NCT00870402Unknown4 期
Effect of Aldosterone Antagonism in the Reduction of Albuminuria and Diastolic Disfunction of Patients With Diabetic Nephropathy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Reduction of albuminuria
研究概览
简要总结
The purpose of this study is to determine whether spironolactone are effective in the reduction of albuminuria and diastolic disfunction of subjects with diabetic nephropathy.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetic subjects with maximum ten years after diagnostic
- •Diabetic nephropathy with albuminuria
- •Normal renal function
- •Diastolic disfunction
- •Taking a IECA or ARA drug family previously
排除标准
- •Diabetics subjects with macroangiopathy
- •Acute coronary syndrome in the three months before
- •Hyperkalemia > 5.5 mEq/L
- •Pregnancy
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Experimental
干预措施: Spironolactone (Drug)
结局指标
主要结局
Reduction of albuminuria
时间窗: 9 months
次要结局
- Reduction of diastolic disfunction(9 months)
研究者
研究点 (1)
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