A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Activecontrolled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in…

Internal Medicine Pulmonology Pulmonary Hypertension Adult Subjects Female Subjects Male Subjects

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.

ADVANCE Outcomes

Internal Medicine Pulmonology Heart and Vascular Pulmonary Hypertension Heart Disease Adult Subjects Female Subjects Male Subjects

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.