At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 58 enrolled
Drug / intervention
Bosentandrug
Likely dose
Bosentan 2mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Bosentan for Pulmonary Arterial Hypertension. Completed, enrolled 58 participants across 36 sites in 18 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesAustralia, Belarus, China, Czechia, France, Germany, Hungary, India, Israel, Italy, Mexico, Poland, Russia, Serbia, South Africa, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2011
First PostedApr 2011
Primary CompletionAug 2014
Study CompletionMay 2020
TodayJul 2026
First PostedApr 19, 2011
Enrollment StartMar 8, 2011
Primary CompletionAug 13, 2014
Study CompletionMay 29, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.2 years ago
Interventions
Bosentandrug
Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day