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

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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