At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 37 enrolled
Drug / intervention
Tracleer®drug
Likely dose
Tracleer® 125 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.
A Multi-Center, Open-Label Extension Study to Protocol AC-052-405 to Evaluate the Safety and Efficacy of Tracleer (Bosentan) in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger Physiology
In Brief
A Phase 4 clinical trial evaluating Tracleer® for Pulmonary Arterial Hypertension. Completed, enrolled 37 participants across 17 sites in 11 countries.
Detailed Summary
This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2004
Primary CompletionDec 2005
First PostedAug 2006
TodayJul 2026
First PostedAug 23, 2006
Enrollment StartJan 1, 2004
Primary CompletionDec 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 19.9 years ago
Interventions
Tracleer®drug
Patients will receive up to 125 mg b.i.d. of Tracleer.