A double-blind, placebo-controlled, intervention trial comparing the triglyceride-lowering effect of omega-3 polyunsaturated fatty acids, as either ethyl ester or triglycerides in patients with moderately elevated triglyceride levels in the blood in non fasting state.

• Conditions: Hypertriglyceridemia; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]; MedDRA version: 15.0Level: LLTClassification code 10071235Term: Combined hyperlipidemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 15.0Level: LLTClassification code 10060754Term: Type IV hyperlipidemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders

• Registration Number: EUCTR2012-003029-11-DK
• Lead Sponsor: Steen Stender

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-10
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Men or women, > 18 years of age.
2. Hypertriglyceridemia with non-fasting plasma triclyceride 2.0 - 5.65 mmol/l (177 - 500 mg/dl) prior to enrolment
3. Body mass index (BMI) > 18 kg/m2 and < 35 kg/m2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Poorly regulated diabetes mellitus
2. Alcohol abuse (more than 3 drinks/day)
3. Drug abuse
4. Participation in lipid lowering studies later than 4 weeks before

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified