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BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary Hypertension (CHEST-2)

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ClinicalTrials.gov Identifier: NCT00910429
Recruitment Status : Active, not recruiting
First Posted : May 29, 2009
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
Patients who have completed the 16 weeks treatment of the CHEST-1 trial (study number 11348) will be asked to participate in this long term extension study with BAY63-2521. The aim of the long term study is to collect additional information to evaluate the safety and tolerability of BAY63-2521. Patients will be treated with open label medication on their individual optimal dose between 0,5 mg - 2,5 mg tid.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Riociguat (Adempas, BAY63-2521) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
Actual Study Start Date : July 1, 2009
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Riociguat

Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 Drug: Riociguat (Adempas, BAY63-2521)
BAY63-2521 - 1 mg tid - 2,5 mg tid orally until end of study


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability (e.g. adverse event collection) [ Time Frame: 5 years 2 months and 14 days ]

Secondary Outcome Measures :
  1. Change in 6-Minute Walking Distance (6MWD) from baseline [ Time Frame: 5 years 2 months and 14 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have completed 16 weeks of treatment in the double blind trial CHEST 1

Exclusion Criteria:

  • Patients who have an ongoing serious adverse event from CHEST 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910429


  Show 73 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Additional Information:
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00910429     History of Changes
Other Study ID Numbers: 11349
2008-003539-19 ( EudraCT Number )
First Posted: May 29, 2009    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Chronic thromboembolic Hypertension
PH
soluble Guanylate Cyclase Stimulator
sGC

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