NCT00823849

Study of Cilostazol and Probucol to Assess Their Effects on Atherosclerosis Related Biomarker

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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 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)

Conditions

• Type 2 Diabetes Mellitus
• Arteriosclerosis Obliterans

Interventions

Type	Name	Description
DRUG	Cilostazol	From 50mg, Bid, PO after breakfast and dinner. After 1-week of administration, if no significant study drug related discomfort, the dose can increase to 100mg, Bid, PO. Otherwise, remain at the 50 mg level.
DRUG	Probucol	250 mg Bid, PO after breakfast and dinner.
DRUG	Cilostazol+Probucol
OTHER	Control Group	Routine treatment

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-08-01
• Completion: 2010-03-01
• First posted: 2009-01-16
• Last updated: 2025-03-27

Locations

1 site across 1 country: China