Ignite Creation Date:
2024-05-05 @ 10:26 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01105091
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2010-04-15
Brief Title:
Epoprostenol for Injection in Pulmonary Arterial Hypertension
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Phase IV Open-label Randomized Multicenter Study of the Safety Tolerabilityand Pharmacokinetics 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
Brief Summary:
This is a prospective multi-center open-label randomized Phase IV exploratory study comparing safety tolerability pharmacokinetics and effectiveness of ACT-385781A and Flolan epoprostenol sodium in patients with pulmonary arterial hypertension who are naïve to injectable prostanoid treatment and in need of such treatment Approximately 30 patients from 8 US clinical sites will be randomized to receive either ACT-385781A or Flolan 21 respectively for 28 days of treatment
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