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A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)

NCT00462748 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 786

Last updated 2024-05-16

Study results available
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Summary

To evaluate the percentage of patients with either established cardiovascular disease (CVD), at "high risk" of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C \> 2mmol/l, who are able to attain the recommended LDL-C target of \< 2mmol/l following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.

Conditions

Interventions

DRUG

ezetimibe (+) simvastatin

ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.

DRUG

Comparator: atorvastatin

atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally

DRUG

Comparator: rosuvastatin

rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.

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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-06-30
Completion
2008-06-30

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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 NCT00462748 on ClinicalTrials.gov