ACT-064992
( DrugBank: - / KEGG DRUG: - )
5 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 88 | 慢性血栓塞栓性肺高血圧症 | 27 |
| 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 1 of 1 trials
| 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-IT (EUCTR) | 11/04/201220120411 | 09/02/201220120209 | A clinical research study with macitentan evaluating its effects on digital ulcers associated with systemic sclerosis (scleroderma) A clinical research study with macitentan evaluating its effects on digital ulcers associated with s ... | 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 ... |
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 11 trials
| 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) | 20/07/201120110720 | 12/04/201120110412 | 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 macitentan is safe and tolerable enough to be used for treatment of idiopathic ... | 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 | EUCTR2010-024211-13-ES (EUCTR) | 27/06/201120110627 | 10/11/201120111110 | 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 macitentan is safe and tolerable enough to be usedfor treatment of idiopathic p ... | 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 | ||
| 3 | EUCTR2010-024211-13-SI (EUCTR) | 13/06/201120110613 | 11/07/201120110711 | 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 macitentan is safe and tolerable enough to be used for treatment of idiopathic ... | 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 | ||
| 4 | EUCTR2010-024211-13-SE (EUCTR) | 26/05/201120110526 | 05/04/201120110405 | 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 macitentan is safe and tolerable enough to be used for treatment of idiopathic ... | 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 | ||
| 5 | EUCTR2008-006054-17-IT (EUCTR) | 26/01/201020100126 | 22/10/200920091022 | 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 | |||
| 6 | EUCTR2008-006054-17-SE (EUCTR) | 12/08/200920090812 | 25/06/200920090625 | 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 macitentan in patients with idiopathic pulmon ... | 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 | |||
| 7 | EUCTR2008-006054-17-ES (EUCTR) | 20/05/200920090520 | 01/04/200920090401 | 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 Macitentan en pacientes con Fibrosis Pulmonar Idio ... | 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 | ||
| 8 | NCT00903331 (ClinicalTrials.gov) | May 200920090500 | 14/5/200920090514 | 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 ... |
| 9 | EUCTR2008-006054-17-FR (EUCTR) | 29/04/200920090429 | 25/03/200920090325 | 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, ... | 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, ... | to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmonary fibrosis to evaluate the efficacy, safety, and tolerability of macitentan in patients with idiopathic pulmona ... | 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 | ||
| 10 | EUCTR2008-006054-17-SI (EUCTR) | 31/03/200920090331 | 06/04/200920090406 | 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 macitentan in patients with idiopathic pulmon ... | 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 |
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 106 trials
| 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 | EUCTR2019-004131-24-PT (EUCTR) | 16/12/202220221216 | 25/08/202220220825 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 2 | EUCTR2019-002533-11-BG (EUCTR) | 08/11/202120211108 | 02/09/202120210902 | 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 macitentan 75 mg versus 10 mg in Pulmona ... | 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: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 3 | EUCTR2017-003934-10-PL (EUCTR) | 23/06/202120210623 | 26/07/201920190726 | 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 macitentan in patients with pulmona ... | 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 macitEntan in patients with puLmona ... | 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 | ||
| 4 | EUCTR2019-004131-24-GB (EUCTR) | 23/11/202020201123 | 26/05/202020200526 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 5 | EUCTR2019-002533-11-AT (EUCTR) | 12/11/202020201112 | 04/09/202020200904 | 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 macitentan 75 mg versus 10 mg in Pulmona ... | 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: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 6 | EUCTR2019-002533-11-SK (EUCTR) | 12/11/202020201112 | 13/08/202020200813 | 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 macitentan 75 mg versus 10 mg in Pulmona ... | 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: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 7 | EUCTR2019-004131-24-LT (EUCTR) | 10/11/202020201110 | 22/09/202020200922 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 | EUCTR2019-002533-11-NO (EUCTR) | 29/10/202020201029 | 03/08/202020200803 | 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 macitentan 75 mg versus 10 mg in Pulmona ... | 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: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Isra ... | ||
| 9 | JPRN-JapicCTI-194971 | 23/10/202020201023 | 25/09/201920190925 | 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) Clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the ... | 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 Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group ... | 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 Intervention name : ACT-064992D INN of the intervention : - Dosage And administration of the intervent ... | Janssen Pharmaceutical K.K. | NULL | complete | 18 | BOTH | 170 | Phase 3 | Japan, South America, Europe | |
| 10 | EUCTR2019-002533-11-NL (EUCTR) | 29/09/202020200929 | 29/04/202020200429 | 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 macitentan 75 mg versus 10 mg in Pulmona ... | 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: macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 United States;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;France ... |
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 27 trials
| 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 | EUCTR2019-004131-24-PT (EUCTR) | 16/12/202220221216 | 25/08/202220220825 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 2 | EUCTR2017-003934-10-PL (EUCTR) | 23/06/202120210623 | 26/07/201920190726 | 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 macitentan in patients with pulmona ... | 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 macitEntan in patients with puLmona ... | 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 | ||
| 3 | EUCTR2019-004131-24-GB (EUCTR) | 23/11/202020201123 | 26/05/202020200526 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 4 | EUCTR2019-004131-24-LT (EUCTR) | 10/11/202020201110 | 22/09/202020200922 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 5 | EUCTR2019-004131-24-DE (EUCTR) | 10/08/202020200810 | 26/05/202020200526 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 6 | EUCTR2019-004131-24-HU (EUCTR) | 27/07/202020200727 | 28/05/202020200528 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 7 | EUCTR2019-004131-24-PL (EUCTR) | 02/07/202020200702 | 02/06/202020200602 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 ... | ||
| 8 | EUCTR2019-004131-24-IT (EUCTR) | 01/07/202020200701 | 14/06/202120210614 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: [JNJ-67896062/ ACT-064992] INN or Proposed INN: MACITENTAN 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 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: [JNJ-67896062/ ACT-064992] INN or P ... | 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-ES (EUCTR) | 05/06/202020200605 | 20/07/202020200720 | A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension. A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients ... | A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive P ... | Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Chronic thromboembolic pulmonary hypertension MedDRA version: 21.1;Level: PT;Classification code 100 ... | Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 Trade Name: Opsumit® Product Name: Macitentan tablets Product Code: JNJ-67896062 / ACT-064992 INN or Pr ... | 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 United States;United Arab Emirates;Serbia;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian ... | ||
| 10 | NCT03809650 (ClinicalTrials.gov) | January 8, 201920190108 | 10/1/201920190110 | A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH). A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic T ... | 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) A Prospective, Multicenter, Open-label, Single Arm, Phase III Study to Assess the Efficacy and Safet ... | 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 |
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 trials
| 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) | 29/04/202020200429 | 23/03/202020200323 | 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 macitentan in teenage a ... | 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) | 05/03/201920190305 | 03/10/201820181003 | 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 macitentan in teenage a ... | 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) | 27/02/201920190227 | 02/01/201920190102 | 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 macitentan in teenage a ... | 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) | 11/10/201720171011 | 08/05/201720170508 | 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) | 12/09/201720170912 | 11/05/201720170511 | 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) | 25/08/201720170825 | 19/05/201720170519 | 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) | 00000000 | 18/09/201820180918 | 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-DE (EUCTR) | 00000000 | 27/12/201820181227 | 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 macitentan in teenage a ... | 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 ... | ||
| 9 | EUCTR2018-002821-45-GB (EUCTR) | 00000000 | 28/12/201820181228 | 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 macitentan in teenage a ... | 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-PL (EUCTR) | 00000000 | 19/09/201920190919 | 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 macitentan in teenage a ... | 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 ... |