JPRN-jRCT2080222722未知2 期
A Phase 2 Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Type 2 Diabetic Subjects With Microalbuminuria
DAIICHISANKYO Co.,Ltd.0 个研究点目标入组 325 人开始时间: 2015年1月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 325
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1)Subject with type 2 diabetes mellitus
- •2)Male or female subjects aged 20 years or older at informed consent
- •3)Subject with urinary albumin to creatine ratio (UACR) >= 45 mg/g Cr and < 300 mg/g Cr
- •4)Estimated glomerular filtration rate by creatinine (eGFRcreat) >= 30 mL/min/1.73 m2
- •5)Subjects treated with angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for more than 3 months prior to treatment period
排除标准
- •Type-1 diabetics
- •2)HbA1c (NGSP) >=8.4%
- •3)Secondary glucose intolerance
- •4)Subjects diagnosed with non-diabetic nephropathy
- •5)Nephrotic syndrome
- •6)Secondary hypertension or malignant hypertension
- •Serum potassium level in any of the following categories: For subjects with eGFRcreat of >= 45 mL/min/1.73 m2, serum potassium level of < 3.5 mEq/L or >= 5.1 mEq/L; For subjects with eGFRcreat of >= 30 mL/min/1.73 m2 and < 45 mL/min/1.73 m2, serum potassium level of < 3.5 mEq/L or >= 4.8 mEq/
研究者
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