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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)

NCT00705211 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1794

Last updated 2022-02-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ezetimibe

Ezetimibe, 10-mg tablets,

DRUG

Ezetimibe + other lipid-lowering medication(s)

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

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Organon and Co

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-12-31
Completion
2009-12-31

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00705211 on ClinicalTrials.gov