Ignite Creation Date:
2024-05-05 @ 11:52 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01431716
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2011-09-07
Brief Title:
Epoprostenol for Injection EFIACT-385781A - Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Multicenter Single-arm Open-label Phase 3b Study to Assess the Effects of Switching From Flolan to EFIACT-385781A in Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPITOME-2
Brief Summary:
This study is investigating the effect of switching from Flolan to Epoprostenol for Injection EFIACT-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 EFIACT-385781A and followed-up for 90 days During these 90 days safety and tolerability of EFIACT-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 EFIACT-385781A in patients with pulmonary arterial hypertension
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None