Clinical trial NCT02625870: Omega-3-Acid Ethyl Esters 90 Soft Capsules for Lowering Very High Triglycerides
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertriglyceridemia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-09
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions
timeFrame: 12 weeks
Secondary outcomes:
measure: End-of-treatment non-HDL-C percentage change from baseline under fasting conditions
timeFrame: 12 weeks
measure: End-of-treatment TC percentage change from baseline under fasting conditions
timeFrame: 12 weeks
measure: End-of-treatment VLDL-C percentage change from baseline under fasting conditions
timeFrame: 12 weeks
measure: End-of-treatment HDL-C percentage change from baseline under fasting conditions
timeFrame: 12 weeks
measure: End-of-treatment LDL-C percentage change from baseline under fasting conditions
timeFrame: 12 weeks
measure: End-of-treatment LDL-C/HDL-C percentage change from baseline under fasting conditions
timeFrame: 12 weeks
measure: End-of-treatment Apo A5 percentage change from baseline under fasting conditions
timeFrame: 12 weeks
measure: End-of-treatment Apo C3 percentage change from baseline under fasting conditions
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: