Efficacy and Safety Study of Lipid-Lowering Effects of XueZhiKang (XZK) in Patients With Hyperlipidemia

Exclusion Criteria

• •1. Patients with myocardial infarction, stroke, transient ischemic attack, cardiovascular surgery or major operations within 6 months prior to screening visit.
• •2. Patients with percutaneous coronary intervention within 3 months.
• •3. Patients who have been taken lipid-lowering medications including statins or XZK during the 4 weeks prior to screening visit.
• •4. Patients with uncontrolled hypertension at the screening visit. Patients on stable antihypertensive medication may be enrolled provided that the medications and dosage remain stable throughout the study.
• •5. Patients who are taking anticoagulants except aspirin at \< 325 mg/day.
• •6. Patients with liver dysfunction as indicated by a serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) level of \> 1.5-times of upper limit of normal (ULN) range, or clinical symptoms.
• •7. Patients with elevated creatine phosphokinase level (above Upper Limit of Normal range).
• •8. Patients with renal dysfunction as indicated by a serum creatinine level above ULN range, or clinical symptoms.
• •9. Patients with gastric or peptic ulcer within 3 months prior to screening visit.
• •10. Patients with uncontrolled diabetes mellitus as defined by a HbA1c level of \> 7.0%.
• •11. Patients with medical history of hypothyroidism, pancreatitis, cholestasis, nephrotic syndrome, gall bladder disease, or primary biliary cirrhosis. Patients on thyroid replacement therapy at stable doses may be enrolled if clinically euthyroid.
• •12. Patients with clinically relevant illness within 4 weeks prior to the screening visit that may interfere with the conduct of this study.
• •13. Patients with a history of alcohol or narcotic substance abuse within two years prior to screening visit.
• •14. Patients with hypersensitivity to lipid-lowering agents.
• •15. Patients who have taken another investigational drug within 4 weeks prior to screening visit.
• •16. Patients with uncontrolled metabolic or endocrine disease knowing to influence lipid values.
• •17. Patients who are known to be HIV positive.
• •18. Patients who have a history or presence of active malignancy (other than non-melanoma skin cancer) or clinically significant psychiatric, neurological, respiratory, hematological, or other conditions that in the opinion of investigators might interfere with or contraindicate participation of the patients in this study.