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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

This study has been completed.
Information provided by (Responsible Party):
Lawrence Baruch, Bronx VA Medical Center Identifier:
First received: September 29, 2008
Last updated: April 19, 2013
Last verified: April 2013
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 Intervention Phase
Hypercholesterolemia Drug: Vytorin Drug: Simvastatin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Lawrence Baruch, Bronx VA Medical Center:

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

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

Enrollment: 34
Study Start Date: March 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00762164

United States, New York
Bronx VA Medical Center
Bronx, New York, United States, 10468
Sponsors and Collaborators
Bronx VA Medical Center
Principal Investigator: Lawrence Baruch, MD Bronx VA Medical Center
  More Information

Responsible Party: Lawrence Baruch, Staff Physician, Bronx VA Medical Center Identifier: NCT00762164     History of Changes
Other Study ID Numbers: VA---19-07-01
Study First Received: September 29, 2008
Results First Received: April 16, 2013
Last Updated: April 19, 2013

Keywords provided by Lawrence Baruch, Bronx VA Medical Center:

Additional relevant MeSH terms:
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 processed this record on September 21, 2017