NCT02234141

Selonsertib in Adults With Pulmonary Arterial Hypertension

A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	Tablet administered orally once daily
DRUG	Selonsertib	Tablets administered orally once daily

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-04-01
• Completion: 2016-12-01
• First posted: 2014-09-09
• Last updated: 2019-04-10
• Results posted: 2019-04-10

Locations

46 sites across 8 countries: United States, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom