Status:
COMPLETED
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)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Bayer
Conditions:
Hypercholesterolemia
Familial Hypercholesterolemia
Eligibility:
All Genders
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...
Detailed Description
The population will be selected from 200 institutions in Japan.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
1794 Patients enrolled
Trial Details
Trial ID
NCT00705211
Start Date
June 1 2007
End Date
December 1 2009
Last Update
February 16 2022
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