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)

• Register: ClinicalTrials.gov
• Last refreshed on: 21 February 2022
• Main ID: NCT00705211
• Date of registration: 23/06/2008
• Prospective Registration: No
• Primary sponsor: Organon and Co
• Public title: 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)
• Scientific title: 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
• Date of first enrolment: June 2007
• Target sample size: 1794
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00705211
• Study type: Observational

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Homozygous Sitosterolemia

Familial Hypercholesterolemia

Hypercholesterolemia

Intervention(s)

Drug: Ezetimibe

Drug: Ezetimibe + other lipid-lowering medication(s)

Primary Outcome(s)

A primary endpoint is change in LDL-C [Time Frame: 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.)]

A primary endpoint is the incidence of adverse events. [Time Frame: 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.)]

Secondary ID(s)

P05245

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bayer