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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
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 will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.
End-of-treatment Serum Triglycerides percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment non-HDL-C percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment TC percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment VLDL-C percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment HDL-C percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment LDL-C percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment LDL-C/HDL-C percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment Apo A5 percentage change from baseline under fasting conditions
Time frame: 12 weeks
End-of-treatment Apo C3 percentage change from baseline under fasting conditions
Time frame: 12 weeks
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