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

Study Overview
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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.

Official Title
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Comparative Efficacy of a Vytorin 10/80 Tablet Split Into 4 (Estimated Dose Ezetimibe 2.5 + Simvastatin 20) Versus Simvastatin 20 Milligrams on LDL Cholesterol

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Vytorin
* Drug: Simvastatin


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1Vytorin 10/80 divided into 4<br>Vytorin 10/80 divided into 4 | Drug: Vytorin<br>* Vytorin 10/80 split into 4<br>|
| Active Comparator: Simvastatin<br>Simvastatin 20 milligrams | Drug: Simvastatin<br>* Simvastatin 20 milligrams<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL Cholesterol |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Cholesterol |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypercholesterolemia, Statins, Ezetimibe