efficacy and safety of hs-25 or in combination with atorvastatin in chinese adults with primary hypercholesterolemia

Conditions: Primary Hypercholesterolemia

Summary: to determine the efficacy of the hs-25 (10mg or 20mg) or in combination with atorvastatin (10mg)in reducing low density lipoprotein-cholesterol (ldl-c) levels after a 12-week period of treatment in adults with primary hypercholesterolemia; to determine the safety of hs-25 (10mg or 20mg) or in combination with atorvastatin (10mg)in subjects with ldl-c after a 40-week period of treament.

this is a 12-week, randomized, double-blind, double dummy, placebo-controlled study designed to assess the effects of the cholesterol absorption inhibitor hs-25 (10mg or 20mg) or in combination with atorvastatin (10mg) on ldl-c levels in adults who have untreated ldl-c levels ranging from 3.36-4.88mmol/l(130-189 mg/dl)and fasting triglyceride levels \< 350 mg/dl. eligibility is restricted to 18-70 years old men or women who are using a highly effective birth control method or are not of childbearing potential;subjects with not treated by statins in six months before signature of the informed consent.subjects with diabetes, a history of myocardial infarction or other clinical evidence of atherosclerotic vascular disease or treated are not eligible for participation in the study.

Eligibility criteria:
inclusion criteria: * subjects who are 18 to 70 years of age, male or female using a highly effective birth control method or not of child-bearing potential, at visit 1 (screening visit); * ldl-c 3.36mmol/l (130 mg/dl) to 4.88 mmol/l (189 mg/dl) (inclusive) on a cholesterol lowering diet but no lipid modifying drug treatment (statins) for at least 6 weeks before signed written informed consent; * a qualifying ldl-c value must be obtained at the beginning and end of the placebo run-in (visit 2 and visit 3) and the visit 3 value must be within 12% of the value at visit 2, higher or lower; the average of both qualifying values must be in the range of 3.36mmol/l (130 mg/dl) to 4.88 mmol/l (189 mg/dl) (inclusive) for inclusion in the study. exclusion criteria: * liver transaminases \> 1.5 x upper limit of normal. * homozygous familial hypercholesterolemia. * subject who was diagnosed as diabetes with aged greater than 40 years old. * subject who was diagnosed as diabetes with one of the following of cardiovascular risk factorss: hypertention bp ≥ 140/90mmhg,or smoking, or low hdl-c (1.04mmol/l), or bmi≥28kg/m2. * women who are pregnant or breast feeding. * atherosclerotic cardiovascular disease including arteriosclerotic heart disease, acute coronary syndrome，coronary artery bypass graft,coronary angioplastyperipheral arteriosclerosis,cerebrovascular accident - history of severe endiocrine disease (for example thyroid function abnormal) - history of a positive test for human immunodeficiency virus, hepatitis b or hepatitis c. * history of advanced cancer - arrhythmias need to be treated by medications * had severe injured or surgery in 6 months before study start. * hypersensitive to hs-25 or place. * history of intolerance to ezetimibe. * participation other studies in three months. * treatment with a fibric acid derivative (eg, fenofibrate, gemfibrozil), probucol, warfarin, systemic corticosteroid, cyclosporine or other immunosuppressant agent within the prior 12 weeks.