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
1 other identifier
interventional
248
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedMarch 5, 2021
March 1, 2021
2.5 years
January 12, 2021
March 3, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in fasting serum TG
Percent change from baseline in fasting serum TG
Baseline to end of treatment at treatment week 12
Secondary Outcomes (1)
Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio
Between baseline and end of treatment week 12
Study Arms (2)
Omacor
EXPERIMENTALOmacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks
Placebo
PLACEBO COMPARATOROmacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks
Interventions
Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pooi Lee Chin
Abbott
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Double Blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2021
First Posted
February 16, 2021
Study Start
October 1, 2016
Primary Completion
April 1, 2019
Study Completion
April 1, 2019
Last Updated
March 5, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share