A Randomized, Multicenter, Open-label, Parallel, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Sarpogrelate SR in Patients Having Intermittent Claudication Among Chronic Artery Occlusive Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 7
- 主要终点
- Change in Ankle-Brachial Index (ABI)
研究概览
简要总结
This clinical trial aims to assess the non-inferiority of Sarpogrelate SR 300mg once daily compared to Sarpogrelate 100mg three times daily in patients having intermittent claudication among chronic artery occlusive disease, based on changes in the Ankle-Brachial Index (ABI).
详细描述
The clinical trial is a randomized, multicenter, open-label, parallel-group, Phase 4 study conducted to evaluate the non-inferiority of Sarpogrelate SR 300mg once daily compared to Sarpogrelate 100mg three times daily in patients having intermittent claudication among chronic artery occlusive disease. Eligible patients who sign the informed consent form voluntarily will receive the investigational products. Subsequently, they will undergo observation and various assessments at the 12-week and 24-week visits. The trial is designed to determine whether Sarpogrelate SR 300mg once daily is inferior to Sarpogrelate 100mg three times daily in terms of changes in the Ankle-Brachial Index (ABI).
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adults aged ≥ 19
- •Diagnosis of chronic arterial occlusive disease
- •Experience of intermittent claudication symptoms for at least 3 months
- •Receiving Sarpogrelate for a minimum of 4 weeks prior to the baseline
- •Lower limb pain measured at VAS 40mm or higher at baseline
排除标准
- •Patients with coronary artery disease or cerebrovascular disease related to arteriosclerosis undergoing or scheduled for surgery or medication treatment
- •Patients with a history of severe heart failure within the 6 months prior to the screening
- •Patients with a history of bleeding
- •Patients receiving anticoagulants or medications with antiplatelet activity at baseline
- •Patients diagnosed with peripheral neuropathy and currently taking neuropathic pain medications
- •Patients with infectious or progressive fibrotic diseases such as rheumatoid arthritis, systemic lupus erythematosus, idiopathic pulmonary fibrosis, etc
研究组 & 干预措施
Sarpogrelate SR 300mg, QD
Sarpogrelate SR 300mg, QD
干预措施: Sarpogrelate SR (Drug)
Sarpogrelate 100mg, TID
Sarpogrelate 100mg, TID
干预措施: Sarpogrelate (Drug)
结局指标
主要结局
Change in Ankle-Brachial Index (ABI)
时间窗: from baseline to the 12-week and 24-week
To evaluate the efficacy following administration of Sarpogrelate SR
次要结局
- the Rate of subjects with grades of Spontaneous Pain, Numbness, and Coldness(at baseline, 12-week, and 24-week timepoints)
- Change in Medication Adherence Index (MMAS-8)(from baseline to the 12-week and 24-week timepoints.)
- Change in Lower Limb Pain Visual Analogue Scale (VAS)(from baseline to the 12-week and 24-week timepoints)
- Change in Walking Impairment Questionnaire (WIQ)(from baseline to the 12-week and 24-week timepoints)