NCT00704444

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)

Designated Drug Use Investigation (12 Weeks) of Zetia 10mg Tablets - A 12-Week Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11,332 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-06-25
• Last updated: 2022-02-16