Clinical trial NCT06886620: Assess the Safety and Effectiveness of Once Daily PMR Compared to Twice Daily Pletaal® in Patients With Intermittent Claudication
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Intermittent Claudication
Keywords: Peripheral Arterial Disease
Ankle Brachial Index
Absolute Claudication Distance
Initial Claudication Distance
PMR
Cilostazol
Lead sponsor: Genovate Biotechnology Co., Ltd.,
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Geometric mean percent change in initial claudication distance (ICD)
timeFrame: At baseline (day 0) and week 24
Secondary outcomes:
measure: Geometric mean percent change in initial claudication distance (ICD)
timeFrame: At baseline (day 0) and week 12
measure: Geometric mean percent change in absolute claudication distance (ACD)
timeFrame: At baseline (day 0) and week 12
measure: Geometric mean percent change in absolute claudication distance (ACD)
timeFrame: At baseline (day 0) and week 24
measure: Subject assessment of treatment response
timeFrame: At week 24
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou
Study officials:
affiliation: National Taiwan University Hospital
name: Jen-Kuang Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chern-En Chiang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mackay Memorail Hospital
name: Jen-Yuan Kuo, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Ming-Shien Wen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cheng-Hsin General Hospital
name: Yin-Wei Hsian, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: