Efficacy and Safety Study of the HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases

Randomized,Double Blind,Double Dummy, Multi-center Study of Efficacy and Safety of HS-25 Combination With Atorvastatin in Subjects With Hypercholesterolemia in Coronary Heart Diseases

To determine the efficacy of HS-25 (20mg) in reducing low density lipoprotein-cholesterol (LDL-C) levels after a 12-week period of treatment in combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases; To determine the safety of HS-25 (20mg) combination with Atorvastatin in subjects with hypercholesterolemia and coronary heart diseases

Inclusion Criteria:

• Diet control for 14 weeks, Atorvastatin 10mg once daily for 6 weeks or above;

• The average of both qualifying values must be in the range of 2.07 mmol/L to 3.36 mmol/L. 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;

• Must meet the one of diseases as following:

  1. Subjects who have stable coronary heart disease;
  2. Subjects who diagnosed ischemic stroke in stable condition;
  3. Subjects who diagnosed as Diabetes mellitus

Exclusion Criteria:

• history of Severe Endiocrine disease (for example Thyroid function abnormal);
• History of advanced cancer
• Arrhythmias need to be treated by medications history of Hemorrhagic stroke;
• Cardiac dysfunction;
• Unstable ASCVD;
• History of organ transplant;
• Hypersensitive to HS-25 or place;
• uncontrolled or new diagnosed diabetes mellitus;
• HCV and HBsAg positive