At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 2 enrolled
Drug / intervention
ACT-385781A (Actelion Epoprostenol) +1 moredrug
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-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan® in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension (PAH)
In Brief
A Phase 4 clinical trial evaluating ACT-385781A (Actelion Epoprostenol) and Flolan® for Pulmonary Arterial Hypertension. Completed, enrolled 2 participants across 7 sites.
Detailed Summary
This is an open-label, non-randomized extension to study AC-066A401. The study will assess safety and tolerability of ACT-385781A and Flolan (epoprostenol sodium) while providing a means for continuing treatment after ending participation in study AC-0066A401.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Arterial Hypertension
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2010
Enrollment StartMay 2010
Primary CompletionJul 2011
Study CompletionDec 2011
TodayJul 2026
First PostedApr 16, 2010
Enrollment StartMay 1, 2010
Primary CompletionJul 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.2 years ago
Interventions
ACT-385781A (Actelion Epoprostenol)drug
per Prescribing Information
Flolan®drug
per Prescribing Information