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

Expanded access is currently available for this treatment.
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01784562
First received: February 4, 2013
Last updated: August 7, 2014
Last verified: August 2014

February 4, 2013
August 7, 2014
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Complete list of historical versions of study NCT01784562 on ClinicalTrials.gov Archive Site
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Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
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.

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Expanded Access
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Hypertension, Pulmonary
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.)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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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)
Both
18 Years to 80 Years
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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
United States,   Austria,   Belgium,   Canada,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Italy,   Japan,   Mexico,   Netherlands,   Portugal,   Russian Federation,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT01784562
16097, 2012-002104-40
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Bayer
Bayer
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Study Director: Bayer Study Director Bayer
Bayer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP