Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

This study has been completed.
Sponsor:
Collaborators:
Danish Heart Foundation
The Danish Kidney Association
North Jutland County
Information provided by:
Pronova BioPharma
ClinicalTrials.gov Identifier:
NCT00257283
First received: November 21, 2005
Last updated: March 10, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Kidney Failure, Chronic
Drug: Omega-3-acid ethyl esters 90
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double Blind Comparison of Omacor and Placebo as Secondary Prevention Against Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

Resource links provided by NLM:


Further study details as provided by Pronova BioPharma:

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

Estimated Enrollment: 200
Study Start Date: November 2002
Estimated Study Completion Date: June 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257283

Locations
Denmark
Department of Nephrology, Aalborg Hospital, Aarhus University Hospital
Aalborg, Denmark, 9100
Sponsors and Collaborators
Pronova BioPharma
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00257283     History of Changes
Other Study ID Numbers: CTN K85 02024
Study First Received: November 21, 2005
Last Updated: March 10, 2008
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Pronova BioPharma:
Chronic renal failure
Hemodialysis
OMACOR (omega-3-acid ethyl ester 90)
intervention study
cardiovascular events
mortality

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 01, 2014