Ignite Creation Date:
2024-05-05 @ 10:35 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01142284
Status:
COMPLETED
Last Update Posted:
2022-07-18
First Post:
2010-06-10
Brief Title:
Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers Endothelial Function and Safety
Sponsor:
Korea Otsuka Pharmaceutical Co Ltd
Organization:
Korea Otsuka Pharmaceutical Co Ltd
Study Overview
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
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None