Trials / No Longer Available
No Longer AvailableNCT01784562
Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adempas (Riociguat, BAY63-2521) | Individual dosing of riociguat between 0.5 and 2.5 mg three times daily based on patient's well being and blood pressure. (The individual optimal dose should be determined during the initial 8-week titration phase based on patient's monitoring of systolic blood pressure and well-being.) |
Timeline
- First posted
- 2013-02-06
- Last updated
- 2016-01-06
Locations
102 sites across 20 countries: United States, Austria, Belgium, Canada, Colombia, Czechia, Denmark, France, Germany, Italy, Japan, Mexico, Netherlands, Portugal, Russia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01784562. Inclusion in this directory is not an endorsement.