Randomized, control, open label, multicentre clinical study. The patient who are in accordance with subject inclusion and exclusion criteria will be randomized to A group: Routine treatment B group: Routine treatment+ Cilostazol; C group : Routine treatment + Probucol; D group: Routine treatment+ Cilostazol+ Probucol .
Efficacy index: After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups. Pharmacokinetics: After 12 weeks of treatment, the study medication plasma concentration including of Probucol ,Cilostazol , Cilostazol metabolism OPC-13015 and OPC-13213 will be measured. Safety evaluation: Analysis the abnormality of Adverse Event, Vital Sign, Physical Examination, 12-lead ECG, and Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin) in 4 modality groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg(2 tablets)Bid.
Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner
Cilostazol: At first, 50 mg (1 tablets) Bid, PO after breakfast and dinner. After administration of study drug for 1 week, and if patient has no significant discomfort, the drug dosage will increase to 100mg(2 tablets)Bid. Probucol: 250 mg (1 tablet) Bid, PO after breakfast and dinner
First Affliate Hospital of Beijing University
Beijing, China
After 12 weeks of treatment, the change difference of arteriosclerosis related biomarker between 4 modality groups.
Time frame: 12 week
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routine treatment