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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00810693 |
The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).
Condition | Intervention | Phase |
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Pulmonary Hypertension |
Drug: Riociguat (BAY63-2521) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled, Multi-Centre, Multi-National Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Symptomatic Pulmonary Arterial Hypertension (PAH) |
Estimated Enrollment: | 462 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Riociguat (BAY63-2521)
BAY63-2521: 1mg tid - 2.5mg tid orally for 12 weeks
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Arm 2: Experimental |
Drug: Riociguat (BAY63-2521)
BAY63-2521: 1.5mg tid orally for 12 weeks
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Arm 3: Active Comparator |
Drug: Placebo
Matching Placebo tid orally for 12 weeks
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Healthcare AG ( Therapeutic Area Head ) |
Study ID Numbers: | 12934, EudraCT: 2008-003482-68 |
Study First Received: | December 17, 2008 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00810693 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Pulmonary arterial hypertension PH Stmulator |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Idiopathic Pulmonary Hypertension Vascular Diseases Hypertension |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Vascular Diseases Cardiovascular Diseases Hypertension |