A 52-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05245)

Study Overview
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Brief Summary
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This study is a non-interventional (observational) study in Japan to confirm the safety and efficacy of Zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 52-week period. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Detailed Description
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The population will be selected from 200 institutions in Japan.

Official Title
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Designated Drug Use Investigation (Long-Term Administration) of Zetia 10-mg Tablets - A 52-Week Long-Term Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy

Conditions
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Hypercholesterolemia, Familial Hypercholesterolemia, Homozygous Sitosterolemia

Intervention / Treatment
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* Drug: Ezetimibe
* Drug: Ezetimibe + other lipid-lowering medication(s)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study. Zetia monotherapy patients must be treated with Zetia alone. Zetia combination therapy patients must be treated with Zetia in combination with other lipid-lowering drugs for hypercholesterolemia. Exclusion Criteria: Patients with a history of hypersensitivity to any ingredient in Zetia Patients with serious hepatic function disorder should not be treated with Zetia in combination with an HMG-CoA reductase inhibitor.
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 |
| --- | --- |
| Zetia monotherapy<br>Patients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia | Drug: Ezetimibe<br>* Ezetimibe, 10-mg tablets,<br>* Other names: Zetia;|
| Zetia combination therapy<br>Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia | Drug: Ezetimibe + other lipid-lowering medication(s)<br>* Ezetimibe, 10-mg tablets, other lipid-lowering medication(s) as prescribed by attending physician<br>* Other names: Zetia + other lipid-lowering medication(s);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A primary endpoint is the incidence of adverse events. |  | Adverse events will be monitored throughout the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy discontinuation.) | 
| A primary endpoint is change in LDL-C |  | LDL-C at start of 52 weeks will be compared to LDL-C at the end of the 52-week period. (Subjects who discontinue Zetia treatment during the 52-week period will be investigated up to the time of therapy discontinuation.) |