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

Genovate Biotechnology

Status and phase

Terminated

Phase 3

Conditions

Intermittent Claudication

Treatments

Drug: Cilostazol 200 mg

Drug: Cilostazol 100 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT06886620

GBL14-001

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.