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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)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia; Familial Hypercholesterolemia; Homozygous Sitosterolemia

Intervention: Ezetimibe (Drug); Ezetimibe + other lipid-lowering medication(s) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

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.

Clinical Details

Official title: 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

Study design: Time Perspective: Prospective

Primary outcome:

A primary endpoint is the incidence of adverse events.

A primary endpoint is change in LDL-C

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

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: June 2007
Last updated: February 24, 2015

Page last updated: August 23, 2015

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