A 12-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 P05244)

NCT ID: NCT00704444

Last Updated: 2022-02-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11332 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-09-30

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 12-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 2,000 institutions in Japan.

Conditions

Hypercholesterolemia; Familial Hypercholesterolemia; Homozygous Sitosterolemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Zetia monotherapy

Patients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia

Ezetimibe

Intervention Type: DRUG

Ezetimibe, 10-mg tablets

Zetia combination therapy

Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia

Ezetimibe + other lipid-lowering medication(s)

Intervention Type: DRUG

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

Interventions

Ezetimibe

Ezetimibe, 10-mg tablets

Intervention Type: DRUG

Ezetimibe + other lipid-lowering medication(s)

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

Intervention Type: DRUG

Other Intervention Names

Zetia; Zetia + other lipid-lowering medication(s)

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P05244

Identifier Type: -

Identifier Source: org_study_id