At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 64 enrolled
Drug / intervention
bosentandrug
Likely dose
bosentan 32 mgfrom 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, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety 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 64 participants.
Detailed Summary
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) \<12 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2010
Enrollment StartMar 2011
Primary CompletionApr 2013
Study CompletionAug 2013
TodayJul 2026
First PostedOct 19, 2010
Enrollment StartMar 8, 2011
Primary CompletionApr 3, 2013
Study CompletionAug 19, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.7 years ago
Interventions
bosentandrug
32 mg quadrisected dispersible tablet. The dosage of bosentan (2 mg/Kg) was adjusted according to the patient's body weight at initiation of the study treatment. Dosage readjustment was permitted after 12 weeks of treatment.