Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)

NCT ID: NCT00704535

Last Updated: 2022-02-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4105 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-04-30

Brief Summary

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The purpose of this study is to evaluate the overall safety, tolerability, and efficacy of Ezetimibe when used alone or in combination with a statin in patients with hypercholesterolemia

Detailed Description

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Conditions

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Primary Hypercholesterolemia Homozygous Familial Hypercholesterolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects with hypercholesterolemia

Subjects with hypercholesterolemia that are using Ezetimibe either alone or in combination with a statin

Ezetimibe

Intervention Type DRUG

1 tablet of 10 mg once daily

Interventions

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Ezetimibe

1 tablet of 10 mg once daily

Intervention Type DRUG

Other Intervention Names

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SCH 58235

Eligibility Criteria

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Inclusion Criteria

* Outpatient men or women, age 18 years and above.
* Patients with primary (heterozygous familial and non-familial) hypercholesterolemia or homozygous familial hypercholesterolemia.

Exclusion Criteria

* Known hypersensitivity to Ezetimibe.
* Moderate to severe hepatic insufficiency.
* Persistent elevation of serum transaminase levels of more than 1.5 times the upper limit of normal.
* Pregnancy or lactation.
* Concomitant intake of bile acid sequestrants (resins), nicotinic acid (niacin), fibric acid (fibrates), or cyclosporine
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P04748

Identifier Type: -

Identifier Source: org_study_id

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