Randomized Parallel Group Trial Of The Efficacy And Safety Of Ezetimibe With A Statin Versus Statin Dose Doubling In Patients With Persistent Primary Hypercholesterolemia (0653-152)(COMPLETED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-05-31

Brief Summary

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To compare the percent (%) change in plasma LDL-C concentration, after a six week course of treatment with ezetimibe 10 mg/day co-administered with an existing statin versus doubling of the existing statin dose

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1

group 1: ezetimibe 10 mg per day is added to actual statin regimen for 6 weeks followed by an observational phase of 6 months.

Group Type EXPERIMENTAL

ezetimibe

Intervention Type DRUG

ezetimibe 10 mg/day for a six week course of treatment.

statins

Intervention Type DRUG

patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase

Group 2

Group 2: patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase.

Group Type ACTIVE_COMPARATOR

statins

Intervention Type DRUG

patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase

Interventions

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ezetimibe

ezetimibe 10 mg/day for a six week course of treatment.

Intervention Type DRUG

statins

patients on statins have their dose doubled for 6 weeks followed by another 6 month observational phase

Intervention Type DRUG

Other Intervention Names

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Zetia® MK0653

Eligibility Criteria

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Inclusion Criteria

* Patients With A Diagnosis Of Primary Hypercholesterolemia And
* Who Are Defined As Being "High Risk" (10-Year Risk Of Coronary Artery Disease \> 20 % Based On The Framingham Model Or History Of Diabetes Mellitus Or Any Atherosclerosis Disease)
* And Have Not Reached Their Recommended Ldl-C Target Levels Of 2.5 Mmol/L While On A Statin Alone