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 | 114 |
| 88 | 慢性血栓塞栓性肺高血圧症 | 34 |
| 210 | 単心室症 | 10 |
51. 全身性強皮症
臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
Showing 1 to 10 of 19 diseases
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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) A clinical research study with macitentanevaluating its effects on digital ulcers associated with sy ... | 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 Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to asse ... | 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] Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classifica ... | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: maciten ... | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 295 | Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Croatia;Australia;Denmark;Bulgaria;Germany Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;United Kingdom;India;France;Hungary; ... | |||
| 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) A clinical research study with macitentanevaluating its effects on digital ulcers associated with sy ... | 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 Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to asse ... | 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] Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classifica ... | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: maciten ... | 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 United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;C ... | |||
| 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) A clinical research study with macitentanevaluating its effects on digital ulcers associated with sy ... | 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 Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to asse ... | 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] Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classifica ... | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: maciten ... | 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 Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdo ... | |||
| 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) A clinical research study with macitentanevaluating its effects on digital ulcers associated with sy ... | 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) Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to asse ... | 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] Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classifica ... | 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 Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: Macitentan Other descriptive nam ... | 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 United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;Hungary;European ... | |||
| 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) A clinical research study with macitentanevaluating its effects on digital ulcers associated with sy ... | 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 Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to asse ... | 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] Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classifica ... | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: maciten ... | 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 Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdo ... | |||
| 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) A clinical research study with macitentanevaluating its effects on digital ulcers associated with sy ... | 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 Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to asse ... | 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] Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classifica ... | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: maciten ... | 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 Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdo ... | |||
| 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) A clinical research study with macitentanevaluating its effects on digital ulcers associated with sy ... | 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 Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to asse ... | 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] Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.0;Level: PT;Classifica ... | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: maciten ... | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 285 | United States;Portugal;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdom;Mexico;Puerto Rico;Argentina;Belgium;Poland;South Africa;Germany;Netherlands;New Zealand United States;Portugal;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdo ... | |||
| 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) A clinical research study with macitentanevaluating its effects on digital ulcers associated with sy ... | 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 Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to asse ... | 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] Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classifica ... | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: maciten ... | 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 Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdo ... | ||
| 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) A clinical research study with macitentanevaluating its effects on digital ulcers associated with sy ... | 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 Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to asse ... | 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] Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classifica ... | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: maciten ... | 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 United States;Belarus;Finland;Ukraine;Russian Federation;Chile;Colombia;Italy;India;France;Hungary;C ... | |||
| 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) A clinical research study with macitentanevaluating its effects on digital ulcers associated with sy ... | 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 Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to asse ... | 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] Ischemic digital ulcers associated with systemic sclerosis MedDRA version: 14.1;Level: PT;Classifica ... | Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: macitentan Product Code: macitentan INN or Proposed INN: macitentan Product Name: maciten ... | 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 Portugal;United States;Greece;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;United Kingdo ... |
85. 特発性間質性肺炎
臨床試験数 : 627 / 薬物数 : 443 - (DrugBank : 120) / 標的遺伝子数 : 99 - 標的パスウェイ数 : 212
Showing 1 to 10 of 12 diseases
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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 Study to evaluate if macitentanis safe and tolerable enough to be used for treatment of idiopathic p ... | 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 Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolera ... | 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] Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 13.1;Level: PT;Classification code 10021 ... | 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 Long Term, Single-arm, Open-label Extension Study of the MUSIC Study to Assess the Safety and Tolera ... | 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 Study to evaluate if macitentanis safe and tolerable enough to be usedfor treatment of idiopathic pu ... | 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 Long term, single-arm, open-label extension study of the MUSIC study toassess the safety and tolerab ... | 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] Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021 ... | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Slovenia;Canada;Spain;Turkey;Australia;South Africa;Israel;Germany;Sweden | ||
| 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 Study to evaluate if macitentanis safe and tolerable enough to be used for treatment of idiopathic p ... | 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 Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolera ... | 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] Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10021 ... | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Slovenia;Canada;Spain;Turkey;Australia;South Africa;Israel;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 Study to evaluate if macitentanis safe and tolerable enough to be used for treatment of idiopathic p ... | 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 Long term, single-arm, open-label extension study of the MUSIC study to assess the safety and tolera ... | 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] Patients with Idiopathic Pulmonary Fibrosis MedDRA version: 13.1;Level: PT;Classification code 10021 ... | Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: macitentan | ACTELION Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 178 | Phase 2 | United States;Slovenia;Canada;Spain;Turkey;Australia;South Africa;Israel;Germany;Sweden | ||
| 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 ef ... | 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 ef ... | 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 ef ... | 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 ef ... | 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 To evaluate the efficacy, safety, and tolerabilitiy of macitentanin patients with idiopathic pulmona ... | 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 e ... | 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 e ... | 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 Evaluar la eficacia, seguridad y tolerabilidad de Macitentanen pacientes con Fibrosis Pulmonar Idiop ... | 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 A Double-blind, Randomized, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Ef ... | 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 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: MacitentanUSe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, p ... | 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: MacitentanUSe in an Idiopathic pulmonary fibrosis Clinical studyA double-blind, randomized, p ... | to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis to evaluate the efficacy, safety, and tolerability of macitentanin patients with idiopathic pulmonar ... | Product Name: ACT-064992 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 |
86. 肺動脈性肺高血圧症
臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
Showing 1 to 10 of 114 diseases
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05731492 (ClinicalTrials.gov) | March 28, 2023 | 9/2/2023 | A Study of Macitentan in Children Below 2 Years of Age | A Multicenter, Open-label, Single-arm Study to Assess the Pharmacokinetics and Safety of Macitentan in Children Aged 1 Month to <2 Years With Pulmonary Arterial Hypertension A Multicenter, Open-label, Single-arm Study to Assess the Pharmacokinetics and Safety of Macitentani ... | Arterial Hypertension, Pulmonary | Drug: Macitentan | Actelion | NULL | Recruiting | 1 Month | 2 Years | All | 10 | Phase 1 | Germany;Poland |
| 2 | EUCTR2019-004131-24-PT (EUCTR) | 16/12/2022 | 25/08/2022 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Russian Federation;Singapore;United States;Czechia;Thailand;Portugal;Saudi Arabia;Austria;China;Korea, Republic of;Poland;Slovakia;France;Lithuania;Bulgaria;Serbia;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Spain;Canada;Turkey;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany Russian Federation;Singapore;United States;Czechia;Thailand;Portugal;Saudi Arabia;Austria;China;Kore ... | ||
| 3 | NCT05167825 (ClinicalTrials.gov) | November 14, 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 A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of M ... | Pulmonary Arterial Hypertension | Drug: Macitentan | Janssen Pharmaceutical K.K. | NULL | Recruiting | 3 Months | 15 Years | All | 6 | Phase 3 | Japan |
| 4 | JPRN-jRCT2011210057 | 30/09/2022 | 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 A Multicenter, Open-label, Phase III Study to Assess the Efficacy, Safety, and Pharmacokinetics of M ... | 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. Macitentanwill be administered orally as a tablet. Participants will receive oral dose of macitentanb ... | Nakano Masayoshi | NULL | Recruiting | >= 3month old | < 15age old | Both | 6 | Phase 3 | Japan |
| 5 | 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 study to compare long-term efficacy and safety of macitentan75 mg versus 10 mg in Pulmonar ... | 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 A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Para ... | 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] Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pu ... | 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 Trade Name: Opsumit® Product Name: macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Norway;Germany;Japan;Sweden Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Isra ... | ||
| 6 | EUCTR2017-003934-10-PL (EUCTR) | 23/06/2021 | 26/07/2019 | A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary hypertension and who were previously treated with macitentan in clinical studies. A clinical study to investigate the long term safety of the drug macitentanin patients with pulmonar ... | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntanin patients with puLmonar ... | Pulmonary arterial hypertension (PAH)Chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] Pulmonary arterial hypertension (PAH)Chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA ve ... | Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 3 | France;Belarus;Belgium;Poland;Ukraine;Turkey;Russian Federation;Germany | ||
| 7 | JPRN-jRCT2061200058 | 23/06/2021 | 19/02/2021 | Outcome Study Assessing a 75 milligrams (mg) Dose of Macitentan in Patients with Pulmonary Arterial Hypertension Outcome Study Assessing a 75 milligrams (mg) Dose of Macitentanin Patients with Pulmonary Arterial H ... | 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 A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Para ... | 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. Macitentan10 mg: Participants will receive macitentan10 mg film-coated tablets orally. Macitentan37.5 ... | Nakano Masayoshi | NULL | Recruiting | >= 18age old | Not applicable | Both | 900 | Phase 3 | Argentina;Australia;Austria;Belarus;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;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;France;Germ ... |
| 8 | EUCTR2019-004131-24-GB (EUCTR) | 23/11/2020 | 26/05/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian ... | ||
| 9 | 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 study to compare long-term efficacy and safety of macitentan75 mg versus 10 mg in Pulmonar ... | 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 A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Para ... | 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] Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pu ... | 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 Trade Name: Opsumit® Product Name: macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | ACTELION Pharmacteuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Malaysia;Viet Nam;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Bulgaria;Norway;Germany;Japan;Sweden Serbia;Portugal;Belarus;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Isra ... | ||
| 10 | 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 study to compare long-term efficacy and safety of macitentan75 mg versus 10 mg in Pulmonar ... | 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 A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Para ... | 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] Pulmonary arterial hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pu ... | 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 Trade Name: Opsumit® Product Name: macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | 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 United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Isra ... |
88. 慢性血栓塞栓性肺高血圧症
臨床試験数 : 157 / 薬物数 : 107 - (DrugBank : 22) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 54
Showing 1 to 10 of 34 diseases
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05140525 (ClinicalTrials.gov) | June 1, 2023 | 28/10/2021 | Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodynamics in CTEPH Effects of Combination Medical Therapy Followed by BPA on Right Ventricular-PA Coupling and Hemodyna ... | Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricular-PA Coupling and Hemodynamics in Chronic Thromboembolic Pulmonary Hypertension Effects of Combination Medical Therapy Followed by Balloon Pulmonary Angioplasty on Right Ventricula ... | CTEPH | Drug: Macitentan Tablets;Drug: Riociguat;Device: balloon pulmonary angioplasty | Dr Sudarshan Rajagopal | Actelion | Not yet recruiting | 18 Years | N/A | All | 15 | Phase 3 | United States |
| 2 | EUCTR2019-004131-24-PT (EUCTR) | 16/12/2022 | 25/08/2022 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Russian Federation;Singapore;United States;Czechia;Thailand;Portugal;Saudi Arabia;Austria;China;Korea, Republic of;Poland;Slovakia;France;Lithuania;Bulgaria;Serbia;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Spain;Canada;Turkey;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany Russian Federation;Singapore;United States;Czechia;Thailand;Portugal;Saudi Arabia;Austria;China;Kore ... | ||
| 3 | JPRN-jRCT2051200150 | 12/07/2021 | 11/03/2021 | A study to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension A study to evaluate efficacy and safety of macitentan75 mg in inoperable or persistent/recurrent chr ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension | Macitentan Participant will receive macitentan at a dose of 10 milligram (mg) once daily (OD) for 4 weeks, followed by a dose of macitentan 37.5 mg for another 4 weeks and continue with the target dose of macitentan 75 mg. Participants who have reached the target dose of 75 mg, completed the Double-blind (DB) period up to Week 28 (either on treatment or in Post-treatment observation period [PTOP]) at minimum, may be eligible for transitioning into the Open label (OL) extension period once all participants have completed the DB part of the study, or earlier if they experienced a Clinical event committee (CEC) confirmed clinical worsening event. Placebo Participants will receive placebo tablets matching the macitentan 10 mg, macitentan 37.5mg and macitentan 75 mg tablets, respectively. Participants who completed the DB period as per protocol either on treatment or in PTOP are eligible for transitioning to the OL extension period and will receive macitentan 75 mg after an 8-week double-dummy uptitration (macitentan 10 mg for 4 weeks, followed by 37.5 mg for another 4 weeks). Macitentan Participant will receive macitentanat a dose of 10 milligram (mg) once daily (OD) for 4 we ... | Nakano Masayoshi | NULL | Recruiting | >= 18age old | <= 80age old | Both | 144 | Phase 3 | USA;Germany;Hungary;South Korea;Japan |
| 4 | EUCTR2017-003934-10-PL (EUCTR) | 23/06/2021 | 26/07/2019 | A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary hypertension and who were previously treated with macitentan in clinical studies. A clinical study to investigate the long term safety of the drug macitentanin patients with pulmonar ... | mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntanin patients with puLmonar ... | Pulmonary arterial hypertension (PAH)Chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] Pulmonary arterial hypertension (PAH)Chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA ve ... | Trade Name: Opsumit Product Name: Macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 3 | France;Belarus;Belgium;Poland;Ukraine;Turkey;Russian Federation;Germany | ||
| 5 | NCT04780932 (ClinicalTrials.gov) | June 14, 2021 | 15/2/2021 | Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension Initial Dual Oral Combination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Ball ... | Initial Dual Oral coMbination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Balloon Pulmonary Angioplasty in Patients With Inoperable Chronic Thromboembolic Pulmonary hyperTension Initial Dual Oral coMbination Therapy Versus Standard-of-care Initial Oral Monotherapy Prior to Ball ... | Thromboembolic Pulmonary Hypertension;Chronic Disease;Inoperable Disease | Drug: Macitentan 10mg;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Janssen, LP | Recruiting | 18 Years | 80 Years | All | 96 | Phase 2/Phase 3 | France |
| 6 | EUCTR2019-004131-24-GB (EUCTR) | 23/11/2020 | 26/05/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian ... | ||
| 7 | EUCTR2019-004131-24-LT (EUCTR) | 10/11/2020 | 22/09/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;I ... | ||
| 8 | EUCTR2019-004131-24-DE (EUCTR) | 10/08/2020 | 26/05/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Czechia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;I ... | ||
| 9 | EUCTR2019-004131-24-HU (EUCTR) | 27/07/2020 | 28/05/2020 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentantablets Product Code: JNJ-67896062 / ACT-064992 INN or Pro ... | ACTELION Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 230 | Phase 3 | Serbia;United States;United Arab Emirates;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan Serbia;United States;United Arab Emirates;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federat ... | ||
| 10 | NCT04271475 (ClinicalTrials.gov) | July 7, 2020 | 13/2/2020 | A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension A Study to Evaluate Efficacy and Safety of Macitentan75 mg in Inoperable or Persistent/Recurrent Chr ... | A Prospective, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Adaptive Phase 3 Study With Open-label Extension to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension A Prospective, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Adaptive P ... | Chronic Thromboembolic Pulmonary Hypertension | Drug: Macitentan;Drug: Placebo | Actelion | NULL | Recruiting | 18 Years | 80 Years | All | 230 | Phase 3 | Portugal;United States;Argentina;Australia;Austria;Bulgaria;Canada;China;Colombia;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Singapore;Slovakia;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom Portugal;United States;Argentina;Australia;Austria;Bulgaria;Canada;China;Colombia;Czechia;Denmark;Fr ... |
210. 単心室症
臨床試験数 : 51 / 薬物数 : 53 - (DrugBank : 22) / 標的遺伝子数 : 32 - 標的パスウェイ数 : 67
Showing 1 to 10 of 10 diseases
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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 An upcoming clinical study to measure the safety and impact of a drug called macitentanin teenage an ... | 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 AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing t ... | 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] Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentri ... | 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 United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;N ... | ||
| 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 An upcoming clinical study to measure the safety and impact of a drug called macitentanin teenage an ... | 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 Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability ... | 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] Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentri ... | 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 United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;N ... | ||
| 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 An upcoming clinical study to measure the safety and impact of a drug called macitentanin teenage an ... | 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 AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing t ... | 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] Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentri ... | 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;Denmark;Australia;Germany;China;New Zealand United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Denmark;Australia;G ... | ||
| 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 Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assess ... | 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] Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentri ... | 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;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;New Zealand;Chin ... | ||
| 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 Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assess ... | 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] Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentri ... | 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 United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;N ... | ||
| 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 Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assess ... | 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] Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentri ... | 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 Poland;Denmark;Australia;Germany;China;New Zealand;Taiwan;Ireland;United Kingdom;France;Czech Republ ... | ||
| 7 | 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 Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assess ... | 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] Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentri ... | 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 United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;G ... | |||
| 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 An upcoming clinical study to measure the safety and impact of a drug called macitentanin teenage an ... | 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 AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing t ... | 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] Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentri ... | 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 United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;G ... | |||
| 9 | 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 An upcoming clinical study to measure the safety and impact of a drug called macitentanin teenage an ... | 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 AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing t ... | 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] Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentri ... | 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 United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;G ... | |||
| 10 | 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 An upcoming clinical study to measure the safety and impact of a drug called macitentanin teenage an ... | 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 Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability ... | 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] Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentri ... | 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 United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;N ... |