A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH
Tracking Information
Start Date ICMJE | February 2009 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: March 3, 2009) | 6 Minute Walking Distance [ Time Frame: 16 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00855465 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 14, 2009) |
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Original Secondary Outcome Measures ICMJE (submitted: March 3, 2009) |
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Descriptive Information
Brief Title ICMJE | A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH. |
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Official Title ICMJE | 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 Chronic Thromboembolic Pulmonary Hypertension (CTEPH) |
Brief Summary | The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521, given orally for 16 weeks, in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Pulmonary Hypertension |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 270 | ||||||||
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Estimated Completion Date | April 2011 | ||||||||
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years to 75 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, Switzerland, Taiwan, Turkey, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00855465 | ||||
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Responsible Party | Therapeutic Area Head, Bayer Healthcare AG | ||||
Study ID Numbers ICMJE | 11348, EudraCT: 2007-000072-16, CHEST 1 | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Bayer |
Source: http://clinicaltrials.gov/