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)
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.
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