Riociguat in children with PAH
Research type
Research Study
Full title
Open-label, individual dose titration study to evaluate safety, tolerability and pharmacokinetics of riociguat in children from 6 to less than 18 years of age with pulmonary arterial hypertension (PAH)
IRAS ID
182165
Contact name
Anna Radomskyj
Contact email
Sponsor organisation
Bayer AG
Eudract number
2014-003952-29
Duration of Study in the UK
3 years, 2 months, 8 days
Research summary
Pulmonary hypertension is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. Pulmonary hypertension begins when tiny arteries in the lungs become narrowed, making it harder for the heart to pump blood through them, and causing the pressure within the lungs arteries to rise. Because the heart has to work harder than normal, patients can feel tired, dizzy, and short of breath. They may find physical activity, such as walking, difficult to do for long.
The study drug, riociguat, can help widen the lung arteries and decrease these symptoms. It is already on the market for the treatment of PAH in adults. The trade name is Adempas.
The purpose of this study is to find out if riociguat is safe and if it can also help children and adolescents with PAH.
There is an unmet need for children with group 1 Pulmonary Arterial Hypertension. Riociguat would be a new class of drugs tested in this patient population and may provide a safe and effective medication for this life threatening disease.REC name
London - Brent Research Ethics Committee
REC reference
15/LO/1747
Date of REC Opinion
25 Nov 2015
REC opinion
Further Information Favourable Opinion