An Efficacy and Safety Study of Omega-3-acid Ethyl Ester... | NCT04756180

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

NCT04756180

Sponsor

Abbott

Status

Completed

Last Update Posted

Mar 5, 2021Actual

Enrollment

248Actual

Phase

Phase 3

Conditions

Hypertriglyceridemia

Interventions

Omega-3-acid ethyl ester or Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Apr 2019Actual

Completion Date

Apr 2019Actual

First Submitted Date

Jan 12, 2021

First Submission Date that Met QC Criteria

Feb 11, 2021

First Posted Date

Feb 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2021

Last Update Posted Date

Mar 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

248Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omacor	Experimental	Omacor 2gm/day for first 4 week followed by 4gms/day for 8 weeks	Drug: Omega-3-acid ethyl ester or Placebo
Placebo	Placebo Comparator	Omacor Placebo 2gm/day for first 4 week followed by 4gms/day for 8 weeks	Drug: Omega-3-acid ethyl ester or Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3-acid ethyl ester or Placebo	Drug	Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week	Omacor Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pooi Lee Chin	Abbott	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015228	Hypertriglyceridemia

Ancestor Terms

ID	Term
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided