ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00705211
Recruitment Status : Completed
First Posted : June 25, 2008
Last Update Posted : February 25, 2015
Sponsor:
Collaborator:
Bayer
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 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 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 200 institutions in Japan.

Study Type : Observational
Actual Enrollment : 1794 participants
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
Study Start Date : June 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 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. 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.) ]
  2. 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.) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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.

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705211     History of Changes
Other Study ID Numbers: P05245
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: February 25, 2015
Last Verified: February 2015

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