Hypercholesterolemia Clinical Trial
Official title:
The Effect of Ezetimibe 10 mg, Simvastatin 20 mg and the Combination of Simvastatin 20 mg Plus 10 mg Ezetimibe on Low Density Lipoprotein (LDL)-Subfractions in Patients With Type 2 Diabetes
It is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type 2 diabetes mellitus. The primary objective of this study will be whether there is a change of the concentrations of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups.
The selective cholesterol resorption inhibitor ezetimibe belongs to a new class of
cholesterol lowering drugs. It is of interest how ezetimibe alone or in combination with
statin may influence atherogenic dense Low Density Lipoprotein (dLDL) in patients with type
2 diabetes mellitus.
The primary objective of this study will be whether there is a change of the concentrations
of Apolipoprotein B (ApoB) in dLDL from baseline in each of the 3 treatment groups. The
comparison between treatment groups is exploratory due to insufficient power to detect any
change between treatments.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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