Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2005-06-30

Brief Summary

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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.

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Detailed Description

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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

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Kidney Failure, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Omega-3-acid ethyl esters 90

Intervention Type DRUG

Eligibility Criteria

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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

1. Angina pectoris
2. Previous Acute myocardial infarction
3. Previous PTCA/CABG or demonstated atheroclerosis after coronary angio
4. Previous Transitory Cerebral Ischemia
5. Previous Apoplexia Cerebri
6. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No