ACT-064992D ( DrugBank: - )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 86 | 肺動脈性肺高血圧症 | 4 |
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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JapicCTI-194971 | 23/10/2020 | 25/09/2019 | Clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed-dose combination therapy in subjects with pulmonary arterial hypertension (PAH) | Prospective, Multi-center, Double-blind, Randomized, Active-controlled, Triple-dummy, Parallel-group, Group-sequential, Adaptive Phase 3 Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies with the Corresponding Fixed Dose Combination in Subjects with Pulmonary Arterial Hypertension (PAH), Followed by an Open-label Treatment Period with Macitentan and Tadalafil Fixed Dose Combination Therapy | pulmonary arterial hypertension | Intervention name : ACT-064992D INN of the intervention : - Dosage And administration of the intervention : Subjects to receive FDC macitentan/tadalafil (macitentan 10 mg and tadalafil 40 mg) plus matching placebos for the two other study treatments. Control intervention name : Macitentan INN of the control intervention : - Dosage And administration of the control intervention : Film-coated tablet with 10 mg macitentan, to be administered orally once daily. Control intervention name : Tadalafil INN of the control intervention : - Dosage And administration of the control intervention : Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : FDC therapy + Placebo macitentan + Placebo tadalafil , Macitentan mono-therapy + Placebo tadalafil + Placebo FDC, Tadalafil mono-therapy + Placebo macitentan + Placebo FDC | Janssen Pharmaceutical K.K. | NULL | complete | 18 | BOTH | 170 | Phase 3 | Japan, South America, Europe | |
| 2 | EUCTR2014-004786-25-BG (EUCTR) | 11/10/2019 | 01/07/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: CJNJ-68150420-ZZZ-G001 (ACT-064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan | ||
| 3 | EUCTR2014-004786-25-ES (EUCTR) | 13/08/2019 | 11/06/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: ACT-064992D INN or Proposed INN: MACITENTAN INN or Proposed INN: TADALAFIL Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Malaysia;Brazil;Australia;Bulgaria;Germany;Japan;China | ||
| 4 | EUCTR2014-004786-25-PL (EUCTR) | 10/08/2019 | 28/05/2019 | A clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH). | Prospective, multi-center, double-blind, randomized, active-controlled, triple-dummy, parallel-group, group-sequential, adaptive Phase 3 clinical study to compare the efficacy and safety of macitentan and tadalafil monotherapies with the corresponding fixed dose combination in subjects with pulmonary arterial hypertension (PAH), followed by an open-label treatment period with macitentan and tadalafil fixed dose combination therapy | Pulmonary Arterial Hypertension MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Code: CJNJ-68150420-ZZZ-G001(ACT-064992D) INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Adcirca® INN or Proposed INN: TADALAFIL Other descriptive name: ACT-178418 Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN Other descriptive name: ACT-064992 | Actelion Pharmaceuticals Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;Bulgaria;South Africa;Germany;China;Japan |