Evaluation of LDL Cholesterol in Patients Switched From 10 to 5 Milligrams of Zetia (Ezetimibe)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-09-30

Brief Summary

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The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.

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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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Ezetimibe 10 mg

A whole ezetimibe 10 mg tablet

Group Type ACTIVE_COMPARATOR

Ezetimibe 10 mg

Intervention Type DRUG

Ezetimibe 10 mg daily for 4 weeks

Ezetimibe 5 mg

Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half

Group Type EXPERIMENTAL

Ezetimibe 5 mg

Intervention Type DRUG

Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half

Interventions

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Ezetimibe 10 mg

Ezetimibe 10 mg daily for 4 weeks

Intervention Type DRUG

Ezetimibe 5 mg

Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half

Intervention Type DRUG

Other Intervention Names

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Zetia Zetia

Eligibility Criteria

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Inclusion Criteria

* Subjects receiving ezetimibe 10 mg
* Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):

* 90 day prescriptions: Filled a ezetimibe prescription within the previous 4 months
* 60 day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months
* 30 day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months
* Patients willing and able to provide signed informed consent

Exclusion Criteria

* Patients not receiving ezetimibe
* Patients receiving ezetimibe 5 milligrams
* Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months
* Cancer undergoing active treatment
* Participation in any clinical study within the last 30 days
* Drug addiction or alcohol abuse within the past 6 months
* Patients unwilling or unable to provide informed consent
* Patients with poor compliance
* Women of childbearing potential

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No