At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 41 enrolled
Drug / intervention
Epoprostenoldrug
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 Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)
In Brief
A Phase 3 clinical trial evaluating Epoprostenol for Pulmonary Arterial Hypertension. Completed, enrolled 41 participants.
Detailed Summary
This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
Countries--
CollaboratorsChiltern International Ltd., Effi-Stat
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
First PostedNov 2011
Primary CompletionJun 2015
Study CompletionJul 2015
TodayJul 2026
First PostedNov 11, 2011
Enrollment StartJun 1, 2011
Primary CompletionJun 1, 2015
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 14.6 years ago
Interventions
Epoprostenoldrug
Administered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit