ezetimibe (ez)/atorvastatin (ator) (mk-0653c) vs. ator in chinese hypercholesterolemic participants (mk-0653c-439)

Conditions: Hypercholesterolemia

Summary: this study will evaluate the ez/ator fixed-dose combination (fdc) tablet (mk-0653c) as second line low-density lipoprotein - cholesterol (ldl-c) treatment in chinese participants. the primary hypothesis is that mk-0653c 10/10 mg is superior to atorvastatin 20 mg in percent change from baseline in ldl-c to 12 weeks after treatment.


Eligibility criteria:
inclusion criteria: * has hypercholesterolemia diagnosed by investigator according to chinese guidelines on prevention and treatment of dyslipidemia in adults (2016 edition). * has been stabilized on atorvastatin treatment at 10 mg or 20 mg (or other statins with ldl-c lowering efficacy equivalent to atorvastatin) for at least 4 weeks prior to visit 1. * if female, is not pregnant or breastfeeding, and is either not a woman of childbearing potential (wocbp), or is a wocbp who has used a contraceptive consistent with local regulations. * if male, has used a contraceptive consistent with local regulations. * agrees to maintain a stable diet and stable exercise during the study. exclusion criteria: * has uncontrolled hypertriglyceridemia which needs drug intervention or a fasting triglyceride (tg) value ≥500 mg/dl (4.52 mmol/l). * is currently treated with statin at dose of equivalent ldl-c lowering effect \>20 mg atorvastatin. * has active liver disease * has new york heart association (nyha) class iii or iv symptomatic congestive heart failure at visit 1. * has had uncontrolled cardiac arrhythmias, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, unstable angina, or stroke within 3 months (12 weeks) prior to visit 1. * has homozygous familial hypercholesterolemia or has undergone ldl apheresis. * has endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia, e.g., hyper or hypothyroidism, cushing's syndrome). * has had a gastrointestinal tract bypass, or other significant intestinal malabsorption. * has a history of cancer within the past 5 years from visit 1 (except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer). * is known to be human immunodeficiency virus (hiv) positive. * has hypersensitivity or intolerance to ezetimibe, atorvastatin, the ezetimibe/atorvastatin combination tablet, or any component of these medications or has a condition or situation, which is described as a contraindication in labeling of ezetrol or lipitor or may interfere with participation in the study. * has disorders of the hematologic, digestive, or central nervous systems including cerebrovascular disease and degenerative disease that would limit study evaluation or participation. * has a history of mental instability, drug/alcohol abuse within the past 5 years, or major psychiatric illness not adequately controlled and stable on pharmacotherapy. * has a history of myopathy or rhabdomyolysis with ezetimibe or any statin. * is a wocbp who has had a positive urine pregnancy test within 24 hours before the first dose of study intervention. if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * is currently taking medications that are potent modulators of cytochrome p-450 3a4 (cyp3a4) including: cyclosporine, systemically administered azole antifungals (e.g., ketoconazole, fluconazole, and itraconazole), macrolide antibiotics (e.g., clarithromycin, and erythromycin), protease inhibitors (e.g., ritonavir, saquinavir, and lopinavir), grapefruit or juice of grapefruit (200 ml/day for \>3 times per week) * is taking any cyclical hormones (e.g., cyclical oral contraceptives, cyclical hormone replacement), including the combination of ethinyl estradiol and norethisterone, or non-cyclical hormones, including non-cyclical hormone replacement therapy (hrt) or any estrogen antagonist/agonist within 8 weeks. * note: if participant has been treated with a stable regimen of non-cyclical hrt for \> 8 weeks and agree to continue this regimen for the duration of the trial, concomitant therapy is acceptable. * is receiving treatment with systemic corticosteroids (intravenous, intramuscular and oral steroids). * is treated with psyllium, other fiber-based laxatives, phytosterol margarine, and herbal medicine and/or over the counter (otc) therapies that are known to affect serum lipids. * note: if participant has been treated with a stable regimen for \> 8 weeks and agrees to continue this regimen for the duration of the trial, concomitant therapy is acceptable. * is treated with an anti-obesity drug (e.g. mazindol) within 12 weeks prior to visit 1. * is treated with warfarin or warfarin-like anticoagulants and has not been on a stable dose with a stable international normalized ratio (inr) for at least 6 weeks. weeks. * has taken lipid-lowering agents (except probucol) including, cholestin, bile acid sequestrants, ezetimibe, fibrates or niacin (\>200 mg/day), proprotein convertases subtilisin/kexin type 9 (pcsk9) inhibitors within 6 weeks prior to visit 1. * has taken probucol within 10 weeks prior to visit 1. * has been treated with any other investigational drug within 30 days. * currently follows an excessive weight reduction diet. * currently engages in a vigorous exercise regimen (e.g., marathon training, body building training) or intends to start training during the study.