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)

February 7, 2022 updated by: Organon and Co

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The population will be selected from 200 institutions in Japan.

Study Type

Observational

Enrollment (Actual)

1794

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population will be selected from 200 institutions in Japan.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • 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 Names:
  • Zetia + other lipid-lowering medication(s)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.)
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.)
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.)
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.)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Organon and Co

Collaborators

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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