Title
Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension
An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)
Phase
Phase 3Lead Sponsor
ActelionStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Pulmonary Arterial HypertensionIntervention/Treatment
epoprostenol ...Study Participants
41This 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.
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
Inclusion Criteria: Signed informed consent prior to initiation of any study-mandated procedure Patients who completed participation in study AC-066A301 Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301 Exclusion Criteria: Patients who prematurely discontinued study drug in study AC-066A301 Patients for whom continued treatment with EFI is no longer considered appropriate
| Event Type | Organ System | Event Term | Treatment |
|---|
Duration of exposure to EFI
