Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pronova BioPharma
• Collaborators: Danish Heart Foundation; North Jutland County; The Danish Kidney Association

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

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.