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

NCT01142284 | Completed Phase 2 DMC

• 1 other identifier: 021-KOA-0901i
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease

Keywords

Biomarker; Endothelial Function; Peripheral Artery Disease; Coronary Artery Disease; Flow Mediated Dilation; Cilostazol; Probucol

Outcome Measures

Primary Outcomes (1)

• On the 12-week change in FMD / Safety

  1. To evaluate the effect of concomitant administration of cilostazol and probucol on the 12-week change 2. To assess the safety of concomitant administration of cilostazol and probucol

  12 weeks

Secondary Outcomes (1)

• Changes in the biomarker and FMD

  12 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Cilostazol, Probucol

Cilostazol

EXPERIMENTAL

cilostazol

Drug: Cilostazol, Probucol

Probucol

EXPERIMENTAL

probucol

Drug: Cilostazol, Probucol

Cilostazol + Probucol

EXPERIMENTAL

cilostazol and probucol

Drug: Cilostazol, Probucol

Interventions

Cilostazol, Probucol DRUG

Treatment Group 1 (control) No cilostazol or probucol Treatment Group 2 (cilostazol alone) 1 tablet cilostazol 100 mg PO BID Treatment Group 3 (probucol alone) 1 tablet probucol 250 mg PO BID Treatment Group 4 (concomitant cilostazol and probucol) 1 tablet cilostazol 100 mg PO BID, and 1 tablet probucol 250 mg PO BID

Cilostazol; Cilostazol + Probucol; Placebo; Probucol

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Coronary Artery Disease

Interventions

Cilostazol; Probucol

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: June 11, 2010
• Study Start: May 19, 2010
• Primary Completion: November 29, 2012
• Study Completion: December 18, 2012
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

KR (1)