Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension PAH
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1156
Healthy volunteers: no

Brief summary:
The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.

Detailed description:

Arms:
arm 1: Selexipag is up-titrated from Day 1 to Week 12 to each patient's maximum tolerated dose in the range of 200-1600 µg twice a day (b.i.d.) in 200 µg steps starting with one 200 µg oral tablet on Day 1. From Day 2 onwards, a b.i.d. dose regimen with an interval of approximately 12 hours is followed. If this dose (selexipag 200 μg b.i.d.) is well-tolerated, selexipag is up-titrated with weekly increments of 200 µg. Up-titration is followed by a stable maintenance treatment period from Week 12 onwards, up to Week 26, at the maximum tolerated dose arm 2: Matching placebo is administered orally with a dosing interval of approximately12 h. A (mock) up-titration scheme is followed

Interventions: intervention 1: Selexipag intervention 2: Placebo
Intervention descriptions: intervention 1: Selexipag 200 µg tablets intervention 2: Placebo tablets matching selexipag

Protocol document: