Comparison of Efficacy and Safety of Ezetimibe or Statin Monotherapy to Co-Administration of Both

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to compare the percent change in LDL cholesterol induced by ezetimibe or simvastatin monotherapy and by co-administration of both agents in Black, White and Hispanic men. Ezetimibe is a drug that blocks sterol absorption and simvastatin blocks hepatic cholesterol biosynthesis. The hypothesis to be tested is that Blacks are likely to be more responsive to LDL lowering by ezetimibe than statins because Blacks have a low production of cholesterol.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Donald W. Reynolds Foundation; Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe; Simvastatin

Criteria

Inclusion Criteria:

• Black, white and hispanic males between the ages of 20 to 70 years

• In good general health

• Having a body mass index (BMI) between 20 and 35 kg/m2

• Plasma LDL-C concentrations greater than or equal to 130 mg/dl but less than or equal to 175 mg/dL

• TG (triglyceride) levels less than or equal to 250 mg/dL.

Exclusion Criteria:

• Any condition that would be likely to render the individual unable to complete the study

• Hypersensitivity to HMG-CoA reductase inhibitors

• Poor mental function, drug or substance abuse, or unstable psychiatric illnesses that may interfere with optimal participation in the study

• Treatment with another investigational drug within 30 days prior to Visit 1

• Alcohol consumption >14 drinks per week

• Phytosterol/phytostanol-containing products including margarines within 2 weeks

• History of CHD, peripheral vascular disease, cerebrovascular disease, CHF, or uncontrolled arrhythmias

• Creatinine >1.5 mg/dL, nephrotic syndrome, or other renal disease

• Fasting plasma glucose (FPG) >126 mg/dL or history of diabetes

• Abnormal TSH

• Uncontrolled hypertension (systolic BP >160 mm Hg and/or diastolic BP >100 mm Hg)

• Known active liver diseases or elevated serum transaminases (ALT and AST >1.5 times the upper limit of normal)

• Digestive disorders or any abdominal surgery within the past 6 months

• Cancer within the past 5 years (except for skin cancer)

• HIV, HBV, or HCV positive

• Lipid-lowering agents: bile-acid binding resins, HMG-CoA reductase inhibitors, ezetimibe, niacin (>200 mg/day), cholestin, fish oil, and fibrates, or cholesterol absorption inhibitors (e.g., neomycin) taken within 8 weeks prior to Visit 1

• Medications that are potent inhibitors of CYP3A4 (cyclosporine, systemic itraconazole or ketoconazole, erythromycin or clarithromycin, nefazodone, verapamil, amiodarone, and protease inhibitors)

• Anti-obesity medications: orlistat or sibutramine taken within 8 weeks prior to Visit 1

• Systemic corticosteroids.