Phase IIIb study of riociguat in patients with chronic thromboembolic
Research type
Research Study
Full title
An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial
IRAS ID
123944
Contact name
Joanna Pepke-Zaba
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2012-002104-40
Research summary
The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial.
In the US the study runs as an Expanded Access program under 21 CFR 312.320.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0278
Date of REC Opinion
20 May 2013
REC opinion
Further Information Favourable Opinion