Conditions: Pulmonary Arterial Hypertension
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 42
Healthy volunteers: no

Brief summary:
This study is investigating the effect of switching from Flolan® to Epoprostenol for Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated with Flolan®. For this purpose patients being treated for at least 12 months with Flolan® will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety, tolerability, efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients with pulmonary arterial hypertension.

Detailed description:

Arms:
arm 1: EFI/ACT-385781 administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump

Interventions: intervention 1: EFI/ACT-385781A
Intervention descriptions: intervention 1: None

Protocol document: