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

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756180
• Other study ID #: PUFA3001
• Status: Completed
• Phase: Phase 3
• Start date: October 2016
• Est. completion date: April 2019

Study information

• Verified date: March 2021
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Hypertriglyceridemia

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