EUCTR2012-005093-54-DK进行中（未招募）不适用
A Double-Blind, Placebo-Controlled, Randomized, Twostage, Parallel-Group, Adaptive Design Phase 2a Study to Evaluate the Effects of BMS-813160 in Subjects with Type 2 Diabetes Mellitus and Diabetic Kidney Disease (DKD) Who Have Residual Macroalbuminuria Despite Treatment with an Inhibitor of the Renin-Angiotensin System.Revised Protocol 04 dated 09- July - 2014Pharmacogenetics Amendment 01, dated 12-OCT-2012, version 1.0
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Clinical diagnosis of type 2 diabetes mellitus with macroalbuminuria (UACR between 200 and 3500 mg/g)
- •-Background angiotensin converting enzyme inhibitor (ACEI) or antiotensin receptor blocker (ARB) therapy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •-Clinical diagnosis of type 1 diabetes
- •-Unstable cardiovascular, metabolic, or other chronic disease status
- •-eGFR < 30 mL/min/1.73 m2
- •-High risk of infection or immune compromise
- •-Clinically significant ECG conduction abnormalities
- •-Drugs with significant potential to affect BMS-813160 exposure
研究者
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