Trial | NCT00257283  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    200
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.
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.
Study Started
Nov 30
2002
Study Completion
Jun 30
2005
Last Update
Mar 11
2008
Estimate

Drug Omega-3-acid ethyl esters 90

Criteria 

Inclusion Criteria:

Males and females above 18 years of age
Patients having been treated with chronic hemodialysis for at least 6 months

Patients with documented cardiovascular disease, at least one of the following

Angina pectoris
Previous Acute myocardial infarction
Previous PTCA/CABG or demonstated atheroclerosis after coronary angio
Previous Transitory Cerebral Ischemia
Previous Apoplexia Cerebri
Symptoms of peripheral vascular disease
Written informed consent

Exclusion Criteria:

Active malignant disease, except basal cell carcinoma or spinocellular carcinoma
Patients undergoing peritoneal dialysis
Any condition associated with a risk of poor compliance, as judged by investigator
Pregnant or breastfeeding
Participation in other clinical studies involving treatment with drugs.
No Results Posted