Official 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
Brief Summary

The aim of the study is to assess safety, tolerability and clinical effects of differentdoses of riociguat in patients with inoperable Chronic Thromboembolic PulmonaryHypertension (CTEPH) and who are not satisfactorily treated and cannot participate in anyother CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR312.320.

Detailed Description

Not Provided

No longer available
Hypertension, Pulmonary

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.)

Eligibility Criteria

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
Austria
Belgium
Canada
Colombia
Czech Republic
Denmark
France
Germany
Italy
Japan
Mexico
Netherlands
Portugal
Russian Federation
Spain
Sweden
Switzerland
Turkey
United Kingdom
United States
Locations

Tucson, Arizona, United States

La Jolla, California, United States

Los Angeles, California, United States

Sacramento, California, United States

Aurora, Colorado, United States

Weston, Florida, United States

Chicago, Illinois, United States

Iowa City, Iowa, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Ann Arbor, Michigan, United States

Omaha, Nebraska, United States

Newark, New Jersey, United States

New York, New York, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Fairfield, Ohio, United States

Philadelphia, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Providence, Rhode Island, United States

Dallas, Texas, United States

El Paso, Texas, United States

Houston, Texas, United States

Graz, Steiermark, Austria

Innsbruck, Tirol, Austria

Wien, Austria

Bruxelles - Brussel, Belgium

Leuven, Belgium

Calgary, Alberta, Canada

London, Ontario, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Bogotá, Cundinamarca, Colombia

Bogotá, Distrito Capital de Bogotá, Colombia

Cali, Valle del Cauca, Colombia

Bogotá, Colombia

Santa Fe de Bogotá, Colombia

Praha 2, Czech Republic

Aarhus N, Denmark

Besancon, France

Brest, France

Bron, France

Caen, France

Le Kremlin-bicetre, France

Montpellier, France

Pessac, France

Rouen, France

Vandoeuvre Les Nancy, France

Heidelberg, Baden-Württemberg, Germany

München, Bayern, Germany

Regensburg, Bayern, Germany

Würzburg, Bayern, Germany

Gießen, Hessen, Germany

Greifswald, Mecklenburg-Vorpommern, Germany

Hannover, Niedersachsen, Germany

Köln, Nordrhein-Westfalen, Germany

Homburg, Saarland, Germany

Dresden, Sachsen, Germany

Leipzig, Sachsen, Germany

Hamburg, Germany

Pavia, Italy

Roma, Italy

Trieste, Italy

Nagoya, Aichi, Japan

Sendai, Miyagi, Japan

Bunkyo-ku, Tokyo, Japan

Chiba, Japan

Mexico. D.F., Distrito Federal, Mexico

México D.F., Distrito Federal, Mexico

Monterrey, Nuevo Leon, Mexico

Amsterdam, Netherlands

Nieuwegein, Netherlands

Rotterdam, Netherlands

Almada, Portugal

Coimbra, Portugal

Lisboa, Portugal

Lisboa, Portugal

Novosibirsk, Russian Federation

St. Petersburg, Russian Federation

Barcelona, Spain

Barcelona, Spain

Madrid, Spain

Sevilla, Spain

Linköping, Sweden

Lund, Sweden

Umeå, Sweden

St. Gallen, Sankt Gallen, Switzerland

Lausanne, Vaud, Switzerland

Bern, Switzerland

Zürich, Switzerland

Ankara, Turkey

Istanbul, Turkey

Istanbul, Turkey

Istanbul, Turkey

Izmir, Turkey

Izmir, Turkey

Cambridge, Cambridgeshire, United Kingdom

Sheffield, South Yorkshire, United Kingdom

Newcastle Upon Tyne, Tyne and Wear, United Kingdom

Glasgow, West Dunbartonshire, United Kingdom

Bayer Study Director, Study Director
Bayer

NCT Number
Keywords
Chronic thromboembolic pulmonary hypertension
MeSH Terms
Hypertension, Pulmonary
Hypertension
Riociguat