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)

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.

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Key information

Conditions

Hypercholesterolemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyslipidemias Familial Hypercholesterolemia Genetic Diseases, Inborn Homozygous Sitosterolemia Hyperlipidemias Hyperlipoproteinemia Type II Hyperlipoproteinemias Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ezetimibe

Drug

Ezetimibe, 10-mg tablets

Other names: Zetia

Ezetimibe + other lipid-lowering medication(s)

Drug

Ezetimibe, 10-mg tablets + other lipid-lowering medication(s), as prescribed by attending physician

Other names: Zetia + other lipid-lowering medication(s)

Primary outcomes

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 )
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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Collaborators

Bayer

Registry information

Official study title

Designated Drug Use Investigation (12 Weeks) of Zetia 10mg Tablets - A 12-Week Designated Drug Use Investigation of Zetia Monotherapy and Combination Therapy

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jun 25, 2008
Registry last updated: Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed