NCT02448628已完成2 期
A Multi-center, Open Label, Dose Titration, Exploratory Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Change from baseline in sitting systolic and diastolic blood pressure
研究概览
简要总结
This study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.
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
- •Men and women Aged 20 years or older and 80 years or younger at informed consent
- •Subjects with hypertension (Sitting systolic blood pressure SBP >= 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP >= 80 mmHg and < 110 mmHg)
- •estimated glomerular filtration rate eGFR >= 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2
排除标准
- •Secondary hypertension or malignant hypertension
- •Diabetes mellitus with albuminuria
- •Serum potassium level < 3.5 or >= 5.1 mEq/L
- •Subjects under Insulin treatment
- •Subjects under or pre-planned for hemodialysis
研究组 & 干预措施
CS-3150
Experimental
CS-3150 1.25 to 5.0 mg , 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
次要结局
- Change from baseline in UACR(Baseline to end of Week 12)
研究者
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