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Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides

NCT ID: NCT02625870

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Brief Summary

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The trial was a double-blind, randomized, parallel-group study comparing Omega-3-Acid Ethyl Esters 90 Soft Capsules and placebo. The primary objective of the present study was to evaluate the efficacy and safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in subjects with severe hypertriglyceridemia (TGs ≥500 mg/dL but \<2000 mg/dL).

Detailed Description

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Conditions

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Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Omega-3-Acid Ethyl Esters 90 Soft Capsules

Group Type EXPERIMENTAL

Omega-3-Acid Ethyl Esters 90 Soft Capsules

Intervention Type DRUG

Omega-3-Acid Ethyl Esters 90 Soft Capsules will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.

Corn Oil

Group Type PLACEBO_COMPARATOR

Corn Oil

Intervention Type DRUG

Corn Oil will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.

Interventions

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Omega-3-Acid Ethyl Esters 90 Soft Capsules

Omega-3-Acid Ethyl Esters 90 Soft Capsules will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.

Intervention Type DRUG

Corn Oil

Corn Oil will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

-1.At least 2 times of fasting serum TG concentrations≥500 mg/dL but\<2000 mg/dL at screening (2and 1 and 0 weeks before random assignment).

2.Two times qualified High Triglycerides Dietary Assessment Table at 2 and 0 weeks before random assignment according to the "prevention and treatment of dyslipidemia in Chinese adults Guide ".

Exclusion Criteria

* 1.Unable to discontinue use of other omega-3 fatty acid-containing products, bile acid sequestrants, fibrates ,niacin or any supplement used to alter lipid metabolism throughout the entire study.

2.Patients taking bile acid sequestrants, fibrate, niacin or any supplement used to alter lipid metabolism more than 6 weeks before entering the study dietary phase.

3.Subjects consuming omega-3 fatty acid-containing products such as cod liver oil, or lipid-decreasing fibers at least 4 weeks before beginning the study.

4.Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\>3 times the upper limit of normal.

5.Serum creatinine \>176μmol/L. 6.Platelet counts\<60×109/L，hemoglobin \<100 g/L. 7.Poorly controlled hypertension(resting blood pressure ≥160 mm Hg systolic or ≥100 mm Hg diastolic) 8.Uncontrolled type II diabetes(fasting blood sugar \>11.1mmol/L). 9.Type II diabetes, nephrotic syndrome, hypothyroidism. 10.Atrial fibrillation. 11.History of pancreatitis and symptomatic gallstone disease, unless treated with cholecystectomy.

12.History of cancer (other than basal cell carcinoma) in the past 2 years. 13.Allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish.

14.History in the past 12 months of drug abuse or alcohol abuse (.14 drinks per week; 1 drink was equivalent to 12 oz beer, 5 oz wine, or 1.5 oz hard liquor) was also exclusionary.

15.Exposure to any investigational product, within 30 days prior to Visit. 16.Presence of any other condition the Investigator believes would interfere the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Liang Ni, Graduate

Role: CONTACT

Phone: 18036618765

Email: [email protected]

Other Identifiers

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HROMEE2015

Identifier Type: -

Identifier Source: org_study_id