Efficacy and Safety of HS-25 or in Combination With Atorvastatin in Chinese Adults With Primary Hypercholesterolemia
Efficacy and Safety of HS-25 or in Combination With Atorvastatin in Chinese Adults With Primary Hypercholesterolemia
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.
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.