Hyperlipidemia Clinical Trial
Official title:
Exploratory Study of the Effects of Omega-3-acid Ethyl Esters on the Lipid and Lipoprotein Profile in the Blood
The purpose of this study is to explore the effects of 8-week treatment with omega-3-acid ethyl esters on the lipid and lipoprotein profile in the blood in hyperlipidemic patients receiving a HMG-CoA reductase inhibitor by use of HPLC in comparison with the control group of patients not treated with omega-3-acid ethyl esters.
This study was designed to explore the effects of omega-3-acid ethyl esters on the lipid and
lipoprotein profile in the blood in hyperlipidemic patients receiving a
hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor in comparison with the control
group of patients not treated with omega-3-acid ethyl esters in an unblinded manner by use of
high performance liquid chromatography (HPLC) using highly-sensitive gel filtration columns,
which is a technique for analyzing lipoprotein.
Study participants who gave consent and were assessed as eligible in the eligibility
assessment will be stratified by the factors of "fasting triacylglycerol (TG; <300 mg/dL or
300 mg/dL≤) and age (<65 years or 65 years≤) at the start of the screening period" and
allocated to either the group treated with omega-3-acid ethyl esters or the group not treated
with omega-3-acid ethyl esters (1:1 ratio).
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