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Completed

NCT Number: NCT04756180

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

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.

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Key information

Conditions

Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omega-3-acid ethyl ester or Placebo

Drug

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

Primary outcomes

  1. Percent change in fasting serum TG

    Time frame: Baseline to end of treatment at treatment week 12

    Percent change from baseline in fasting serum TG

Secondary outcomes

  1. Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 16, 2021
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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