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

Phase 4

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Simvastatin; Drug: Vytorin

• Registration Number: NCT00762164
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-09-29
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2013-04
• Results First Submitted: 2013-04-16
• Results First Submitted QC: 2013-04-19
• Last Update Submitted: 2013-04-19
• Results First Posted: 2013-07-03
• Last Update Posted: 2013-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin	Simvastatin	Simvastatin 20 milligrams
1Vytorin 10/80 divided into 4	Vytorin	Vytorin 10/80 divided into 4

Primary Outcome Measures

Name	Time	Method
LDL Cholesterol	6 weeks

Secondary Outcome Measures

Name	Time	Method
Total Cholesterol	6 weeks

Trial Locations

Locations (1)

Bronx VA Medical Center; 🇺🇸 Bronx, New York, United States