NCT01784562No Longer AvailableNot Applicable
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
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- No Longer Available
- Sponsor
- Bayer
Study Overview
Brief 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.
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female patients with CTEPH either inoperable or with persistent or recurrent PH after surgery
Exclusion Criteria
- •All types of pulmonary hypertension other than Dana Point Classification Group 4
- •Operable patients listed for PEA (Pulmonary Endarterectomy)
Investigators
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