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Clinical Trials/NCT00092599
NCT00092599
Completed
Phase 3

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of Ezetimibe 10 mg or Placebo Co-administered With Existing Simvastatin 10 mg or 20 mg in Attaining Low-Density Lipoprotein Cholesterol Target Levels in Patients With Hypercholesterolemia and Coronary Heart Disease.

Organon and Co0 sites410 target enrollmentFebruary 2003
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ConditionsHypercholesterolemiaCoronary Disease
DrugsMK0653, ezetimibeComparator: ezetimibe, placebo

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Hypercholesterolemia
Sponsor
Organon and Co
Enrollment
410
Primary Endpoint
Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

This study will evaluate patients who have coronary heart disease to determine if an investigational drug will further lower cholesterol when taken in combination with an approved cholesterol lowering medication.

Detailed Description

The duration of treatment is 10 weeks.

Registry
clinicaltrials.gov
Start Date
February 2003
End Date
July 2004
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria

  • •Patients who do not meet specific cholesterol levels as required by the study

Outcomes

Primary Outcomes

Percentage of patients reaching LDL goal of <2.60 mmol/L after 6 weeks of treatment

Secondary Outcomes

  • Safety and tolerability.

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