Trials / Completed
CompletedNCT00319020
Bosentan in Children With Pulmonary Arterial Hypertension Extension Study
An Open Label, Long-term, Safety, and Tolerability Extension Study Using the Pediatric Formulation of Bosentan in the Treatment of Children With Idiopathic or Familial Pulmonary Arterial Hypertension Who Completed FUTURE 1
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 2 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of the FUTURE 2 study was to assess the long-term safety and tolerability of the pediatric formulation of bosentan in children with idiopathic pulmonary arterial hypertension or familial pulmonary arterial hypertension who completed FUTURE 1 study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bosentan | 32-mg dispersible and breakable tablet. The body weight-adjusted dose of the dispersible tablet was dispersed in a teaspoon of water (not mixed with food) before being administered orally |
Timeline
- Start date
- 2005-08-23
- Primary completion
- 2011-10-28
- Completion
- 2011-10-28
- First posted
- 2006-04-27
- Last updated
- 2025-02-04
- Results posted
- 2017-03-29
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT00319020. Inclusion in this directory is not an endorsement.