86. 肺動脈性肺高血圧症 [臨床試験数:1,083,薬物数:667(DrugBank:122),標的遺伝子数:98,標的パスウェイ数:185

Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
85 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004131-24-GB23/11/202026/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United 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
2EUCTR2019-002533-11-SK12/11/202013/08/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United 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
3EUCTR2019-004131-24-LT10/11/202022/09/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;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
4EUCTR2019-002533-11-NO29/10/202003/08/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Serbia;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
5JPRN-JapicCTI-19497123/10/202025/09/2019Clinical 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 hypertensionIntervention 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.NULLrecruiting18BOTH170Phase 3Japan, South America, Europe
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-002533-11-NL29/09/202029/04/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
655Phase 3United 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
7EUCTR2019-004131-24-DE10/08/202026/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan;Saudi Arabia;Serbia;United States;United Arab Emirates
8EUCTR2019-004131-24-HU27/07/202028/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;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
9EUCTR2019-004131-24-PL02/07/202002/06/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United 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
10EUCTR2019-002533-11-GB30/06/202016/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-002533-11-DE17/06/202014/02/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United 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
12EUCTR2019-002533-11-DK27/05/202031/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3Serbia;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
13EUCTR2019-002533-11-HU10/05/202011/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Portugal;Taiwan;Thailand;Spain;Ukraine;Israel;Russian Federation;Italy;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan;Sweden
14EUCTR2019-002533-11-CZ07/05/202011/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
15EUCTR2019-002533-11-SE06/05/202013/03/2020A Phase 3 study to compare long-term efficacy and safety of macitentan 75 mg versus 10 mg in Pulmonary Arterial Hypertension.A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients with Pulmonary Arterial Hypertension, Followed by an Open-label TreatmentPeriod With Macitentan 75 mg. - UNISUS Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmacteuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United States;Serbia;Belarus;Portugal;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Vietnam;France;Malaysia;Denmark;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Germany;Norway;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2014-004786-25-BG11/10/201901/07/2019A 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: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Brazil;Malaysia;Poland;Australia;South Africa;Bulgaria;Germany;China;Japan
17EUCTR2017-003934-10-PL19/09/201926/07/2019A clinical study to investigate the long term safety of the drug macitentan in patients with pulmonary arterial hypertension and who were previously treated with macitentan in clinical studies.mUlticenter, single-arM, open-laBel, long-teRm safety study with macitEntan in patients with puLmonary arterial hypertension previousLy treated with mAcitentan in clinical studies - UMBRELLA Pulmonary arterial hypertension (PAH)
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
152Phase 3France;Belarus;Poland;Ukraine
18EUCTR2014-004786-25-DE05/09/201902/05/2019A 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: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Italy;Hungary;Mexico;Canada;Brazil;Malaysia;Poland;Australia;South Africa;Bulgaria;Germany;China;Japan
19EUCTR2014-004786-25-ES13/08/201911/06/2019A 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: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 3United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Malaysia;Brazil;Australia;Bulgaria;Germany;Japan;China
20EUCTR2014-004786-25-PL10/08/201928/05/2019A 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: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Taiwan;Spain;Turkey;Russian Federation;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;South Africa;Bulgaria;Germany;China;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2016-001062-28-FI03/07/201903/07/2019A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Philippines;Finland;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Colombia;Vietnam;France;Hungary;Mexico;Canada;Poland;Malaysia;Brazil;Australia;South Africa;China;Korea, Republic of
22EUCTR2015-003438-28-GB21/06/201813/11/2017The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden
23EUCTR2015-003438-28-ES19/01/201801/12/2017The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Sweden
24EUCTR2016-001062-28-ES13/07/201713/01/2017A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide Pulmonary arterial hypertension
MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of
25EUCTR2016-001062-28-AT07/02/201721/12/2016A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide Pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Portugal;Philippines;Finland;Thailand;Spain;Ukraine;Austria;Russian Federation;Israel;Colombia;Vietnam;France;Hungary;Mexico;Canada;Poland;Brazil;Malaysia;Australia;South Africa;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2016-001062-28-HU25/01/201715/12/2016A study to find out whether the medicine macitentan works in children with pulmonary arterial hypertension (PAH)A multicenter, open-label, randomized, event-driven study to assess efficacy, safety and pharmacokinetics of macitentan versus standard of care in children with pulmonary arterial hypertension - TOMORROW: pediaTric use Of Macitentan tO delay disease pRogRessiOn in PAH Worldwide Pulmonary arterial hypertension
MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3Portugal;United States;Philippines;Spain;Thailand;Ukraine;Austria;Russian Federation;Israel;Vietnam;France;Hungary;Mexico;Canada;Argentina;Poland;Australia;South Africa;Bulgaria;Germany;China;Korea, Republic of
27EUCTR2015-003438-28-DK17/08/201630/05/2016The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden
28EUCTR2015-003438-28-FR20/06/201621/04/2016The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
MedDRA version: 19.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: Tadalafil
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
144Phase 3United States;Spain;Austria;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
29EUCTR2015-003438-28-DE04/03/201619/01/2016The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
30EUCTR2015-003438-28-BE03/03/201609/06/2020The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON - Macitentan, Tadalafil and Selexipag Study in Patients with PAH Pulmonary arterial hypertension (PAH)
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: TADALAFIL
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2015-003438-28-AT12/01/201625/07/2017The efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combination therapy in patients with newly diagnosed pulmonary arterial hypertension: A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: Tadalafil
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
238Phase 3United States;Spain;Ireland;Austria;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Brazil;Australia;Denmark;Germany;Netherlands;Norway;Sweden
32EUCTR2012-004411-31-CZ01/10/201512/12/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 18.0Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
33EUCTR2014-004066-20-DE27/07/201509/03/2015A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right vEntricular remodeling in Pulmonary ArterIal hypeRtension Pulmonary Arterial Hypertension
MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;France;Hong Kong;Malaysia;Singapore;Australia;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy
34EUCTR2014-004066-20-NL27/03/201519/01/2015A study of the effects of macitentan on the heart in patients with elevated blood pressure in blood vessels of the lungs.A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging - REPAIR: Right vEntricular remodeling in Pulmonary ArterIal hypeRtension Pulmonary Arterial Hypertension
MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
100Phase 4United States;France;Hong Kong;Malaysia;Singapore;Australia;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy
35EUCTR2012-004411-31-GR19/03/201529/04/2015Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 18.0Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2012-003335-33-GR22/09/201425/06/2014Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 17.0Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany
37EUCTR2012-004411-31-RO18/07/201413/05/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 17.1Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Serbia;Portugal;United States;Philippines;Taiwan;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany
38EUCTR2013-003462-14-ES20/02/201405/12/2013Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT.A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT? - ORCHESTRA Pulmonary arterial hypertensionHipertensión arterial pulmonar
MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
160Phase 3Spain
39EUCTR2013-003489-15-ES20/02/201427/12/2013An extension of the ORCHESTRA (AC-055-310) studyExtension del estudio ORCHESTRA (AC-055-310)An extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext. Pulmonary arterial hypertension
MedDRA version: 16.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
160Phase 3Spain;Italy
40EUCTR2012-004411-31-HU28/01/201429/11/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 14.1Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2013-003489-15-IT10/12/201320/11/2013An extension of the ORCHESTRA (AC-055-310) studyAn extension of AC-055-310, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Ext. Pulmonary arterial hypertension
MedDRA version: 16.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Spain;Italy
42EUCTR2013-003462-14-IT10/12/201320/11/2013Study of the drug macitentan in patients with pulmonary arterial hypertension in order to test the French, Italian, and Spanish translations of a patient questionnaire called PAH-SYMPACT.A multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with pulmonary arterial hypertension to psychometrically validate the French, Italian and Spanish versions of the PAH-SYMPACT™ - ORCHESTRA Pulmonary arterial hypertension
MedDRA version: 16.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
ACTELION Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
160Phase 3Spain;Italy
43EUCTR2012-003335-33-CZ04/12/201316/08/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 18.0Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
44EUCTR2012-003335-33-HU26/11/201330/04/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 14.1Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Bulgaria;Germany
45EUCTR2012-004411-31-DE07/10/201325/06/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 20.0Level: LLTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 100000164933;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2012-004411-31-ES07/10/201308/10/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 16.0Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220United States;Serbia;Portugal;Philippines;Taiwan;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Belgium;Bulgaria;Germany
47EUCTR2012-003335-33-NL01/10/201307/02/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 17.0Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
48EUCTR2012-004411-31-AT30/07/201301/07/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 20.0Level: LLTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 100000164933;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Spain;Russian Federation;Chile;Israel;Italy;Vietnam;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany;Philippines;Taiwan;Greece;Serbia;Portugal;United States
49EUCTR2012-003335-33-ES12/05/201309/04/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 14.1Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Bulgaria;Germany;Israel;Italy;Vietnam;India;France;Malaysia;South Africa
50EUCTR2012-003335-33-BG13/03/201314/01/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 18.0Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2012-003335-33-PT01/03/201306/02/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 17.1Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;United States;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany
52EUCTR2012-003335-33-DE28/02/201331/01/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 19.0Level: LLTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
53EUCTR2012-003335-33-AT19/02/201307/02/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 17.0Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany
54EUCTR2012-003335-33-BE07/02/201323/01/2013Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of Eisenmenger syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO : MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity Eisenmenger Syndrome
MedDRA version: 16.1Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Serbia;Portugal;Philippines;Taiwan;Greece;Spain;Russian Federation;Israel;Chile;Italy;Vietnam;India;France;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Germany
55EUCTR2012-004411-31-IT01/02/201311/01/2013Long-term study to evaluate if macitentan is safe, tolerable and efficient to be used for treatment of Eisenmenger Syndrome.Long term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome. - MAESTRO-OL Eisenmenger Syndrome
MedDRA version: 14.1Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: Macitentan
ACTELION PHARMACEUTICALS LTD.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Philippines;Taiwan;Greece;Spain;Turkey;Austria;Russian Federation;Chile;Israel;Italy;Vietnam;India;Czech Republic;Hungary;Mexico;Canada;Malaysia;Romania;Bulgaria;South Africa;Germany;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2012-003335-33-IT01/02/201311/01/2013Study to evaluate if macitentan is efficient, safe and tolerable to be used for treatment of Eisenmenger Syndrome.A multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to evaluate the effects of macitentan on exercise capacity in subjects with Eisenmenger Syndrome. - MAESTRO Eisenmenger Syndrome
MedDRA version: 14.1Level: PTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
ACTELION PHARMACEUTICALS LTD.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Portugal;Philippines;Taiwan;Greece;Spain;Israel;Chile;Russian Federation;Italy;India;Vietnam;Malaysia;South Africa;Netherlands;China;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Belgium;Bulgaria;Germany
57EUCTR2007-003694-27-BG27/11/201212/01/2009Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial HypertensionSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 20.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
700Phase 3Singapore;Romania;Croatia;Bulgaria;Germany;Sweden;Belgium;Brazil;Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland
58JPRN-JapicCTI-12198601/9/201217/10/2012Macitentan PAHA multicenter, open-label, phase II/III study to asseses the efficacy, safety and Pharmacokinetics(PK) of macitentan (ACT-064992) in patients with pulmonary arterial hypertension Pulmonary arterial hypertension (PAH)Intervention name : ACT-064992
INN of the intervention : macitentan
Dosage And administration of the intervention : macitentan tablet 10 mg once daily
Nippon Shinyaku co.,LTD./Actelion Pharmaceuticals Japan Ltd.NULL16BOTH22Phase 2/3NULL
59EUCTR2007-003694-27-GB17/11/201126/11/2007Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial HypertensionSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 17.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
60EUCTR2007-003694-27-DK30/10/200910/03/2008SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OLSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Portugal;Finland;Germany;United Kingdom;Netherlands;Belgium;Denmark;France;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2007-003694-27-DE28/10/200812/12/2007Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial HypertensionSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 17.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
700Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
62EUCTR2007-002440-14-DK14/10/200806/03/2008A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHINA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;France;Finland;Belgium;Austria;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden
63EUCTR2007-002440-14-BG10/10/200813/10/2008A study to assess the effects of macitentan on morbidity and mortality in patients with symptomatic pulmonary arterial hypertensionA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 14.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-064992
Product Code: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Norway;Sweden
64EUCTR2007-002440-14-PT05/09/200805/05/2008A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHINA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
525Phase 3France;Portugal;Finland;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden
65EUCTR2007-003694-27-PT24/07/200805/05/2008SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OLSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
525Finland;Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2007-003694-27-NL04/07/200808/01/2008Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial HypertensionSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 16.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Portugal;United States;Belarus;Serbia;Hong Kong;Taiwan;Slovakia;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
67EUCTR2007-002440-14-NL03/07/200808/01/2008A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHINA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
525Phase 3Portugal;Finland;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;France;Italy;Austria;Sweden
68EUCTR2007-003694-27-IT14/06/200816/05/2008Long-term, single-arm, open label extension study of the SERAPHIN study to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension. - SERAPHIN OLLong-term, single-arm, open label extension study of the SERAPHIN study to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension. - SERAPHIN OL Pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10037405Term: Pulmonary hypertension primary
Product Name: ACT-064992
Product Code: ACT-064992
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Portugal;Finland;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Italy;Austria;Sweden
69EUCTR2007-002440-14-FR03/06/200806/02/2008A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHINA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Phase 3Portugal;Finland;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;France;Italy;Austria;Sweden
70EUCTR2007-002440-14-DE29/05/200820/12/2007A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHINA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;France;Finland;Belgium;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2007-002440-14-SK16/05/200818/04/2008A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHINA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
525Phase 3Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Denmark;Bulgaria;Germany;Netherlands;Sweden
72EUCTR2007-003694-27-SK16/05/200818/04/2008SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OLSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
525Phase 3Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Denmark;Bulgaria;Germany;Netherlands;Sweden
73EUCTR2007-002440-14-GB15/05/200826/11/2007A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHINA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 9.1 Level: LLT Classification code 10064911 Term: Pulmonary arterial hypertension
Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noPortugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Denmark;Bulgaria;Germany;Netherlands;Sweden
74EUCTR2007-003694-27-AT18/04/200819/02/2008Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial HypertensionSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 17.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;Serbia;Belarus;United States;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
75EUCTR2007-002440-14-AT18/04/200819/02/2008A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHINA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;Finland;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;France;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2007-002440-14-SE04/04/200811/02/2008A study to assess the effects of macitentan on morbidity and mortality in patients with symptomatic pulmonary arterial hypertensionA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 14.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: ACT-064992
Product Code: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Serbia;Portugal;United States;Belarus;Hong Kong;Taiwan;Slovakia;Spain;Thailand;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
77EUCTR2007-003694-27-BE01/04/200826/02/2008Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial HypertensionSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 16.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Portugal;United States;Belarus;Serbia;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
78EUCTR2007-002440-14-BE01/04/200818/12/2007A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHINA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;Slovakia;Finland;Austria;United Kingdom;Italy;France;Belgium;Denmark;Bulgaria;Germany;Netherlands;Sweden
79EUCTR2007-002440-14-IT27/03/200815/07/2008A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel group, Event driven, Phase III study to assess the effects of ACT-064992 on Morbidity and Mortality in patients with Symptomatic Pulmonary Arterial Hypertension - SERAPHINA Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel group, Event driven, Phase III study to assess the effects of ACT-064992 on Morbidity and Mortality in patients with Symptomatic Pulmonary Arterial Hypertension - SERAPHIN Pulmonary Arterial Hypertension
MedDRA version: 9.1Level: LLTClassification code 10037405Term: Pulmonary hypertension primary
Product Name: ACT - 064992
Product Code: ACT - 064992
Product Name: ACT - 064992
Product Code: ACT - 064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
525Phase 3Portugal;Finland;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;France;Italy;Austria;Sweden
80EUCTR2007-002440-14-FI10/03/200811/02/2008A multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHINA multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven, Phase III study to assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension - SERAPHIN To assess the effects of ACT-064992 on morbidity and mortality in patients with symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;Finland;Germany;United Kingdom;Netherlands;Belgium;Bulgaria;France;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2007-003694-27-FI10/03/200811/02/2008SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OLSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Product Name: ACT-064992
Product Code: ACT-064992
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
525Portugal;France;Finland;Belgium;Denmark;Austria;Bulgaria;Netherlands;Germany;Italy;United Kingdom;Sweden
82EUCTR2007-003694-27-SE07/03/200811/02/2008Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial HypertensionSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 16.0Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Portugal;Serbia;United States;Belarus;Hong Kong;Taiwan;Slovakia;Thailand;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Malaysia;Denmark;Peru;Australia;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Bulgaria;Germany;Sweden
83EUCTR2015-003438-28-NO09/03/2016The efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertensionThe efficacy and safety of initial triple versus initial dual oral combinationtherapy in patients with newly diagnosed pulmonary arterial hypertension:A multi-center, double-blind, placebo-controlled, Phase 3b study - TRITON Pulmonary arterial hypertension (PAH)
MedDRA version: 18.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: Selexipag
Other descriptive name: SELEXIPAG
Trade Name: Opsumit
Product Name: Macitentan
Product Code: ACT-064992
INN or Proposed INN: Macitentan
Other descriptive name: MACITENTAN
Trade Name: Adcirca
Product Name: Adcirca
INN or Proposed INN: Tadalafil
Other descriptive name: TADALAFIL
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 3United States;Austria;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden
84EUCTR2007-003694-27-PL26/05/2008Clinical research to assess the long-term safety and tolerability of ACT- 064992 in patients with Pulmonary Arterial HypertensionSERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL symptomatic pulmonary arterial hypertension
MedDRA version: 21.1Level: PTClassification code 10064911Term: Pulmonary arterial hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
700Phase 3Portugal;United States;Serbia;Belarus;Taiwan;Hong Kong;Slovakia;Thailand;Ukraine;Chile;Israel;Russian Federation;Colombia;Italy;India;France;Malaysia;Denmark;Australia;Peru;South Africa;Netherlands;China;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Bulgaria;Germany;Sweden
85EUCTR2012-004411-31-PL29/08/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndromeLong term, single-arm, open-label extension study of protocol AC-055-305 to assess the safety, tolerability and efficacy of macitentan in subjects with Eisenmenger Syndrome - MAESTRO-OL: MAcitentan in Eisenmenger Syndrome To RestOre exercise capacity (Open-Label) Eisenmenger Syndrome
MedDRA version: 20.0Level: LLTClassification code 10058554Term: Eisenmenger's syndromeSystem Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: macitentan
Other descriptive name: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3France;Malaysia;South Africa;Netherlands;China;Serbia;Portugal;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Israel;Italy;Vietnam;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;Singapore;Romania;Bulgaria;Germany