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

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. Identifier: NCT01784562
Expanded Access Status : No longer available
First Posted : February 6, 2013
Last Update Posted : January 6, 2016
Information provided by (Responsible Party):

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.)
McLaughlin VV, Jansa P, Nielsen-Kudsk JE, Halank M, Simonneau G, Grünig E, Ulrich S, Rosenkranz S, Gómez Sánchez MA, Pulido T, Pepke-Zaba J, Barberá JA, Hoeper MM, Vachiéry JL, Lang I, Carvalho F, Meier C, Mueller K, Nikkho S, D'Armini AM. Riociguat in patients with chronic thromboembolic pulmonary hypertension: results from an early access study. BMC Pulm Med. 2017 Dec 28;17(1):216. doi: 10.1186/s12890-017-0563-7.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Not Provided
Study Director: Bayer Study Director Bayer
January 2016