Dyslipidemias Clinical Trial
Official title:
Vascepa to Accelerate Lipoprotein Uptake and Elimination (VALUE): An Open-Label, Mechanistic, Randomized, Controlled, Single-Center Trial of AMR101 in Patients With Dyslipidemia
This study is a Phase 1 pilot/feasibility mechanistic experiment to help clarify the mechanism of action of an EPA-rich fish oil preparation, icosapent ethyl, on lipid changes in statin-treated patients with residual triglyceridemia.
This is a prospective randomized, controlled pilot/feasibility experiment in a small number of statin-treated patients with residual triglyceridemia assigned to chronic daily exposure to icosapent ethyl 4 g daily vs usual care to get preliminary data to ultimately design a definitive hypothesis-testing experiment to clarify the mechanism of action whereby icosapent ethyl alters lipoprotein kinetics. The formal statistical aim is to develop statistical parameters such as central tendency, dispersion, and distributional shape to design a robust hypothesis-testing study. The primary outcome is based around stable-isotope lipoprotein kinetics, specifically apolipoprotein B kinetics. ;
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