Riociguat study in PAH insufficient response to PDE-5i patients (IIIb)
Research type
Research Study
Full title
An open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment who phosphodiesterase-5 inhibitors (PDE-5i)
IRAS ID
157343
Contact name
Laura Hunt
Contact email
Sponsor organisation
Bayer Healthcare AG delegated to Bayer Plc
Eudract number
2013-001759-10
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 1 days
Research summary
BAY63-2521 Riociguat leads to the relaxation of muscle cells localized in organs and blood vessels which also affects cells of the lung blood vessels. Furthermore, there is some basis to believe that Riociguat also may inhibit an abnormal reorganization of smaller lung blood vessels. In patients with pulmonary hypertension it was confirmed that the compound is able to reduce the pulmonary blood pressure which has a positive impact on the heart function without unacceptable side effects. In this study Riociguat will be given orally for 24 weeks. The dose of the study drug will be increased over 8 weeks and then followed by a Maintenance Phase of 16 weeks. Targeted for this study are pulmonary hypertension patients treated with Phosphodiesterase Type-5 Inhibitors (eg Sildenafil, Tadalafil) but without sufficient clinical response to therapy as assessed by the treating physician. Based on the promising results from previous clinical trials, an improvement of the exercise capacity, the heart function and the quality of life may be expected.
In case Riociguat does not have a market approval or is not reimbursed by the insurance once the individual treatment phase is completed, the drug can be made available according to applicable local regulations for another max 18 months under study conditions.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
14/NE/1073
Date of REC Opinion
29 Sep 2014
REC opinion
Further Information Favourable Opinion