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The Effects of Omega-3 Fatty Acid (OMACOR) on the Low-density Lipoprotein (LDL) Sub-fraction in Type 2 Diabetic Patients

NCT00758927 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2009-08-06

No results posted yet for this study

Summary

The purpose of this study is to verify the possible effects of OMACOR(omega-3 fatty acid) on the percentage change of small dense LDL fraction in type 2 diabetic patients with combined hyperlipidemia, we perform open-label prospective randomized multi-institutional phase IV study.

Conditions

Interventions

DRUG

Omega-3 acid 4 grams per day

OMACOR 4 grams per day is administered simultaneously with exercise and diet therapy

DRUG

Placebo control

Placebo will be administered simultaneously with exercise and diet therapy in same intensity with the experimental arm

Sponsors & Collaborators

  • Kuhnil Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Inje University

    lead OTHER

Principal Investigators

  • Jeong H Park, M.D., Ph.D. · Director, Paik Diabetes Center, Pusan Paik Hospital, Inje University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-04-30
Completion
2010-07-31

Countries

  • South Korea

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 NCT00758927 on ClinicalTrials.gov