88. 慢性血栓塞栓性肺高血圧症 Chronic thromboembolic pulmonary hypertension Clinical trials / Disease details
臨床試験数 : 157 / 薬物数 : 107 - (DrugBank : 22) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 54
Showing 1 to 10 of 34 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 |
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1 | NCT05140525 (ClinicalTrials.gov) | June 1, 2023 | 28/10/2021 | Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodyna ... | Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricula ... | CTEPH | Drug: Macitentan Tablets;Drug: Riociguat;Device: balloon pulmonary angioplasty | Dr Sudarshan Rajagopal | Actelion | Not yet recruiting | 18 Years | N/A | All | 15 | Phase 3 | United States |
2 | EUCTR2019-004131-24-PT (EUCTR) | 16/12/2022 | 25/08/2022 | 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 macitentan75 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 | Russian Federation;Singapore;United States;Czechia;Thailand;Portugal;Saudi Arabia;Austria;China;Korea, Republic of;Poland;Slovakia;France;Lithuania;Bulgaria;Serbia;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Spain;Canada;Turkey;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany Russian Federation;Singapore;United States;Czechia;Thailand;Portugal;Saudi Arabia;Austria;China;Kore ... | ||
3 | 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 macitentan75 mg in inoperable or persistent/recurrent chr ... | 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 |
4 | EUCTR2017-003934-10-PL (EUCTR) | 23/06/2021 | 26/07/2019 | A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary hypertension and who were previously treated with macitentan in clinical studies. A clinical study to investigate the long term safety of the drug macitentanin patients with pulmonar ... | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntanin patients with puLmonar ... | Pulmonary arterial hypertension (PAH)Chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] Pulmonary arterial hypertension (PAH)Chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA ve ... | 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 | 176 | Phase 3 | France;Belarus;Belgium;Poland;Ukraine;Turkey;Russian Federation;Germany | ||
5 | 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 |
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 macitentan75 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 macitentan75 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 macitentan75 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 macitentan75 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 Macitentan75 mg in Inoperable or Persistent/Recurrent Chr ... | 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 | 230 | Phase 3 | Portugal;United States;Argentina;Australia;Austria;Bulgaria;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Singapore;Slovakia;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom Portugal;United States;Argentina;Australia;Austria;Bulgaria;Canada;China;Colombia;Czechia;Denmark;Fr ... |