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. (UNISUS)

drug protocol number

AC-055-315

drug sponsor

Actelion Pharmaceuticals Ltd.

drug study

Macitentan

drug trial site

King Faisal Specialist Hospital and Research Center (Riyadh),King Fahad Medical City (Riyadh)

drug status

Ongoing

drug phase