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

Protocol No
PULM-ACTELION-UNISUS
Phase
III
Summary

This project is being done to compare macitentan 75 mg with the approved macitentan 10 mg to see if it is well tolerated, safe and useful for treating patients with Pulmonary Arterial Hypertension (PAH).

Description
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension (UNISUS)
Participating Institutions
MCW Adult TRU
Froedtert Hospital
Status
OPEN TO ACCRUAL