Pulmonary Hypertension
Conditions
Keywords
Pulmonary arterial hypertension, PAH, PPH, bosentan, early
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 suffering from PAH Class II.
Interventions
DRUGbosentan
65 mg tablet twice a day for 4 weeks followed by 125 mg tablet twice a day until end of study
DRUGplacebo
placebo for 6 months followed by an open-label period
Sponsors
Actelion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| exercise capacity | Baseline to end of study |
| cardiac hemodynamics | Baseline to end of study |
Countries
Australia, Austria, Belgium, Canada, China, Czechia, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Outcome results
None listed