88. Chronic thromboembolic pulmonary hypertension
[
49 clinical trials,
54 drugs（DrugBank:
23 drugs),
10 target genes / 24 target pathways ]
Searched query = "Chronic thromboembolic pulmonary hypertension", "CTEPH", "Idiopathic chronic pulmonary thromboembolism"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04081012 | May 21, 2019 | 30 September 2019 | N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension. | N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Pulmonary Balloon Angioplasty and Pulmonary Endarterectomy. | Chronic Thromboembolic Pulmonary Hypertension | Drug: N-acetyl cysteine;Drug: Placebo | Instituto Nacional de Cardiologia Ignacio Chavez | Recruiting | N/A | N/A | All | 34 | N/A | Mexico | |
| 2 | NCT03806907 | April 1, 2019 | 25 February 2019 | Iodine Subtraction Mapping in the Diagnosis of Chronic Pulmonary Thromboembolic Disease | IodiNe Subtraction maPpIng in the Diagnosis of chRonic Pulmonary thromboEmbolic Disease (INSPIRE): An Observational Diagnostic Study | Chronic Thromboembolic Pulmonary Hypertension | Radiation: Computed tomography lung subtraction iodine mapping | University of Sheffield | Sheffield Teaching Hospitals NHS Foundation Trust | Not recruiting | 18 Years | 90 Years | All | 100 | Phase 3 | |
| 3 | NCT03754660 | January 21, 2019 | 11 November 2019 | This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | A Non-randomized Two Part Multi-Center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel Group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592 | Hypertension, Pulmonary | Drug: BAY1237592;Drug: PH-monotherapy;Drug: PH-combination therapy;Procedure: NO gas | Bayer | Recruiting | 18 Years | 80 Years | All | 60 | Phase 1 | Germany | |
| 4 | NCT03689244 | January 14, 2019 | 16 September 2019 | A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential, Adaptive, Phase 3 Study With Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an add-on to Standard of Care Therapy in Subjects With Inoperable or Persistent/Recurrent After Surgical and/or Interventional Treatment Chronic Thromboembolic Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Drug: Placebo;Drug: Selexipag | Actelion | Recruiting | 18 Years | 85 Years | All | 400 | Phase 3 | United States;Argentina;Belgium;Brazil;Bulgaria;Czechia;Hungary;Israel;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Russian Federation;Sweden;Taiwan;Thailand;Turkey;United Kingdom | |
| 5 | NCT03809650 | January 8, 2019 | 4 November 2019 | A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A Prospective, Multicenter, Open-label, Single Arm, Phase III Study to Assess the Efficacy and Safety of Macitentan (ACT-064992) in Subjects With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Drug: macitentan 10 mg | Actelion | EPS Corporation;Imepro Inc.;General Laboratory, BML, Inc.;Mitsubishi Logistics Corporation | Recruiting | 18 Years | 89 Years | All | 27 | Phase 3 | Japan |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT03273257 | August 17, 2018 | 24 September 2018 | Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study) | A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance | Chronic Thromboembolic Pulmonary Hypertension;CTEPH | Drug: Riociguat;Drug: Placebo;Procedure: Pulmonary endarterectomy | International CTEPH Association | Recruiting | 18 Years | 80 Years | All | 80 | Phase 2 | United States;France;Germany;United Kingdom | |
| 7 | EUCTR2017-001121-40-DE | 17/05/2018 | 23 July 2018 | A study to assess the effectiveness of Riociguat when it is used in patients who have an operable form of CTEPH. The effectiveness of Riociguat will be studied in those patients prior to undergoing the operation (known as Pulmonary Endarterectomy) | A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance - Riociguat in patients with operable CTEPH prior to pulmonary endarterectomy | Chronic Thromboembolic Pulmonary Disease (CTEPH) MedDRA version: 20.0 Level: LLT Classification code 10068740 Term: CTEPH System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 Pharmaceutical Form: Tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Other descriptive name: RIOCIGUAT 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 Trade Name: Adempas® Product Name: Riociguat 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- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Adempas® Product Name: Riociguat 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- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Adempas® Product Name: Riociguat 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- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Adempas® Product Name: Riociguat 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- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | International CTEPH Association (ICA) | Authorised | Female: yes Male: yes | 88 | Phase 2 | France;United States;Germany;United Kingdom | |||
| 8 | NCT03074539 | February 1, 2017 | 18 March 2019 | Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension | Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension - a Prospective, Descriptive Cohort Study | Chronic Thromboembolic Pulmonary Hypertension;Sleep Disordered Breathing | Drug: Riociguat;Procedure: Pulmonary Endarteriectomy;Procedure: Ballon Pulmonary Angioplasty | Medical University of Vienna | Recruiting | 18 Years | N/A | All | 50 | N/A | Austria | |
| 9 | EUCTR2016-000347-14-ES | 16/06/2016 | 20 June 2016 | Comparative study between patients with pulmonary hypertension and healthy subjects detecting pulmonary cell changes by FDG PET imaging | Cell proliferation in pulmonary hypertension: mollecular imaging detection by FDG PET. Comparative study between patients and healthy subjects | Pulmonary artery hypertension and thromboembolic chronic pulmonary hypertension MedDRA version: 19.0 Level: LLT Classification code 10037405 Term: Pulmonary hypertension primary System Organ Class: 100000004855 MedDRA version: 19.0 Level: LLT Classification code 10068739 Term: Chronic thromboembolic pulmonary hypertension System Organ Class: 100000004855 ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] | Trade Name: Barnascan Product Name: BARNASCAN Pharmaceutical Form: Solution for injection INN or Proposed INN: FLUDEOXYGLUCOSE CAS Number: 105851-17-0 Other descriptive name: FLUDEOXYGLUCOSE Concentration unit: MBq megabecquerel(s) Concentration type: up to Concentration number: 3000- | IDIBAPS | Authorised | Female: yes Male: yes | Phase 2 | Spain | ||||
| 10 | JPRN-JapicCTI-163279 | 10/6/2016 | 16 July 2019 | A confirmatory (phase III) study of the efficacy and safety of NS-304 (selexipag) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | A confirmatory (phase III) study of the efficacy and safety of NS-304 (selexipag) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | Chronic thromboembolic pulmonary hypertension (CTEPH) | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration Control intervention name : NS-304 Placebo INN of the control intervention : - Dosage And administration of the control intervention : Oral administration | Nippon Shinyaku Co., Ltd. | Not Recruiting | 20 | 85 | BOTH | 72 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | JPRN-jRCTs031180239 | 14/04/2016 | 22 July 2019 | MR BPA study | Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - MR BPA study | Chronic Thromboembolic Pulmonary Hypertension | Group A: BPA treatment BPA is performed after allocation to this group (initial date of implementation will be the reference date). BPA will be completed within four months of the reference date. Group B: Riociguat treatment Riociguat treatment will be initiated after allocation to this group (the initial administration day will be the reference date). Riociguat will be initially administered three times per day at 1.0 mg per dose. Using systolic blood pressure (95 mmHg or higher) as a guide, the dose will be increased by 0.5 mg for each subject every two weeks with a thrice-daily administration of 2.5 mg/dose set as the maximum dosage. Dosage adjustment, including the maintenance dosage, is based on the judgment of the responsible investigators and investigators. Dosage adjustment will be completed within four months of the reference date. | Keiichi Fukuda | Takashi Kawakami | Recruiting | >=20 age old | <=80 age old | Both | 60 | N/A | none |
| 12 | JPRN-UMIN000019549 | 2016/04/01 | 2 April 2019 | Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension | Chronic thromboembolic pulmonary hypertension (CTEPH) | Group A: BPA treatment Basically BPA treatment needs to be finished within 4 months from the day of first BPA session Group B: Riociguat treatment First, starting with riociguat 3 times per day (1.0mg/time). Then increase the dose by 0.5mg every two weeks (with systolic blood pressure 95mmHg or higher). The maximum dose is 2.5mg per dose (three times per day). Dosage is adjusted accordingly for each patient, and the adjustment is finished within 4 months from the day of starting riociguat. | Keio University School of Medicine | Recruiting | 20years-old | 80years-old | Male and Female | 60 | Not selected | Japan | ||
| 13 | JPRN-UMIN000018520 | 2016/01/01 | 2 April 2019 | Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension | CTEPH (chronic thromboembolic pulmonary hypertension) | Initiation of once-daily Edoxaban(60mg) during 6 months after 2 days discontinuation of warfarin | Division of Cardiovascular Medicine, Department of Internal Medicine Kobe University Graduate School of Medicine | Not Recruiting | 20years-old | Not applicable | Male and Female | 60 | Phase 4 | Japan | ||
| 14 | NCT02634203 | January 2016 | 16 December 2017 | Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension | Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Procedure: Balloon Pulmonary Angioplasty (BPA);Drug: Riociguat | Assistance Publique - Hôpitaux de Paris | Bayer | Recruiting | 18 Years | 80 Years | All | 124 | N/A | France |
| 15 | NCT02545465 | September 15, 2015 | 16 December 2017 | A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical Practice | Retrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to Adempas | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | Not recruiting | N/A | N/A | All | 125 | N/A | Belgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT02558582 | September 2015 | 26 August 2019 | Effect of Exercise Training in Patients With Pulmonary Hypertension | Effect of Exercise Training in Arterial and Chronic Thromboembolic Pulmonary Hypertension in Switzerland and Standardization With European Countries | Hypertension, Pulmonary | Behavioral: respiratory and exercise therapy;Behavioral: respiratory and exercise therapy with supplemental oxygen | University of Zurich | Recruiting | 18 Years | N/A | All | 32 | N/A | Switzerland | |
| 17 | JPRN-UMIN000026882 | 2015/04/01 | 5 November 2019 | Effect of oxygen administration on pulmonary vascular resistance and cardiac index in patients with chronic thromboembolic pulmonary hypertension. | Effect of oxygen administration on pulmonary vascular resistance and cardiac index in patients with chronic thromboembolic pulmonary hypertension. - Effect of oxygen administration on PVR and CI in CTEPH. | chronic thromboembolic pulmonary hypertension. | Oxygen administration | Department of Cardiology, Hospital Organization Okayama Medical Center | Recruiting | 20years-old | Not applicable | Male and Female | 100 | Not applicable | Japan | |
| 18 | NCT03195543 | March 12, 2015 | 1 April 2019 | Assessment of Blood Coagulation Disorders in Patients With Pulmonary Hypertension | Assessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension. | Pulmonary Artery Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Diagnostic Test: Platelet function analyzer-100;Diagnostic Test: Light transmission aggregometry;Diagnostic Test: Rotational thromboelastometry;Diagnostic Test: Endogenous thrombin potential | National and Kapodistrian University of Athens | Recruiting | 18 Years | N/A | All | 60 | N/A | Greece | |
| 19 | EUCTR2013-003457-25-GB | 22/09/2014 | 28 February 2019 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 20.0 Level: LLT Classification code 10068739 Term: Chronic thromboembolic pulmonary hypertension System Organ Class: 100000004855 ;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 | 78 | Phase 2 | China;Germany;Netherlands;South Africa;Belgium;Poland;Canada;Mexico;Czech Republic;Hungary;France;Switzerland;United Kingdom;Chile;Russian Federation;Austria;Lithuania;Ukraine;Thailand;United States | |||
| 20 | NCT02021292 | August 20, 2014 | 5 March 2018 | Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension | Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Drug: Macitentan;Drug: Placebo | Actelion | Not recruiting | 18 Years | 84 Years | All | 80 | Phase 2 | Canada;Chile;Czech Republic;Italy;Netherlands;South Africa;United States;Vietnam;Bulgaria;Belgium;China;Czechia;France;Germany;Hungary;Korea, Republic of;Lithuania;Mexico;Poland;Russian Federation;Switzerland;Thailand;Turkey;Ukraine;United Kingdom;Austria | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2013-003457-25-DE | 14/08/2014 | 28 February 2019 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 20.0 Level: LLT Classification code 10068739 Term: Chronic thromboembolic pulmonary hypertension System Organ Class: 100000004855 ;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 | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China | |||
| 22 | NCT02117791 | July 16, 2014 | 4 November 2019 | Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH ) | Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH) | Hypertension, Pulmonary | Drug: Riociguat (ADEMPAS, BAY63-2521) | Bayer | Not recruiting | N/A | N/A | All | 1298 | Phase 3 | Japan | |
| 23 | EUCTR2013-003457-25-CZ | 13/06/2014 | 20 August 2018 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 20.0 Level: LLT Classification code 10068739 Term: Chronic thromboembolic pulmonary hypertension System Organ Class: 100000004855 ;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. | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China | |||
| 24 | NCT02094001 | May 2014 | 10 September 2018 | Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH | Evaluation of Right Ventricular Function and Metabolism Following Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension- Images of Rio | Chronic Thromboembolic Pulmonary Hypertension | Radiation: Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3) | Ottawa Heart Institute Research Corporation | Bayer | Not recruiting | 18 Years | N/A | All | 6 | Phase 2 | Canada |
| 25 | EUCTR2013-002950-56-DE | 21/03/2014 | 2 October 2017 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 18.1 Level: LLT Classification code 10068739 Term: Chronic thromboembolic pulmonary hypertension System Organ Class: 100000004855 ;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 | 78 | Phase 2 | Korea, Republic of;China;Germany;Netherlands;South Africa;Belgium;Poland;Canada;Mexico;Czech Republic;Hungary;France;Vietnam;United Kingdom;Switzerland;Chile;Russian Federation;Austria;Lithuania;Ukraine;Thailand;United States | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2013-002950-56-CZ | 20/02/2014 | 2 October 2017 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.1 Level: LLT Classification code 10068739 Term: Chronic thromboembolic pulmonary hypertension System Organ Class: 100000004855 ;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 | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Germany;China;Sweden | |||
| 27 | NCT01894022 | January 23, 2014 | 16 December 2017 | A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Hypertension | Drug: Ambrisentan 5 mg | GlaxoSmithKline | Not recruiting | 18 Years | 80 Years | All | 19 | Phase 3 | United States;Argentina;Austria;Canada;China;Czechia;Germany;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Russian Federation;Saudi Arabia;Spain;United Kingdom;Czech Republic | |
| 28 | NCT01884675 | September 2013 | 16 December 2017 | Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension. | A Randomised, Multicentre, Double-Blind, Placebo-Controlled Study Of Ambrisentan In Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | Hypertension | Drug: Ambrisentan 5 mg;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | 80 Years | All | 33 | Phase 3 | United States;Argentina;Austria;Canada;China;Czech Republic;Germany;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Russian Federation;Saudi Arabia;Spain;United Kingdom | |
| 29 | NCT01953965 | September 2013 | 8 August 2016 | Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. | 11C-acetate/18Fluorodeoxyglucose-FDG PET/Cardiac MRI in Pulmonary Hypertension | Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Drug: 11C-acetate;Drug: [18F]Fluoro-2-deoxy-2-D-glucose;Drug: MultiHance | Brigham and Women's Hospital | University of Pennsylvania;University of Maryland;Yale University | Not recruiting | 18 Years | 72 Years | Both | 4 | Phase 2 | United States |
| 30 | JPRN-JapicCTI-132159 | 01/5/2013 | 23 April 2019 | NS-304 CTEPH OE | The open-label extension study of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | Chronic thromboembolic pulmonary hypertension (CTEPH) | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration | NIPPON SHINYAKU CO., LTD. | BOTH | 2 | Phase 2 | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT01884012 | May 2013 | 16 December 2017 | Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension | Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension | Procedure: long term oxygen therapy | University of Zurich | Not recruiting | 16 Years | 85 Years | All | 30 | Phase 3 | Switzerland | ||
| 32 | EUCTR2012-001642-17-ES | 26/04/2013 | 7 December 2015 | An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). MedDRA version: 15.1 Level: LLT Classification code 10068739 Term: Chronic thromboembolic pulmonary hypertension System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AMBRISENTAN CAS Number: 177036-94-1 Current Sponsor code: GSK1325760 Other descriptive name: ambrisentan Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- | GlaxoSmithKline, S.A. | Not Recruiting | Female: yes Male: yes | 275 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||||
| 33 | EUCTR2012-001646-18-ES | 25/04/2013 | 10 July 2015 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled study of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). MedDRA version: 14.1 Level: LLT Classification code 10068739 Term: Chronic thromboembolic pulmonary hypertension System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ambrisentan CAS Number: 177036-94-1 Current Sponsor code: GSK1325760 Other descriptive name: ambrisentan 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 | GlaxoSmithKline, S.A. | Not Recruiting | Female: yes Male: yes | 275 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | ||||
| 34 | EUCTR2012-002104-40-SE | 14/03/2013 | 29 August 2016 | To assess safety and tolerability, clinical effects of riociguat. To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial. | An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension | Chronic Trombo Embolic Pulmonary Hypertention MedDRA version: 18.0 Level: LLT Classification code 10068740 Term: CTEPH System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 IR tablet 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: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Product Name: BAY 63-2521 IR tablet 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: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Product Name: BAY 63-2521 IR tablet 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: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.0- Product Name: BAY 63-2521 IR tablet 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: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Product Name: BAY 63-2521 IR tablet 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: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- | Bayer HealthCare AG | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden;Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia | |||
| 35 | NCT01748474 | December 2012 | 22 August 2016 | Effect of Short-term Oxygen During CPET in Pulmonary Hypertension | Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension | Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension;Chronic Cardiorespiratory Disease | Procedure: Supplemental oxygen via a mask | University of Zurich | Not recruiting | 20 Years | 80 Years | Both | 20 | Phase 2 | Switzerland | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | JPRN-JapicCTI-111666 | 01/6/2010 | 23 April 2019 | NS-304 CTEPH OL study | The open-label extension study of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who completed the exploratory evaluation study | Chronic thromboembolic pulmonary hypertension (CTEPH) | 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. | BOTH | 32 | Phase 2 | |||||
| 37 | JPRN-JapicCTI-111667 | 01/2/2010 | 23 April 2019 | NS-304 CTEPH DB study | An exploratory study to assess the efficacy and safety of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | Chronic thromboembolic pulmonary hypertension (CTEPH) | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration Control intervention name : Placebo Dosage And administration of the control intervention : Oral administration | NIPPON SHINYAKU CO., LTD. / Actelion Pharmaceuticals Japan Ltd. | 20 | 75 | BOTH | 32 | Phase 2 | |||
| 38 | NCT00910429 | July 1, 2009 | 9 September 2019 | BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension | Long-term Extension, Multicentre, Multi-international 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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | Pulmonary Hypertension | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | Not recruiting | 18 Years | 80 Years | All | 237 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Israel;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Taiwan;Turkey;United Kingdom;Czech Republic;Ireland;Netherlands | |
| 39 | EUCTR2008-006441-10-AT | 03/06/2009 | 28 February 2019 | Study to evaluate the efficacy and safety of Treprostinil which will be continuously administered under the skin by patients with inoperable Chronic Thromboembolic Pulmonary Hypertension. | A double blind controlled clinical study to investigate the efficacy and tolerability of subcutaneous Treprostinil sodium in patients with severe non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH II) | Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Treprostinil Sodium Pharmaceutical Form: Solution for infusion INN or Proposed INN: Treprostinil CAS Number: 289480644 Other descriptive name: TREPROSTINIL SODIUM Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- INN or Proposed INN: Treprostinil CAS Number: 289480644 Other descriptive name: TREPROSTINIL SODIUM Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2,5- INN or Proposed INN: Treprostinil CAS Number: 289480644 Other descriptive name: TREPROSTINIL SODIUM Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- INN or Proposed INN: Treprostinil CAS Number: 289480644 Other descriptive name: TREPROSTINIL SODIUM Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Product Name: Treprostinil Sodium Pharmaceutical Form: Solution for infusion INN or Proposed INN: Treprostinil CAS Number: 289480644 Other descriptive name: TREPROSTINIL SODIUM Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- | SCIPHARM SáRL | Authorised | Female: yes Male: yes | 100 | Phase 3 | Czech Republic;Slovakia;Poland;Austria;Germany | |||
| 40 | NCT01416636 | March 2009 | 16 December 2017 | Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH) | A Double Blind Controlled Clinical Study to Investigate the Efficacy and Tolerability of Subcutaneous Treprostinil Sodium in Patients With Severe Non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH) | Non-operable Chronic Thromboembolic Pulmonary Hypertension | Drug: Treprostinil sodium | SciPharm SàRL | Not recruiting | 18 Years | 100 Years | All | 100 | Phase 3 | Austria;Czechia;Germany;Poland;Czech Republic | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2008-003539-19-NL | 13/02/2009 | 26 September 2016 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 | Chronic Thromboembolic Pulmonary Hypertention MedDRA version: 13.1 Level: LLT Classification code 10037406 Term: Pulmonary hypertension secondary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Product Name: BAY 63-2521 tablets 2.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) | Bayer HealthCare AG, Bayer Vital GmbH, D-51368 Leverkusen | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Portugal;France;Czech Republic;Belgium;Spain;Ireland;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy | |||
| 42 | EUCTR2008-003539-19-DE | 26/11/2008 | 25 February 2013 | Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 | Chronic Thromboembolic Pulmonary Hypertension MedDRA version: 14.1 Level: LLT Classification code 10037406 Term: Pulmonary hypertension secondary System Organ Class: 100000004855 | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Product Name: BAY 63-2521 tablets 2.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) | Bayer HealthCare AG, | Authorised | Female: yes Male: yes | 270 | United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan | ||||
| 43 | ChiCTR-TNRC-08000263 | 2008-06-01 | 18 April 2017 | The study of the intervention with statin on PE and CTEPH | The study of the intervention with statin on PE and CTEPH | pulmonary embolism and chronic thromboembolic pulmonary hypertension | Group A:basic treatment + atorvastatin;Group B:basic treatment; | Tongji Hospital of Tongji University | Not Recruiting | 18 | 80 | Both | Group A:30;Group B:30; | Post-market | China | |
| 44 | EUCTR2007-000072-16-DE | 7 January 2013 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study | Chronic Thromboembolic Pulmonary Hypertension MedDRA version: 14.1 Level: LLT Classification code 10037406 Term: Pulmonary hypertension secondary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | Bayer HealthCare AG | Not Recruiting | Female: yes Male: yes | 270 | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | |||||
| 45 | EUCTR2006-003520-10-DE | 20/10/2006 | 28 November 2016 | Long-term study to collect additional information to evaluate the saftey and tolerability of BAY 63-2521 in different doses | A multicenter, non-randomized, non-blinded, non-controlled study to investigate the impact of multiple doses of BAY 63 2521 on safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with pulmonary hypertension in a 12 week 3 times a day individual dose titration scheme | Subjects with PH due to • Pulmonary arterial hypertension (PAH) [Venice protocol] or • Chronic thrombembolic PH (CTEPH) MedDRA version: 19.0 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Product Name: BAY 63-2521 Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.5- Product Name: BAY 63-2521 Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Product Name: BAY 63-2521 Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.5- Product Name: BAY 63-2521 Product Code: BAY 63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2.0- | Bayer HealthCare AG | Not Recruiting | Female: yes Male: yes | 0 | Phase 1;Phase 2 | Germany | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT00319111 | January 2006 | 19 October 2017 | Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222) | Pulmonary Hypertension | Drug: bosentan | Actelion | Not recruiting | 18 Years | 80 Years | All | 151 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom | |
| 47 | EUCTR2005-001965-33-DE | 01/11/2005 | 18 April 2012 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 8.1 Level: LLT Classification code 10037436 Term: Pulmonary thromboembolism | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: Ro-47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 62.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: bosentan monohydrate CAS Number: 157212-55-0 Current Sponsor code: Ro-47-0203/029 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Spain;Italy | ||||
| 48 | NCT00313222 | October 2005 | 19 February 2015 | Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension | Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Chronic Thromboembolic Pulmonary Hypertension | Drug: bosentan | Actelion | Not recruiting | 18 Years | 80 Years | Both | 157 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom | |
| 49 | EUCTR2005-002900-40-AT | 15/08/2005 | 27 May 2013 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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- 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- | Actelion Pharmaceuticals Ltd. | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom |