Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

March 10, 2008 updated by: Pronova BioPharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9100
        • Department of Nephrology, Aalborg Hospital, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
- 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pronova BioPharma

Collaborators

Danish Heart Foundation
The Danish Kidney Association
North Jutland County

Investigators

  • Principal Investigator: My Svensson, MD, Department of Nephrology, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (ESTIMATE)

November 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 11, 2008

Last Update Submitted That Met QC Criteria

March 10, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTN K85 02024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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