Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257283
• Other study ID #: CTN K85 02024
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2005
• Last updated: March 10, 2008
• Start date: November 2002
• Est. completion date: June 2005

Study information

• Verified date: March 2008
• Source: Pronova BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Omega-3-acid ethyl esters 90

Locations

Country	Name	City	State
Denmark	Department of Nephrology, Aalborg Hospital, Aarhus University Hospital	Aalborg

Sponsors (4)

Lead Sponsor	Collaborator
Pronova BioPharma	Danish Heart Foundation, North Jutland County, The Danish Kidney Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint, including either of the following events:
Primary	- Acute Myocardial Infarction
Primary	- Angina Pectoris, leading to coronary investigation or intervention
Primary	- Transient Cerebral Ischemia (TCI)
Primary	- Apoplexia cerebri (stroke)
Primary	- Peripheral Vascular disease, new symptoms or worsening of old symptoms
Primary	- Death
Secondary	- Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)
Secondary	- Efficacy, fatty acid profile for phospholipids fraction
Secondary	- Efficacy: diet registration, fish score
Secondary	- Thrombosis and/or stenosis of dialysis graft
Secondary	- Effect on heart rate variability, substudy of 50 patients at baseline and after three months