MACITENTAN ( DrugBank: Macitentan )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 51 | 全身性強皮症 | 19 |
| 85 | 特発性間質性肺炎 | 12 |
| 86 | 肺動脈性肺高血圧症 | 111 |
| 88 | 慢性血栓塞栓性肺高血圧症 | 32 |
| 210 | 単心室症 | 10 |
51. 全身性強皮症
臨床試験数 : 523 / 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
| 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 | EUCTR2010-022710-77-CZ (EUCTR) | 06/01/2014 | 02/02/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | Germany;Bulgaria;Denmark;Australia;Croatia;Poland;Canada;Czech Republic;Hungary;France;India;United Kingdom;Italy;Colombia;Chile;Russian Federation;Ukraine;Finland;Belarus | |||
| 2 | EUCTR2010-022710-77-PL (EUCTR) | 30/05/2012 | 12/03/2012 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | |||
| 3 | EUCTR2010-022969-95-PL (EUCTR) | 30/05/2012 | 12/03/2012 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand | |||
| 4 | EUCTR2010-022710-77-IT (EUCTR) | 11/04/2012 | 09/02/2012 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-1 (Digital Ulcers with mAcitentan in systemic scLerosis) | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: NA Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: NA | ACTELION PHARMACEUTICALS LTD. | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;Hungary;European Union;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany | |||
| 5 | EUCTR2010-022969-95-GR (EUCTR) | 02/04/2012 | 28/03/2012 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand | |||
| 6 | EUCTR2010-022969-95-NL (EUCTR) | 27/02/2012 | 12/12/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand | |||
| 7 | EUCTR2010-022969-95-PT (EUCTR) | 03/02/2012 | 12/12/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Portugal;Greece;Spain;New Zealand;Netherlands;Germany;South Africa;Poland;Belgium;Argentina;Puerto Rico;Mexico;United Kingdom;Colombia;Russian Federation;Turkey;Ireland;Ukraine | |||
| 8 | EUCTR2010-022969-95-BE (EUCTR) | 16/01/2012 | 29/11/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | Phase 3 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand | ||
| 9 | EUCTR2010-022710-77-FI (EUCTR) | 10/01/2012 | 07/12/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany | |||
| 10 | EUCTR2010-022969-95-GB (EUCTR) | 21/12/2011 | 27/01/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | Phase 3 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand | ||
| 11 | EUCTR2010-022969-95-IE (EUCTR) | 07/12/2011 | 31/01/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand | |||
| 12 | NCT01474122 (ClinicalTrials.gov) | December 2011 | 31/10/2011 | Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients | Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis | Digital Ulcers | Drug: Macitentan 3 mg;Drug: Macitentan 10 mg;Drug: Placebo | Actelion | NULL | Terminated | 18 Years | N/A | All | 265 | Phase 3 | United States;Argentina;Belgium;China;Colombia;Germany;Greece;Ireland;Israel;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Russian Federation;South Africa;Spain;Turkey;Ukraine;United Kingdom |
| 13 | NCT01474109 (ClinicalTrials.gov) | December 2011 | 31/10/2011 | Macitentan for the Treatment of Digital Ulcers in Systemic Sclerosis Patients | Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Patients With Ischemic Digital Ulcers Associated With Systemic Sclerosis | Systemic Sclerosis;Ulcers | Drug: macitentan 3mg;Drug: macitentan 10mg;Drug: placebo | Actelion | NULL | Completed | 18 Years | N/A | All | 289 | Phase 3 | United States;Australia;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Denmark;Finland;Germany;Hungary;India;Italy;Poland;Russian Federation;Ukraine |
| 14 | EUCTR2010-022710-77-BG (EUCTR) | 17/11/2011 | 26/08/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany | |||
| 15 | EUCTR2010-022969-95-DE (EUCTR) | 09/08/2011 | 31/01/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Netherlands;Germany;New Zealand | |||
| 16 | EUCTR2010-022710-77-DE (EUCTR) | 16/06/2011 | 31/01/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany | |||
| 17 | EUCTR2010-022969-95-ES (EUCTR) | 26/05/2011 | 18/11/2011 | A clinical research study with macintentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma). | Prospective, randommized, placebo-controlled, double-blind, multicenter, parallel, group study to assess th eefficacy, safety and tolerability of macitentan i patients with ischemic digital ulcers associated with systemic sclerosis. - DUAL-2: Digital Ulcers with mAcitentan in systemic scLerosis. | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Poland;Belgium;South Africa;Netherlands;Germany;New Zealand | |||
| 18 | EUCTR2010-022710-77-DK (EUCTR) | 22/03/2011 | 03/02/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Denmark;Australia;Bulgaria;Germany | |||
| 19 | EUCTR2010-022710-77-HU (EUCTR) | 28/02/2011 | 01/02/2011 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of macitentan in patients with ischemic digital ulcers associated with systemic sclerosis - DUAL-1: Digital Ulcers with mAcitentan in systemic scLerosis | Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17] | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany |
85. 特発性間質性肺炎
臨床試験数 : 598 / 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
| 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 | EUCTR2010-024211-13-DE (EUCTR) | 20/07/2011 | 12/04/2011 | Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study | Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL | Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel | |||
| 2 | NCT01346930 (ClinicalTrials.gov) | July 2011 | 2/5/2011 | Safety and Tolerability Study of Macitentan in Patients With Idiopathic Pulmonary Fibrosis | Long Term, Single-arm, Open-label Extension Study of the MUSIC Study to Assess the Safety and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: Macitentan | Actelion | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | NULL |
| 3 | EUCTR2010-024211-13-ES (EUCTR) | 27/06/2011 | 10/11/2011 | Study to evaluate if macitentan is safe and tolerable enough to be usedfor treatment of idiopathic pulmonary fibrosis, following the MUSICstudy | Long term, single-arm, open-label extension study of the MUSIC study toassess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL | Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 178 | Germany;Canada;Turkey;Spain;United States;Sweden;South Africa;Australia;Israel | |||
| 4 | EUCTR2010-024211-13-SI (EUCTR) | 13/06/2011 | 11/07/2011 | Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study | Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL | Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 178 | United States;Slovenia;Canada;Spain;Turkey;Australia;Israel;South Africa;Germany;Sweden | |||
| 5 | EUCTR2010-024211-13-SE (EUCTR) | 26/05/2011 | 05/04/2011 | Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of idiopathic pulmonary fibrosis, following the MUSIC study | Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC OL | Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 13.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 178 | Germany;Canada;Turkey;Spain;United States;South Africa;Australia;Sweden;Israel | |||
| 6 | EUCTR2008-006054-17-IT (EUCTR) | 26/01/2010 | 22/10/2009 | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC | Idiopathic Pulmonary Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10021240 | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan | Actelion Pharamceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 156 | Germany;Slovenia;France;Spain;Italy;Sweden | |||
| 7 | EUCTR2008-006054-17-SE (EUCTR) | 12/08/2009 | 25/06/2009 | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Germany;Slovenia;France;Spain;Italy;Sweden | |||
| 8 | EUCTR2008-006054-17-ES (EUCTR) | 20/05/2009 | 01/04/2009 | Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC | Estudio multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática.A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis. - MUSIC | Evaluar la eficacia, seguridad y tolerabilidad de Macitentan en pacientes con Fibrosis Pulmonar Idiopática. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2 | France;Slovenia;Spain;Germany;Italy;Sweden | ||
| 9 | NCT00903331 (ClinicalTrials.gov) | May 2009 | 14/5/2009 | Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study | A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Macitentan in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis | Drug: ACT-064992 (macitentan);Drug: Placebo | Actelion | NULL | Completed | 18 Years | N/A | All | 178 | Phase 2 | United States;Australia;Canada;France;Germany;Israel;Italy;Slovenia;South Africa;Spain;Sweden;Turkey |
| 10 | EUCTR2008-006054-17-FR (EUCTR) | 29/04/2009 | 25/03/2009 | MUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, placebo-controlled, multicenter, parallel group studyto evaluate the efficacy, safety, and tolerability of macitentan in patients withidiopathic pulmonary fibrosis - MUSIC | MUSIC: Macitentan USe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, placebo-controlled, multicenter, parallel group studyto evaluate the efficacy, safety, and tolerability of macitentan in patients withidiopathic pulmonary fibrosis - MUSIC | to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis | Product Name: ACT-064992 Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Germany;Slovenia;France;Spain;Italy;Sweden | |||
| 11 | EUCTR2008-006054-17-SI (EUCTR) | 31/03/2009 | 06/04/2009 | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Germany;Slovenia;France;Spain;Italy;Sweden | |||
| 12 | EUCTR2008-006054-17-DE (EUCTR) | 05/03/2009 | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | A double-blind, randomized, placebo-controlled, multicenter, parallel group study to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC | To evaluate the efficacy, safety, and tolerabilitiy of macitentan in patients with idiopathic pulmonary fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 156 | France;Slovenia;Spain;Germany;Italy;Sweden |
86. 肺動脈性肺高血圧症
臨床試験数 : 1,181 / 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192
| 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 | NCT05167825 (ClinicalTrials.gov) | March 31, 2022 | 24/11/2021 | A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension | A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (>=3 Months to <15 Years) With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Macitentan | Janssen Pharmaceutical K.K. | NULL | Not yet recruiting | 3 Months | 15 Years | All | 6 | Phase 3 | Japan |
| 2 | JPRN-jRCT2011210057 | 21/01/2022 | 18/12/2021 | A Study of Macitentan in Japanese Pediatric Participants with Pulmonary Arterial Hypertension | A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of Macitentan in Japanese Pediatric Patients (>=3 months to <15 years) with Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Macitentan will be administered orally as a tablet. Participants will receive oral dose of macitentan based on age and weight through Week 52. | Nakano Masayoshi | NULL | Pending | >= 3month old | < 15age old | Both | 6 | Phase 3 | Japan |
| 3 | EUCTR2019-002533-11-BG (EUCTR) | 08/11/2021 | 02/09/2021 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Bulgaria;Norway;Germany;Japan;Sweden | ||
| 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. | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA | 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] | 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 | JPRN-jRCT2061200058 | 23/06/2021 | 19/02/2021 | Outcome Study Assessing a 75 milligrams (mg) Dose of Macitentan in Patients with Pulmonary Arterial Hypertension | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS | Pulmonary Arterial Hypertension | Macitentan 10 mg: Participants will receive macitentan 10 mg film-coated tablets orally. Macitentan 37.5 mg: Participants will receive macitentan 37.5 mg film-coated tablets orally. Macitentan 75 mg: Participants will receive macitentan 75 mg film-coated tablets orally. Placebo: Participants will receive matching placebo film-coated tablets orally. | Nakano Masayoshi | NULL | Recruiting | >= 18age old | Not applicable | Both | 900 | Phase 3 | Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Korea, Republic Of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Japan;Argentina;Australia;Austria;Belarus |
| 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 | EUCTR2019-002533-11-AT (EUCTR) | 12/11/2020 | 04/09/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden | ||
| 8 | EUCTR2019-002533-11-SK (EUCTR) | 12/11/2020 | 13/08/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Norway;Germany;Japan;Sweden | ||
| 9 | 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 | ||
| 10 | EUCTR2019-002533-11-NO (EUCTR) | 29/10/2020 | 03/08/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Norway;Germany;Japan;Sweden | ||
| 11 | JPRN-JapicCTI-194971 | 23/10/2020 | 25/09/2019 | Clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed-dose combination therapy in subjects with pulmonary arterial hypertension (PAH) | Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies with the Corresponding Fixed Dose Combination in Subjects with Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period with Macitentan and Tadalafil Fixed Dose Combination Therapy | pulmonary arterial hypertension | Intervention name : ACT-064992D INN of the intervention : - Dosage And administration of the intervention : Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments. Control intervention name : Macitentan INN of the control intervention : - Dosage And administration of the control intervention : Film-coated tablet with 10 mg macitentan, to be administered orally once daily. Control intervention name : Tadalafil INN of the control intervention : - Dosage And administration of the control intervention : Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : FDC therapy + Placebo macitentan + Placebo tadalafil , Macitentan mono-therapy + Placebo tadalafil + Placebo FDC, Tadalafil mono-therapy + Placebo macitentan + Placebo FDC | Janssen Pharmaceutical K.K. | NULL | recruiting | 18 | BOTH | 170 | Phase 3 | Japan, South America, Europe | |
| 12 | NCT04567602 (ClinicalTrials.gov) | October 6, 2020 | 23/9/2020 | A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag | Non-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO) | Pulmonary Arterial Hypertension | Drug: PAH medication | Janssen-Cilag S.p.A. | NULL | Recruiting | 18 Years | N/A | All | 200 | Italy | |
| 13 | EUCTR2019-002533-11-NL (EUCTR) | 29/09/2020 | 29/04/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 655 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Norway;Germany;Japan;Sweden | ||
| 14 | EUCTR2019-002533-11-PT (EUCTR) | 31/08/2020 | 11/05/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Belarus;Portugal;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Norway;Germany;Japan;Sweden | ||
| 15 | 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 | ||
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | NCT04273945 (ClinicalTrials.gov) | June 30, 2020 | 31/1/2020 | Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg | Pulmonary Arterial Hypertension | Drug: Macitentan 10 mg;Drug: Macitentan 37.5 mg;Drug: Macitentan 75 mg;Drug: Placebo | Actelion | NULL | Recruiting | 18 Years | N/A | All | 900 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Russian Federation;Serbia;Singapore;Slovakia;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Vietnam;Brazil;Romania |
| 20 | EUCTR2019-002533-11-GB (EUCTR) | 30/06/2020 | 16/03/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden;United Kingdom;Austria;Turkey;Korea, Republic of;China;Netherlands;Australia;Denmark;Malaysia;France;Vietnam;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Thailand;Slovakia;Taiwan;Portugal;Belarus;Serbia;United States | ||
| 21 | EUCTR2019-002533-11-DE (EUCTR) | 17/06/2020 | 14/02/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Taiwan;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden;Czech Republic;United Kingdom;Austria;Turkey;Korea, Republic of;China;Netherlands;Australia;Denmark;Malaysia;France;Vietnam;Italy;Colombia;Israel;Russian Federation;Ukraine;Spain;Thailand;Slovakia;Portugal;Belarus;Serbia;United States | ||
| 22 | 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 | ||
| 23 | EUCTR2019-002533-11-DK (EUCTR) | 27/05/2020 | 31/03/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Norway;Germany;Japan;Sweden | ||
| 24 | EUCTR2019-002533-11-HU (EUCTR) | 10/05/2020 | 11/03/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden;Hungary;Czech Republic;United Kingdom;Turkey;Korea, Republic of;China;Netherlands;Australia;Denmark;Malaysia;France;Italy;Russian Federation;Israel;Ukraine;Spain;Thailand;Taiwan;Portugal;United States | ||
| 25 | EUCTR2019-002533-11-CZ (EUCTR) | 07/05/2020 | 11/03/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden | ||
| 26 | EUCTR2019-002533-11-SE (EUCTR) | 06/05/2020 | 13/03/2020 | A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS | Pulmonary arterial 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 tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden | ||
| 27 | EUCTR2019-002533-11-IT (EUCTR) | 15/04/2020 | 15/06/2021 | A Randomized Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period with Macitentan 75 mg. | A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg - UNISUS | Pulmonary arterial 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] | 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 tablets 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 | 900 | Phase 3 | Portugal;Belarus;Serbia;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Australia;Denmark;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Norway;Germany;Japan;Sweden | ||
| 28 | EUCTR2014-004786-25-BG (EUCTR) | 11/10/2019 | 01/07/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial 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] | Product Code: CJNJ-68150420-ZZZ-G001 (ACT-064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: 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 | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 29 | EUCTR2014-004786-25-DE (EUCTR) | 05/09/2019 | 02/05/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial 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] | Product Code: CJNJ-68150420-ZZZ-G001 (ACT- 064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: 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 | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 30 | EUCTR2014-004786-25-ES (EUCTR) | 13/08/2019 | 11/06/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: ACT-064992D INN or Proposed INN: MACITENTAN INN or Proposed INN: TADALAFIL Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Malaysia;Brazil;Australia;Bulgaria;Germany;Japan;China | ||
| 31 | EUCTR2014-004786-25-PL (EUCTR) | 10/08/2019 | 28/05/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial 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] | Product Code: CJNJ-68150420-ZZZ-G001(ACT-064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: 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 | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 32 | EUCTR2014-004786-25-IT (EUCTR) | 06/08/2019 | 17/06/2021 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy - Nap | Pulmonary Arterial 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] | Product Name: CJNJ-68150420-ZZZ-G001 (ACT- 064992D) Product Code: [CJNJ-68150420-ZZZ-G001 (ACT- 064992D)] INN or Proposed INN: MACITENTAN Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera INN or Proposed INN: TADALAFIL Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera Trade Name: Adcirca® Product Name: G04BE08 Product Code: [G04BE08] INN or Proposed INN: TADALAFIL Other descriptive name: D.3.6.2 - dose massima specificare: giornaliera Trade Name: Opsumit® Product Name: macitentan Product Code: [ACT-064992] INN or Proposed INN: MACITENTAN | ACTELION PHARMACEUTICALS LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 33 | NCT03904693 (ClinicalTrials.gov) | July 29, 2019 | 4/4/2019 | Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) | Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed Dose Combination in Subjects With Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period With Macitentan and Tadalafil Fixed Dose Combination Therapy | Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) | Drug: FDC macitentan/tadalafil;Drug: Macitentan 10 mg;Drug: Tadalafil 40 mg;Drug: Placebo FDC;Drug: Placebo macitentan;Drug: Placebo tadalafil | Actelion | NULL | Recruiting | 18 Years | N/A | All | 170 | Phase 3 | United States;Australia;Brazil;Bulgaria;Canada;China;Czechia;Germany;Hungary;Italy;Japan;Malaysia;Mexico;Poland;Russian Federation;South Africa;Spain;Taiwan;Turkey |
| 34 | EUCTR2016-001062-28-FI (EUCTR) | 03/07/2019 | 03/07/2019 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, study with single-arm extension period to assess the pharmacokinetics, safety and efficacy of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial 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] | Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992/ JNJ-67896062 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Philippines;Finland;Thailand;Spain;Ukraine;Austria;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Malaysia;Poland;Brazil;Viet Nam;Australia;South Africa;China;Korea, Republic of | ||
| 35 | JPRN-UMIN000035389 | 2019/04/01 | 01/04/2019 | Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension | Effects of dual initial combination therapy with macitentan plus riociguat or macitentan plus selexipag on hemodynamics in patients with pulmonary arterial hypertension - SETOUCHI PH study | Pulmonary arterial hypertension | Dose: macitentan 10 mg/day+riociguat 3 mg/day. Max dose of riociguat is 7.5 mg/day.Intervention period: 8 month Dose: macitentan 10 mg/day+selexipag 0.4 mg/day. Max dose of selexipag is 3.2 mg/day. Intervention period: 8 month | Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 76 | Not selected | Japan |
| 36 | EUCTR2015-003438-28-GB (EUCTR) | 21/06/2018 | 13/11/2017 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 37 | NCT03422328 (ClinicalTrials.gov) | April 5, 2018 | 30/1/2018 | A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies. | mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies | Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Drug: macitentan | Actelion | NULL | Enrolling by invitation | N/A | N/A | All | 150 | Phase 3 | Belarus;Belgium;France;Poland;Russian Federation;Ukraine |
| 38 | EUCTR2017-003934-10-FR (EUCTR) | 19/03/2018 | 19/01/2018 | A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary arterial hypertension and who were previously treated with macitentan in clinical studies. | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 94 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 39 | NCT03362047 (ClinicalTrials.gov) | March 1, 2018 | 22/11/2017 | (RIGHT HEART III Study - Right Ventricular Hemodynamic Evaluation and Response to Treatment) | Untersuchung Des Einflusses PAH-spezifischer Medikation Auf Die rechtsventrikuläre Funktion Bei Patienten Mit Pulmonaler Arterieller Hypertonie (PAH) Unter Basalen Bedingungen | Pulmonary Arterial Hypertension (PAH) | Drug: Riciguat Group;Drug: Macitentan Group | University of Giessen | Philipps University Marburg Medical Center | Recruiting | 18 Years | 85 Years | All | 30 | Phase 2 | Germany |
| 40 | EUCTR2015-003438-28-ES (EUCTR) | 19/01/2018 | 01/12/2017 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 41 | NCT02932410 (ClinicalTrials.gov) | October 24, 2017 | 12/10/2016 | A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) | A Multicenter, Open-label, Randomized, Study With Single-arm Extension Period to Assess the Pharmacokinetics, Safety and Efficacy of Macitentan Versus Standard of Care in Children With Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Macitentan;Other: Standard-of-care | Actelion | NULL | Recruiting | 1 Month | 17 Years | All | 300 | Phase 3 | United States;Australia;Austria;Brazil;Canada;China;Colombia;Finland;France;Hungary;Israel;Korea, Republic of;Malaysia;Mexico;Philippines;Poland;Portugal;Russian Federation;South Africa;Spain;Thailand;Ukraine;Vietnam;Argentina;Bulgaria |
| 42 | EUCTR2016-001062-28-ES (EUCTR) | 13/07/2017 | 13/01/2017 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of | ||
| 43 | EUCTR2016-001062-28-PT (EUCTR) | 15/05/2017 | 23/12/2016 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial 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] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United States;Portugal;Philippines;Finland;Thailand;Spain;Ukraine;Austria;Russian Federation;Israel;Colombia;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Viet Nam;Australia;South Africa;China;Korea, Republic of | ||
| 44 | EUCTR2016-001062-28-AT (EUCTR) | 07/02/2017 | 21/12/2016 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial 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] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Israel;Russian Federation;Colombia;Vietnam;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;South Africa;China;Korea, Republic of | ||
| 45 | EUCTR2016-001062-28-HU (EUCTR) | 25/01/2017 | 15/12/2016 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of | ||
| 46 | EUCTR2015-003438-28-DK (EUCTR) | 17/08/2016 | 30/05/2016 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden | ||
| 47 | EUCTR2015-003438-28-FR (EUCTR) | 20/06/2016 | 21/04/2016 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 48 | NCT02885012 (ClinicalTrials.gov) | June 2016 | 3/5/2016 | Crossover Study From Macitentan or Bosentan Over to Ambrisentan | A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH) | Pulmonary Arterial Hypertension | Drug: Ambrisentan | Medical University of South Carolina | Ochsner Health System | Terminated | 18 Years | 80 Years | All | 3 | Phase 4 | United States |
| 49 | NCT02558231 (ClinicalTrials.gov) | May 1, 2016 | 22/9/2015 | The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension | The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension: A Multi-center, Double-blind, Placebo-controlled, Phase 3b Study | Pulmonary Arterial Hypertension | Drug: Macitentan;Drug: Tadalafil;Drug: Selexipag | Actelion | NULL | Completed | 18 Years | 75 Years | All | 247 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom;Norway |
| 50 | EUCTR2015-003438-28-NO (EUCTR) | 11/04/2016 | 09/03/2016 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden | ||
| 51 | EUCTR2015-003438-28-DE (EUCTR) | 04/03/2016 | 19/01/2016 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 52 | EUCTR2015-003438-28-BE (EUCTR) | 03/03/2016 | 09/06/2020 | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH | Pulmonary arterial hypertension (PAH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: TADALAFIL Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 53 | EUCTR2015-002835-17-DE (EUCTR) | 18/01/2016 | 26/11/2015 | RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatment | Investigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions - RIGHT HEART III | Pulmonary arterial Hypertension (PAH) MedDRA version: 21.1;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Adempas® INN or Proposed INN: RIOCIGUAT Trade Name: Opsumit® INN or Proposed INN: MACITENTAN | Justus Liebig Universität Gießen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Germany | ||
| 54 | EUCTR2015-003438-28-AT (EUCTR) | 12/01/2016 | 25/07/2017 | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension | The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON | Pulmonary arterial hypertension (PAH) MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Uptravi Product Name: Selexipag Product Code: ACT-293987 INN or Proposed INN: Selexipag Other descriptive name: SELEXIPAG Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: MACITENTAN Trade Name: Adcirca Product Name: Adcirca INN or Proposed INN: Tadalafil Other descriptive name: TADALAFIL | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 238 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 55 | EUCTR2012-004411-31-GB (EUCTR) | 25/11/2015 | 12/06/2013 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Germany;Bulgaria;Romania;Singapore;Poland;Belgium | ||
| 56 | EUCTR2015-002078-19-FR (EUCTR) | 14/10/2015 | 05/08/2015 | Prospective, multicenter, open-label study evaluating the effects of first-line oral combination therapy of macitentan and tadalafil in patients with newly diagnosed pulmonary arterial hypertension | Prospective, multicenter, open-label study evaluating the effects of first-line oral combination therapy of macitentan and tadalafil in patients with newly diagnosed pulmonary arterial hypertension. - OPTIMA | Pulmonary arterial hypertension MedDRA version: 18.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: Opsumit Trade Name: Adcirca Product Name: tadalafil INN or Proposed INN: TADALAFIL Other descriptive name: Adcirca | ACTELION Pharmaceuticals France | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France | ||
| 57 | EUCTR2012-004411-31-CZ (EUCTR) | 01/10/2015 | 12/12/2013 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany | ||
| 58 | NCT02968901 (ClinicalTrials.gov) | September 1, 2015 | 14/11/2016 | Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA) | Prospective, Multicenter, Open-label Study Evaluating the Effects of First-line Oral Combination Therapy of Macitentan and Tadalafil in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (OPTIMA). | Pulmonary Arterial Hypertension | Drug: macitentan;Drug: tadalafil | Actelion | NULL | Terminated | 18 Years | 75 Years | All | 46 | Phase 4 | France |
| 59 | EUCTR2014-004066-20-DE (EUCTR) | 27/07/2015 | 09/03/2015 | A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs. | A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right vEntricular remodeling in Pulmonary ArterIal hypeRtension | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;France;Hong Kong;Malaysia;Singapore;Australia;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 60 | NCT02310672 (ClinicalTrials.gov) | June 1, 2015 | 4/12/2014 | REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension | A Prospective, Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Effects of Macitentan on Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension Assessed by Cardiac Magnetic Resonance Imaging | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Completed | 18 Years | 64 Years | All | 89 | Phase 4 | United States;Australia;France;Germany;Hong Kong;Israel;Italy;Malaysia;Netherlands;Russian Federation;Singapore;United Kingdom |
| 61 | EUCTR2014-004066-20-GB (EUCTR) | 14/05/2015 | 12/01/2015 | A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs. | A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right ventricular remodeling in pulmonary arterIal hypertension | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom;Italy;Germany;Netherlands;Israel;Russian Federation;Australia;Singapore;Malaysia;Hong Kong;United States;France | ||
| 62 | EUCTR2014-004066-20-NL (EUCTR) | 27/03/2015 | 19/01/2015 | A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs. | A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right vEntricular remodeling in Pulmonary ArterIal hypeRtension | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;France;Hong Kong;Malaysia;Singapore;Australia;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy | ||
| 63 | EUCTR2012-004411-31-GR (EUCTR) | 19/03/2015 | 29/04/2015 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany | ||
| 64 | EUCTR2012-003335-33-GR (EUCTR) | 22/09/2014 | 25/06/2014 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;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 | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany | ||
| 65 | EUCTR2012-004411-31-RO (EUCTR) | 18/07/2014 | 13/05/2014 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 17.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United States;Portugal;Serbia;Philippines;Taiwan;Greece;Spain;Israel;Chile;Russian Federation;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Italy;Vietnam;India | ||
| 66 | NCT02112487 (ClinicalTrials.gov) | June 23, 2014 | 8/4/2014 | Extension of the Psychometric Validation Study ORCHESTRA in Patients With PAH | An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™ | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Completed | 18 Years | 80 Years | All | 88 | Phase 3 | France;Italy;Spain |
| 67 | NCT02126943 (ClinicalTrials.gov) | April 30, 2014 | 29/4/2014 | OPsumit USers Registry | US-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical Practice | Pulmonary Arterial Hypertension | Drug: Opsumit (macitentan) | Actelion | NULL | Completed | N/A | N/A | All | 2686 | United States;Puerto Rico | |
| 68 | NCT02081690 (ClinicalTrials.gov) | March 1, 2014 | 5/3/2014 | A Pulmonary Arterial Hypertension Study With Macitentan to Validate the PAH-SYMPACT™ in France, Italy and Spain | A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™ | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Terminated | 18 Years | 80 Years | All | 160 | Phase 3 | France;Italy;Spain |
| 69 | EUCTR2013-003462-14-ES (EUCTR) | 20/02/2014 | 05/12/2013 | Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT. | A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT? - ORCHESTRA | Pulmonary arterial hypertensionHipertensión arterial pulmonar MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain | ||
| 70 | EUCTR2013-003489-15-ES (EUCTR) | 20/02/2014 | 27/12/2013 | An extension of the ORCHESTRA (AC-055-310) studyExtension del estudio ORCHESTRA (AC-055-310) | An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext. | Pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Italy | ||
| 71 | EUCTR2012-004411-31-HU (EUCTR) | 28/01/2014 | 29/11/2013 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany | ||
| 72 | EUCTR2013-003489-15-IT (EUCTR) | 10/12/2013 | 20/11/2013 | An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext. | An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext. | Pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Italy | ||
| 73 | EUCTR2013-003462-14-IT (EUCTR) | 10/12/2013 | 20/11/2013 | Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT. | A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA | Pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | Spain;Italy | ||
| 74 | EUCTR2012-003335-33-CZ (EUCTR) | 04/12/2013 | 16/08/2013 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;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 | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany | ||
| 75 | EUCTR2012-003335-33-HU (EUCTR) | 26/11/2013 | 30/04/2013 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany | ||
| 76 | EUCTR2012-004411-31-DE (EUCTR) | 07/10/2013 | 25/06/2013 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain | ||
| 77 | EUCTR2012-004411-31-ES (EUCTR) | 07/10/2013 | 08/10/2013 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 16.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United States;Portugal;Serbia;Philippines;Taiwan;Greece;Spain;Israel;Chile;Russian Federation;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 78 | EUCTR2012-003335-33-NL (EUCTR) | 01/10/2013 | 07/02/2013 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;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 | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany | ||
| 79 | NCT01739400 (ClinicalTrials.gov) | September 10, 2013 | 29/11/2012 | Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome | Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome | Pulmonary Arterial Hypertension | Drug: Macitentan 10 mg tablet, once daily. | Actelion | NULL | Terminated | 12 Years | N/A | All | 217 | Phase 3 | United States;Austria;Bulgaria;Chile;China;France;Germany;Greece;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;United Kingdom;Vietnam;Belgium;Canada;Czech Republic;Hungary;India;Israel;Italy;Netherlands;South Africa;Taiwan;Turkey |
| 80 | NCT01847014 (ClinicalTrials.gov) | September 1, 2013 | 2/5/2013 | Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument | AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Terminated | 18 Years | 80 Years | All | 4 | Phase 3 | United States |
| 81 | EUCTR2012-004411-31-AT (EUCTR) | 30/07/2013 | 01/07/2013 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Philippines;Taiwan;Greece;Serbia;Portugal;United States | ||
| 82 | EUCTR2012-004411-31-BG (EUCTR) | 17/07/2013 | 15/05/2013 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000164933 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Germany;Bulgaria;Romania;Singapore;Poland;Belgium;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Turkey;China;Netherlands;South Africa;Malaysia;France;Vietnam;Italy;Israel;Chile;Russian Federation;Spain | ||
| 83 | EUCTR2012-004411-31-PT (EUCTR) | 03/07/2013 | 01/07/2013 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 18.1;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Germany;Bulgaria;Romania;Singapore;Belgium;Poland;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Turkey;China;Netherlands | ||
| 84 | NCT01743001 (ClinicalTrials.gov) | May 21, 2013 | 29/11/2012 | Clinical Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome | A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Evaluate the Effects of Macitentan on Exercise Capacity in Subjects With Eisenmenger Syndrome | Pulmonary Arterial Hypertension | Drug: Macitentan 10 mg;Drug: Placebo | Actelion | NULL | Completed | 12 Years | N/A | All | 226 | Phase 3 | United States;Austria;Bulgaria;Chile;China;France;Germany;Greece;Israel;Malaysia;Mexico;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Turkey;United Kingdom;Vietnam;Belgium;Canada;Czech Republic;Hungary;India;Italy;Netherlands;South Africa;Taiwan |
| 85 | EUCTR2012-003335-33-ES (EUCTR) | 12/05/2013 | 09/04/2013 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Bulgaria;Germany;Israel;Italy;Vietnam;India;France;Malaysia;South Africa | ||
| 86 | NCT03236818 (ClinicalTrials.gov) | May 2013 | 18/3/2013 | Goal Oriented Strategy to Preserve Ejection Fraction Trial | Raising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction Trial | Pulmonary Arterial Hypertension | Drug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan) | VU University Medical Center | NULL | Active, not recruiting | 18 Years | 80 Years | All | 30 | Phase 4 | Netherlands |
| 87 | NCT01841762 (ClinicalTrials.gov) | April 1, 2013 | 27/3/2013 | Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Completed | 18 Years | N/A | All | 284 | Phase 3 | United States |
| 88 | EUCTR2012-003335-33-BG (EUCTR) | 13/03/2013 | 14/01/2013 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;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 | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany | ||
| 89 | EUCTR2012-003335-33-PT (EUCTR) | 01/03/2013 | 06/02/2013 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 17.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;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 | 220 | Phase 3 | Serbia;United States;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany | ||
| 90 | EUCTR2012-003335-33-DE (EUCTR) | 28/02/2013 | 31/01/2013 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 19.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850;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 | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany | ||
| 91 | EUCTR2012-003335-33-GB (EUCTR) | 27/02/2013 | 21/11/2012 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 18.1;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850 ;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 | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany | ||
| 92 | EUCTR2012-003335-33-AT (EUCTR) | 19/02/2013 | 07/02/2013 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;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 | 220 | Phase 3 | Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany | ||
| 93 | EUCTR2012-003335-33-BE (EUCTR) | 07/02/2013 | 23/01/2013 | Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity | Eisenmenger Syndrome MedDRA version: 16.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;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 | 220 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Israel;Chile;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany | ||
| 94 | EUCTR2012-004411-31-IT (EUCTR) | 01/02/2013 | 11/01/2013 | Long-term study to evaluate if macitentan is safe, tolerable and efficient to be used for treatment of Eisenmenger Syndrome. | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome. - MAESTRO-OL | Eisenmenger Syndrome MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive name: Macitentan | ACTELION PHARMACEUTICALS LTD. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Austria;Russian Federation;Chile;Israel;Italy;Vietnam;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Romania;Bulgaria;South Africa;Germany;China | ||
| 95 | EUCTR2012-003335-33-IT (EUCTR) | 01/02/2013 | 11/01/2013 | Study to evaluate if macitentan is efficient, safe and tolerable to be used for treatment of Eisenmenger Syndrome. | A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO | Eisenmenger Syndrome MedDRA version: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan | ACTELION PHARMACEUTICALS LTD. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United States;Portugal;Philippines;Taiwan;Greece;Spain;Israel;Chile;Russian Federation;Italy;India;Vietnam;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Bulgaria;Germany | ||
| 96 | EUCTR2007-003694-27-BG (EUCTR) | 27/11/2012 | 12/01/2009 | Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension | SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL | symptomatic pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India | ||
| 97 | JPRN-JapicCTI-121986 | 01/9/2012 | 17/10/2012 | Macitentan PAH | A multicenter, open-label, phase II/III study to asseses the efficacy, safety and Pharmacokinetics(PK) of macitentan (ACT-064992) in patients with pulmonary arterial hypertension | Pulmonary arterial hypertension (PAH) | Intervention name : ACT-064992 INN of the intervention : macitentan Dosage And administration of the intervention : macitentan tablet 10 mg once daily | Nippon Shinyaku co.,LTD./Actelion Pharmaceuticals Japan Ltd. | NULL | 16 | BOTH | 22 | Phase 2-3 | NULL | ||
| 98 | EUCTR2007-003694-27-GB (EUCTR) | 17/11/2011 | 26/11/2007 | Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension | SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL | symptomatic pulmonary arterial hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 525 | Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | |||
| 99 | EUCTR2007-003694-27-DE (EUCTR) | 28/10/2008 | 12/12/2007 | Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension | SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL | symptomatic pulmonary arterial hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 100 | NCT00667823 (ClinicalTrials.gov) | October 17, 2008 | 24/4/2008 | Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension | Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: Macitentan | Actelion | NULL | Completed | 12 Years | N/A | All | 550 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;Finland;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Sweden;Taiwan;Thailand;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Japan;Korea, Republic of;Norway;Portugal;Spain |
| 101 | EUCTR2007-002440-14-BG (EUCTR) | 10/10/2008 | 13/10/2008 | A study to assess the effects of macitentan on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension | A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN | To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Norway;Sweden | ||
| 102 | EUCTR2007-003694-27-NL (EUCTR) | 04/07/2008 | 08/01/2008 | Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension | SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL | symptomatic pulmonary arterial hypertension MedDRA version: 16.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden | ||
| 103 | NCT00660179 (ClinicalTrials.gov) | May 2008 | 14/4/2008 | Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension | A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Event-driven, Phase III Study to Assess the Effects of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension | Pulmonary Arterial Hypertension | Drug: macitentan (ACT-064992);Drug: placebo | Actelion | NULL | Completed | 12 Years | N/A | All | 742 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Chile;China;Colombia;Croatia;France;Germany;Hong Kong;Hungary;India;Israel;Italy;Malaysia;Mexico;Netherlands;Norway;Peru;Poland;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Brazil;Czech Republic;Denmark;Finland;Former Serbia and Montenegro;Portugal |
| 104 | EUCTR2007-003694-27-AT (EUCTR) | 18/04/2008 | 19/02/2008 | Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension | SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL | symptomatic pulmonary arterial hypertension MedDRA version: 17.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 105 | EUCTR2007-002440-14-SE (EUCTR) | 04/04/2008 | 11/02/2008 | A study to assess the effects of macitentan on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension | A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN | To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: ACT-064992 Product Code: ACT-064992 Product Name: ACT-064992 Product Code: ACT-064992 Other descriptive name: ACT-064992 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 106 | EUCTR2007-003694-27-BE (EUCTR) | 01/04/2008 | 26/02/2008 | Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension | SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL | symptomatic pulmonary arterial hypertension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden | ||
| 107 | EUCTR2007-003694-27-SE (EUCTR) | 07/03/2008 | 11/02/2008 | Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension | SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL | symptomatic pulmonary arterial hypertension MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Portugal;United States;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden;United Kingdom;Austria;Finland;China;Netherlands;South Africa;Peru;Australia;Denmark;Malaysia;France;India;Italy;Colombia;Russian Federation;Israel;Chile;Ukraine;Thailand;Slovakia;Hong Kong;Taiwan;Belarus;Serbia | ||
| 108 | EUCTR2016-001062-28-FR (EUCTR) | 03/07/2018 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Colombia;Vietnam;France;Hungary;Mexico;Canada;Poland;Australia;South Africa;Germany;China;Korea, Republic of | |||
| 109 | EUCTR2016-001062-28-PL (EUCTR) | 06/03/2018 | A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH) | A multicenter, open-label, randomized, study with single-arm extension period to assess the pharmacokinetics, safety and efficacy of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide | Pulmonary arterial 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] | Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN Product Name: macitentan Product Code: ACT-064992 / JNJ-67896062 INN or Proposed INN: MACITENTAN | ACTELION Pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 300 | Phase 3 | Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Israel;Russian Federation;Colombia;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Viet Nam;Australia;South Africa;China;Korea, Republic of | |||
| 110 | EUCTR2007-003694-27-PL (EUCTR) | 26/05/2008 | Clinical research to assess the long-term safety and tolerability of ACT- 064992 in patients with Pulmonary Arterial Hypertension | SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL | symptomatic pulmonary arterial 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 Product Code: ACT-064992 INN or Proposed INN: macitentan | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 700 | Phase 3 | Croatia;Romania;Bulgaria;Germany;Sweden;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia | |||
| 111 | EUCTR2012-004411-31-PL (EUCTR) | 29/08/2014 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome | Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) | Eisenmenger Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Opsumit Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan Other descriptive name: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | France;Malaysia;South Africa;Netherlands;China;Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany |
88. 慢性血栓塞栓性肺高血圧症
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 | 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. | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA | 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] | 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 | ||
| 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 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 |
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | NCT03809650 (ClinicalTrials.gov) | January 8, 2019 | 10/1/2019 | A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH). | A Prospective, Multicenter, Open-label, Single Arm, Phase III Study to Assess the Efficacy and Safety of Macitentan (ACT-064992) in Subjects With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Drug: macitentan 10 mg | Actelion | EPS Corporation;Imepro Inc.;General Laboratory, BML, Inc.;Mitsubishi Logistics Corporation | Terminated | 18 Years | 89 Years | All | 9 | Phase 3 | Japan |
| 13 | NCT03422328 (ClinicalTrials.gov) | April 5, 2018 | 30/1/2018 | A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies. | mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Arterial Hypertension previousLy Treated With mAcitentan in Clinical Studies | Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary Hypertension | Drug: macitentan | Actelion | NULL | Enrolling by invitation | N/A | N/A | All | 150 | Phase 3 | Belarus;Belgium;France;Poland;Russian Federation;Ukraine |
| 14 | EUCTR2013-003457-25-LT (EUCTR) | 20/08/2015 | 02/06/2015 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;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;United Kingdom;Switzerland;France;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;South Africa;Germany;Netherlands;China | ||
| 15 | EUCTR2013-003457-25-NL (EUCTR) | 29/05/2015 | 08/05/2014 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 78 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Germany;Netherlands;China | |||
| 16 | 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 | ||
| 17 | NCT02060721 (ClinicalTrials.gov) | February 3, 2015 | 2/1/2014 | Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension | MERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Chronic Thromboembolic Pulmonary Hypertension | Drug: Macitentan | Actelion | NULL | Active, not recruiting | 18 Years | N/A | All | 76 | Phase 2 | Belgium;China;Czechia;France;Germany;Hungary;Lithuania;Mexico;Poland;Russian Federation;Switzerland;Thailand;Turkey;Ukraine;United Kingdom;Austria;Bulgaria;Canada;Chile;Czech Republic;Italy;Korea, Republic of;Netherlands;South Africa;United States;Vietnam |
| 18 | EUCTR2013-003457-25-BE (EUCTR) | 22/12/2014 | 11/04/2014 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;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;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Germany;Netherlands;China | ||
| 19 | EUCTR2013-003457-25-GB (EUCTR) | 22/09/2014 | 17/04/2014 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 78 | Phase 2 | United States;Czechia;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;South Africa;Germany;Netherlands;China | ||
| 20 | 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 |
| 21 | EUCTR2013-003457-25-DE (EUCTR) | 14/08/2014 | 30/04/2014 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;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;Czechia;Thailand;Ukraine;Lithuania;Austria;Chile;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;South Africa;Germany;Netherlands;China | ||
| 22 | EUCTR2013-003457-25-AT (EUCTR) | 03/07/2014 | 06/05/2014 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | 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;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Germany;China | ||
| 23 | EUCTR2013-003457-25-CZ (EUCTR) | 13/06/2014 | 01/04/2014 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 20.0;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;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China | ||
| 24 | EUCTR2013-003457-25-HU (EUCTR) | 11/06/2014 | 29/04/2014 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 20.0;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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 78 | Phase 2 | United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China | ||
| 25 | 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 | ||
| 26 | EUCTR2013-003457-25-FR (EUCTR) | 17/04/2014 | 20/11/2020 | Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;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;Czechia;Thailand;Ukraine;Lithuania;Austria;Chile;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;South Africa;Germany;Netherlands;China | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 |
210. 単心室症
臨床試験数 : 49 / 薬物数 : 53 - (DrugBank : 23) / 標的遺伝子数 : 32 - 標的パスウェイ数 : 67
| 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 | EUCTR2018-002821-45-CZ (EUCTR) | 29/04/2020 | 23/03/2020 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | 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 | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China | ||
| 2 | EUCTR2018-002821-45-FR (EUCTR) | 05/03/2019 | 03/10/2018 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | 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 | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China | ||
| 3 | EUCTR2018-002821-45-DK (EUCTR) | 27/02/2019 | 02/01/2019 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 134 | Phase 3 | United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Denmark;Australia;Germany;China;New Zealand | ||
| 4 | EUCTR2016-003320-23-GB (EUCTR) | 11/10/2017 | 08/05/2017 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 134 | Phase 3 | United Kingdom;China;New Zealand;Germany;Australia;Denmark;Ireland;Poland;Czech Republic;Taiwan;France;United States | ||
| 5 | EUCTR2016-003320-23-DE (EUCTR) | 12/09/2017 | 11/05/2017 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | 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 | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China | ||
| 6 | EUCTR2016-003320-23-DK (EUCTR) | 25/08/2017 | 19/05/2017 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | 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 | 134 | Phase 3 | Poland;Denmark;Australia;Germany;China;New Zealand;Taiwan;Ireland;United Kingdom;France;Czech Republic;United States;Czechia | ||
| 7 | EUCTR2018-002821-45-DE (EUCTR) | 27/12/2018 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | 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 | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China | |||
| 8 | EUCTR2018-002821-45-PL (EUCTR) | 19/09/2019 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 134 | Phase 3 | New Zealand;China;Germany;Denmark;Australia;Poland;Czech Republic;France;United Kingdom;Ireland;Taiwan;Czechia;United States | |||
| 9 | EUCTR2016-003320-23-PL (EUCTR) | 18/09/2018 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | 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 | 134 | Phase 3 | United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;Germany;China;New Zealand | |||
| 10 | EUCTR2018-002821-45-GB (EUCTR) | 28/12/2018 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 134 | Phase 3 | United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;Germany;China;New Zealand |