Back to resultsAn Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
Primary Purpose
Hypertriglyceridemia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Omega-3-acid ethyl ester or Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertriglyceridemia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omacor
Placebo
Arm Description
Omacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks
Omacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks
Outcomes
Primary Outcome Measures
Percent change in fasting serum TG
Percent change from baseline in fasting serum TG
Secondary Outcome Measures
Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio
Change from baseline in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04756180
Brief Title
An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Double Blinded
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omacor
Arm Type
Experimental
Arm Description
Omacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Omacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Omega-3-acid ethyl ester or Placebo
Intervention Description
Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week
Primary Outcome Measure Information:
Title
Percent change in fasting serum TG
Description
Percent change from baseline in fasting serum TG
Time Frame
Baseline to end of treatment at treatment week 12
Secondary Outcome Measure Information:
Title
Change in total cholesterol, LDL-cholesterol, HDL cholesterol, non-HDL-cholesterol and the LDL/HDL ratio
Description
Change from baseline 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pooi Lee Chin
Organizational Affiliation
Abbott
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Efficacy and Safety Study of Omega-3-acid Ethyl Ester in Chinese Subjects With Hypertriglyceridemia.
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