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A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)

NCT00479713 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 618

Last updated 2024-05-16

Study results available
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Summary

This is a multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus rosuvastatin in participants with high cholesterol.

Conditions

Interventions

DRUG

ezetimibe (+) simvastatin

ezetimibe/simvastatin 10/20mg. The treatment duration will be 6 weeks.

DRUG

Comparator : rosuvastatin calcium

rosuvastatin 10mg. The treatment duration will be 6 weeks.

DRUG

Comparator: Placebo (unspecified)

rosuvastatin 10mg Placebo. The treatment duration will be 6 weeks.

DRUG

Comparator: Placebo (unspecified)

ezetimibe/simvastatin 10/20mg Placebo. The treatment duration will be 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
2007-02-01
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 NCT00479713 on ClinicalTrials.gov