MedTrace Logo

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

NCT00651391 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2024-08-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-01
Primary Completion
2004-09-01
Completion
2004-09-01

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00651391 on ClinicalTrials.gov