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

Launched by GENOVATE BIOTECHNOLOGY CO., LTD., · Mar 19, 2025

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• 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.