Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

NCT00257283 | Completed Phase 4

• 1 other identifier: CTN K85 02024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure, Chronic

Keywords

Chronic renal failure; Hemodialysis; OMACOR (omega-3-acid ethyl ester 90); intervention study; cardiovascular events; mortality

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• - 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

Interventions

Omega-3-acid ethyl esters 90 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pronova BioPharma: lead
• Danish Heart Foundation: collaborator
• The Danish Kidney Association: collaborator
• North Denmark Region: collaborator

Study Sites (1)

Department of Nephrology, Aalborg Hospital, Aarhus University Hospital

Aalborg, 9100, Denmark

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• My Svensson, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 21, 2005
• First Posted: November 22, 2005
• Study Start: November 1, 2002
• Study Completion: June 1, 2005
• Last Updated: March 11, 2008

Record last verified: 2008-03

Locations

DK (1)