CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 151 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02234141
NCT02234141Phase 2Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Sep 9, 2014·Updated Apr 10, 2019

In Brief

A Phase 2 clinical trial evaluating Placebo and Selonsertib for Pulmonary Arterial Hypertension. Completed, enrolled 151 participants across 46 sites in 8 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesCanada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 9, 2014
Enrollment StartNov 1, 2014
Primary CompletionApr 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 11.8 years ago

Interventions

Placebodrug

Tablet administered orally once daily

Selonsertibdrug

Tablets administered orally once daily