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:

  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

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:

  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)

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