A Study to Evaluate the Efficacy and Safety of Pletaal SR Capsule (Cilostazol) in Subjects With Peripheral Arterial Disease Symptom Due to Chronic Occlusive Arterial Disease

NCT01711333 | Completed Phase 4

• 1 other identifier: 021-KOA-1102i
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate symptomatic changes and safety before and after the administration of Pletaal® SR Capsules based on Peripheral Artery Questionnaire (PAQ) in subjects with peripheral arterial disease symptom due to chronic occlusive arterial disease (COAD).

Conditions

Chronic Occlusive Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Summary score based on PAQ (Peripheral artery questionnaire)

  Change from Baseline in PAQ summary score at Week 12

Secondary Outcomes (7)

• Score of domain (physical limitation) based on PAQ

  Change from Baseline in PAQ domain (physical limitation) at Week 12

• Assessement based on HAQ-DI

  Change from Baseline in HAQ-DI at Week 12

• Score of domain(symptom) based on PAQ

  Change from Baseline in PAQ domain(symptom) at Week 12

• Score of domain(symptom stability) based on PAQ

  Change from Baseline in PAQ domain(symptom stability) at Week 12

• Score ofdomain(social limitation) based on PAQ

  Change from Baseline in PAQ domain (social limitation) at Week 12

Study Arms (1)

Pletaal SR capsule

EXPERIMENTAL

Drug: Pletaal SR capsule

Interventions

Pletaal SR capsule DRUG

two capsules once a day of Pletaal SR 100mg Capsules

Pletaal SR capsule

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female outpatients between 40 and 75 years of age,
• Patients confirmed to have symptoms of peripheral arterial disease (including intermittent claudication, pain, coldness and fatigue) in the lower extremities,
• Patients who have a steady symptom without significant improvement within 12 weeks prior to screening visit and whose PAQ score of the question number 3 is 3 or less at enrollment visit,
• Ankle Branchial Index (ABI) ≤0.90 when measuring the pressure in a supine position after resting for 10 minutes,
• Patients who are equal to or less than 10% of the difference in PAQ summary scores at between screening and enrollment,
• Patients who have been fully explained about this study, voluntarily decided to participate in this study, and provided written informed consent.

You may not qualify if:

• Patients with ischemic pain at rest or having ischemic ulcer or gangrene,
• Patients with Ankle Branchial Index (ABI) ≤ 0.40
• Patients who underwent sympathectomy or lower extremity arterial reparative surgery including endovascular procedures within 12 weeks prior to screening visit,
• Patients diagnosed of deep vein thrombosis within 12 weeks prior to screening visit, (provided that patients with isolated calf vein thrombosis may be enrolled)
• Patients with the following disease:
• Patients who is on or needs the treatment for Congestive heart failure
• Myocardial infarction which occurred within 24 weeks prior to screening visit
• Patients who is on or needs the treatment for unstable angina pectoris,
• Patients with hemorrhage (hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal hemorrhage, urinary hemorrhage, hemoptysis, vitreous hemorrhage, etc.) and predisposition to hemorrhage (active peptic ulcer, hemorrhagic stroke within the recent 24 weeks, suspected hemorrhage when administering cilostazol for wound due to surgery within the recent 12 weeks, and proliferative diabetic retinopathy),
• PT, aPTT level greater than 1.5 times the upper limit of normal at screening visit,
• Uncontrolled hypertension defined as ≥ 160 mmHg of systolic blood pressure or ≥ 100 mmHg of diastolic blood pressure,
• Creatinine clearance(Ccr)a ≤ 25mL/min at screening a. Creatinine clearance (Ccr) is calculated by the following modified Cockcroft-Gault formula using the serum creatinine as determined by the site laboratory.
• Ccr(mL/min)=\[260-age(year)\] x Body weight(kg) / 160 x Serum creatinine(mg/dL) (male) Ccr(mL/min)=\[236-age(year)\] x Body weight(kg) / 180 x Serum creatinine(mg/dL) (female), 10) AST or ALT level greater than 3 times the upper limit of normal at screening, 11) Total bilirubin level greater than 2 times the upper limit of normal at screening, 12) Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c greater than 9%), 13) Patients determined ineligible to participate in this clinical trial at the discretion of Investigator due to critical diabetic complications (diabetic foot ulcer, foot deformity, etc.), 14) Female patients whose serum pregnancy test at screening or urine pregnancy test at enrollment is positive in case of childbearing potential and breastfeeding women,
• For female patients, those who have been at their postmenopause at least for one year or longer, who have no potential to be pregnant by surgery or procedure, or who agreed to use acceptable contraceptive methods (intrauterine device \[loop or Mirena\], double barrier method \[diaphragm or condom/femidom + spermicide\], vasectomy in spouse, oral contraceptives or non-oral contraceptives) throughout the entire study period,Female patients whose pregnancy test at screening is positive in case of childbearing potential or breastfeeding women 15) History of malignant disease (excluding treated basal cell or squamous cell carcinoma of skin) within 5 years prior to Screening. Resolution of a prior malignancy more than 5 years prior to Screening must be deemed as cured by the investigator, 16) Patients who have history of taking or plan to take the following medications:
• Cilostazol-containing medications within 12 weeks prior to screening visit,

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

KYUNG-HEE UNIVERSITY HOSPITAL at GANGDONG

Seoul, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: October 26, 2012
• Primary Completion: May 20, 2014
• Study Completion: August 18, 2014
• Last Updated: June 10, 2022

Record last verified: 2022-06

Locations

KR (1)