A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg
A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.
Inclusion Criteria:
Exclusion Criteria:
Torrance, California 90502-2006, United States
Burlington, Vermont 05405, United States
C.a.b.a., C1180AAX, Argentina
Caba, 1199ABB, Argentina
Caba, C1048AAN, Argentina
Caba, C1426ABP, Argentina
Belo Horizonte, 30441-070, Brazil
Brasília, 70840-901, Brazil
Campina Grande do Sul, 83430-000, Brazil
Porto Alegre, 90610-000, Brazil
Bucaramanga - Piedecuesta - Valle de Menzuli, 6810002, Colombia
Prague, 128 08, Czechia
Budapest, 1096, Hungary
Szeged, 6720, Hungary
Chengalpetu, 603203, India
Hyderbad, 500034, India
Suita-Shi, 564-8565, Japan
Nordbyhagen, 1478, Norway
Bydgoszcz, 85-168, Poland
Katowice, 40 635, Poland
Krakow, 31 202, Poland
Kazan', 420101, Russia
Kemerovo, 650002, Russia
Saint Petersburg, 197341, Russia
Tyumen, 625032, Russia
Kartal Istanbul, 34865, Turkey (Türkiye)
Cherkasy, 18009, Ukraine
Dnipro, 49070, Ukraine
Kyiv, 02000, Ukraine
Kyiv, 03680, Ukraine
Lviv, 79010, Ukraine
Ternopil, 46002, Ukraine
Sheffield, S10 2RX, United Kingdom