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To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)

NCT00276458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2024-05-13

Study results available
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Summary

The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.

Conditions

Interventions

DRUG

Comparator: atorvastatin

Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks

DRUG

Comparator: Placebo

Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks

DRUG

Comparator: ezetimibe

Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.

DRUG

Comparator: Placebo.

Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2008-01-31
Completion
2008-01-31

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Entities

Diseases

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 NCT00276458 on ClinicalTrials.gov