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Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol

NCT ID: NCT00762164

Last Updated: 2013-07-03

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

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-05-31

Brief Summary

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The purpose of this study is to compare the efficacy of a Vytorin 10/80 tablet, an approved agent for the treatment of elevated LDL cholesterol which combines the cholesterol absorption inhibitor Ezetimibe 10 mg and simvastatin 80 mg, when split into 4 using a tablet splitter, versus a whole simvastatin 20 milligram tablet.

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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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1Vytorin 10/80 divided into 4

Vytorin 10/80 divided into 4

Group Type ACTIVE_COMPARATOR

Vytorin

Intervention Type DRUG

Vytorin 10/80 split into 4

Simvastatin

Simvastatin 20 milligrams

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Simvastatin 20 milligrams

Interventions

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Vytorin

Vytorin 10/80 split into 4

Intervention Type DRUG

Simvastatin

Simvastatin 20 milligrams

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects with an LDL-cholesterol greater than 100 mg/dL
* Patients willing and able to provide signed informed consent

Exclusion Criteria

* Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
* Patients intolerant of statins
* Patients receiving ezetimibe
* Patients intolerant of ezetimibe
* Patients receiving a niacin preparation
* Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
* Cancer undergoing active treatment
* Creatinine clearance \< 50 ml/minute
* Active liver disease or persistent elevation of SGOT or SGPT \> 2 times the upper limit of normal level
* Participation in any clinical study within the last 30 days
* Drug addition or alcohol abuse within the past 6 months
* Use of azole antifungal agents, amiodarone, fibrates or immunosuppressant drugs within the last 3 months
* Active use of macrolide antibiotics or verapamil
* Consumption of grapefruit juice on a daily basis
* Patients unwilling or unable to provide informed consent
* Patients with poor compliance
* Women of childbearing potential
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bronx VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Lawrence Baruch

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lawrence Baruch, MD

Role: PRINCIPAL_INVESTIGATOR

Bronx VA Medical Center

Locations

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Bronx VA Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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VA---19-07-01

Identifier Type: -

Identifier Source: org_study_id

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