Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)

NCT ID: NCT00157924

Last Updated: 2024-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-09-30

Brief Summary

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An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

1\. simvastatin/ezetimibe 10/20mg

Group Type EXPERIMENTAL

simvastatin (+) ezetimibe

Intervention Type DRUG

simvastatin (+) ezetimibe 10/20mg.

2

2\. atorvastatin 10mg

Group Type ACTIVE_COMPARATOR

atorvastatin

Intervention Type DRUG

atorvastatin 10mg

Interventions

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simvastatin (+) ezetimibe

simvastatin (+) ezetimibe 10/20mg.

Intervention Type DRUG

atorvastatin

atorvastatin 10mg

Intervention Type DRUG

Other Intervention Names

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MK0653A Vytorin® Lipitor®

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of hypercholesterolemia
* Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal

Exclusion Criteria

* Hypersensitivity to HMG-CoA inhibitor or Ezetimibe
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

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Related Links

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http://www.merck.com/clinical-trials/policies-perspectives.html

Click here to access a synopsis of the study results.

Other Identifiers

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MK0653A-093

Identifier Type: -

Identifier Source: secondary_id

2005_064

Identifier Type: -

Identifier Source: secondary_id

0653A-093

Identifier Type: -

Identifier Source: org_study_id

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