At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 33 enrolled
Drug / intervention
Bosentandrug
Likely dose
Not stated in 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.
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
In Brief
A Phase 3 clinical trial evaluating Bosentan for Pulmonary Arterial Hypertension. Completed, enrolled 33 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2005
First PostedApr 2006
Primary CompletionOct 2011
TodayJul 2026
First PostedApr 27, 2006
Enrollment StartAug 23, 2005
Primary CompletionOct 28, 2011
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 20.2 years ago
Interventions
Bosentandrug
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