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Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (EAS)

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01784562
First Posted: February 6, 2013
Last Update Posted: January 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
February 4, 2013
February 6, 2013
January 6, 2016
 
Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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.
Not Provided
Expanded Access
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.)
Not Provided
 
No longer available
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Italy,   Japan,   Mexico,   Netherlands,   Portugal,   Russian Federation,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom,   United States
 
 
NCT01784562
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2016