a study to evaluate the effectiveness of ezetimibe/atorvastatin 10 mg/40 mg combination tablet compared to marketed ezetimibe 10 mg and atorvastatin 40 mg tablets in participants with high cholesterol (mk-0653c-190 am1)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to determine whether ezetimibe/atorvastatin 10 mg/40 mg combination tablet is equivalent to the coadministration of ezetimibe 10 mg and atorvastatin 40 mg in lowering low-density-lipoprotein-cholesterol (ldl-c) after 6 weeks of treatment.


Eligibility criteria:
inclusion criteria: * at low, moderate, or moderately high cardiovascular risk (according to national cholesterol education program adult treatment panel iii \[ncep atp iii\] guidelines) and either statin-naïve with ldl-c ≥130 mg/dl for low risk or ≥100 mg/dl for moderate or moderately high risk or on an allowable statin with on-therapy ldl-c ≥100 mg/dl in acceptable range and can safely discontinue and switch to study medication. * is willing to maintain a cholesterol-lowering diet throughout the study. * female of reproductive potential agrees to remain abstinent or to use (or have their partner use) 2 acceptable methods of birth control throughout the study. * female receiving non-cyclical hormone therapy, if maintained on a stable dose and regimen for at least 8 weeks prior to the study and if willing to continue the same regimen throughout the study. * off-therapy ldl-c levels are: for low risk patients, ≥130 mg/dl and ≤300 mg/dl; for moderate risk patients, ≥100 mg/dl and ≤300 mg/dl; for moderately high risk patients, ≥100 mg/dl and ≤275 mg/dl. * has liver transaminases ≤2 x upper limit of normal (uln) with no active liver disease. * has creatine kinase (ck) levels ≤3 x uln. * has triglyceride (tg) concentrations ≤400 mg/dl. exclusion criteria: * hypersensitivity or intolerance to ezetimibe, atorvastatin, the ezetimibe/atorvastatin combination tablet, or any component of these medications, or a history of myopathy or rhabdomyolysis with ezetimibe or any statin. * routinely consumes more than 2 alcoholic drinks per day (average \>14 alcoholic drinks per week). * is pregnant or lactating. * has been treated with any other investigational drug within 30 days of the study. * is high risk (according to ncep atp iii guidelines), including but not limited to one or more of the following: diabetes mellitus (type i or ii), myocardial infarction, coronary artery bypass surgery, angioplasty, stable or unstable angina. * has any of the following medical conditions: congestive heart failure; uncontrolled cardiac arrhythmias or recent significant changes in an electrocardiogram (ecg); homozygous familial hypercholesterolemia or has undergone ldl apheresis; partial ileal bypass, gastric bypass, or other significant intestinal malabsorption; uncontrolled hypertension; kidney disease; disease known to influence serum lipids or lipoproteins; hematologic, digestive, or central nervous system disorder; known to be human immunodeficiency virus (hiv) positive; history of malignancy ≤5 years prior to the study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer; mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy. - taking prohibited medications/foods including: systemic azole antifungals (e.g., fluconazole, ketoconazole), erythromycin or clarithromycin, and cyclosporine; ritonavir and saquinavir or lopinavir; \>5 cups of grapefruit juice per day; combination therapies of ezetimibe + atorvastatin (10/80 mg) or ezetimibe + rosuvastatin (10/20 mg or 10/40 mg); non-statin lipid-lowering agents including fish oils containing \>900 mg/day of eicosapentaenoic acid and docosahexaenoic acid (epa+dha), red yeast extract, cholestin™, bile acid sequestrants, other cholesterol-lowering agents, niacin (\>200 mg/day), or fibrates; systemic corticosteroids; psyllium, other fiber-based laxatives, phytosterol margarines, and/or over the counter (otc) therapies known to affect serum lipid levels; orlistat or other anti-obesity medications and not maintained on a stable dose; any cyclical hormones; warfarin treatment without a stable dose or a stable international normalized ratio (inr).