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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04756180
Other study ID # PUFA3001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2016
Est. completion date April 2019

Study information

Verified date March 2021
Source Abbott
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 248
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Abbott

Outcome

Type Measure Description Time frame Safety issue
Primary Percent change in fasting serum TG Percent change from baseline in fasting serum TG Baseline to end of treatment at treatment week 12
Secondary 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 Between baseline and end of treatment week 12
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