At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 116 enrolled
Drug / intervention
Bosentan 62.5 mg +1 moredrug
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 Bosentan Open Label Extension of the AC-052-331 Study in Systemic Sclerosis Patients With Ischemic Digital Ulcers
In Brief
A Phase 3 clinical trial evaluating Bosentan 62.5 mg and Bosentan 125 mg for Digital Ulcers. Completed, enrolled 116 participants.
Detailed Summary
The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDigital Ulcers
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2004
First PostedApr 2006
Primary CompletionJan 2009
TodayJul 2026
First PostedApr 27, 2006
Enrollment StartJul 8, 2004
Primary CompletionJan 22, 2009
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 20.2 years ago
Interventions
Bosentan 62.5 mgdrug
Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose)
Bosentan 125 mgdrug
Bosentan 125-mg oral tablets administered b.i.d. (target dose)