Selonsertib in Adults With Pulmonary Arterial Hypertension
NCT02234141 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151
Last updated 2019-04-10
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
Interventions
- DRUG
-
Tablet administered orally once daily
- DRUG
-
Selonsertib
Tablets administered orally once daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2016-04-30
- Completion
- 2016-12-31
Countries
- United States
- Canada
- France
- Germany
- Italy
- Netherlands
- Spain
- United Kingdom
Study Locations
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