drugset / Trial / NCT01431716

Epoprostenol for Injection (EFI/ACT-385781A) - Pulmonary Arterial Hypertension

NCT01431716

Phase 3 Completed 42 enrolled Actelion
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-03
Primary completion
2012-02
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject epoprostenol Other / unclassified Intravenous