Pediatric Formulation of bosentan in pulmonary arterial hypertension.
- Conditions
- Persistent pulmonary arterial hypertensionPPHNbosentanpediatricspersisterende pulmonale arteriële hypertensie pasgeborene
- Registration Number
- NL-OMON20918
- Lead Sponsor
- ACTELION Pharmaceuticals LtdGewerbestrasse 16CH-4123 AllschwilSwitzerland
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
1. Signed informed consent by the parent(s) or the legal representative(s);
2. Term and near-term newborns (gestational age > 34 weeks);
Exclusion Criteria
1. PH associated with conditions other than PPHN;
2. Immediate need for cardiac resuscitation or extracorporeal membrane oxygenation (ECMO) (profound hypoxemia [PaO2] < 30 mm Hg; OI > 40);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of bosentan in neonates with PPHN who are in need of continued inhaled iNO after at least 4 hours of continuous iNO treatment and to evaluate the PK, tolerability, and safety of bosentan in this patient population.
- Secondary Outcome Measures
Name Time Method