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)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Collaborator:
Bayer
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00705211
First received: June 23, 2008
Last updated: March 7, 2013
Last verified: March 2013
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Purpose
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 52-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.
| Condition | Intervention |
|---|---|
|
Hypercholesterolemia Familial Hypercholesterolemia Homozygous Sitosterolemia |
Drug: Ezetimibe Drug: Ezetimibe + other lipid-lowering medication(s) |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Chanarin-Dorfman syndrome
cholesteryl ester storage disease
Farber lipogranulomatosis
hypercholesterolemia
sitosterolemia
MedlinePlus related topics:
Cholesterol
Drug Information available for:
Ezetimibe
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- 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.) ] [ Designated as safety issue: Yes ]
- 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.) ] [ Designated as safety issue: Yes ]
| Enrollment: | 1794 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Zetia monotherapy
Patients to be treated with Zetia alone (10-mg tablets,) for hypercholesterolemia
|
Drug: Ezetimibe
Ezetimibe, 10-mg tablets,
Other Name: Zetia
|
|
Zetia combination therapy
Patients to be treated with Zetia (10-mg tablets,) in combination with other lipid-lowering drugs for hypercholesterolemia
|
Drug: Ezetimibe + other lipid-lowering medication(s)
Ezetimibe, 10-mg tablets, other lipid-lowering medication(s) as prescribed by attending physician
Other Name: Zetia + other lipid-lowering medication(s)
|
Detailed Description:
The population will be selected from 200 institutions in Japan.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
The population will be selected from 200 institutions in Japan.
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00705211 History of Changes |
| Other Study ID Numbers: | P05245 |
| Study First Received: | June 23, 2008 |
| Last Updated: | March 7, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipoproteinemia Type II Intestinal Diseases Lipid Metabolism, Inborn Errors Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Metabolism, Inborn Errors Genetic Diseases, Inborn Hyperlipoproteinemias |
Gastrointestinal Diseases Digestive System Diseases Hypolipidemic Agents Ezetimibe Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Anticholesteremic Agents |
ClinicalTrials.gov processed this record on June 18, 2013