JPRN-jRCT2080223639已完成3 期
A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Placebo in Japanese Type 2 Diabetic Patients with Microalbuminuria (ESAX-DN study)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 455
研究概览
简要总结
When CS-3150 was administered for 52 weeks to patients with type 2 diabetes and microalbuminuria taking ARB or ACE inhibitors, the superiority of CS-3150 over placebo was demonstrated in achieving and remission rate of UACR and UACR reduction. Also, progression rate to overt albuminuria in CS-3150 group was significantly lower than that in the placebo group. There were no apparent differences in the incidence of SAEs between CS-3150 and placebo groups.
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) Patients aged 20 years or older at the time obtaining informed consent
- •2) Patients diagnosed to have type 2 diabetes mellitus
- •3) Patients who meet any of the following in the laboratory tests (central measurement) at run in period.
- •i.Patients with UACR >= 45 mg/g creatinine and < 300 mg/g creatinine in the early morning first urine at least twice.
- •ii. Patients with eGFRcreat >= 30 mL/min/1.73 m2
- •4) Hypertensive patients who have been taking an ARB or an ACE inhibitor for at least 12 weeks prior to the study drug administration without changing the dosage and administration.
排除标准
- •1) Patients with type 1 diabetes mellitus
- •2) Patients with secondary glucose tolerance impairment
- •3) Patients diagnosed to have non-diabetic nephropathy
- •4) Patients with secondary hypertension
- •5) Patients who were hospitalized for hyperkalemia within 1 year before informed consent
研究者
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