GS-US-357-1394, Study of GS-4997 in Subjects with PAH
Research type
Research Study
Full title
A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS-4997 in Subjects with Pulmonary Arterial Hypertension
IRAS ID
172724
Contact name
Andrew Peacock
Contact email
Sponsor organisation
Gilead Sciences, Inc
Eudract number
2014-002131-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, days
Research summary
The purpose of this research study is to provide more information about whether giving GS-4997 can benefit patients with Pulmonary Arterial Hypertension (PAH). GS-4997 is a new drug being developed by Gilead Sciences, Inc. for the treatment of PAH. It is the first drug of its kind to block the action of a protein called apoptosis signal-regulating kinase 1 (ASK1). This protein may have a key role in causing and the progression of PAH. Therefore, by blocking ASK1, GS-4997 may slow or halt the progression of PAH.
PAH causes a narrowing of the blood vessels that connect the lungs to the heart, and leads to an increase in the pressure inside these blood vessels. PAH makes your heart work very hard to move blood through your lungs and body. Over time this may lead to dizziness, shortness of breath, and chronic tiredness. Also, your heart may not work as well as it should, which could possibly lead to death. There is no cure for PAH at this time.
The study will involve approximately 120 patients at about 70 study sites around the world. This study is open to male and female patients who are 18 to 75 years of age and meet all other the study requirements. It is anticipated that the study will be open for approximately 7 years.REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0050
Date of REC Opinion
15 May 2015
REC opinion
Further Information Favourable Opinion