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)

Completed

• Conditions: Hypercholesterolemia; Familial Hypercholesterolemia; Homozygous Sitosterolemia
• Interventions: Drug: Ezetimibe; Drug: Ezetimibe + other lipid-lowering medication(s)

• Registration Number: NCT00705211
• Lead Sponsor: Organon and Co

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-25
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1794

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Zetia monotherapy	Ezetimibe	Patients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia
Zetia combination therapy	Ezetimibe + other lipid-lowering medication(s)	Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia

Primary Outcome Measures

Name	Time	Method
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.)