88. 慢性血栓塞栓性肺高血圧症 Chronic thromboembolic pulmonary hypertension Clinical trials / Disease details
臨床試験数 : 159 / 薬物数 : 118 - (DrugBank : 23) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 53
| 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 | JPRN-jRCT2051200150 | 12/07/2021 | 11/03/2021 | A study to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension | Chronic thromboembolic pulmonary hypertension | Macitentan Participant will receive macitentan at a dose of 10 milligram (mg) once daily (OD) for 4 weeks, followed by a dose of macitentan 37.5 mg for another 4 weeks and continue with the target dose of macitentan 75 mg. Participants who have reached the target dose of 75 mg, completed the Double-blind (DB) period up to Week 28 (either on treatment or in Post-treatment observation period [PTOP]) at minimum, may be eligible for transitioning into the Open label (OL) extension period once all participants have completed the DB part of the study, or earlier if they experienced a Clinical event committee (CEC) confirmed clinical worsening event. Placebo Participants will receive placebo tablets matching the macitentan 10 mg, macitentan 37.5mg and macitentan 75 mg tablets, respectively. Participants who completed the DB period as per protocol either on treatment or in PTOP are eligible for transitioning to the OL extension period and will receive macitentan 75 mg after an 8-week double-dummy uptitration (macitentan 10 mg for 4 weeks, followed by 37.5 mg for another 4 weeks). | Nakano Masayoshi | NULL | Recruiting | >= 18age old | <= 80age old | Both | 144 | Phase 3 | USA;Germany;Hungary;South Korea;Japan |
| 2 | JPRN-jRCTs041200052 | 30/06/2021 | 22/10/2020 | THERAPY-HYBRID-BPA trial | The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients after Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty. - Riociguat-CTEPH | chronic thromboembolic pulmonary hypertension CTEPH;D000081029 | In this study, we will perform continuous verification by allocating the Chronic Thromboembolic Pulmonary Hypertension (CTEPH) patients whose hemodynamics were normalized after Balloon Pulmonary Angioplasty (BPA) to the the riociguat active group and placebo group for 16 weeks. | Shimokawahara Hiroto | NULL | Recruiting | >= 18age old | < 85age old | Both | 72 | Phase 2 | Japan |
| 3 | NCT04780932 (ClinicalTrials.gov) | June 14, 2021 | 15/2/2021 | Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension | Initial Dual Oral coMbination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary hyperTension | Thromboembolic Pulmonary Hypertension;Chronic Disease;Inoperable Disease | Drug: Macitentan 10mg;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Janssen, LP | Recruiting | 18 Years | 80 Years | All | 96 | Phase 2/Phase 3 | France |
| 4 | JPRN-jRCT2071200098 | 09/04/2021 | 08/02/2021 | Phase III Investigator-Initiated Trial to Investigate Safety and Efficacy of Edoxaban in Patients with Chronic Thromboembolic Pulmonary Hypertension | An Investigator-initiated, multicenter, phase 3, randomized, single-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of edoxaban versus warfarin (Vitamin K antagonist) in subjects with chronic thromboembolic pulmonaty hypertension taking warfarin (Vitamin K antagonist) at baseline - KABUKI | Chronic Thromboembolic Pulmonary Hypertension CTEPH, DOAC, warfarin | Oral administeration of (1) or (2) (1) Edoxaban group - Edoxaban 30 mg/60 mg tablet according to body weight. 60 kg or less: 30 mg once daily over 60 kg: 60 mg once daily (reduced to 30 mg once daily depending on renal function and concomitant medications) - Warfarin K 1 mg placebo tablets once daily (2)Warfarin group - Edoxaban 30 mg/60 mg placebo tablet according to body weight. 60 kg or less: 30 mg once daily over 60 kg: 60 mg once daily (reduced to 30 mg once daily depending on renal function and concomitant medications) - Warfarin K 1 mg tablets once daily (Dose adjusted with target PT-INR of 1.5-2.5) | Abe Kohtaro | NULL | Recruiting | >= 20age old | <= 85age old | Both | 74 | Phase 3 | Japan |
| 5 | NCT04730037 (ClinicalTrials.gov) | April 9, 2021 | 25/1/2021 | Clinical Trial to Investigate Safety and Efficacy of Edoxaban in Patients With CTEPH (KABUKI) | An Investigator-initiated, Multicenter, Phase 3, Randomized, Single-blind, Double-dummy, Parallel-group Study of Evaluate the Efficacy and Safety of Edoxaban Versus Warfarin (Vitamin K Antagonist) in Subjects With Chronic Thromboembolic Pulmonary Hypertension Taking Warfarin (Vitamin K Antagonist) at Baseline: KABUKI | CTEPH | Drug: Edoxaban;Drug: Warfarin Potassium;Drug: Warfarin Potassium placebo;Drug: Edoxaban placebo | Kyushu University | Daiichi Sankyo Co., Ltd. | Recruiting | 20 Years | 85 Years | All | 74 | Phase 3 | Japan |
| 6 | EUCTR2019-004131-24-GB (EUCTR) | 23/11/2020 | 26/05/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension 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: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 7 | EUCTR2019-004131-24-LT (EUCTR) | 10/11/2020 | 22/09/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension 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: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 8 | EUCTR2019-004131-24-DE (EUCTR) | 10/08/2020 | 26/05/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension 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: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 9 | EUCTR2019-004131-24-HU (EUCTR) | 27/07/2020 | 28/05/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension 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: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;United Arab Emirates;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 10 | NCT04271475 (ClinicalTrials.gov) | July 7, 2020 | 13/2/2020 | A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension | A Prospective, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Adaptive Phase 3 Study With Open-label Extension to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Drug: Macitentan;Drug: Placebo | Actelion | NULL | Recruiting | 18 Years | 80 Years | All | 144 | Phase 3 | United States;Argentina;Australia;Austria;Bulgaria;Canada;China;Colombia;Czechia;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Singapore;Slovakia;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
| 11 | EUCTR2019-004131-24-PL (EUCTR) | 02/07/2020 | 02/06/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension 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: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 12 | EUCTR2019-004131-24-IT (EUCTR) | 01/07/2020 | 14/06/2021 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension 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: Opsumit® Product Name: Macitentan tablets Product Code: [JNJ-67896062/ ACT-064992] INN or Proposed INN: MACITENTAN Product Name: MACITENTAN TABLETS Product Code: [JNJ-67896062 / ACT-064992] INN or Proposed INN: MACITENTAN Product Name: MACITENTAN COMPRESSE Product Code: [JNJ-67896062 / ACT-064992] INN or Proposed INN: MACITENTAN | ACTELION PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 13 | EUCTR2019-004131-24-ES (EUCTR) | 05/06/2020 | 20/07/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH | Chronic thromboembolic pulmonary hypertension 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: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;United Arab Emirates;Serbia;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan | ||
| 14 | EUCTR2018-002823-41-AT (EUCTR) | 04/10/2019 | 04/04/2019 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 15 | EUCTR2018-002823-41-BG (EUCTR) | 17/07/2019 | 19/04/2019 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 16 | EUCTR2018-002823-41-DK (EUCTR) | 15/07/2019 | 26/04/2019 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Switzerland;Italy;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden | ||
| 17 | EUCTR2018-002823-41-IT (EUCTR) | 03/07/2019 | 14/06/2021 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or ChronicThromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallelgroup,group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an addonto standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment ChronicThromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: SELEXIPAG Product Code: [ACT-293987] INN or Proposed INN: SELEXIPAG | ACTELION PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 3 | Portugal;United States;Taiwan;Hong Kong;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;South Africa;Netherlands;Latvia;China;Czechia;Finland;Korea, Democratic People's Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden | ||
| 18 | EUCTR2018-002823-41-PT (EUCTR) | 18/06/2019 | 30/05/2019 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 3 | Portugal;United States;Taiwan;Hong Kong;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Israel;Switzerland;Italy;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Czechia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Bulgaria;Germany;Sweden | ||
| 19 | EUCTR2018-002823-41-DE (EUCTR) | 03/06/2019 | 11/09/2018 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 280 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 20 | NCT04081012 (ClinicalTrials.gov) | May 21, 2019 | 16/8/2019 | N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension. | N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Pulmonary Balloon Angioplasty and Pulmonary Endarterectomy. | Chronic Thromboembolic Pulmonary Hypertension | Drug: N-acetyl cysteine;Drug: Placebo | Instituto Nacional de Cardiologia Ignacio Chavez | NULL | Recruiting | N/A | N/A | All | 34 | N/A | Mexico |
| 21 | EUCTR2018-002823-41-NL (EUCTR) | 30/04/2019 | 20/12/2018 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 3 | Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Sweden;Hungary;Czech Republic;United Kingdom;Austria;Turkey;Finland;Czechia;Korea, Republic of;China;Netherlands;South Africa;Denmark;Australia;Italy;Switzerland;Israel;Russian Federation;Ukraine;Thailand;Spain;Slovakia;Taiwan;Portugal;United States | ||
| 22 | EUCTR2018-002823-41-GB (EUCTR) | 25/03/2019 | 18/09/2018 | A clinical study to assess the efficacy and safety of selexipag as an add-onto standard of care therapy in subjects with inoperable orpersistent/recurrent, after surgical treatment and/or ChronicThromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallelgroup,group-sequential, adaptive, Phase 3 study with open-labelextension period to assess the efficacy and safety of selexipag as an addonto standard of care therapy in subjects with inoperable orpersistent/recurrent after surgical and/or interventional treatment ChronicThromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 23 | EUCTR2018-002823-41-BE (EUCTR) | 18/03/2019 | 20/12/2018 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Switzerland;Italy;India;Malaysia;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden | ||
| 24 | EUCTR2018-002823-41-HU (EUCTR) | 27/02/2019 | 08/01/2019 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment, Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 20.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden | ||
| 25 | EUCTR2018-002823-41-CZ (EUCTR) | 22/02/2019 | 01/11/2018 | A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT | Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: SELEXIPAG | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 280 | Phase 3 | Portugal;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Sweden | ||
| 26 | NCT03689244 (ClinicalTrials.gov) | January 23, 2019 | 27/9/2018 | A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional Treatment | A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential, Adaptive, Phase 3 Study With Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an add-on to Standard of Care Therapy in Subjects With Inoperable or Persistent/Recurrent After Surgical and/or Interventional Treatment Chronic Thromboembolic Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Drug: Selexipag;Drug: Placebo | Actelion | NULL | Recruiting | 18 Years | 85 Years | All | 280 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Czechia;Denmark;Germany;Hungary;India;Israel;Italy;Korea, Republic of;Malaysia;Mexico;Netherlands;Poland;Portugal;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Singapore;South Africa |
| 27 | 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 | ||
| 28 | 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 |
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | JPRN-JapicCTI-163279 | 10/6/2016 | 01/06/2016 | A confirmatory (phase III) study of the efficacy and safety of NS-304 (selexipag) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | A confirmatory (phase III) study of the efficacy and safety of NS-304 (selexipag) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | Chronic thromboembolic pulmonary hypertension (CTEPH) | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration Control intervention name : NS-304 Placebo INN of the control intervention : - Dosage And administration of the control intervention : Oral administration | Nippon Shinyaku Co., Ltd. | NULL | complete | 20 | 85 | BOTH | 72 | Phase 3 | Japan |
| 32 | EUCTR2013-002950-56-LT (EUCTR) | 18/02/2015 | 29/12/2014 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 19.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China;Korea, Republic of | ||
| 33 | NCT02021292 (ClinicalTrials.gov) | August 20, 2014 | 20/12/2013 | Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension | Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Drug: Macitentan;Drug: Placebo | Actelion | NULL | Completed | 18 Years | 84 Years | All | 80 | Phase 2 | Belgium;China;Czechia;France;Germany;Hungary;Korea, Republic of;Lithuania;Mexico;Poland;Russian Federation;Switzerland;Thailand;Turkey;Ukraine;United Kingdom;Austria;Bulgaria;Canada;Chile;Czech Republic;Italy;Netherlands;South Africa;United States;Vietnam |
| 34 | EUCTR2013-002950-56-NL (EUCTR) | 05/06/2014 | 24/02/2014 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 18.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Germany;Netherlands;China;Korea, Republic of | ||
| 35 | EUCTR2012-001646-18-IT (EUCTR) | 08/04/2014 | 26/06/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 16.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | ||
| 36 | EUCTR2013-002950-56-GB (EUCTR) | 01/04/2014 | 29/01/2014 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 16.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Thailand;Ukraine;Lithuania;Austria;Chile;Russian Federation;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Germany;China;Sweden | ||
| 37 | EUCTR2013-002950-56-DE (EUCTR) | 21/03/2014 | 23/01/2014 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 18.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China;Korea, Republic of | ||
| 38 | EUCTR2013-002950-56-HU (EUCTR) | 13/03/2014 | 20/02/2014 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 19.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China;Korea, Republic of | ||
| 39 | EUCTR2013-002950-56-BE (EUCTR) | 27/02/2014 | 27/01/2014 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 19.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China;Korea, Republic of | ||
| 40 | EUCTR2013-002950-56-CZ (EUCTR) | 20/02/2014 | 14/01/2014 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Germany;China;Sweden | ||
| 41 | EUCTR2013-002950-56-AT (EUCTR) | 12/02/2014 | 27/01/2014 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 19.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China;Korea, Republic of | ||
| 42 | EUCTR2012-001646-18-NL (EUCTR) | 27/09/2013 | 15/08/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of;Canada;Mexico;Czech Republic;France;United Kingdom;Italy;Israel;Russian Federation;Austria;Turkey;Spain | |||
| 43 | EUCTR2012-001646-18-CZ (EUCTR) | 18/09/2013 | 09/07/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | |||
| 44 | EUCTR2012-001646-18-GB (EUCTR) | 02/09/2013 | 12/06/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | |||
| 45 | NCT01884675 (ClinicalTrials.gov) | September 2013 | 20/6/2013 | Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension. | A Randomised, Multicentre, Double-Blind, Placebo-Controlled Study Of Ambrisentan In Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | Hypertension | Drug: Ambrisentan 5 mg;Drug: Placebo | GlaxoSmithKline | NULL | Terminated | 18 Years | 80 Years | All | 33 | Phase 3 | United States;Argentina;Austria;Canada;China;Czech Republic;Germany;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Russian Federation;Saudi Arabia;Spain;United Kingdom |
| 46 | EUCTR2012-001646-18-DE (EUCTR) | 30/07/2013 | 05/06/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | |||
| 47 | EUCTR2012-001646-18-AT (EUCTR) | 11/07/2013 | 04/06/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline Research & Developement Ltd | NULL | Not Recruiting | Female: yes Male: yes | 160 | Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of | |||
| 48 | EUCTR2012-001646-18-ES (EUCTR) | 25/04/2013 | 09/04/2013 | Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH) | A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) | Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH). MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Volibris Product Name: GSK1325760 Product Code: GSK1325760 INN or Proposed INN: Ambrisentan Other descriptive name: ambrisentan | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 275 | United States;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden | |||
| 49 | JPRN-JapicCTI-111667 | 01/2/2010 | 18/10/2011 | NS-304 CTEPH DB study | An exploratory study to assess the efficacy and safety of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) | Chronic thromboembolic pulmonary hypertension (CTEPH) | Intervention name : NS-304 INN of the intervention : Selexipag Dosage And administration of the intervention : Oral administration Control intervention name : Placebo Dosage And administration of the control intervention : Oral administration | NIPPON SHINYAKU CO., LTD. / Actelion Pharmaceuticals Japan Ltd. | NULL | 20 | 75 | BOTH | 32 | Phase 2 | NULL | |
| 50 | 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 | |||
| 51 | EUCTR2007-000072-16-SK (EUCTR) | 23/11/2009 | 10/09/2009 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study | Chronic Thromboembolic Pulmonary Hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 52 | 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 | |||
| 53 | 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 | ||||
| 54 | 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 | ||
| 55 | EUCTR2007-000072-16-GB (EUCTR) | 09/03/2009 | 17/10/2008 | Study to evaluate the efficacy and safety of different doses of Bay 63-2521 in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study | Chronic Thromboembolic Pulmonary Hypertension MedDRA version: 14.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG, D-51368 Leverkusen | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Germany;Japan | ||
| 56 | 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 | ||||
| 57 | 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 |
| 58 | 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 | |||
| 59 | EUCTR2007-000072-16-BE (EUCTR) | 07/01/2009 | 21/11/2008 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study | Chronic Thromboembolic Pulmonary Hypertension | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 60 | 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 | ||
| 61 | EUCTR2007-000072-16-ES (EUCTR) | 26/12/2008 | 27/10/2008 | Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg,tid), administrado por vía oral, en pacientes con Hipertensión Pulmonar Tromboembólica Crónica (HPTEC). Estudio CHEST ?1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study | Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg,tid), administrado por vía oral, en pacientes con Hipertensión Pulmonar Tromboembólica Crónica (HPTEC). Estudio CHEST ?1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study | Hipertensión Pulmonar Tromboembólica Crónica (HPTEC) Chronic Thromboembolic Pulmonary Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary | Product Name: BAY 63-2521 tablets 0.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb Product Name: BAY 63-2521 tablets 1.5 mg Product Code: BAY 63-2521 INN or Proposed INN: riociguat Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 62 | EUCTR2007-000072-16-IT (EUCTR) | 15/12/2008 | 20/11/2008 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST 1 | Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST 1 | Chronic Thromboembolic Pulmonary Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary | Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat Product Name: BAY 63-2521 INN or Proposed INN: riociguat | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 270 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Slovakia;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands | ||
| 63 | EUCTR2005-001965-33-AT (EUCTR) | 15/12/2005 | 11/10/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Spain;Austria;Germany;Italy;United Kingdom | |||
| 64 | EUCTR2005-001965-33-CZ (EUCTR) | 16/11/2005 | 12/10/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 3 | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom | ||
| 65 | EUCTR2005-001965-33-GB (EUCTR) | 04/11/2005 | 31/08/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom | ||
| 66 | EUCTR2005-001965-33-DE (EUCTR) | 01/11/2005 | 29/08/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 8.1;Level: LLT;Classification code 10037436;Term: Pulmonary thromboembolism | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Spain;Italy | |||
| 67 | EUCTR2005-001965-33-IT (EUCTR) | 20/10/2005 | 25/01/2006 | PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF BOSENTAN IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH . | PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF BOSENTAN IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH . | Treatment of the inoperable chronic thromboembolic pulmonary hypertension MedDRA version: 6.1;Level: PT;Classification code 10037400 | Trade Name: TRACLEER 125MG 56CPR RIV. INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Spain;Italy | |||
| 68 | NCT00313222 (ClinicalTrials.gov) | October 2005 | 10/4/2006 | Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension | Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Chronic Thromboembolic Pulmonary Hypertension | Drug: bosentan | Actelion | NULL | Completed | 18 Years | 80 Years | Both | 157 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 69 | 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 |