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

  joanna.pepkezaba@papworth.nhs.uk

• 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