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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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ClinicalTrials.gov Identifier: NCT00704444
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : February 25, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Hypercholesterolemia Familial Hypercholesterolemia Homozygous Sitosterolemia Drug: Ezetimibe Drug: Ezetimibe + other lipid-lowering medication(s)

Detailed Description:
The population will be selected from 2,000 institutions in Japan.

Study Type : Observational
Actual Enrollment : 11332 participants
Time Perspective: Prospective
Official Title: Designated Drug Use Investigation (12 Weeks) of Zetia 10mg Tablets - A 12-Week Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy
Study Start Date : June 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Group/Cohort Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 ) ]
  2. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population will be selected from 2,000 institutions in Japan.

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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704444     History of Changes
Other Study ID Numbers: P05244
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: February 25, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hypolipidemic Agents
Anticholesteremic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents