RESTORE - Protocol 67896049PAH4005
Research type
Research Study
Full title
A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging (RESTORE)
IRAS ID
283858
Contact name
John Coghlan
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2019-004783-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 15 days
Research summary
This is an open-label, multicentre, single-arm, interventional study to assess the effect of selexipag in adult participants (≥18 to <65 years) with a diagnosis of pulmonary arterial hypertension (PAH) after 26 weeks on treatment.
Selexipag is an investigational drug used for the treatment of pulmonary arterial hypertension (PAH). The study will look at the effects of selexipag on how the heart pumps blood to the lungs. This will be evaluated by two ways of making medical imaging, one called magnetic resonance imaging (MRI) and the other called echocardiography (Echo).
The duration of individual participation will be approximately 34 weeks. The study will be conducted in 3 phases: a 28-day screening phase, a 26-week treatment phase (which will include an initial 12-week up-titration period), and a post-intervention safety follow-up period of at least 30 days.
The study will enroll approximately 80 participants in total. Eligible participants will be treated with selexipag for 26 weeks.
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/1067
Date of REC Opinion
16 Nov 2020
REC opinion
Further Information Favourable Opinion