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
Showing 1 to 10 of 69 diseases
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 study to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent ch ... | 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 A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | 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). Macitentan Participant will receive macitentanat a dose of 10 milligram (mg) once daily (OD) for 4 we ... | 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 The Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in Chronic Thromboem ... | 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. In this study, we will perform continuous verification by allocating the Chronic Thromboembolic Pulm ... | 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 Ball ... | 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 Ball ... | 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 Phase III Investigator-Initiated Trial to Investigate Safety and Efficacy of Edoxaban in Patients wi ... | 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 An Investigator-initiated, multicenter, phase 3, randomized, single-blind, double-dummy, parallel-gr ... | 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) Oral administeration of (1) or (2) (1) Edoxabangroup - Edoxaban30 mg/60 mg tablet according to body w ... | 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 An Investigator-initiated, Multicenter, Phase 3, Randomized, Single-blind, Double-dummy, Parallel-gr ... | 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 Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | 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 A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | 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] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | 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 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | 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 United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian ... | ||
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 Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | 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 A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | 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] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | 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 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | 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 Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;I ... | ||
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 Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | 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 A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | 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] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | 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 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | 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 Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;I ... | ||
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 Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | 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 A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | 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] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | 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 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | 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 Serbia;United States;United Arab Emirates;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federat ... | ||
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 Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Ch ... | 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 A Prospective, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Adaptive P ... | 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 United States;Argentina;Australia;Austria;Bulgaria;Canada;China;Colombia;Czechia;France;Germany;Hung ... |