NCT01869881已完成4 期
Effect of Sarpogrelate On the Nephropathy in Type 2 Diabetes
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2013年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- ACR(Urine Albumin/Creatinine ratio)
研究概览
简要总结
Phase 4 Study to evaluate the safety and effect on decreasing subjects' albuminuria who have Type 2 Diabetes by using sarpogrelate and placebo.
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
- Double (Participant, Investigator)
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
- •person who signed on ICF
- •Type 2 diabetic patient who have microalbuminuria or overt proteinuria
- •In case of hypertension patients, who keep the same medication steadily over last 4 weeks
排除标准
- •patients who have hypersensitivity on sarpogrelate or other salicylic acid
- •patients who should keep the antiplatelet agent because of acute cardiac disease or peripheral vein disease
- •patients who took other anticoagulant agent within 1 month
- •patient who take ACEI OR ARB but not controlled(over 150/100mmHg)
- •Type 1 diabetes patients
- •Patient who have cardiac or liver problem
- •Cr: >1.8mg/dl or GFR: <40ml/min
- •malignant tumor patients
研究组 & 干预措施
Sarpogrelate
Active Comparator
干预措施: Anplag(Sarpogrelate) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
ACR(Urine Albumin/Creatinine ratio)
时间窗: treatment period(24 weeks)
change of percentage
次要结局
- urinary 5-HIAA(5-Hydroxyindoleacetic acid), type 4 collagen(treatment period(24 weeks))
- Creatinine(treatment period(24 weeks))
- ACR(Urine Albumin/Creatinine ratio)(treatment period(24 weeks))
- PCR(Protein to Creatinine ratio in Urine)(treatment period(24 weeks))
研究者
研究点 (1)
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