Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257283
Status:
COMPLETED
Last Update Posted:
2008-03-11
First Post:
2005-11-21
Brief Title:
Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
Sponsor:
Pronova BioPharma
Organization:
Pronova BioPharma
Study Overview
Official Title:
A Double Blind Comparison of Omacor and Placebo as Secondary Prevention Against Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
Status:
COMPLETED
Status Verified Date:
2008-03
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:
None
Brief Summary:
The aim of this investigator initated study is to examine the effect of OMACOR Omega-3-acid ethyl ester 90 on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis who has previously experienced a cardiovascular event
Detailed Description:
Patients with renal failure have a high incidence of cardiovascular disease and increased premature mortality Omega-3 polyunsaturated fatty acids from fish are known to have cardioprotective effects in subects with normal renal function The aim of present study is to examine the effect of OMACOR Omega-3-acid ethyl ester 90 on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis who has previously experienced a cardiovascular event
Design A prospective randomised placebo controlled study 2 year treatment period
Design A prospective randomised placebo controlled study 2 year treatment period
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