88. 慢性血栓塞栓性肺高血圧症 Chronic thromboembolic pulmonary hypertension Clinical trials / Disease details
臨床試験数 : 157 / 薬物数 : 107 - (DrugBank : 22) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 54
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05140525 (ClinicalTrials.gov) | June 1, 2023 | 28/10/2021 | Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH | Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension | CTEPH | Drug: Macitentan Tablets;Drug: Riociguat;Device: balloon pulmonary angioplasty | Dr Sudarshan Rajagopal | Actelion | Not yet recruiting | 18 Years | N/A | All | 15 | Phase 3 | United States |
| 2 | NCT04954742 (ClinicalTrials.gov) | April 13, 2022 | 29/6/2021 | Effects of Riociguat on RIght VEntricular Size and Function in PAH and CTEPH | An Open-label, Prospective, Single Centre Study of the Effects of Riociguat on RIght VEntricular Size and Function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension | Primary Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Drug: Riociguat | Heidelberg University | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | Germany |
| 3 | JPRN-jRCTs041200052 | 30/06/2021 | 22/10/2020 | THERAPY-HYBRID-BPA trial | The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients after Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty. - Riociguat-CTEPH | chronic thromboembolic pulmonary hypertension CTEPH;D000081029 | In this study, we will perform continuous verification by allocating the Chronic Thromboembolic Pulmonary Hypertension (CTEPH) patients whose hemodynamics were normalized after Balloon Pulmonary Angioplasty (BPA) to the the riociguat active group and placebo group for 16 weeks. | Shimokawahara Hiroto | NULL | Recruiting | >= 18age old | < 85age old | Both | 72 | Phase 2 | Japan |
| 4 | EUCTR2020-005462-34-DE (EUCTR) | 23/06/2021 | 25/02/2021 | Study to investigate the effect of riociguat on right heart size and function in pulmonary hypertension | An open-label, prospective, single centre study of the effects of Riociguat on RIght VEntricular size and function in Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension - RIVER II | Symptomatic pulmonary arterial hypertension with a mean pulmonary artery pressure >20 mmHg and pulmonary vascular resistance =2 Wood Units, pulmonary arterial wedge pressure =15 mmHg (Group I / Nice Clinical Classification of Pulmonary Hypertension (PH)) or CTEPH (Group IV) with hemodynamics as stated above defined as inoperable measured at least 3 months after start of full anticoagulation or with persisting or recurrent PH after pulmonary endarterectomy at least 6 months after surgery MedDRA version: 20.0;Level: HLT;Classification code 10037401;Term: Pulmonary hypertensions;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 Product Name: Riociguat Product Code: MK-4836 INN or Proposed INN: RIOCIGUAT Other descriptive name: BAY 63-2521 | Thoraxklinik Heidelberg gGmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Germany | ||
| 5 | JPRN-jRCT1041200111 | 11/03/2021 | 11/03/2021 | Pharmacokinetic changes in Riociguat before and after catheterization | Effect of balloon pulmonary angioplasty on the pharmacokinetics of riociguat - BPA: Balloon Pulmonary Angiotherapy | CTEPH | Right heart catheterization on the day before BPA treatment and 3 months after BPA treatment, except at the time of blood sampling, which is usually performed in clinical practice. During hospitalization, 5 ml / dose of blood is taken 6 times (before and 30 minutes after taking the drug). , 1 hour after taking the drug, 2 hours after taking the drug, 3 hours after taking the drug, 5 hours after taking the drug). | Tatsuguchi Mariko | NULL | Recruiting | >= 20age old | <= 80age old | Both | 30 | N/A | Japan |
| 6 | JPRN-jRCT1041210122 | 11/01/2021 | 26/12/2021 | Investigational Randomized Controlled Trial of Patients with Chronic Thromboembolic Pulmonary Hypertension treated with Riociguat vs Selexipag | Investigational Randomized Controlled Trial of Patients with Chronic Thromboembolic Pulmonary Hypertensiontreated with Riociguat vs Selexipag - RISE-CTEPH study | chronic thromboembolic pulmonary hypertension chronic thromboembolic pulmonary hypertension;D006976 | Patients will be randomly allocated to riociguat treated group or selexipag treated group with PVR as a allocated factor. Riociguat is taken up to a maximum of 2.5mg taken three times a day. Selexipag is taken up to a maximum of 1.6mg taken two times a day. | Adachi Shiro | NULL | Recruiting | >= 20age old | Not applicable | Both | 20 | N/A | Japan |
| 7 | ChiCTR2000032403 | 2021-01-01 | 2020-04-27 | Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study) | Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study) | chronic thromboembolic pulmonary hypertension | Riociguat Group:Riociguat;Riociguat+BPA Group:Riociguat and BPA; | Shanghai Pulmonary Hospital | NULL | Pending | 18 | Both | Riociguat Group:30;Riociguat+BPA Group:30; | China | ||
| 8 | NCT04600492 (ClinicalTrials.gov) | October 16, 2020 | 19/10/2020 | THERAPY-HYBRID-BPA Trial | The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in CTEPH Patients After Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty | Hypertension, Pulmonary | Drug: Riociguat Oral Tablet | National Hospital Organization Okayama Medical Center | Bayer Yakuhin, Ltd. | Recruiting | 18 Years | 85 Years | All | 72 | Phase 2 | Japan |
| 9 | EUCTR2017-001121-40-GB (EUCTR) | 17/09/2018 | 05/02/2018 | 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 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | International CTEPH Association (ICA) | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;France;Germany;United Kingdom | ||
| 10 | NCT03273257 (ClinicalTrials.gov) | August 17, 2018 | 25/8/2017 | 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 | NULL | Terminated | 18 Years | 80 Years | All | 14 | Phase 2 | United States;France;Germany;United Kingdom |
| 11 | EUCTR2017-001121-40-DE (EUCTR) | 17/05/2018 | 13/02/2018 | 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 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | International CTEPH Association (ICA) | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;France;Germany;United Kingdom | ||
| 12 | EUCTR2017-001121-40-FR (EUCTR) | 11/05/2018 | 21/02/2018 | 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 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas® Product Name: Riociguat Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | International CTEPH Association (ICA) | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;France;Germany;United Kingdom | ||
| 13 | NCT03074539 (ClinicalTrials.gov) | February 1, 2017 | 14/2/2017 | 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 | NULL | Completed | 18 Years | N/A | All | 50 | N/A | Austria |
| 14 | JPRN-jRCTs031180239 | 14/04/2016 | 12/03/2019 | 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. | Fukuda Keiichi | Kawakami Takashi | Complete | >= 20age old | <= 80age old | Both | 60 | N/A | Japan |
| 15 | JPRN-UMIN000019549 | 2016/04/01 | 28/10/2015 | Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension | Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension(MR BPA study) | 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 | NULL | Complete: follow-up continuing | 20years-old | 80years-old | Male and Female | 60 | Not selected | Japan |
| 16 | NCT02634203 (ClinicalTrials.gov) | January 19, 2016 | 8/12/2015 | 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 | Completed | 18 Years | 80 Years | All | 105 | N/A | France |
| 17 | NCT02545465 (ClinicalTrials.gov) | September 15, 2015 | 8/9/2015 | 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 | NULL | Completed | N/A | N/A | All | 125 | N/A | Belgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom |
| 18 | NCT02117791 (ClinicalTrials.gov) | July 16, 2014 | 16/4/2014 | 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 | NULL | Recruiting | N/A | N/A | All | 1298 | Japan | |
| 19 | EUCTR2012-002104-40-AT (EUCTR) | 01/10/2013 | 11/03/2013 | 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: 17.0;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 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 20 | EUCTR2012-002104-40-NL (EUCTR) | 18/07/2013 | 21/02/2013 | 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: 17.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Germany;Netherlands;Japan;Korea, Republic of;Sweden | ||
| 21 | EUCTR2012-002104-40-GB (EUCTR) | 20/05/2013 | 19/03/2013 | 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 Thromboembolic Pulmonary Hypertension MedDRA version: 18.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 IR coated tablet 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR coated tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR coated tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR coated tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;Italy;United Kingdom;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 22 | EUCTR2012-002104-40-CZ (EUCTR) | 18/04/2013 | 06/02/2013 | 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: 17.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 23 | EUCTR2012-002104-40-PT (EUCTR) | 05/04/2013 | 17/01/2013 | 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: 19.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 IR tablet 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 24 | EUCTR2012-002104-40-ES (EUCTR) | 02/04/2013 | 04/02/2013 | 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: 14.1;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 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 25 | EUCTR2012-002104-40-BE (EUCTR) | 25/03/2013 | 06/02/2013 | 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 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 26 | EUCTR2012-002104-40-IT (EUCTR) | 21/03/2013 | 22/02/2013 | 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: 14.1;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 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 27 | EUCTR2012-002104-40-SE (EUCTR) | 14/03/2013 | 17/12/2012 | 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 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | 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 | ||
| 28 | EUCTR2012-002104-40-DK (EUCTR) | 01/03/2013 | 20/02/2013 | 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: 14.1;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 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | United States;Portugal;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 29 | EUCTR2012-002104-40-DE (EUCTR) | 25/02/2013 | 19/12/2012 | 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: 19.0;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 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 IR tablet 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden | ||
| 30 | NCT01784562 (ClinicalTrials.gov) | January 2013 | 4/2/2013 | Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | 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 | Hypertension, Pulmonary | Drug: Adempas (Riociguat, BAY63-2521) | Bayer | NULL | No longer available | 18 Years | 80 Years | Both | Phase 3 | United States;Austria;Belgium;Canada;Colombia;Czech Republic;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Portugal;Russian Federation;Spain;Sweden;Switzerland;Turkey;United Kingdom | |
| 31 | EUCTR2007-000072-16-DK (EUCTR) | 15/01/2010 | 04/11/2009 | 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: 12.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | |||
| 32 | EUCTR2008-003539-19-DK (EUCTR) | 15/01/2010 | 04/11/2009 | 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: 17.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan | ||
| 33 | EUCTR2008-003539-19-SK (EUCTR) | 14/01/2010 | 14/01/2010 | 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: 19.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08] | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan | ||
| 34 | EUCTR2007-000072-16-SK (EUCTR) | 23/11/2009 | 10/09/2009 | 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 | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 35 | EUCTR2008-003539-19-PT (EUCTR) | 03/11/2009 | 21/09/2009 | 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: 19.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Japan | ||
| 36 | EUCTR2007-000072-16-PT (EUCTR) | 26/10/2009 | 21/09/2009 | 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 | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | |||
| 37 | NCT00910429 (ClinicalTrials.gov) | July 1, 2009 | 27/5/2009 | 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 | NULL | Completed | 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 |
| 38 | EUCTR2008-003539-19-CZ (EUCTR) | 22/05/2009 | 06/05/2009 | 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: 17.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan | ||
| 39 | EUCTR2008-003539-19-GB (EUCTR) | 20/04/2009 | 25/11/2010 | 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 Hypertention MedDRA version: 20.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: r | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan | ||
| 40 | EUCTR2007-000072-16-CZ (EUCTR) | 09/04/2009 | 27/03/2009 | 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 | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Czech Republic;United Kingdom;Slovakia;Belgium;Denmark;Spain | ||||
| 41 | EUCTR2008-003539-19-IE (EUCTR) | 06/04/2009 | 08/01/2009 | 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: 9.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG, Bayer Vital GmbH, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 270 | Portugal;United Kingdom;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria | |||
| 42 | EUCTR2007-000072-16-AT (EUCTR) | 13/03/2009 | 21/10/2008 | 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 | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 43 | EUCTR2008-003539-19-AT (EUCTR) | 13/03/2009 | 18/11/2008 | 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: 17.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: BAY 63-2521 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan | ||
| 44 | EUCTR2007-000072-16-GB (EUCTR) | 09/03/2009 | 17/10/2008 | Study to evaluate the efficacy and safety of different doses of Bay 63-2521 in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | 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: 14.0;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 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Germany;Japan | ||
| 45 | EUCTR2008-003539-19-BE (EUCTR) | 05/03/2009 | 23/01/2009 | 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: 18.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 coated tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan | ||
| 46 | EUCTR2008-003539-19-NL (EUCTR) | 13/02/2009 | 30/10/2008 | 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 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG, Bayer Vital GmbH, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Germany | ||
| 47 | EUCTR2007-000072-16-NL (EUCTR) | 13/02/2009 | 30/10/2008 | 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 | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;United Kingdom;Czech Republic;Slovakia;Belgium;Denmark;Spain | ||||
| 48 | NCT00855465 (ClinicalTrials.gov) | February 2009 | 15/12/2008 | A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. | Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Pulmonary Hypertension | Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo | Bayer | NULL | Completed | 18 Years | 80 Years | All | 262 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;France;Germany;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Taiwan;Turkey;United Kingdom |
| 49 | EUCTR2008-003539-19-FR (EUCTR) | 14/01/2009 | 13/11/2008 | 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: 9.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG, Bayer Vital GmbH, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 50 | EUCTR2007-000072-16-IE (EUCTR) | 13/01/2009 | 10/10/2008 | 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 | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | |||
| 51 | EUCTR2007-000072-16-BE (EUCTR) | 07/01/2009 | 21/11/2008 | 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 | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 52 | EUCTR2007-000072-16-FR (EUCTR) | 27/12/2008 | 14/11/2008 | 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 | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 53 | EUCTR2007-000072-16-ES (EUCTR) | 26/12/2008 | 27/10/2008 | Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg,tid), administrado por vía oral, en pacientes con Hipertensión Pulmonar Tromboembólica Crónica (HPTEC). Estudio CHEST ?1 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 | Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg,tid), administrado por vía oral, en pacientes con Hipertensión Pulmonar Tromboembólica Crónica (HPTEC). Estudio CHEST ?1 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 | Hipertensión Pulmonar Tromboembólica Crónica (HPTEC) Chronic Thromboembolic Pulmonary Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 54 | EUCTR2007-000072-16-IT (EUCTR) | 15/12/2008 | 20/11/2008 | 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 | 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 | Chronic Thromboembolic Pulmonary Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary | Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 55 | EUCTR2008-003539-19-DE (EUCTR) | 26/11/2008 | 20/10/2008 | 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 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG | ,NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Germany;Japan | ||
| 56 | EUCTR2006-003520-10-DE (EUCTR) | 20/10/2006 | 23/08/2006 | 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 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth Product Name: BAY 63-2521 Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 0 | Phase 1;Phase 2 | Germany | ||
| 57 | EUCTR2007-000072-16-DE (EUCTR) | 29/09/2008 | 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 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 2 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands |