NCT01431716

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

A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to EFI/ACT-385781A in Patients With Pulmonary Arterial Hypertension

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	EFI/ACT-385781A

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-02-01
• Completion: 2012-07-01
• First posted: 2011-09-12
• Last updated: 2015-01-13
• Results posted: 2015-01-13

Locations

8 sites across 6 countries: Belgium, Canada, France, Italy, Netherlands, Spain