Macitentan 37.5 mg
( DrugBank: Macitentan / KEGG DRUG: Macitentan )
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 | 28 |
86. 肺動脈性肺高血圧症
臨床試験数 : 1,288 / 薬物数 : 565 - (DrugBank : 126) / 標的遺伝子数 : 81 - 標的パスウェイ数 : 191
Showing 1 to 10 of 28 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 macitentan75 mgis an effective and safe treatment for patients w ... | 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 | Not Recruiting | 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;Czech Republic;Turkey;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany Russian Federation;Singapore;United States;Czechia;Thailand;Portugal;Saudi Arabia;Austria;China;Kore ... | ||
| 2 | EUCTR2019-004131-24-DK (EUCTR) | 25/10/202220221025 | 02/09/202220220902 | 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 mgis an effective and safe treatment for patients w ... | 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 | Not Recruiting | 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;Czech Republic;Turkey;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany Russian Federation;Singapore;United States;Czechia;Thailand;Portugal;Saudi Arabia;Austria;China;Kore ... | ||
| 3 | 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 macitentan75 mgversus 10 mgin Pulmonary ... | 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 | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Russian Federation;Singapore;Viet Nam;Czechia;United States;Malaysia;Thailand;Portugal;Austria;Netherlands;Sweden;China;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Serbia;Colombia;Argentina;Hungary;Japan;Ukraine;United Kingdom;Belarus;Spain;Canada;Czech Republic;Turkey;Belgium;Norway;Taiwan;Denmark;Italy;Mexico;Israel;Australia;Germany Russian Federation;Singapore;Viet Nam;Czechia;United States;Malaysia;Thailand;Portugal;Austria;Nethe ... | ||
| 4 | JPRN-jRCT2061200058 (jRCT2061200058) | 23/06/202120210623 | 19/02/202120210219 | 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. Macitentan 10 milligrams (mg) +Placebo:Run-in period:Participants who are either endothelin receptor antagonist (ERA)-naive or who are receiving daily dose of macitentan or ambrisentan less (<) 10 milligrams (mg), or daily dose of bosentan <250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated participants will bypass run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.Double-blind Treatment (DBT) Period:Participants will receive macitentan 10 mg orally up to End of DBT.To maintain blind, participants will receive macitentan 37.5 mg-matching placebo for 4 weeks and macitentan 75 mg-matching placebo thereafter up to DBT.Treatment Extension Period:After EDBT, participants will receive macitentan 37.5 mg once a day (qd) orally for 4 weeks, prior to receiving open-label macitentan 75 mg qd orally for 2 years. To maintain blind, participants will receive macitentan 75 mg-matching placebo during 4-week uptitration. Macitentan 75 mg + Placebo:Run-in period:Participants who are either ERA-naive or who are receiving a daily dose of macitentan or ambrisentan <10 mg, or a daily dose of bosentan <250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated patients will bypass the run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.DBT Period: participan Macitentan10 mg:Participants will receive macitentan10 mgfilm-coated tablets orally Macitentan 37.5 m ... | Nakano Masayoshi | NULL | Not Recruiting | >= 18age old | Not applicable | Both | 900 | Phase 3 | Argentina;Japan;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 Argentina;Japan;Australia;Austria;Belarus;Belgium;Brazil;Canada;China;Colombia;Czechia;Denmark;Franc ... |
| 5 | EUCTR2019-004131-24-FR (EUCTR) | 06/05/202120210506 | 02/02/202120210202 | 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 mgis an effective and safe treatment for patients w ... | 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 | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Russian Federation;Singapore;United States;Czechia;Portugal;Saudi Arabia;Austria;China;Korea, Republic of;Poland;Slovakia;France;Serbia;Bulgaria;Lithuania;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Spain;Canada;Czech Republic;Turkey;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany Russian Federation;Singapore;United States;Czechia;Portugal;Saudi Arabia;Austria;China;Korea, Republ ... | ||
| 6 | EUCTR2019-004131-24-AT (EUCTR) | 04/01/202120210104 | 04/09/202020200904 | 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 mgis an effective and safe treatment for patients w ... | 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 | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Russian Federation;Singapore;United States;Portugal;Saudi Arabia;Austria;China;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Lithuania;Serbia;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Spain;Canada;Czech Republic;Turkey;Taiwan;Denmark;Italy;Mexico;Israel;Australia;Germany Russian Federation;Singapore;United States;Portugal;Saudi Arabia;Austria;China;Korea, Republic of;Po ... | ||
| 7 | EUCTR2019-004131-24-SK (EUCTR) | 12/12/202020201212 | 04/09/202020200904 | 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 mgis an effective and safe treatment for patients w ... | 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 | Not Recruiting | Female: yes Male: yes | 230 | Phase 3 | Russian Federation;Singapore;United States;Portugal;Saudi Arabia;Austria;China;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Lithuania;Serbia;Colombia;Argentina;Romania;Hungary;Japan;Ukraine;United Kingdom;Spain;Canada;Czech Republic;Turkey;Taiwan;Denmark;Italy;Mexico;Israel;Australia;Germany Russian Federation;Singapore;United States;Portugal;Saudi Arabia;Austria;China;Korea, Republic of;Po ... | ||
| 8 | 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 macitentan75 mgis an effective and safe treatment for patients w ... | 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-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 macitentan75 mgversus 10 mgin Pulmonary ... | 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 tabletsProduct Code: JNJ-67896062 / ACT-064992Pharmaceutical Form: Film-coated tabletINN or Proposed INN: MACITENTANCAS Number: 441798-33-0Concentration unit: mg milligram(s)Concentration type: equalConcentration number: 10-Pharmaceutical form of the placebo: Film-coated tabletRoute of administration of the placebo: Oral useProduct Name: macitentan tabletsProduct Code: JNJ-67896062 / ACT-064992Pharmaceutical Form: Film-coated tabletINN or Proposed INN: MACITENTANCAS Number: 441798-33-0Concentration unit: mg milligram(s)Concentration type: equalConcentration number: 75-Pharmaceutical form of the placebo: Film-coated tabletRoute of administration of the placebo: Oral useProduct Name: macitentan tabletsProduct Code: JNJ-67896062 / ACT-064992Pharmaceutical Form: Film-coated tabletINN or Proposed INN: MACITENTANCAS Number: 441798-33-0Concentration unit: mg milligram(s)Concentration type: equalConcentration number: 37.5-Pharmaceutical form of the placebo: Film-coated tabletRoute of administration of the placebo: Oral use Trade Name: Opsumit®Product Name: macitentantabletsProduct Code: JNJ-67896062 / ACT-064992Pharmaceut ... | ACTELION Pharmacteuticals Ltd. | NULL | Not Recruiting | Female: yesMale: yes | 900 | Phase 3 | Russian Federation;Singapore;Viet Nam;Czechia;United States;Malaysia;Thailand;Portugal;Austria;Netherlands;Sweden;China;Korea, Republic of;Poland;Slovakia;Bulgaria;France;Serbia;Colombia;Argentina;Hungary;Japan;Ukraine;United Kingdom;Belarus;Spain;Canada;Czech Republic;Turkey;Belgium;Norway;Taiwan;Denmark;Italy;Mexico;Israel;Australia;Germany Russian Federation;Singapore;Viet Nam;Czechia;United States;Malaysia;Thailand;Portugal;Austria;Nethe ... | ||
| 10 | 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 macitentan75 mgversus 10 mgin Pulmonary ... | 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 | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | Russian Federation;Singapore;Viet Nam;United States;Czechia;Malaysia;Thailand;Portugal;Austria;Netherlands;Sweden;China;Poland;Korea, Republic of;Slovakia;Serbia;Bulgaria;France;Colombia;Argentina;Hungary;Japan;Ukraine;United Kingdom;Belarus;Spain;Canada;Czech Republic;Turkey;Belgium;Norway;Taiwan;Denmark;Mexico;Italy;Israel;Australia;Germany Russian Federation;Singapore;Viet Nam;United States;Czechia;Malaysia;Thailand;Portugal;Austria;Nethe ... |