NCT06886620终止3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 5
- 主要终点
- Geometric mean percent change in initial claudication distance (ICD)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Pletaal®
Active Comparator
Cilostazol 100 mg, tablet, PO, BID
干预措施: Cilostazol 100 mg (Drug)
PMR
Experimental
Cilostazol 200 mg, tablet, PO, QN
干预措施: Cilostazol 200 mg (Drug)
结局指标
主要结局
Geometric mean percent change in initial claudication distance (ICD)
时间窗: 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.
次要结局
- Geometric mean percent change in initial claudication distance (ICD)(At baseline (day 0) and week 12)
- Geometric mean percent change in absolute claudication distance (ACD)(At baseline (day 0) and week 24)
- Subject assessment of treatment response(At week 24)
研究者
研究点 (5)
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