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)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00705211

Enrollment

1794

Registered

2008-06-25

Start date

2007-06-30

Completion date

2009-12-31

Last updated

2022-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Hypercholesterolemia, Homozygous Sitosterolemia, Hypercholesterolemia

Brief 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.

Detailed description

The population will be selected from 200 institutions in Japan.

Interventions

DRUGEzetimibe

Ezetimibe, 10-mg tablets,

DRUGEzetimibe + other lipid-lowering medication(s)

Ezetimibe, 10-mg tablets, other lipid-lowering medication(s) as prescribed by attending physician

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	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.)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026