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

Expanded access is currently available for this treatment.
Verified July 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01784562
First received: February 4, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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 Intervention
Hypertension, Pulmonary
Drug: Adempas (Riociguat, BAY63-2521)

Study Type: Expanded Access     What is 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

Resource links provided by NLM:


Further study details as provided by Bayer:

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.)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784562

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

  Hide Study Locations
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, 02118
Boston, Massachusetts, United States, 02111
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
Austria
Graz, Steiermark, Austria, 8036
Innsbruck, Tirol, Austria, 6020
Wien, Austria, 1090
Belgium
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
Colombia
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, 12800
Denmark
Aarhus N, Denmark, 8200
France
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
Germany
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
Italy
Pavia, Italy, 27100
Roma, Italy, 00161
Trieste, Italy, 34149
Japan
Nagoya, Aichi, Japan, 467-8602
Sendai, Miyagi, Japan, 980-8574
Bunkyo-ku, Tokyo, Japan, 113-8655
Chiba, Japan, 260-8677
Mexico
Mexico. D.F., Distrito Federal, Mexico, 14000
México D.F., Distrito Federal, Mexico, 14080
Monterrey, Nuevo Leon, Mexico, 64718
Netherlands
Amsterdam, Netherlands, 1081 HV
Nieuwegein, Netherlands, 3435 CM
Rotterdam, Netherlands, 3015 CE
Portugal
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
Spain
Barcelona, Spain, 08036
Barcelona, Spain, 08035
Madrid, Spain, 28041
Sevilla, Spain, 41013
Sweden
Linköping, Sweden, 581 85
Lund, Sweden, 221 85
Umeå, Sweden, 901 85
Switzerland
St. Gallen, Sankt Gallen, Switzerland, 9007
Lausanne, Vaud, Switzerland, 1011
Bern, Switzerland, 3010
Zürich, Switzerland, 8091
Turkey
Ankara, Turkey
Istanbul, Turkey, 34-300
Istanbul, Turkey, 34304
Istanbul, Turkey, 34-390
Izmir, Turkey
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01784562     History of Changes
Other Study ID Numbers: 16097, 2012-002104-40
Study First Received: February 4, 2013
Last Updated: July 14, 2014
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Health and Medicines Authority
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Portugal: INFARMED - National Authority of Medicines and Health Products

Keywords provided by Bayer:
Chronic thromboembolic pulmonary hypertension

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

ClinicalTrials.gov processed this record on July 22, 2014