Status:
COMPLETED
Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II
Lead Sponsor:
Actelion
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients sufferi...
Eligibility Criteria
Inclusion
- PAH NYHA Class II
- Significant elevation of mean pulmonary arterial pressure
- Significant elevation of pulmonary vascular resistance at rest
- Limited 6-minute walk distance
Exclusion
- PAH secondary to portal hypertension, complex congenital heart disease or reverse shunt
- Restrictive or obstructive lung disease
- Significant vasoreactivity
- Treatments for PAH (within 4 weeks of randomization)
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT00091715
Start Date
April 1 2004
End Date
February 1 2011
Last Update
August 30 2011
Active Locations (34)
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1
University of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
2
Harbor UCLA Medical Center
Torrance, California, United States, 90509
3
Tufts- New England Medical Center
Boston, Massachusetts, United States, 02111
4
University of Michigan
Ann Arbor, Michigan, United States, 48109