Comparison of the Effect of Vytorin 10/80 Tablet Split Into 4 and Simvastatin 20 Milligrams on Low-Density Lipoprotein (LDL) Cholesterol
Information source: Bronx VA Medical Center
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Vytorin (Drug); Simvastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bronx VA Medical Center Official(s) and/or principal investigator(s):
Lawrence Baruch, MD, Principal Investigator, Affiliation: Bronx VA Medical Center
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: LDL cholesterol
Secondary outcome: Total cholesterol
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bronx VA Medical Center, Bronx, New York 10468, United States; Recruiting
Lawrence Baruch, MD, Phone: 718-584-9000, Ext: 6771, Email: lawrence.baruch@va.gov
Calvin Eng, MD, Phone: 718-584-9000, Ext: 6771, Email: calvin.eng@va.gov
Lawrence Baruch, MD, Principal Investigator
Additional Information
Starting date: March 2007
Ending date: December 2008
Last updated: September 29, 2008
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