung, and Blood Institute (NHLBI);Columbia UniversityNot recruiting18 YearsN/ABoth20Phase 2United States
502NCT00034307February 200219 February 2015Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial HypertensionA Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium Treatment in Patients With Pulmonary Arterial HypertensionPulmonary HypertensionDrug: sitaxsentan sodiumICOS-Texas BiotechnologyICOS Corporation;Texas Biotechnology CorporationNot recruiting16 Years75 YearsBoth180Phase 2/Phase 3United States;Canada
503NCT02784808January 200020 June 2016Retrospective 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 ArthritisDrug: Biological DMARDs;Drug: Non-Biologic DMARDsHoffmann-La RocheNot recruitingN/A18 YearsBoth4557N/A
504JPRN-UMIN0000203861999/04/012 April 2019Acute Vasoreactivity Testing with Nicardipine in Patients with Pulmonary Arterial Hypertensionplumonary arterial hypertensionNicardipine 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 SciencesNational Hospital Organization, Okayama Medical CenterNot RecruitingNot applicableNot applicableMale and Female100Not applicableJapan
505JPRN-JapicCTI-13235616 July 2019A Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial HypertensionA Double-Blind Efficacy and Safety Study of the Phosphodiesterase Type 5 Inhibitor Tadalafil in Pediatric Patients with Pulmonary Arterial HypertensionHypertension, PulmonaryIntervention 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.RecruitingBOTHPhase 3

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