Trials / Completed
CompletedNCT00319267
Bosentan in Children With Pulmonary Arterial Hypertension
An Open Label, Multicenter Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Pediatric Formulation of Bosentan in Children With Idiopathic or Familial Pulmonary Arterial Hypertension
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 2 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to demonstrate that the exposure to bosentan in children with idiopathic pulmonary arterial hypertension (PAH) or familial pulmonary arterial hypertension, using a pediatric formulation, is similar to that in adults with PAH and to evaluate the tolerability and safety of a pediatric formulation of bosentan in this patient population.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bosentan | Pediatric oral formulation of bosentan, i.e., 32 mg dispersible and breakable tablets |
Timeline
- Start date
- 2005-05-01
- Primary completion
- 2006-12-01
- Completion
- 2007-02-01
- First posted
- 2006-04-27
- Last updated
- 2025-02-03
Source: ClinicalTrials.gov record NCT00319267. Inclusion in this directory is not an endorsement.