NCT00257283

Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

A Double Blind Comparison of Omacor and Placebo as Secondary Prevention Against Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Pronova BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Failure, Chronic

Interventions

Type	Name	Description
DRUG	Omega-3-acid ethyl esters 90

Timeline

• Start date: 2002-11-01
• Completion: 2005-06-01
• First posted: 2005-11-22
• Last updated: 2008-03-11

Locations

1 site across 1 country: Denmark