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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00091715 |
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Date of registration:
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16/09/2004 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH) |
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Date of first enrolment:
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April 2004 |
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Target sample size:
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185 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00091715 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Austria
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Belgium
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Canada
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China
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Czech Republic
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France
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Germany
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Italy
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Netherlands
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Spain
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Switzerland
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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)
Age minimum:
12 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Hypertension
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Intervention(s)
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Drug: bosentan
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Drug: placebo
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Primary Outcome(s)
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exercise capacity
[Time Frame: Baseline to end of study]
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cardiac hemodynamics
[Time Frame: Baseline to end of study]
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Secondary ID(s)
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AC-052-364
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EARLY
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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