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"
49 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-GB
(EUCTR)
23/11/202026/05/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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-SK
(EUCTR)
12/11/202013/08/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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-LT
(EUCTR)
10/11/202022/09/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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-NO
(EUCTR)
29/10/202003/08/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
5EUCTR2019-002533-11-NL
(EUCTR)
29/09/202029/04/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-004131-24-DE
(EUCTR)
10/08/202026/05/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
7EUCTR2019-004131-24-HU
(EUCTR)
27/07/202028/05/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
8EUCTR2019-004131-24-PL
(EUCTR)
02/07/202002/06/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
9EUCTR2019-002533-11-GB
(EUCTR)
30/06/202016/03/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
10EUCTR2019-002533-11-DE
(EUCTR)
17/06/202014/02/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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-DK
(EUCTR)
27/05/202031/03/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
12EUCTR2019-002533-11-HU
(EUCTR)
10/05/202011/03/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
13EUCTR2019-002533-11-CZ
(EUCTR)
07/05/202011/03/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
14EUCTR2019-002533-11-SE
(EUCTR)
06/05/202013/03/2020A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
15EUCTR2014-004786-25-BG
(EUCTR)
11/10/201901/07/2019A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: CJNJ-68150420-ZZZ-G001 (ACT-064992D)
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-003934-10-PL
(EUCTR)
19/09/201926/07/2019A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System 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
17EUCTR2014-004786-25-DE
(EUCTR)
05/09/201902/05/2019A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: CJNJ-68150420-ZZZ-G001 (ACT- 064992D)
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.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
18EUCTR2014-004786-25-ES
(EUCTR)
13/08/201911/06/2019A 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: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: ACT-064992D
INN or Proposed INN: MACITENTAN
INN or Proposed INN: TADALAFIL
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.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
19EUCTR2014-004786-25-PL
(EUCTR)
10/08/201928/05/2019A 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: CJNJ-68150420-ZZZ-G001(ACT-064992D)
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Adcirca®
INN or Proposed INN: TADALAFIL
Other descriptive name: ACT-178418
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Actelion Pharmaceuticals Ltd.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
20EUCTR2015-003438-28-GB
(EUCTR)
21/06/201813/11/2017The 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: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2015-003438-28-ES
(EUCTR)
19/01/201801/12/2017The 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: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product 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
22EUCTR2015-003438-28-DK
(EUCTR)
17/08/201630/05/2016The 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: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
23EUCTR2015-003438-28-FR
(EUCTR)
20/06/201621/04/2016The 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: 19.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product 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
24NCT02885012
(ClinicalTrials.gov)
June 20163/5/2016Crossover Study From Macitentan or Bosentan Over to AmbrisentanA Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: AmbrisentanMedical University of South CarolinaOchsner Health SystemTerminated18 Years80 YearsAll3Phase 4United States
25EUCTR2015-003438-28-DE
(EUCTR)
04/03/201619/01/2016The 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
26EUCTR2015-003438-28-BE
(EUCTR)
03/03/201609/06/2020The 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
27EUCTR2015-002835-17-DE
(EUCTR)
18/01/201626/11/2015RIGHT HEART III Study – Right ventricular hemodynamic evaluation and response to treatmentInvestigation of the influence of PAH-specific medication on right ventricular function in patients with pulmonary arterial hypertension (PAH) under basal conditions - RIGHT HEART III Pulmonary arterial Hypertension (PAH)
MedDRA version: 20.0;Level: LLT;Classification code 10037403;Term: Pulmonary hypertension NOS;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Adempas®
INN or Proposed INN: RIOCIGUAT
Trade Name: Opsumit®
INN or Proposed INN: MACITENTAN
Justus Liebig Universität GießenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Germany
28EUCTR2015-003438-28-AT
(EUCTR)
12/01/201625/07/2017The 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: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
29EUCTR2012-004411-31-CZ
(EUCTR)
01/10/201512/12/2013Long-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: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
30EUCTR2014-004066-20-DE
(EUCTR)
27/07/201509/03/2015A 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: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2014-004066-20-NL
(EUCTR)
27/03/201519/01/2015A 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: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
32EUCTR2012-004411-31-GR
(EUCTR)
19/03/201529/04/2015Long-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: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
33EUCTR2012-003335-33-GR
(EUCTR)
22/09/201425/06/2014Study 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: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
34NCT02126943
(ClinicalTrials.gov)
April 30, 201429/4/2014OPsumit USers RegistryUS-based, Observational, Drug Registry of Opsumit® (Macitentan) New Users in Clinical PracticePulmonary Arterial HypertensionDrug: Opsumit (macitentan)ActelionNULLCompletedN/AN/AAll2686United States;Puerto Rico
35EUCTR2012-004411-31-HU
(EUCTR)
28/01/201429/11/2013Long-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: 14.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
36EUCTR2012-003335-33-CZ
(EUCTR)
04/12/201316/08/2013Study 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: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
37EUCTR2012-004411-31-DE
(EUCTR)
07/10/201325/06/2013Long-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: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
38EUCTR2012-003335-33-NL
(EUCTR)
01/10/201307/02/2013Study 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: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
39EUCTR2012-004411-31-AT
(EUCTR)
30/07/201301/07/2013Long-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: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
40EUCTR2012-003335-33-BG
(EUCTR)
13/03/201314/01/2013Study 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: 18.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
41EUCTR2012-003335-33-PT
(EUCTR)
01/03/201306/02/2013Study 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: 17.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
42EUCTR2012-003335-33-DE
(EUCTR)
28/02/201331/01/2013Study 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: 19.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
43EUCTR2012-003335-33-AT
(EUCTR)
19/02/201307/02/2013Study 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: 17.0;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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-BE
(EUCTR)
07/02/201323/01/2013Study 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: 16.1;Level: PT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
45EUCTR2007-003694-27-BG
(EUCTR)
27/11/201212/01/2009Clinical 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: 20.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT01389206
(ClinicalTrials.gov)
June 1, 20116/7/2011Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension ProgramPulmonary Arterial HypertensionDrug: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or UptraviActelionCanadian Heart Research CentreCompleted18 YearsN/AAll797United States;Puerto Rico
47EUCTR2015-003438-28-NO
(EUCTR)
09/03/2016The 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: 18.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product 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
48EUCTR2012-004411-31-PL
(EUCTR)
29/08/2014Long-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: 20.0;Level: LLT;Classification code 10058554;Term: Eisenmenger's syndrome;System 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
49EUCTR2007-003694-27-PL
(EUCTR)
26/05/2008Clinical 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: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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