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Ezetimibe Plus Simvastatin Versus Simvastatin Alone in African-American Subjects With Primary Hypercholesterolemia (P03377)

NCT00650663 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 247

Last updated 2024-08-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether coadministration of ezetimibe 10 mg/day with simvastatin 20 mg/day for 12 weeks will result in greater reduction of LDL-C, total cholesterol (TC), triglycerides (TG), non HDL-C, and apolipoprotein B (ApoB), and greater increase in HDL-C, compared with simvastatin 20 mg/day as monotherapy for 12 weeks in African-American subjects with primary hypercholesterolemia. This study is being performed to better define the efficacy of ezetimibe coadministered with simvastatin in this population.

Conditions

Interventions

DRUG

Ezetimibe + Simvastatin

oral tablets; ezetimibe 10 mg and simvastatin 20 mg once daily for 12 weeks

DRUG

Simvastatin

oral tablet; simvastatin 20 mg once daily for 12 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
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

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Entities

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 NCT00650663 on ClinicalTrials.gov