Efficacy and Safety of Imported Probucol to Treat Hyperlipidemia

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

• Signing Informed Content Form;
• Age >= 20 (the age at the time of signing ICF; both gender);
• 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);
• Framingham: Coronary Heart Disease 2-year risk probabilities < 10%.

Exclusion criteria

• Subjects who receive antilipemic agents within 1 month prior to the pre-screening period;
• Subjects who receive Probucol within 6 months prior to the pre-screening period;
• Coronary Heart Disease subjects;
• Subjects being treated with cyclosporine;
• Subjects with a history of hypersensitivity to Probucol;
• QTc interval > 450ms (male); QTc interval > 470ms (female);
• 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
• Female subjects who are pregnant, lactating, or who plan to conceive;
• Subjects who are considered by the investigator to be inappropriate to participate in this trial.