NCT05906199已完成4 期
A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV, Exploratory Clinical Trial to Compare the Effects of Improving the Carotid Artery Intima Media Thickness and Changing Lipid Levels by Cilostazol/Ginkgo Leaf Extract (Renexin CR) and Aspirin (Aspirin Protect Tab.) in Diabetic Peripheral Angiopathy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Changes in carotid IMT
研究概览
简要总结
This study is to compare and evaluate the effect of improving the carotid IMT and lipid level of the Cilostazol/Ginkgo leaf extract group with the aspirin administrated group in patients with diabetic peripheral angiopathy.
详细描述
A Prospective, Randomized, Active-controlled, Parallel, Open, Multi-center, Phase IV
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
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Renexin CR 200/160mg
Experimental
Single oral administration of Renexin CR 200/160mg, QD
干预措施: Renexin CR 200/160mg (Drug)
Aspirin 100mg
Active Comparator
Single oral administration of Aspirin 100mg, QD
干预措施: Aspirin 100mg (Drug)
结局指标
主要结局
Changes in carotid IMT
时间窗: 24weeks, 48weeks
Changes in carotid IMT after 24weeks, 48weeks of administration compared to before administration of investigational product
次要结局
未报告次要终点
研究者
研究点 (2)
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