MedTrace Logo

Effects of High-dose n-3 Fatty Acids on Clinical Outcome and Serum Lipids - Omacor Following Acute Myocardial Infarction

NCT01422317 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-02-22

No results posted yet for this study

Summary

The object of this study was to evaluate the effect of a high-dose ethylester concentrate of of n-3 fatty acids administered early after an acute myocardial infarction on subsequent cardiac events and serum lipids.The second purpose of this study was to assess the impact of high-dose n-3 fatty acids on several markers of coagulation, inflammation, endothelial dysfunction and lipid peroxidation. Re-investigation was intended after a prolonged wash-out-period.

Conditions

Interventions

DRUG

EPA / DHA / Alpha-Tocopherol

Two gelatine capsules of Omacor-R (Pronova AS, Oslo) twice a day, each containing 850-882 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as ethylesters in the average ratio of EPA to DHA of 1:2. Alpha-Tocopherol (4 mg) was added to each capsule.

DRUG

Corn Oil / Alpha-Tocopherol (4 mg)

Two gelatine capsules twice a day. Each capsule contains 1g Corn Oil and 4 mg Alpha-Tocopherol

Sponsors & Collaborators

  • University of Bergen

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Pharmacia and Upjohn

    collaborator INDUSTRY

  • Pronova BioPharma

    collaborator INDUSTRY

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Dennis WT Nilsen, PhD · Department of Medicine, the Division of Cardiology, the Central Hospital in Rogaland, Norway, and the University of Bergen, Norway

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-09-30
Primary Completion
1997-12-31
Completion
2002-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01422317 on ClinicalTrials.gov