Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

A Randomized, Double Blind, Placebo Control, Multi-center Clinical Study to Evaluate the Efficacy and Safety of Imported Probucol in Hyperlipidemia Patients

The purpose of this study is to evaluate the efficacy and safety of imported Probucol in hyperlipidemia patients.

This is a randomized, double blind, placebo control, multi-centre clinical study in hyperlipidemia patients.

Enrolled subjects will be randomized to the treatment group or control group, and receive Probucol or placebo continuously for 8 weeks; Treatment group: Imported Probucol 250 mg (1 tablet) bid. p.o Control group: Placebo 1 tablet bid. p.o

Inclusion Criteria:

1. Signing Informed Content Form;

2. Age >= 20 (the age at the time of signing ICF; both gender);

3. hyperlipidemia patients who meet the following criteria:

   • 4.14 mmol/L (160mg/dL) =< LDL-C (Serum low density lipoprotein-cholesterol) < 6 mmol/L (232mg/dL)
   • TG (Serum triglycerides) < 4.5 mmol/L (398mg/dL);

4. Framingham: Coronary Heart Disease 2-year risk probabilities < 10%.

Exclusion Criteria:

1. Subjects who receive antilipemic agents within 1 month prior to the pre-screening period;

2. Subjects who receive Probucol within 6 months prior to the pre-screening period;

3. Coronary Heart Disease subjects;

4. Subjects being treated with cyclosporine;

5. Subjects with a history of hypersensitivity to Probucol;

6. QTc interval > 450ms (male); QTc interval > 470ms (female);

7. Subjects with impaired hepatic and renal function, who meet any of the following abnormal value:

   • AST >= 100IU/L
   • ALT >= 100IU/L
   • Serum creatinine >= 1.5mg/dL

8. Female subjects who are pregnant, lactating, or who plan to conceive;

9. Subjects who are considered by the investigator to be inappropriate to participate in this trial.