Clinical Trial: Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Control,Open Label, Multicentre Clinical Study to Evaluate the Efficacy and Safety of Cilostazol and Probucol Alone and in Combination on Atherosclerosis Related Biomarker
Brief Summary:
- To evaluate the efficacy of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker
- To evaluate the safety of Cilostazol and Probucol alone and in combination on atherosclerosis related biomarker
Detailed Summary:
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:
- Adverse Event
- Vital Sign and Physical Examination
- 12-lead ECG
- Laboratory Tests (including blood routine examination, routine urine analysis, blood biochemistry examination, glycosylated hemoglobin)
Sponsor: Otsuka Beijing Research Institute
Current Primary Outcome: Primary Efficacy Evaluation: Comparing with the basic line information, the change value of arteriosclerosis related biomarker in 4 groups after 12 weeks of treatment. [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Otsuka Beijing Research Institute
Dates:
Date Received: January 14, 2009
Date Started: October 2008
Date Completion:
Last Updated: April 21, 2010
Last Verified: April 2010