NCT00651391

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Ezetimibe Plus Simvastatin Compared With Simvastatin Alone on Flow-Mediated Brachial Artery Vasoactivity in Subjects With Primary Hypercholesterolemia (The EFFECTS Trial)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypercholesterolemia
• Atherosclerosis

Interventions

Type	Name	Description
DRUG	Ezetimibe + Simvastatin	oral tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily in the evening for 12 weeks
DRUG	Simvastatin	oral simvastatin 20 mg once daily in the evening for 12 weeks
DRUG	Placebo	oral placebo once daily in the evening for 12 weeks

Timeline

• Start date: 2003-10-01
• Primary completion: 2004-09-01
• Completion: 2004-09-01
• First posted: 2008-04-02
• Last updated: 2024-08-15