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

March 3, 2021 updated by: Abbott

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Omacor
Omacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks
Drug: Omega-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
PLACEBO_COMPARATOR: Placebo
Omacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks
Drug: Omega-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to end of treatment at treatment week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Between baseline and end of treatment week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Pooi Lee Chin, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2016

Primary Completion (ACTUAL)

April 1, 2019

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (ACTUAL)

February 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUFA3001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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