Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication

A Phase III Prospective, Randomized, Double Blind, Active Controlled, Multicenter, Parallel Group Study to Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication

The study is designed to compare the efficacy and safety of once daily PMR treatment with twice daily Pletaal® treatment in patients with intermittent claudication caused by peripheral arterial disease and are currently treated with cilostazol of any strength and any dosing frequency.

Study Overview

• Status: Terminated
• Conditions: Intermittent Claudication
• Intervention / Treatment: Drug: Cilostazol 200 mg; Drug: Cilostazol 100 mg

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 112
    • Cheng Hsin General Hospital
  • Taipei, Taiwan, 10016
    • National Taiwan University Hospital
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital LinKou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria:

• Stable use of Cilostazol of any strength and any dosing frequency for at least 3 months prior to screening, for the treatment of peripheral arterial disease.
• Initial claudication distance ≥ 30 meters at the constant workload treadmill test.

Main Exclusion Criteria:

• Presence of limb-threatening chronic limb ischemia, manifested by ischemic rest pain, ulceration or gangrene.
• History of lower-extremity surgical or endovascular arterial reconstructions or sympathectomy within 3 months prior to screening.
• Presence of illness(es) (such as angina pectoris, respiratory disease, orthopaedic disease, or neurological disorders, except the study disease) limiting the exercise capacity.
• Presence of uncontrolled hypertension (based on physician's judgment) or other unstable cardiovascular disease such as congestive heart failure of any severity and myocardial infarction within 6 months prior to screening.
• History of coronary artery bypass graft (CABG) or major cardiovascular surgical procedures within 6 months prior to screening.
• History of Buerger's disease or deep vein thrombosis within 3 months prior to screening.
• Presence of haemostatic disorders or active pathologic bleeding, such as bleeding peptic ulcer and intracranial bleeding.
• Presence or history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular tachycardia with or without adequate treatment, QTc prolongation associated with cardiac disorders, or severe tachyarrhythmia within 6 months prior to screening, which is considered not suitable for this study by Investigator.
• History of type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
• Use of anticoagulant agent(s) within 6 months prior to screening.
• Use of two or more than two anti-platelet agents within 3 months prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PMR; Cilostazol 200 mg, tablet, PO, QN	Drug: Cilostazol 200 mg; Provided as 1# placebo tablet in the morning and 1# PMR 200 mg/tablet in the evening, orally, for 24 weeks.; Other Names: PMR
Active Comparator: Pletaal®; Cilostazol 100 mg, tablet, PO, BID	Drug: Cilostazol 100 mg; Provided as 1# Pletaal® 100 mg/tablet, orally twice a day, for 24 weeks.; Other Names: Pletaal®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean percent change in initial claudication distance (ICD)	The standardized workload treadmill test will be conducted for evaluation of walking performance. ICD is defined as the distance walked to the point of the onset of claudication symptoms.	At baseline (day 0) and week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean percent change in initial claudication distance (ICD)	The standardized workload treadmill test will be conducted for evaluation of walking performance. ICD is defined as the distance walked to the point of the onset of claudication symptoms.	At baseline (day 0) and week 12
Geometric mean percent change in absolute claudication distance (ACD)	The standardized workload treadmill test will be conducted for evaluation of walking performance. ACD is defined as the maximal distance walked to the point where severe claudication pain forced cessation of exercise.	At baseline (day 0) and week 12
Geometric mean percent change in absolute claudication distance (ACD)	The standardized workload treadmill test will be conducted for evaluation of walking performance. ACD is defined as the maximal distance walked to the point where severe claudication pain forced cessation of exercise.	At baseline (day 0) and week 24
Subject assessment of treatment response	Participants will subjectively evaluate the treatment response of study drug on claudication symptoms which will be categorized into: Much Better; Better; Unchanged; Worse; Much Worse Participants rating their improvement on claudication symptoms as "Much Better" or "Better" are classified as responders.	At week 24

Collaborators and Investigators

• Sponsor: Genovate Biotechnology Co., Ltd.,
• Investigators: Principal Investigator: Jen-Kuang Lee, M.D., National Taiwan University Hospital; Principal Investigator: Chern-En Chiang, M.D., Ph.D., Taipei Veterans General Hospital, Taiwan; Principal Investigator: Jen-Yuan Kuo, M.D., Mackay Memorail Hospital; Principal Investigator: Ming-Shien Wen, M.D., Chang Gung Memorial Hospital; Principal Investigator: Yin-Wei Hsian, M.D., Ph.D., Cheng-Hsin General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2016
• Primary Completion (Actual): February 8, 2017
• Study Completion (Actual): February 8, 2017

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Peripheral Arterial Disease; Ankle Brachial Index; Cilostazol; PMR; Initial Claudication Distance; Absolute Claudication Distance
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrin Modulating Agents; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Protective Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Vasodilator Agents; Neuroprotective Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Cilostazol
• Other Study ID Numbers: GBL14-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO