Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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21 February 2022 |
Main ID: |
NCT00704444 |
Date of registration:
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23/06/2008 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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)
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Scientific title:
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Designated Drug Use Investigation (12 Weeks) of Zetia 10mg Tablets - A 12-Week Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy |
Date of first enrolment:
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June 2007 |
Target sample size:
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11332 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT00704444 |
Study type:
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Observational |
Study design:
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Phase:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Hypercholesterolemia
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Homozygous Sitosterolemia
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Familial Hypercholesterolemia
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Intervention(s)
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Drug: Ezetimibe
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Drug: Ezetimibe + other lipid-lowering medication(s)
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Primary Outcome(s)
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Change in LDL-C
[Time Frame: LDL-C at start of 12 weeks will be compared to LDL-C at the end of the 12-week period.]
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Incidence of adverse events
[Time Frame: Adverse events will be monitored throughout the 12-week period. (Subjects who discontinue Zetia treatment during the 12-week period will be investigated up to the time of therapy discontinuation )]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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