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The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)

NCT00423579 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-22

Study results available
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Summary

This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients with hypercholesterolemia and coronary heart disease.

Conditions

Interventions

DRUG

Ezetimibe/Simvastatin 10/20 mg

1 tablet containing 10 mg of ezetimibe and 20 mg of simvastatin per day for 6 weeks

DRUG

simvastatin 40 mg

1 tablet containing 40 mg of simvastatin per day for 6 weeks

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-07-01
Primary Completion
2008-03-01
Completion
2008-03-01

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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 NCT00423579 on ClinicalTrials.gov