Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension SERAPHIN
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 742
Healthy volunteers: no

Brief summary:
The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.

Detailed description:

Arms:
arm 1: Macitentan (ACT-064992) tablet, 3 mg, once daily arm 2: Macitentan (ACT-064992) tablet, 10 mg, once daily arm 3: Matching placebo, once daily

Interventions: intervention 1: macitentan (ACT-064992) intervention 2: macitentan (ACT-064992) intervention 3: placebo
Intervention descriptions: intervention 1: Tablet, 3 mg dosage, once daily intervention 2: Tablet, 10 mg dosage, once daily intervention 3: Matching placebo, once daily

Protocol document: