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):

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.

Condition or disease Intervention/treatment
Hypertension, Pulmonary Drug: Adempas (Riociguat, BAY63-2521)

Study Type : Expanded Access
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

Intervention Details:
  • 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.)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01784562

  Hide Study Locations
United States, Arizona
Tucson, Arizona, United States, 85724
United States, California
La Jolla, California, United States, 92037
Los Angeles, California, United States, 90073
Sacramento, California, United States, 95817
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Weston, Florida, United States, 33331
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Iowa
Iowa City, Iowa, United States, 52242-1089
United States, Maryland
Baltimore, Maryland, United States, 21201-1595
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Boston, Massachusetts, United States, 02118
United States, Michigan
Ann Arbor, Michigan, United States, 48109
United States, Nebraska
Omaha, Nebraska, United States, 68131
United States, New Jersey
Newark, New Jersey, United States, 07112
United States, New York
New York, New York, United States, 10032
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43221
Fairfield, Ohio, United States, 45014
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Providence, Rhode Island, United States, 02903-4900
United States, Texas
Dallas, Texas, United States, 75390
El Paso, Texas, United States, 79902
Houston, Texas, United States, 77030
Graz, Steiermark, Austria, 8036
Innsbruck, Tirol, Austria, 6020
Wien, Austria, 1090
Bruxelles - Brussel, Belgium, 1070
Leuven, Belgium, 3000
Canada, Alberta
Calgary, Alberta, Canada, T1Y 6J4
Canada, Ontario
London, Ontario, Canada, N6C 2R5
Ottawa, Ontario, Canada, K1Y 4W7
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Bogotá, Cundinamarca, Colombia
Bogotá, Distrito Capital de Bogotá, Colombia
Cali, Valle del Cauca, Colombia
Bogotá, Colombia
Santa Fe de Bogotá, Colombia
Czech Republic
Praha 2, Czech Republic, 12808
Aarhus N, Denmark, 8200
Besancon, France, 25030
Brest, France, F-29609
Bron, France, 69500
Caen, France, 14033
Le Kremlin-bicetre, France, 94275
Montpellier, France, 34059
Pessac, France, 33604
Rouen, France, 76031
Vandoeuvre Les Nancy, France, 54511
Heidelberg, Baden-Württemberg, Germany, 69126
München, Bayern, Germany, 81377
Regensburg, Bayern, Germany, 93042
Würzburg, Bayern, Germany, 97074
Gießen, Hessen, Germany, 35392
Greifswald, Mecklenburg-Vorpommern, Germany, 17475
Hannover, Niedersachsen, Germany, 30625
Köln, Nordrhein-Westfalen, Germany, 50924
Homburg, Saarland, Germany, 66421
Dresden, Sachsen, Germany, 01307
Leipzig, Sachsen, Germany, 04103
Hamburg, Germany, 20246
Pavia, Italy, 27100
Roma, Italy, 00161
Trieste, Italy, 34149
Nagoya, Aichi, Japan, 467-8602
Sendai, Miyagi, Japan, 980-8574
Bunkyo-ku, Tokyo, Japan, 113-8655
Chiba, Japan, 260-8677
Mexico. D.F., Distrito Federal, Mexico, 14000
México D.F., Distrito Federal, Mexico, 14080
Monterrey, Nuevo Leon, Mexico, 64718
Amsterdam, Netherlands, 1081 HV
Nieuwegein, Netherlands, 3435 CM
Rotterdam, Netherlands, 3015 CE
Almada, Portugal, 2801-951
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1169-024
Lisboa, Portugal, 1649-035
Russian Federation
Novosibirsk, Russian Federation, 630055
St. Petersburg, Russian Federation, 197341
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Madrid, Spain, 28041
Sevilla, Spain, 41013
Linköping, Sweden, 581 85
Lund, Sweden, 221 85
Umeå, Sweden, 901 85
St. Gallen, Sankt Gallen, Switzerland, 9007
Lausanne, Vaud, Switzerland, 1011
Bern, Switzerland, 3010
Zürich, Switzerland, 8091
Ankara, Turkey
Istanbul, Turkey, 34-300
Istanbul, Turkey, 34-390
Istanbul, Turkey, 34304
Izmir, Turkey, 34098
Izmir, Turkey, 35100
United Kingdom
Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
Glasgow, West Dunbartonshire, United Kingdom, G81 4DY
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Bayer Identifier: NCT01784562     History of Changes
Other Study ID Numbers: 16097
2012-002104-40 ( EudraCT Number )
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016

Keywords provided by Bayer:
Chronic thromboembolic pulmonary hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases