NCT02807974已完成3 期
A Study of CS-3150 to Evaluate Efficacy and Safety in Hypertensive Patients With Type 2 Diabetes and Albuminuria.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 主要终点
- Change from baseline in sitting systolic and diastolic blood pressure
研究概览
简要总结
To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 20 to 80 years at informed consent
- •Subjects with type 2 diabetes and albuminuria (urine albumin-to-creatinine ratio ≥ 30, < 1000 mg/g/Cr)
- •Subjects with hypertension (Sitting SBP ≥ 140 mmHg, <180 mmHg and Sitting DBP ≥ 80 mmHg, <110 mmHg
- •Treatment with an ARB or ACE inhibitor
- •eGFR ≥ 30 mL/min/1.73m^2
排除标准
- •Secondary hypertension or malignant hypertension
- •Type 1 diabetes
- •Secondary glucose intolerance
- •Diagnosed with non-diabetic nephropathy
- •Serum potassium level < 3.5 or ≥ 4.8 mEq/L
研究组 & 干预措施
CS-3150
Experimental
CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks
干预措施: CS-3150 (Drug)
结局指标
主要结局
Change from baseline in sitting systolic and diastolic blood pressure
时间窗: Baseline to end of Week 12
Change from baseline in sitting systolic and diastolic blood pressure
次要结局
- Time course of urine-albumin-to-creatinine ratio(Baseline to end of Week 12)
- Change rate from baseline in urine-albumin-to-creatinine ratio(Baseline to end of Week 12)
- Time course of systolic and diastolic blood pressure(Baseline to end of Week 12)
- Proportion of patients achieving blood pressure control(Baseline to end of Week 12)
研究者
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