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Effectiveness and Safety of Ezetimibe Added to Atorvastatin in Patients With High Cholesterol and Coronary Heart Disease (Study P03740)

NCT00202904 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2022-02-16

No results posted yet for this study

Summary

This is a multicenter, randomized, parallel group, placebo controlled study designed to evaluate the efficacy, safety, and tolerability of ezetimibe added to ongoing atorvastatin therapy compared with ongoing atorvastatin treatment alone. This study will involve subjects with primary hypercholesterolemia and coronary heart disease (CHD) who are currently being treated with atorvastatin and who would benefit from additional reduction in low-density lipoprotein cholesterol (LDL-C).

Conditions

Interventions

DRUG

ezetimibe

ezetimibe 10 mg tablets, one tablet taken daily with atorvastatin 10 mg daily for 6 weeks

DRUG

placebo

placebo tablets matched to ezetimibe, one tablet taken daily with atorvastatin 10 mg daily for 6 weeks

Sponsors & Collaborators

  • Organon and Co

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-10-31
Completion
2006-10-31

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Entities

Drugs
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 NCT00202904 on ClinicalTrials.gov