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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bronx VA Medical Center
• Treatments: Ezetimibe; Ezetimibe, Simvastatin Drug Combination; Simvastatin

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