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.

First Received: September 29, 2008 Last Updated: August 12, 2009 History of Changes

Sponsor:	Bronx VA Medical Center
Information provided by:	Bronx VA Medical Center
ClinicalTrials.gov Identifier:	NCT00762164

Purpose

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
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:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Ezetimibe Vytorin

U.S. FDA Resources

Further study details as provided by Bronx VA Medical Center:

Primary Outcome Measures:

LDL cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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
1Vytorin 10/80 divided into 4: Active Comparator Vytorin 10/80 divided into 4	Drug: Vytorin Vytorin 10/80 split into 4
Simvastatin: Active Comparator Simvastatin 20 milligrams	Drug: Simvastatin Simvastatin 20 milligrams

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762164

Locations

United States, New York
Bronx VA Medical Center
Bronx, New York, United States, 10468

Sponsors and Collaborators

Bronx VA Medical Center

Investigators

Principal Investigator:

Lawrence Baruch, MD

Bronx VA Medical Center

More Information

No publications provided

Responsible Party:	Bronx VA Medical Center ( Lawrence Baruch, MD )
Study ID Numbers:	VA---19-07-01
Study First Received:	September 29, 2008
Last Updated:	August 12, 2009
ClinicalTrials.gov Identifier:	NCT00762164 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Bronx VA Medical Center:

Hypercholesterolemia
Statins
Ezetimibe

Additional relevant MeSH terms:

Antimetabolites
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010