Ignite Creation Date:
2024-05-05 @ 10:26 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01105117
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2010-04-15
Brief Title:
Epoprostenol for Injection in Pulmonary Arterial Hypertension - Extension of AC-066A401
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
An Open-label Extension of Study AC-066A401 Investigating the Safety and Tolerability of ACT-385781A Compared to Flolan in Injectable Prostanoid Treatment-naïve Patients With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2012-11
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-1 Ext
Brief Summary:
This is an open-label non-randomized extension to study AC-066A401 The study will assess safety and tolerability of ACT-385781A and Flolan epoprostenol sodium while providing a means for continuing treatment after ending participation in study AC-0066A401
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