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Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

Primary Purpose

Kidney Failure, Chronic

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Omega-3-acid ethyl esters 90
Sponsored by
Pronova BioPharma
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Chronic renal failure, Hemodialysis, OMACOR (omega-3-acid ethyl ester 90), intervention study, cardiovascular events, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Nephrology, Aalborg Hospital, Aarhus University Hospital

Outcomes

Primary Outcome Measures

Composite endpoint, including either of the following events:
- Acute Myocardial Infarction
- Angina Pectoris, leading to coronary investigation or intervention
- Transient Cerebral Ischemia (TCI)
- Apoplexia cerebri (stroke)
- Peripheral Vascular disease, new symptoms or worsening of old symptoms
- Death

Secondary Outcome Measures

- Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)
- Efficacy, fatty acid profile for phospholipids fraction
- Efficacy: diet registration, fish score
- Thrombosis and/or stenosis of dialysis graft
- Effect on heart rate variability, substudy of 50 patients at baseline and after three months

Full Information

First Posted
November 21, 2005
Last Updated
March 10, 2008
Sponsor
Pronova BioPharma
Collaborators
Danish Heart Foundation, The Danish Kidney Association, North Jutland County
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1. Study Identification

Unique Protocol Identification Number
NCT00257283
Brief Title
Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
Official Title
A Double Blind Comparison of Omacor and Placebo as Secondary Prevention Against Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pronova BioPharma
Collaborators
Danish Heart Foundation, The Danish Kidney Association, North Jutland County

4. Oversight

5. Study Description

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 hemodialysis, who has previously experienced a cardiovascular event.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Chronic renal failure, Hemodialysis, OMACOR (omega-3-acid ethyl ester 90), intervention study, cardiovascular events, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Omega-3-acid ethyl esters 90
Primary Outcome Measure Information:
Title
Composite endpoint, including either of the following events:
Title
- Acute Myocardial Infarction
Title
- Angina Pectoris, leading to coronary investigation or intervention
Title
- Transient Cerebral Ischemia (TCI)
Title
- Apoplexia cerebri (stroke)
Title
- Peripheral Vascular disease, new symptoms or worsening of old symptoms
Title
- Death
Secondary Outcome Measure Information:
Title
- Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)
Title
- Efficacy, fatty acid profile for phospholipids fraction
Title
- Efficacy: diet registration, fish score
Title
- Thrombosis and/or stenosis of dialysis graft
Title
- Effect on heart rate variability, substudy of 50 patients at baseline and after three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
My Svensson, MD
Organizational Affiliation
Department of Nephrology, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nephrology, Aalborg Hospital, Aarhus University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

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