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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
• Treatments: Cilostazol; Probucol

Criteria

Inclusion Criteria:

1. Age is ≥ 40 and <80 years at Screening.

2. The subject has a diagnosis of PAD

3. The subject has a diagnosis of CAD

4. Stable background medical therapy over the past 3 months

5. Taking 100mg/day of aspirin or 75mg/day of clopidogrel over the past 3 months

6. Hyperlipidemia defined as a LDL cholesterol concentration > 70 mg/dL

7. The subject is willing to participate in this study as documented by written informed consent

Exclusion Criteria:

1. New diagnosis of PAD within 3 months.

2. Currently taking cilostazol or has taken cilostazol

3. Currently taking probucol or has taken probucol within the last 3 months

4. Critical limb ischemia (CLI)

5. Congestive heart failure

6. Transient ischemic attack (TIA)

7. Endovascular peripheral or coronary revascularization procedure within 3 months

8. Coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months

9. Major surgical procedures within 3 months

10. Uncontrolled hypertension

11. Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus

12. Diabetic complications of severe peripheral neuropathy or active retinopathy.

13. Inflammatory bowel disease.

14. Unstable angina

15. QT prolongation

16. Severe or life threatening ventricular arrhythmias

17. History of syncope

18. Serum creatinine > 2.5 mg/dL, Creatinine Clearance ≤25ml/min or renal failure requiring dialysis.

19. History or evidence of any hematological or clotting disorder.

20. Hematocrit ≤ 28% or ≥ 55%.

21. AST or ALT > 3 times the upper limit of normal (ULN).

22. Any form of chronic anticoagulation.

23. Coagulopathies defined as an INR > 1.5

24. History of malignant disease within 5 years.

25. Acute or chronic hepatitis.

26. Hemophilia or known increased risk of hemorrhage.

27. Other clinically significant disorders resulting in a remaining life expectancy less than one year.

28. Current alcohol or drug abuse.

29. If female, the subject cannot be pregnant or breastfeeding and must be of non-childbearing potential