At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 151 enrolled
Drug / intervention
bosentandrug
Likely dose
bosentan 62.5 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.
Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222)
In Brief
A Phase 3 clinical trial evaluating bosentan for Pulmonary Hypertension. Completed, enrolled 151 participants.
Detailed Summary
The present trial investigates the long-term safety, tolerability and efficacy of bosentan in patients with inoperable CTEPH.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Hypertension
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2006
First PostedApr 2006
Primary CompletionFeb 2009
Study CompletionApr 2009
TodayJul 2026
First PostedApr 27, 2006
Enrollment StartJan 1, 2006
Primary CompletionFeb 1, 2009
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.2 years ago
Interventions
bosentandrug
Oral bosentan * Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients * Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight \< 40 kg)