Bosentan for PAH pediatric patients
Phase 3
- Conditions
- Pulmonary arterial hypertension (PAH)
- Registration Number
- JPRN-jRCT2080222108
- Lead Sponsor
- Actelion Pharmaceuticals Japan Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Idiopathic PAH, Heritable PAH, PAH associated with CHD
Exclusion Criteria
Co-exisiting hepatic impairment etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in cardiopulmonary hemodynamics (PVR ) from baseline to week 12 of treatment <br>RHC
- Secondary Outcome Measures
Name Time Method To evaluate<br>the effect of bosentan on other hemodynamic variables and WHO functional class,<br>the pharmacokinetics (PK) of bosentan,<br>safety and tolerability.<br>RHC, Blood samples