Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers, Endothelial Function and Safety

Peripheral Artery Disease Clinical Trial

Official title: Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers, Endothelial Function and Safety in Peripheral Artery Disease Subjects Complicated With Coronary Artery Disease.

Status Completed

Clinical Trial Summary

Based upon evidence of efficacy and safety of both cilostazol and probucol administration in independent randomized controlled trials in PAD and CAD, the present trial seeks to investigate the effect of concomitant administration of cilostazol and probucol on FMD compared to each drug individually, as well as to evaluate biomarker measures and safety indices in this context.

Clinical Trial Description

Primary:

1. To evaluate the effect of concomitant administration of cilostazol and probucol on the 12-week change in FMD from baseline compared, with individual drugs alone.

2. To assess the safety of concomitant administration of cilostazol and probucol in peripheral artery disease (PAD) subjects complicated with coronary artery disease (CAD) as determined by physical examination, vital signs, adverse events (AEs), laboratory tests, ECGs.

Secondary:

1. To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on changes in FMD from baseline to Weeks 6 and 12.

2. To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on changes in metabolic, inflammatory, oxidative, and platelet biomarkers from baseline to Weeks 6 and 12.

3. To evaluate the effect of cilostazol and probucol administered concomitantly and as individual drugs, compared with control, on the time course (over the 12-week treatment period) of changes in FMD and biomarkers levels.

4. To assess the effect of drug withdrawal on these endpoints at follow-up (from Week 12 to Week 16).

5. To explore the relationship between changes in FMD and changes in the biomarker levels at Week 12. ;

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

• NCT number: NCT01142284
• Study type: Interventional
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Status: Completed
• Phase: Phase 2
• Start date: May 19, 2010
• Completion date: December 18, 2012