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

January 5, 2016 updated by: Bayer

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

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
    • Steiermark
      • Graz, Steiermark, Austria, 8036
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
  • Belgium
      • Bruxelles - Brussel, Belgium, 1070
      • Leuven, Belgium, 3000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
    • Ontario
      • London, Ontario, Canada, N6C 2R5
      • Ottawa, Ontario, Canada, K1Y 4W7
      • Toronto, Ontario, Canada, M5G 2C4
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
  • Colombia
      • Bogotá, Colombia
      • Santa Fe de Bogotá, Colombia
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia
    • Distrito Capital de Bogotá
      • Bogotá, Distrito Capital de Bogotá, Colombia
    • Valle del Cauca
      • Cali, Valle del Cauca, Colombia
  • Czech Republic
      • Praha 2, Czech Republic, 12808
  • 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
      • Hamburg, Germany, 20246
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69126
    • Bayern
      • München, Bayern, Germany, 81377
      • Regensburg, Bayern, Germany, 93042
      • Würzburg, Bayern, Germany, 97074
    • Hessen
      • Gießen, Hessen, Germany, 35392
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50924
    • Saarland
      • Homburg, Saarland, Germany, 66421
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Leipzig, Sachsen, Germany, 04103
  • Italy
      • Pavia, Italy, 27100
      • Roma, Italy, 00161
      • Trieste, Italy, 34149
  • Japan
      • Chiba, Japan, 260-8677
    • Aichi
      • Nagoya, Aichi, Japan, 467-8602
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
  • Mexico
    • Distrito Federal
      • Mexico. D.F., Distrito Federal, Mexico, 14000
      • México D.F., Distrito Federal, Mexico, 14080
    • Nuevo Leon
      • 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, 1649-035
      • Lisboa, Portugal, 1169-024
  • 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
      • Bern, Switzerland, 3010
      • Zürich, Switzerland, 8091
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
  • Turkey
      • Ankara, Turkey
      • Istanbul, Turkey, 34-300
      • Istanbul, Turkey, 34304
      • Istanbul, Turkey, 34-390
      • Izmir, Turkey, 35100
      • Izmir, Turkey, 34098
  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
    • Tyne and Wear
      • Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
    • West Dunbartonshire
      • Glasgow, West Dunbartonshire, United Kingdom, G81 4DY
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
    • California
      • La Jolla, California, United States, 92037
      • Los Angeles, California, United States, 90073
      • Sacramento, California, United States, 95817
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Weston, Florida, United States, 33331
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Iowa
      • Iowa City, Iowa, United States, 52242-1089
    • Maryland
      • Baltimore, Maryland, United States, 21201-1595
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Boston, Massachusetts, United States, 02118
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New Jersey
      • Newark, New Jersey, United States, 07112
    • New York
      • New York, New York, United States, 10032
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43221
      • Fairfield, Ohio, United States, 45014
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15212
    • Rhode Island
      • Providence, Rhode Island, United States, 02903-4900
    • Texas
      • Dallas, Texas, United States, 75390
      • El Paso, Texas, United States, 79902
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 4, 2013

First Posted (Estimate)

February 6, 2013

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16097
  • 2012-002104-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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