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

Bronx VA Medical Center

Status and phase

Completed

Phase 4

Conditions

Hypercholesterolemia

Treatments

Drug: Simvastatin

Drug: Vytorin

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00762164

VA---19-07-01

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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