Trials / Completed
CompletedNCT01338415
FUTURE 3 Study Extension
A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 3 Months – 12 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bosentan | Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day |
Timeline
- Start date
- 2011-03-08
- Primary completion
- 2014-08-13
- Completion
- 2020-05-29
- First posted
- 2011-04-19
- Last updated
- 2025-03-30
- Results posted
- 2017-12-11
Locations
36 sites across 18 countries: United States, Australia, Belarus, China, Czechia, France, Germany, Hungary, India, Israel, Italy, Mexico, Poland, Russia, Serbia, South Africa, Spain, Ukraine
Source: ClinicalTrials.gov record NCT01338415. Inclusion in this directory is not an endorsement.