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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00762164
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : July 3, 2013
Last Update Posted : July 3, 2013
Information provided by (Responsible Party):
Lawrence Baruch, Bronx VA Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Vytorin Drug: Simvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
Active Comparator: 1Vytorin 10/80 divided into 4
Vytorin 10/80 divided into 4
Drug: Vytorin
Vytorin 10/80 split into 4

Active Comparator: Simvastatin
Simvastatin 20 milligrams
Drug: Simvastatin
Simvastatin 20 milligrams

Primary Outcome Measures :
  1. LDL Cholesterol [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Total Cholesterol [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00762164

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United States, New York
Bronx VA Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
Bronx VA Medical Center
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Principal Investigator: Lawrence Baruch, MD Bronx VA Medical Center
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Responsible Party: Lawrence Baruch, Staff Physician, Bronx VA Medical Center Identifier: NCT00762164    
Other Study ID Numbers: VA---19-07-01
First Posted: September 30, 2008    Key Record Dates
Results First Posted: July 3, 2013
Last Update Posted: July 3, 2013
Last Verified: April 2013
Keywords provided by Lawrence Baruch, Bronx VA Medical Center:
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors