Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
This study has been completed.
Sponsor:
Actelion
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00317486
First received: April 21, 2006
Last updated: February 11, 2010
Last verified: February 2010
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Tracking Information | |
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First Received Date ICMJE | April 21, 2006 |
Last Updated Date | February 11, 2010 |
Start Date ICMJE | September 2003 |
Primary Completion Date | April 2005 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00317486 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE |
Changes from baseline to Week 16 in cardiac hemodynamics |
Original Secondary Outcome Measures ICMJE | Same as current |
Current Other Outcome Measures ICMJE | |
Original Other Outcome Measures ICMJE | |
Descriptive Information | |
Brief Title ICMJE | Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger Physiology |
Official Title ICMJE | A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Tracleer (Bosentan) on Oxygen Saturation and Cardiac Hemodynamics in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology |
Brief Summary | This study evaluates the effects of bosentan on oxygen saturation, hemodynamics and exercise capacity in patients with pulmonary arterial hypertension related to Eisenmenger physiology. Patients receive bosentan or placebo for 16 weeks. |
Detailed Description | |
Study Type ICMJE | Interventional |
Study Phase | Phase 4 |
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Condition ICMJE | Pulmonary Arterial Hypertension Related to Eisenmenger Physiology |
Intervention ICMJE | Drug: bosentan |
Study Arm (s) | |
Publications * | |
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |
Recruitment Status ICMJE | Completed |
Enrollment ICMJE | 54 |
Completion Date | April 2005 |
Primary Completion Date | April 2005 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both |
Ages | 12 Years and older |
Accepts Healthy Volunteers | No |
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
Location Countries ICMJE | United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom |
Administrative Information | |
NCT Number ICMJE | NCT00317486 |
Other Study ID Numbers ICMJE | AC-052-405 |
Has Data Monitoring Committee | |
Responsible Party | |
Study Sponsor ICMJE | Actelion |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Actelion |
Verification Date | February 2010 |
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |