An open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAH
- Conditions
- Treatment of pulmonary arterial hypertension in children.MedDRA version: 6.1Level: PTClassification code 10037405
- Registration Number
- EUCTR2004-005157-63-IT
- Lead Sponsor
- ACTELION PHARMACEUTICALS ITALIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie bosentan's endothelin receptor antagonism in pediatric idiopathic pulmonary arterial hypertension (iPAH)?
How does the pediatric bosentan formulation compare to standard-of-care endothelin receptor antagonists (ERAs) in iPAH treatment outcomes?
Which biomarkers predict response to bosentan in children with familial pulmonary arterial hypertension (fPAH) per EUCTR2004-005157-63-IT?
What adverse events are reported in EUCTR2004-005157-63-IT and how are they managed in pediatric iPAH patients?
Are there combination therapies involving bosentan and phosphodiesterase-5 (PDE5) inhibitors for pediatric pulmonary arterial hypertension treatment?