TRACE:Selexipag Study in Patients with Pulmonary Arterial Hypertension
Research type
Research Study
Full title
A multi-center, double-blind, placebo-controlled, Phase 4 study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts.
IRAS ID
225090
Contact name
Luke Howard
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd.
Eudract number
2017-000216-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
Pulmonary Arterial Hypertension (PAH) is a rare disorder of the blood vessels in the lungs which affects 15-50 people per million. PAH occurs when the blood pressure in the pulmonary arteries becomes higher than normal. Through time, scarring of the blood vessels makes them stiffer and thicker, and some may become completely blocked. These less flexible blood vessels make it more difficult for blood to get through to the lungs, and the heart must pump harder. The extra stress of pumping harder causes the heart to enlarge and start to work poorly. As this disease progresses, less\nand less blood is able to flow out of the heart, through the lungs, and into the body, and more symptoms begin to appear. If not diagnosed early and/or left untreated, the patient’s condition\nwill deteriorate rapidly, which can ultimately lead to right heart failure and premature death. The primary objective of this exploratory study is to evaluate the effect of selexipag on the\nphysical activity of patients with PAH in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient’s real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient’s real environment. Patients will be assigned randomly to receive either selexipag or placebo. Patients will be in the study for about 32 weeks. Regular phone calls to the patient are scheduled for follow-up. This study will be performed in approx. 45 hospitals in approx. 12 countries, with a total of approx. 100 patients participating. Adult men and women, aged 18 to 75 years, with PAH will be included in this study. The study is sponsored by Actelion\nPharmaceuticals Ltd.
REC name
West of Scotland REC 1
REC reference
17/WS/0120
Date of REC Opinion
11 Jul 2017
REC opinion
Further Information Favourable Opinion