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

Hypertriglyceridemia Clinical Trial

— OMEELVHT  

Official title:

A 12-Week, Randomized, Double-Blind, Corn Oil-Controlled Phase 3 Study to Assess the Efficacy and Safety of Omega-3-Acid Ethyl Esters 90 Soft Capsules in Subjects With Severe Hypertriglyceridemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02625870
• Other study ID #: HROMEE2015
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 7, 2015
• Last updated: December 7, 2015
• Start date: December 2015

Study information

• Verified date: December 2015
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Liang Ni, Graduate
• Phone: 18036618765
• Email: niliang[@]hrs.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions		12 weeks	No
Secondary	End-of-treatment non-HDL-C percentage change from baseline under fasting conditions		12 weeks	No
Secondary	End-of-treatment TC percentage change from baseline under fasting conditions		12 weeks	No
Secondary	End-of-treatment VLDL-C percentage change from baseline under fasting conditions		12 weeks	No
Secondary	End-of-treatment HDL-C percentage change from baseline under fasting conditions		12 weeks	No
Secondary	End-of-treatment LDL-C percentage change from baseline under fasting conditions		12 weeks	No
Secondary	End-of-treatment LDL-C/HDL-C percentage change from baseline under fasting conditions		12 weeks	No
Secondary	End-of-treatment Apo A5 percentage change from baseline under fasting conditions		12 weeks	No
Secondary	End-of-treatment Apo C3 percentage change from baseline under fasting conditions		12 weeks	No