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

Phase 3

Terminated

• Conditions: Intermittent Claudication
• Interventions: Drug: Cilostazol 200 mg; Drug: Cilostazol 100 mg

• Registration Number: NCT06886620
• Lead Sponsor: Genovate Biotechnology Co., Ltd.,

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-14
• Primary Completion: 2017-02-08
• Study Completion: 2017-02-08
• Status Verified: 2025-03
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PMR	Cilostazol 200 mg	Cilostazol 200 mg, tablet, PO, QN
Pletaal®	Cilostazol 100 mg	Cilostazol 100 mg, tablet, PO, BID

Primary Outcome Measures

Name	Time	Method
Geometric mean percent change in initial claudication distance (ICD)	At baseline (day 0) and week 24	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.

Secondary Outcome Measures

Name	Time	Method
Geometric mean percent change in initial claudication distance (ICD)	At baseline (day 0) and week 12	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.
Geometric mean percent change in absolute claudication distance (ACD)	At baseline (day 0) and week 24	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.
Subject assessment of treatment response	At week 24	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.

Trial Locations

Locations (5)

Cheng Hsin General Hospital; 🇨🇳 Taipei, Taiwan

Chang Gung Memorial Hospital Linkou; 🇨🇳 Taoyuan, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan