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

Expanded access is currently available for this treatment.
Verified October 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01784562
First received: February 4, 2013
Last updated: October 27, 2014
Last verified: October 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

  Show 102 Study Locations
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: October 27, 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
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014