A Study of CS-3150 to Evaluate Efficacy and Safety to in combination with ARB or ACE inhibitor in Hypertensive Patients with Moderate Kidney Dysfunction

DAIICHI SANKYO Co.,Ltd.0 个研究点目标入组 58 人开始时间: 2016年6月6日最近更新: 2023年10月17日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: DAIICHI SANKYO Co.,Ltd.
入组人数: 58

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

The efficacy and safety of CS-3150 titrated from 1. 25 mg, 2.5 mg to 5 mg, in combination with ARB or ACE inhibitors were investigated in hypertensive patients with moderate kidney dysfunction for 12 weeks. In the evaluation of the change in sitting blood pressure, the blood pressure value at the end of treatment significantly decreased both systolic and diastolic blood pressure compared with the baseline blood pressure value in the run-in period. No safety issues were observed.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 <= 80age old（—）
性别: All

入选标准

•) Male and female subjects aged 20 or older to 80 years or younger at informed consent
•2) Subjects with hypertension (i)Sitting SBP >= 140 mmHg, <180 mmHg and Sitting DBP >= 80 mmHg, <110 mmHg, ii) between two measurement difference =<30/15 mmHg at run-in period)
•3) eGFR >= 30 mL/min/1.73m2 and < 60 mL/min/1.73m2
•4) Treated with an ARB or ACE inhibitor

排除标准

•1)Secondary hypertension (except renoparenchymal hypertension) or malignant hypertension
•2)Diabetes mellitus with albuminuria
•3)Subjects under Insulin treatment
•4)Subjects under or pre-planned for hemodialysis
•5)Serum potassium level < 3.5 or >= 4.8 mEq/

研究者

发起方

DAIICHI SANKYO Co.,Ltd.

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