An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.

A Placebo-Controlled, Multicenter, Randomized, Double-Blind, Parallel Group Study to Investigate the Efficacy and Safety of Omega-3-acid Ethyl Ester Over 12 Weeks in Chinese Subjects With Hypertriglyceridemia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04756180

Enrollment

248

Registered

2021-02-16

Start date

2016-10-31

Completion date

2019-04-30

Last updated

2021-03-05

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

Conditions

Hypertriglyceridemia

Brief summary

The primary objective was to investigate the effect of 12-week treatment of Omacor on fasting serum triglycerides (TG) in Chinese subjects with hypertriglyceridemia (HTG). The secondary objectives were to investigate the safety and tolerability and effect of Omacor on lipid parameters after 12 weeks treatment.

Detailed description

This was a multicenter, randomized, double-blind, parallel-group study of twice daily treatment of Omacor or matching placebo in subjects with moderate or severe HTG.

Interventions

DRUGOmega-3-acid ethyl ester or Placebo

Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

Double Blinded

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Baseline fasting serum TG level \> 200mg/dL and \<1000mg/dL, in subjects treated for HTG. * If on previous statin therapy, the treatment should have been kept stable in the last 3 months before entering the study. * Able and willing to give written informed consent.

Exclusion criteria

* Subjects taking fish oil capsules 8 weeks prior to inclusion in this study. * Known allergy to the active ingredient, or fish, soya, corn or olive oild (placebos). * Pregnant of lactating females. * Known increased risk of hemorrhage such as recent surgery, gastrointestinal hemorrhagic disease. * Significant hepatic disease. * Significantly reduced renal function. * Alcohol consumption \>30g for male and 20g for female daily. * Concomitant use of other investigational drugs. * Subject related to the investigator. * Subject expected to be not compliant.

Design outcomes

Primary

Measure	Time frame	Description
Percent change in fasting serum TG	Baseline to end of treatment at treatment week 12	Percent change from baseline in fasting serum TG

Secondary

Measure	Time frame	Description
Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio	Between baseline and end of treatment week 12	Change from baseline in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026