Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia

Official Title
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Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino Patients

Conditions
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Primary Hypercholesterolemia, Homozygous Familial Hypercholesterolemia

Intervention / Treatment
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* Drug: Ezetimibe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatient men or women, age 18 years and above. Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia. Exclusion Criteria: Known hypersensitivity to Ezetimibe. Moderate to severe hepatic insufficiency. Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal. Pregnancy or lactation. Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with hypercholesterolemia<br>Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin | Drug: Ezetimibe<br>* 1 tablet of 10 mg once daily<br>* Other names: SCH 58235;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as Measured by Number of Subjects With at Least One Adverse Event | Evaluation of the overall safety of ezetimibe as measured by number of subjects who experienced at least one adverse event | 28 days after Visit 1 | 
| Safety as Measured by Number and Type of Adverse Events. | Evaluation of the overall safety of ezetimibe as measured by the number and type of adverse events. | 28 days after Visit 1 | 
| Safety as Measured by Severity of Adverse Events as Determined by the Investigator | To evaulate the safety of ezetimibe as measured by severity of adverse events, as determined by the investigator | 28 days after Visit 1 | 
| Safety as Measured by Adverse Event Relatedness to Study Drug as Reported by the Investigator. | To evaluate the overall safety of ezetimibe as measured by adverse event relatedness to study drug as reported by the investigator. | 28 days after Visit 1 | 
| Safety as Measured by Dose Adjustment Upon Incidence of an Adverse Event | To evaluate the overall safety of ezetimibe as measured by action taken by the investigator upon incidence of an adverse event | 28 days after Visit 1 | 
| Safety as Measured by Outcome of Adverse Events | To evaluate overall safety of ezetimibe as measured by outcome of adverse events | 28 days after Visit 1 | 
| Tolerability as Measured by Subject Self-assessment | Evaluation of the overall tolerability of ezetimibe as measured by subject self-assessment | 28 days after Visit 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Efficacy of Ezetimibe in Lowering Serum Cholesterol Levels 28 Days After Visit 1 (Baseline) | Change in mean total cholesterol values | 28 days after Visit 1 |