Riociguat rEplacing PDE-5i therapy evaLuated Against Continued PDE-5i
Research type
Research Study
Full title
A prospective, randomized, international, multicenter, double-arm, controlled, open-label study of Riociguat in patients with pulmonary arterial hypertension (PAH) who are on a stable dose of phosphodiesterase-5 inhibitors (PDE-5i) with or without endothelin receptor antagonist (ERA), but not at treatment goal.
IRAS ID
213242
Contact name
Alistair Church
Contact email
Sponsor organisation
Bayer AG
Eudract number
2016-001067-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
Pulmonary arterial hypertension (PAH) is a type of high blood pressure that occurs in the right side of the heart and the arteries that supply blood to the lungs (pulmonary arteries). PAH occurs when the arteries thicken or grow rigid, making blood flow more difficult. The heart has to work harder to push blood through the arteries, and the arteries aren’t able to carry adequate blood to the lungs. When this happens, the body can’t get enough oxygen. This causes someone with PAH to grow tired more easily. They may also experience shortness of breath, chest pain, and dizziness. \nCurrent treatments include PDE-5i therapy (Sildenafil/Tadalafil) which relax blood vessels, increasing blood flow and lowering blood pressure. The goal of treatment with PDE-5i is to relieve symptoms of PAH, reduce blood pressure and damage to blood vessels and the heart, and increase ability to exercise. \nThe purpose of this study is to investigate the effectiveness of Riociguat (Adempas®) as replacement of currently approved stable dose PDE-5i therapy, with or without endothelin receptor antagonist (drug that blocks endothelin receptors), in patients with PAH, where treatment has not been sufficiently successful.\nRiociguat is a Soluble Guanylate Cyclase Stimulator. Soluble Guanylate Cyclase is a substance which causes blood vessels to become wider, and Riociguat works by increasing the amount of Guanylate Cyclase produced by the body. As Riociguat works in a different way to PDE-5i treatments it is hoped that people who have not had very successful PDE-5i treatment will show improvement when taking Riociguat instead. Riociguat, as mono/combination therapy with endothelin receptor antagonists, is indicated for the treatment of adult patients with PAH to improve ability to exercise.\n Approximately 218 people worldwide will take part in this study, involving at least 3 UK medical centres. Participants will take part for approximately 30 weeks.
REC name
West of Scotland REC 1
REC reference
16/WS/0223
Date of REC Opinion
21 Dec 2016
REC opinion
Further Information Favourable Opinion