Hyperlipidemia Clinical Trial
Official title:
Exploratory Study of the Effect of Omega-3-acid Ethyl Esters on Vascular Endothelial Function in Patients With Hyperlipidemia by Flow Mediated Dilation
The purpose of this study is to explore the effects of omega-3-acid ethyl esters (TAK-085) on vascular endothelial function when administered for 8 weeks, as measured by FMD, in patients with hyperlipidemia.
This is a multicenter, collaborative, randomized, open-label study designed to explore the
effects of administration of omega-3-acid ethyl esters (TAK-085) [2 g (2 g PO QD) or 4 g (2 g
PO BID) for 8 weeks] on vascular endothelial function, as measured by flow-mediated dilation
(FMD), in patients receiving a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor
and have concurrent hypertriglyceridemia.
Considering the potential bias by factors that affect FMD between treatment groups,
stratified allocation will be performed with fasting triglyceride (TG) level as a factor.
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