Riociguat (DrugBank: Riociguat)
6 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 51 | 全身性強皮症 | 10 |
| 84 | サルコイドーシス | 1 |
| 86 | 肺動脈性肺高血圧症 | 70 |
| 88 | 慢性血栓塞栓性肺高血圧症 | 43 |
| 225 | 先天性腎性尿崩症 | 1 |
| 299 | 嚢胞性線維症 | 5 |
| 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 | NCT02915835 (ClinicalTrials.gov) | September 2016 | 15/9/2016 | Riociguat in Scleroderma Associated Digital Ulcers | A Multi-center Randomized, Double Blind, Placebo-controlled, Pilot Study to Assess the Efficacy and Safety of Riociguat in Scleroderma - Associated Digital Ulcers | Scleroderma;Digital Ulcers | Drug: Riociguat;Drug: Placebo | Dinesh Khanna, MD, MS | Bayer | Completed | 18 Years | N/A | All | 17 | Phase 2 | United States |
| 2 | EUCTR2014-001353-16-GB (EUCTR) | 17/04/2015 | 03/10/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomised, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Adempas Product Name: riociguat coated tablet 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.5 m | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan | ||
| 3 | EUCTR2014-001353-16-DE (EUCTR) | 19/02/2015 | 16/10/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Adempas Product Name: riociguat coated tablet 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;New Zealand;Japan | ||
| 4 | EUCTR2014-001353-16-CZ (EUCTR) | 22/01/2015 | 06/11/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 20.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan | |||
| 5 | EUCTR2014-001353-16-IT (EUCTR) | 19/01/2015 | 14/05/2015 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) - Effectiveness and safety of riociguat in patients with sclerosis of the skin | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan | |||
| 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 |
| 6 | NCT02283762 (ClinicalTrials.gov) | January 15, 2015 | 3/11/2014 | Efficacy and Safety of Riociguat in Patients With Systemic Sclerosis | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | Scleroderma, Systemic | Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo | Bayer | NULL | Completed | 18 Years | N/A | All | 121 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Netherlands;New Zealand;Switzerland;Turkey;United Kingdom;Czech Republic;Spain |
| 7 | EUCTR2014-001353-16-NL (EUCTR) | 31/12/2014 | 20/10/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 19.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan | |||
| 8 | EUCTR2014-001353-16-HU (EUCTR) | 30/12/2014 | 14/11/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Japan | |||
| 9 | EUCTR2014-001353-16-ES (EUCTR) | 22/12/2014 | 03/11/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 17.1;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Trade Name: Adempas Product Name: riociguat coated tablet 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: riociguat coated tablet 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan | ||
| 10 | EUCTR2014-001353-16-BE (EUCTR) | 09/12/2014 | 21/10/2014 | Effectiveness and safety of riociguat in patients with sclerosis of the skin | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of Riociguat in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) | diffuse cutaneous systemic sclerosis (dcSSc) MedDRA version: 18.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United States;Spain;Turkey;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Australia;Netherlands;Germany;Japan |
| 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 | NCT02625558 (ClinicalTrials.gov) | April 2015 | 26/5/2015 | Riociguat for Sarcoidosis Associated Pulmonary Hypertension | A Double Blind, Placebo Controlled Trial of Oral Riociguat for Sarcoidosis Associated Pulmonary Hypertension | Sarcoidosis | Drug: Riociguat;Drug: Placebo | University of Cincinnati | NULL | Recruiting | 18 Years | N/A | Both | 60 | Phase 4 | United States |
| 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 | EUCTR2016-001067-36-PL (EUCTR) | 08/05/2019 | 18/02/2019 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 2 | JPRN-UMIN000035389 | 2019/04/01 | 01/04/2019 | Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension | Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension - SETOUCHI PH study | Pulmonary arterial hypertension | Dose: macitentan 10 mg/day+riociguat 3 mg/day. Max dose of riociguat is 7.5 mg/day.Intervention period: 8 month Dose: macitentan 10 mg/day+selexipag 0.4 mg/day. Max dose of selexipag is 3.2 mg/day. Intervention period: 8 month | Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 76 | Not selected | Japan |
| 3 | NCT04062565 (ClinicalTrials.gov) | March 25, 2019 | 29/3/2019 | Trial to Evaluate Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Those With Advanced PAH | A Prospective Trial to Evaluate Up-front Parenteral Treprostinil and Riociguat on Right Ventriculo-vascular Coupling and Morphology in Patients With Advanced Pulmonary Arterial Hypertension (IIR-3810) | Pulmonary Arterial Hypertension | Drug: Treprostinil Injectable Product;Drug: Riociguat Pill | University of Arizona | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 3 | United States |
| 4 | EUCTR2014-003952-29-BE (EUCTR) | 07/06/2017 | 03/01/2017 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan | |||
| 5 | EUCTR2016-001067-36-DE (EUCTR) | 22/03/2017 | 10/11/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 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 |
| 6 | EUCTR2016-001067-36-DK (EUCTR) | 15/03/2017 | 23/12/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 7 | EUCTR2016-001067-36-GR (EUCTR) | 02/03/2017 | 17/01/2017 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | Switzerland;Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 8 | EUCTR2016-001067-36-NL (EUCTR) | 23/02/2017 | 07/12/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 9 | EUCTR2016-001067-36-BE (EUCTR) | 20/02/2017 | 14/11/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 10 | EUCTR2016-001067-36-CZ (EUCTR) | 19/01/2017 | 13/10/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Revatio Product Name: Revatio 20 mg film-coated tablets INN or Proposed INN: SILDENAF | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 218 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 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 |
| 11 | NCT02891850 (ClinicalTrials.gov) | January 11, 2017 | 26/8/2016 | Riociguat rEplacing PDE-5i Therapy evaLuated Against Continued PDE-5i thErapy | A Prospective, Randomized, International, Multicenter, Double-arm, Controlled, Open-label Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Are on a Stable Dose of Phosphodiesterase-5 Inhibitors (PDE-5i) With or Without Endothelin Receptor Antagonist (ERA), But Not at Treatment Goal | Pulmonary Arterial Hypertension | Drug: Adempas (Riociguat, BAY63-2521);Drug: Sildenafil;Drug: Tadalafil | Bayer | NULL | Completed | 18 Years | 75 Years | All | 225 | Phase 4 | United States;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Spain;Taiwan;Turkey;United Kingdom;Australia;Switzerland |
| 12 | EUCTR2016-001067-36-PT (EUCTR) | 29/12/2016 | 13/09/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Tadalafil INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 13 | EUCTR2016-001067-36-GB (EUCTR) | 21/12/2016 | 24/10/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Tadalafil INN or Proposed INN: TADALAFIL | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 14 | EUCTR2016-001067-36-IT (EUCTR) | 12/12/2016 | 05/11/2020 | A study to find out whether some PAH patients may benefit by replacing their current hosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: ADEMPAS - 1 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 1.0 INN or Proposed INN: Riociguat Other descriptive name: Riociguat Trade Name: ADEMPAS - 1,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 1.5 mg INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: ADEMPAS - 0,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 0.5 mg compressa rivestita con film INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: ADEMPAS - 2 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 2.0 mg INN or Proposed INN: Riociguat Other descriptive name: Riociguat Trade Name: ADEMPAS - 2,5 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (PP/ALU) - 42 COMPRESSE Product Name: Adempas¿ 2.5 mg INN or Proposed INN: Riociguat | BAYER AG | NULL | Not Recruiting | Female: yes Male: yes | 218 | Phase 4 | France;Denmark;Australia;Netherlands;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Germany;Japan;New Zealand;Portugal;United States;Taiwan;Greece;Spain;Italy;Switzerland | ||
| 15 | EUCTR2016-001067-36-ES (EUCTR) | 21/11/2016 | 09/09/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Revatio Product Name: Revatio 20 mg film-coated tablets INN or Proposed INN: SILDENAF | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 218 | Phase 4 | United States;Portugal;Taiwan;Greece;Spain;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 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 |
| 16 | EUCTR2016-001067-36-AT (EUCTR) | 10/11/2016 | 20/09/2016 | A study to find out whether some PAH patients may benefit by replacing their current phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), with Riociguat | A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal - Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i thErapy | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas® 0.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 1.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.0 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas® 2.5 mg film-coated tablets INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adcirca Product Name: ADCIRCA 20 mg film-coated tablets INN or Proposed INN: TADALAFIL Trade Name: Revatio Product Name: Revatio 20 mg film-coated tablets INN or Proposed INN: SILDENAF | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 218 | Phase 4 | Portugal;United States;Taiwan;Greece;Spain;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Australia;Denmark;Netherlands;Germany;New Zealand;Japan;Korea, Republic of | ||
| 17 | EUCTR2014-003952-29-PL (EUCTR) | 28/07/2016 | 13/04/2016 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Poland;Belgium;Romania;Netherlands;Germany;Japan | |||
| 18 | NCT02759419 (ClinicalTrials.gov) | June 16, 2016 | 29/4/2016 | A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension. | An Open-label, Multi-national, Multi-center, Single-arm, Uncontrolled, Long-term Extension Study of Orally Administered Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) Who Received Riociguat in a Bayer Clinical Trial. | Hypertension, Pulmonary | Drug: Adempas (Riociguat, BAY63-2521) | Bayer | NULL | Recruiting | 18 Years | N/A | All | 25 | Phase 4 | France;Italy;Korea, Republic of;Poland;Thailand |
| 19 | NCT03809156 (ClinicalTrials.gov) | April 26, 2016 | 9/1/2019 | Upfront Combination Pulmonary Arterial Hypertension Therapy | Upfront Riociguat and Ambrisentan Combination Therapy for Pulmonary Arterial Hypertension: A Safety and Efficacy Pilot Study | Pulmonary Hypertension | Drug: Riociguat Oral Product | University of Calgary | Bayer | Recruiting | 18 Years | N/A | All | 20 | Phase 4 | Canada |
| 20 | EUCTR2014-003952-29-DE (EUCTR) | 21/04/2016 | 10/08/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Taiwan;Spain;Turkey;Colombia;Italy;United Kingdom;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Japan | ||
| 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 |
| 21 | EUCTR2014-003952-29-ES (EUCTR) | 01/04/2016 | 17/02/2016 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer Healthcare AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United Kingdom;France;Hungary;Belgium;Poland;Spain;Turkey;Netherlands;Germany;Japan;Italy | ||
| 22 | EUCTR2015-002835-17-DE (EUCTR) | 18/01/2016 | 26/11/2015 | RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatment | Investigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions - RIGHT HEART III | Pulmonary arterial Hypertension (PAH) MedDRA version: 20.0;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Adempas® INN or Proposed INN: RIOCIGUAT Trade Name: Opsumit® INN or Proposed INN: MACITENTAN | Justus Liebig Universität Gießen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Germany | ||
| 23 | EUCTR2014-003952-29-GB (EUCTR) | 25/11/2015 | 27/07/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 3 | United States;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 24 | NCT02562235 (ClinicalTrials.gov) | October 29, 2015 | 28/9/2015 | Riociguat in Children With Pulmonary Arterial Hypertension (PAH) | Open-label, Individual Dose Titration Study to Evaluate Safety, Tolerability and Pharmacokinetics of Riociguat in Children From 6 to Less Than 18 Years of Age With Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | Merck Sharp & Dohme Corp. | Active, not recruiting | 6 Years | 17 Years | All | 24 | Phase 3 | Colombia;Germany;Hungary;Italy;Japan;Mexico;Poland;Taiwan;Turkey;Belgium;Brazil;France;Netherlands;Romania;Spain;United Kingdom;United States |
| 25 | 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 |
| 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 |
| 26 | EUCTR2014-003952-29-IT (EUCTR) | 09/09/2015 | 15/07/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer Healthcare AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Spain;Turkey;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Germany;Netherlands;Japan | |||
| 27 | EUCTR2014-003952-29-HU (EUCTR) | 25/08/2015 | 06/07/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat | Bayer AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 3 | United States;Taiwan;Spain;Turkey;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 28 | NCT02428985 (ClinicalTrials.gov) | June 29, 2015 | 21/4/2015 | Prospective, Non-interventional, Multi-center, Post-authorization Safety Study of Riociguat for Pulmonary Arterial Hypertension (PAH) | Drug Use Investigation of Riociguat for Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Riociguat (ADEMPAS, BAY63-2521) | Bayer | NULL | Recruiting | N/A | N/A | All | 600 | Japan | |
| 29 | EUCTR2013-001759-10-GB (EUCTR) | 29/09/2014 | 27/08/2014 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Film Coated Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Germany;Switzerland;United Kingdom | ||
| 30 | NCT02191137 (ClinicalTrials.gov) | September 23, 2014 | 27/6/2014 | Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION) | A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | NULL | Completed | 18 Years | 80 Years | All | 75 | Phase 4 | United States;Puerto Rico |
| 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 |
| 31 | NCT02007629 (ClinicalTrials.gov) | February 18, 2014 | 6/12/2013 | Riociguat Clinical Effects Studied in Patients With Insufficient Treatment Response to Phosphodiesterase-5 Inhibitor | An Open-label, International, Multicenter, Single-arm, Uncontrolled, Phase IIIb Study of Riociguat in Patients With Pulmonary Arterial Hypertension (PAH) Who Demonstrate an Insufficient Response to Treatment With Phosphodiesterase-5 Inhibitors (PDE-5i) | Hypertension, Pulmonary | Drug: Riociguat (Adempas, BAY63-2521) | Bayer | NULL | Completed | 18 Years | 75 Years | All | 61 | Phase 3 | United States;Belgium;Canada;Czechia;France;Germany;Italy;Switzerland;United Kingdom;Czech Republic |
| 32 | EUCTR2013-001759-10-CZ (EUCTR) | 23/01/2014 | 24/10/2013 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland | ||
| 33 | EUCTR2013-001759-10-IT (EUCTR) | 14/01/2014 | 28/10/2013 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland;Italy | |||
| 34 | EUCTR2013-001759-10-FR (EUCTR) | 06/01/2014 | 28/09/2015 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;France;Czech Republic;Canada;Belgium;Germany;United Kingdom;Italy;Switzerland | ||
| 35 | EUCTR2013-001759-10-DE (EUCTR) | 03/01/2014 | 15/10/2013 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) | Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland | ||
| 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 |
| 36 | EUCTR2013-001759-10-BE (EUCTR) | 20/12/2013 | 20/11/2013 | Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) | An open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE | Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: BAY 63-2521 Tablet Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2;Phase 3 | United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland | ||
| 37 | EUCTR2011-001893-24-DE (EUCTR) | 13/10/2011 | 21/09/2011 | To determine oral bioavailability of the oral liquid formulation and potential food effects. | Relative bioavailability and food effect study of two oral liquid formulations in comparison to a 1mg tablet of riociguat to characterize its pharmacokinetic properties in healthy male and female adult subjects in a randomized, open label, 5 fold crossover design | Children with PH due to • Pulmonary arterial hypertension (PAH) • persistent pulmonary hypertension of the newborn (PPHN) MedDRA version: 14.0;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Classification code 10036727;Term: Primary pulmonary hypertension;Classification code 10053592;Term: Newborn persistent pulmonary hypertension;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: BAY 63-2521 0.3 % Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Product Name: BAY 63-2521 0.06 % Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Product Name: BAY 63-2521 IR tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Germany | |||
| 38 | EUCTR2010-018863-40-ES (EUCTR) | 29/07/2011 | 20/06/2011 | Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters | An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS | Pulmonary arterial hypertension MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR 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 Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR 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 Product Name: BAY 63-2521 IR tablets 0.5 mg Product Code: BAY 63-2521 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Poland;Spain;Austria;Germany;United Kingdom;Italy | |||
| 39 | EUCTR2010-018863-40-GB (EUCTR) | 24/06/2011 | 24/03/2011 | Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters | An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS | Pulmonary arterial hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Czech Republic;Spain;Poland;Austria;Germany;Italy;United Kingdom | |||
| 40 | EUCTR2010-018863-40-PL (EUCTR) | 25/01/2011 | 07/06/2010 | Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters | An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS | Pulmonary arterial hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR 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 Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR 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 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy | |||
| 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 |
| 41 | EUCTR2010-018863-40-AT (EUCTR) | 05/01/2011 | 20/07/2010 | An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS | An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS | Pulmonary arterial hypertension MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR 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 Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR 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 | Bayer Health Care AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | United Kingdom;Czech Republic;Germany;Spain;Italy;Poland;Austria | |||
| 42 | NCT01179334 (ClinicalTrials.gov) | August 2010 | 10/8/2010 | Evaluation of the Pharmacodynamic Effect of the Combination of Sildenafil and Riociguat on Blood Pressure and Other Safety Parameters. | An Interaction Study to Evaluate Changes in Blood Pressure Following 1, 1.5, 2, and 2.5 mg Riociguat Tid (Dose Titration) Compared to Placebo Treatment on the Background of Stable Sildenafil Pretreatment in Subjects With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Hypertension | Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo;Drug: Sildenafil | Bayer | NULL | Completed | 18 Years | 75 Years | All | 18 | Phase 2 | United States;Austria;Czech Republic;Germany;Italy;New Zealand;Poland;Spain;United Kingdom |
| 43 | EUCTR2010-018863-40-CZ (EUCTR) | 22/07/2010 | 02/06/2010 | Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters | An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS | Pulmonary arterial hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR 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 Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR 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 Product Name: BAY 63-2521 IR tablets 0.5 mg Product Code: BAY 63-2521 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy | |||
| 44 | EUCTR2010-018863-40-IT (EUCTR) | 20/07/2010 | 20/08/2010 | An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS | An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS | Pulmonary arterial hypertension. MedDRA version: 9.1;Level: LLT;Classification code 10064911 | Product Name: Riociguat Product Name: Riociguat Product Name: Riociguat Product Name: Riociguat | Bayer Health Care AG | NULL | Not Recruiting | Female: yes Male: yes | 36 | Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy | |||
| 45 | EUCTR2010-018863-40-DE (EUCTR) | 16/07/2010 | 26/04/2010 | Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parameters | An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS | Pulmonary arterial hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 IR tablets 1.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR 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 Product Name: BAY 63-2521 IR tablets 2.0 mg Product Code: BAY 63-2521 INN or Proposed INN: Riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo Product Name: BAY 63-2521 IR 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 Product Name: BAY 63-2521 IR tablets 0.5 mg Product Code: BAY 63-2521 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 18 | Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy | |||
| 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 |
| 46 | EUCTR2008-003482-68-GR (EUCTR) | 15/06/2010 | 09/11/2009 | 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study, amend 4 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study, amend 4 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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 | 462 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 47 | EUCTR2008-003482-68-PT (EUCTR) | 04/11/2009 | 22/09/2009 | 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;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 | 462 | United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Germany;Japan;New Zealand;Sweden | |||
| 48 | EUCTR2008-003610-94-PT (EUCTR) | 04/11/2009 | 22/09/2009 | 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: 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 | 462 | Phase 3 | United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Singapore;Poland;Belgium;Brazil;Germany;New Zealand;Japan;Sweden | ||
| 49 | EUCTR2008-003610-94-ES (EUCTR) | 29/09/2009 | 29/07/2009 | Estudio de extensión a largo plazo, multicéntrico y multinacional, para evaluar la seguridad y tolerabilidad de BAY 63 2521 (1 mg, 1,5 mg, 2 mg o 2,5 mg tid) administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática. Estudio PATENT-2 - PATENT-2 | Estudio de extensión a largo plazo, multicéntrico y multinacional, para evaluar la seguridad y tolerabilidad de BAY 63 2521 (1 mg, 1,5 mg, 2 mg o 2,5 mg tid) administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática. Estudio PATENT-2 - PATENT-2 | Hipertensión Arterial Pulmonar Sintomática MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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 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 | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 462 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece | |||
| 50 | EUCTR2008-003610-94-DK (EUCTR) | 24/04/2009 | 12/03/2009 | Long-term study to collect additional information to evaluate the safetyand tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: 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 | 462 | Phase 3 | Portugal;United States;Taiwan;Greece;Thailand;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;Singapore;Germany;New Zealand;Japan;Sweden | ||
| 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 |
| 51 | EUCTR2008-003610-94-IE (EUCTR) | 06/04/2009 | 09/01/2009 | 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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 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 | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece | |||
| 52 | EUCTR2008-003482-68-DK (EUCTR) | 16/03/2009 | 02/02/2009 | 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | |||
| 53 | EUCTR2008-003610-94-AT (EUCTR) | 13/03/2009 | 18/11/2008 | Long-term study to collect additional information to evaluate the safetyand tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 17.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: 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 | 462 | Phase 3 | Portugal;United States;Taiwan;Greece;Thailand;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;Singapore;Germany;New Zealand;Japan;Sweden | ||
| 54 | EUCTR2008-003482-68-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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 | 462 | Phase 3 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 55 | NCT00863681 (ClinicalTrials.gov) | March 12, 2009 | 13/3/2009 | BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension | Long-term Extension, Multicentre, Multi-national Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg,1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) | Hypertension, Pulmonary | Drug: Riociguat (BAY63-2521) | Bayer | NULL | Completed | 18 Years | 80 Years | All | 396 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Singapore;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Czech Republic;Ireland;Israel;Netherlands;New Zealand;Slovakia;Spain |
| No. | TrialID | Date_ 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 |
| 56 | EUCTR2008-003482-68-GB (EUCTR) | 09/03/2009 | 07/01/2009 | Study to evaluate the efficacy and safety of different doses of Bay 63-2521 in patients with pulmonary arterial hypertension. | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: 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, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Germany;New Zealand;Japan;Sweden | ||
| 57 | EUCTR2008-003610-94-IT (EUCTR) | 05/03/2009 | 17/03/2009 | 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 symptomatic Pulmonary Arterial Hypertension (PAH - PATENT 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 symptomatic Pulmonary Arterial Hypertension (PAH - PATENT 2 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | 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 Product Name: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden;Portugal;Greece;Spain;Ireland;Austria;Italy | |||
| 58 | EUCTR2008-003482-68-IT (EUCTR) | 17/02/2009 | 17/03/2009 | 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 symptomatic Pulmonary Arterial Hypertension (PAH) - PATENT 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 symptomatic Pulmonary Arterial Hypertension (PAH) - PATENT 1 | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | 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 Product Name: BAY 63-2521 INN or Proposed INN: riociguat | Bayer Healthcare AG | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 59 | EUCTR2008-003482-68-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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 | 462 | Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece | |||
| 60 | EUCTR2008-003482-68-CZ (EUCTR) | 23/01/2009 | 23/01/2009 | Study to assess the efficacy and safety of different doses of a new drug (BAY 63 2521), given orally to patients with Pulmonary Arterial Hypertension. | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: 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 | 462 | Germany;France;Ireland;Singapore;Austria;Sweden;Brazil;Australia;Czech Republic;Canada;New Zealand;Belgium;Korea, Republic of;United States;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Israel;United Kingdom;Russian Federation;Taiwan;Denmark;Argentina;Mexico;China;Thailand;Spain;Japan | |||
| 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 |
| 61 | EUCTR2008-003482-68-BE (EUCTR) | 14/01/2009 | 13/02/2009 | 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 462 | Phase 3 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 62 | EUCTR2008-003482-68-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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 | 462 | Phase 3 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 63 | EUCTR2008-003482-68-FR (EUCTR) | 27/12/2008 | 06/11/2008 | 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63 2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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 | 462 | Phase 3 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | ||
| 64 | EUCTR2008-003482-68-SE (EUCTR) | 05/12/2008 | 07/11/2008 | 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 462 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | |||
| 65 | NCT00810693 (ClinicalTrials.gov) | December 2008 | 17/12/2008 | A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH) | 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 Symptomatic Pulmonary Arterial Hypertension (PAH) | Pulmonary Hypertension | Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo | Bayer | NULL | Completed | 18 Years | 80 Years | All | 445 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;France;Germany;Greece;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Singapore;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom;Slovakia |
| 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 |
| 66 | EUCTR2008-003482-68-DE (EUCTR) | 26/11/2008 | 02/10/2008 | 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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 | 462 | Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden | |||
| 67 | EUCTR2008-003610-94-DE (EUCTR) | 26/11/2008 | 31/10/2008 | Long-term study to collect additional information to evaluate the safetyand tolerability of BAY 63-2521 in different doses | Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study | Pulmonary Arterial Hypertension (PAH) MedDRA version: 15.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 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 | 462 | Phase 3 | United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand;Sweden | ||
| 68 | 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 | ||
| 69 | EUCTR2014-003952-29-Outside-EU/EEA (EUCTR) | 07/12/2016 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: riociguat Other descriptive name: RIOCIGUAT | Bayer AG | NULL | NA | Female: yes Male: yes | 20 | Phase 3 | Turkey;Japan | |||
| 70 | EUCTR2014-003952-29-FR (EUCTR) | 04/12/2015 | Riociguat for treatment of PAH in children from 6 to less than 18 years old | Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH) - PATENT-CHILD | Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Riociguat granules 0.3% for oral application Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer Healthcare AG | NULL | NA | Female: yes Male: yes | 20 | Phase 3 | France;Hungary;Belgium;Spain;Poland;Turkey;Netherlands;Germany;Japan;Italy;United Kingdom |
| 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 | 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 | ||
| 2 | JPRN-jRCTs041200052 | 22/10/2020 | 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 |
| 3 | 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 |
| 4 | 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 | ||
| 5 | 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 |
| 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 |
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | Recruiting | 18 Years | N/A | All | 50 | N/A | Austria |
| 9 | 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 | Not Recruiting | >= 20age old | <= 80age old | Both | 60 | N/A | Japan |
| 10 | JPRN-UMIN000019549 | 2016/04/01 | 28/10/2015 | 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 | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 60 | Not selected | Japan | |
| 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 |
| 11 | NCT02634203 (ClinicalTrials.gov) | January 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 | Recruiting | 18 Years | 80 Years | All | 124 | N/A | France |
| 12 | 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 |
| 13 | 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 | |
| 14 | NCT02094001 (ClinicalTrials.gov) | May 2014 | 17/3/2014 | 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 | Completed | 18 Years | N/A | All | 6 | Phase 2 | Canada |
| 15 | 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 3b | 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 | ||
| 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 |
| 16 | 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 3b | 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 | ||
| 17 | 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] | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | 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 | |||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 3b | 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 | ||
| 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 |
| 21 | 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 | ||
| 22 | 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 3b | 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 | ||
| 23 | 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 | ||
| 24 | 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 3b | 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 | ||
| 25 | 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 | ||
| 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 |
| 26 | 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 3b | United States;Austria;Belgium;Canada;Colombia;Czech Republic;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Portugal;Russian Federation;Spain;Sweden;Switzerland;Turkey;United Kingdom | |
| 27 | 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 | ||
| 28 | 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 | |||
| 29 | 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 | ||
| 30 | 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 | ||
| 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 |
| 31 | 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 | |||
| 32 | 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 |
| 33 | 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 | ||||
| 34 | 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 | |||
| 35 | 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 | ||
| 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 |
| 36 | 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 | ||
| 37 | 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 | ||||
| 38 | 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 |
| 39 | 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 | |||
| 40 | 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 | ||
| 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 |
| 41 | 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 | ||
| 42 | 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 | ||
| 43 | 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 |
| 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 | EUCTR2016-001591-30-DK (EUCTR) | 06/11/2017 | 09/03/2017 | Treatment of congenital nephrogenic diabetes insipidus with riociguat or sildenafil | Treatment of congenital nephrogenic diabetes insipidus with a guanylate cyclase stimulator, riociguat or a phosphodiesterase type 5 inhibitor, sildenafil | Nephrogenic diabetes insipidus because of AVP2R-mutation MedDRA version: 20.0;Level: LLT;Classification code 10012626;Term: Diabetes nephrogenic (excludes glycosuria);System Organ Class: 100000004857 ;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Odense University Hospital | NULL | Not Recruiting | Female: no Male: yes | 2 | Phase 2 | Denmark |
| 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 | EUCTR2013-004595-35-NL (EUCTR) | 15/10/2015 | 09/07/2015 | Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients | Multi-center, randomized, double-blind, placebo-controlled phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients | Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;United States;Canada;Belgium;Germany;Netherlands;United Kingdom | ||
| 2 | EUCTR2013-004595-35-BE (EUCTR) | 03/09/2015 | 23/07/2015 | Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients | Multi-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Adempas 0.125 mg Product Code: BAY63-2521 INN or Proposed INN: RIOCIGUAT Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 3 | NCT02170025 (ClinicalTrials.gov) | September 30, 2014 | 20/6/2014 | Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients | Multi-center Phase 2 Study to Assess the Safety, Tolerability and Early Signs of Efficacy of Tid Orally Administered BAY63-2521 in Adult Delta F508 Homozygous Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo | Bayer | Merck Sharp & Dohme Corp. | Terminated | 18 Years | N/A | All | 21 | Phase 2 | United States;Belgium;Canada;France;Germany;Netherlands;United Kingdom;Greece;Italy |
| 4 | EUCTR2013-004595-35-GB (EUCTR) | 11/09/2014 | 16/05/2014 | Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients | Multi-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Adempas 0.125 mg Product Code: BAY63-2521 | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 5 | EUCTR2013-004595-35-DE (EUCTR) | 29/08/2014 | 29/08/2014 | Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients | Multi-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Adempas 0.125 mg Product Code: BAY63-2521 INN or Proposed INN: RIOCIGUAT Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom |