Status:
COMPLETED
Evaluation of Concomitant Administration of Cilostazol and Probucol on Biomarkers, Endothelial Function and Safety
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
40-79 years
Phase:
PHASE2
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 ...
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 o...
Eligibility Criteria
Inclusion
- Age is ≥ 40 and \<80 years at Screening.
- The subject has a diagnosis of PAD
- The subject has a diagnosis of CAD
- Stable background medical therapy over the past 3 months
- Taking 100mg/day of aspirin or 75mg/day of clopidogrel over the past 3 months
- Hyperlipidemia defined as a LDL cholesterol concentration \> 70 mg/dL
- The subject is willing to participate in this study as documented by written informed consent
Exclusion
- New diagnosis of PAD within 3 months.
- Currently taking cilostazol or has taken cilostazol
- Currently taking probucol or has taken probucol within the last 3 months
- Critical limb ischemia (CLI)
- Congestive heart failure
- Transient ischemic attack (TIA)
- Endovascular peripheral or coronary revascularization procedure within 3 months
- Coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months
- Major surgical procedures within 3 months
- Uncontrolled hypertension
- Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus
- Diabetic complications of severe peripheral neuropathy or active retinopathy.
- Inflammatory bowel disease.
- Unstable angina
- QT prolongation
- Severe or life threatening ventricular arrhythmias
- History of syncope
- Serum creatinine \> 2.5 mg/dL, Creatinine Clearance ≤25ml/min or renal failure requiring dialysis.
- History or evidence of any hematological or clotting disorder.
- Hematocrit ≤ 28% or ≥ 55%.
- AST or ALT \> 3 times the upper limit of normal (ULN).
- Any form of chronic anticoagulation.
- Coagulopathies defined as an INR \> 1.5
- History of malignant disease within 5 years.
- Acute or chronic hepatitis.
- Hemophilia or known increased risk of hemorrhage.
- Other clinically significant disorders resulting in a remaining life expectancy less than one year.
- Current alcohol or drug abuse.
- If female, the subject cannot be pregnant or breastfeeding and must be of non-childbearing potential
Key Trial Info
Start Date :
May 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01142284
Start Date
May 19 2010
End Date
December 18 2012
Last Update
July 18 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea