Conditions: Pulmonary Arterial Hypertension
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 151
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the effect of selonsertib (GS-4997) on pulmonary vascular resistance (PVR), as measured by right heart catheterization (RHC) in adults with pulmonary arterial hypertension (PAH). The study will consist of a 24-week placebo-controlled treatment period and a long-term selonsertib treatment period. Participants completing the 24-week placebo-controlled period will be eligible to receive active treatment with selonsertib in the long-term treatment period.

Detailed description:

Arms:
arm 1: Participants will receive selonsertib 2 milligrams (mg) for 24 weeks and may continue on this dose during the long-term treatment phase. arm 2: Participants will receive selonsertib 6 mg for 24 weeks and may continue on this dose during the long-term treatment phase. arm 3: Participants will receive selonsertib 18 mg for 24 weeks and may continue on this dose during the long-term treatment phase. arm 4: Participants will receive selonsertib placebo for 24 weeks, and may then be rerandomized 1:1:1 to selonsertib 2, 6, or 18 mg during the long-term treatment phase.

Interventions: intervention 1: Placebo intervention 2: Selonsertib
Intervention descriptions: intervention 1: Tablet administered orally once daily intervention 2: Tablets administered orally once daily

Protocol document: