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)
- Conditions
- HypercholesterolemiaFamilial HypercholesterolemiaHomozygous Sitosterolemia
- Interventions
- Registration Number
- NCT00704444
- Lead Sponsor
- Organon and Co
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 11332
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Zetia monotherapy Ezetimibe Patients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia Zetia combination therapy Ezetimibe + other lipid-lowering medication(s) Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia
- Primary Outcome Measures
Name Time Method Incidence of adverse events 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 ) Change in LDL-C LDL-C at start of 12 weeks will be compared to LDL-C at the end of the 12-week period.
- Secondary Outcome Measures
Name Time Method