Status:
COMPLETED
Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
Lead Sponsor:
Pronova BioPharma
Collaborating Sponsors:
Danish Heart Foundation
The Danish Kidney Association
Conditions:
Kidney Failure, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 hemo...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00257283
Start Date
November 1 2002
End Date
June 1 2005
Last Update
March 11 2008
Active Locations (1)
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1
Department of Nephrology, Aalborg Hospital, Aarhus University Hospital
Aalborg, Denmark, 9100