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

Study Overview
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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.

Official Title
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Prospective Evaluation of LDL Levels in Patients Converted From Zetia (Ezetimibe)10 mg to 5 mg

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Ezetimibe 10 mg
* Drug: Ezetimibe 5 mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ezetimibe 10 mg<br>A whole ezetimibe 10 mg tablet | Drug: Ezetimibe 10 mg<br>* Ezetimibe 10 mg daily for 4 weeks<br>* Other names: Zetia;|
| Experimental: Ezetimibe 5 mg<br>Ezetimibe 5 mg, formulated by splitting a 10 mg ezetimibe tablet in half | Drug: Ezetimibe 5 mg<br>* Ezetimibe 5 mg daily for 4 weeks, formulated as a 10 mg tablet split in half<br>* Other names: Zetia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL Cholesterol | LDL cholesterol | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol | Total cholesterol fasting | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholesterol, Ezetimibe