Vytorin Reexamination Study (0653A-174)

NCT ID: NCT01070966

Last Updated: 2022-02-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2089 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2010-04-30

Brief Summary

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This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of VYTORIN through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.

Detailed Description

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Conditions

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Primary Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)

Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/10 (ezetimibe 10 mg/simvastatin 10 mg tablets)

No interventions assigned to this group

VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)

Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/20 (ezetimibe 10 mg/simvastatin 20 mg tablets)

No interventions assigned to this group

VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)

Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/40 (ezetimibe 10 mg/simvastatin 40 mg tablets)

No interventions assigned to this group

VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)

Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® 10/80 (ezetimibe 10 mg/simvastatin 80 mg tablets)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participants Who Receives Vytorin In Usual Medical Practice Within Local Label For The First Time
Minimum Eligible Age

10 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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2010_010

Identifier Type: -

Identifier Source: secondary_id

0653A-174

Identifier Type: -

Identifier Source: org_study_id

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