Status:
COMPLETED
Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-density Lipoprotein (LDL) Cholesterol
Lead Sponsor:
Bronx VA Medical Center
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Ezet...
Eligibility Criteria
Inclusion
- Subjects with an LDL-cholesterol greater than 100 mg/dL
- Patients willing and able to provide signed informed consent
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00762164
Start Date
March 1 2007
End Date
May 1 2009
Last Update
July 3 2013
Active Locations (1)
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1
Bronx VA Medical Center
The Bronx, New York, United States, 10468