Effect of Ezetimibe Plus Simvastatin on Flow-Mediated Brachial Artery Vasoactivity in Subjects With Primary Hypercholesterolemia (Study P03336)

Summary

The purpose of this study is to evaluate the effect of ezetimibe coadministered with simvastatin compared with simvastatin alone when administered for 12 weeks on endothelial function as assessed by brachial artery reactivity testing (BART) using high-frequency ultrasound to image the brachial artery vasomotor response to a flow-mediated stimulus (high-shear stress) in subjects with high cholesterol. The secondary objectives include evaluation of nitroglycerin-induced vasodilation. In addition, lipid parameters (low-density-lipoprotein cholesterol \[LDL-C\], high-density-lipoprotein cholesterol \[HDL-C\], triglycerides \[TG\], total cholesterol \[TC\]) and C reactive protein (CRP) will be assessed by treatment group.

Timeline

Start

2003-10-01

Primary completion

2004-09-01

Completion

2004-09-01

Drugs

Indications