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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.

Ethyl ester Versus Triglyceride formulations of long chained omega-3 fatty acids in moderate hypertriglyceridemia - a randomized placebo-controlled clinical trial (EVT) - EVT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-003029-11-DK
Enrollment
Unknown
Registered
2012-09-10
Start date
2012-09-10
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertriglyceridemia MedDRA version: 15.0 Level: LLT Classification code 10071235 Term: Combined hyperlipidemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 15.0 Level: LLT Classification code 10060754 Term: Type IV hyperlipidemia System Organ Class: 10010331 - Congenital, familial and genetic disorders

Interventions

Trade Name: Omacor Pharmaceutical Form: Capsule, soft INN or Proposed INN: EICOSAPENTAENOIC ACID ETHYL ESTER CAS Number: 73310-10-8 Other descriptive name: EICOSAPENTAENOIC ACID ETHYL ESTER Concentrat

Sponsors

Steen Stender
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: A comparison of the triglyceride lowering effect, in th non-fasting state of the prescription drug Lovaza/Omacor given in the approved dose of 4 g/day (1,860 mgEPA + 1,500 mg DHA in the ethyl ester form) to that of a non-presription;Secondary Objective: Any alteration in efficacy tests No. 2 - 15. 2. P-total cholesterol (TC) 3. P-LDL-cholesterol (LDL-C) 4. P-HDL-cholesterol (HDL-C) 5. TC: HDL-C ratio 6. LDL-C:HDL-C ratio;Primary end point(s): 1. Alteration in non-fasting plasma triglycerides concentration from study-start to study-end group 1-2, as comparet to the placebo group (group 3);Timepoint(s) of evaluation of this end point: Eight weeks for all primary endpoints—

Secondary

MeasureTime frame
Secondary end point(s): 1. Any alteration in efficacy tests No. 2-15. 2. Correlation between changes in the omega-3 index, TG, and other efficacy tests;Timepoint(s) of evaluation of this end point: Eight weeks for all secondary endpoints—

Countries

Denmark

Contacts

Public ContactDepartment of Clinical Biochemistry

Gentofe University Hospital

steen.stender@regionh.dk4539773120

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026