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Clinical Trial Summary

1. To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker

2. To evaluate the safety of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker


Clinical Trial Description

Efficacy evaluation:

Primary efficacy index:

After 12 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information

Secondary efficacy index:

After 8 weeks of treatment, the change of arteriosclerosis related biomarker in 4 modality groups, comparing with the base line information

Safety evaluation:

1. Adverse Event

2. Vital Sign and Physical Examination

3. 12-lead ECG

4. Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin) ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00823849
Study type Interventional
Source Otsuka Beijing Research Institute
Contact
Status Completed
Phase Phase 4
Start date October 2008
Completion date March 2010

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