A Study of CS-3150 to Evaluate Efficacy and Safety in Hypertensive Patients with Type 2 Diabetes and Albuminuria

DAIICHI SANKYO Co.,Ltd.0 个研究点目标入组 51 人开始时间: 2016年6月9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: 51

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 hypertension with type 2 diabetes and albuminuria for 12 weeks. In the evaluation of the amount of 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 major safety concerns were noted.

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

•1) Male and female subjects aged 20 to 80 years at informed consent
•2) Subjects with type 2 diabetes and albuminuria (urine albumin-to-creatinine ratio >= 30, < 1000 mg/g/Cr
•3) 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)
•4) Treated with an ARB or ACE inhibitor
•5) eGFR >= 30 mL/min/1.73m^2

排除标准

•1)Secondary hypertension or malignant hypertension
•2)Type 1 diabetes
•3)Secondary glucose intolerance
•4)Diagnosed with non-diabetic nephropathy
•5)Serum potassium level < 3.5 or >= 4.8 mEq/

研究者

发起方

DAIICHI SANKYO Co.,Ltd.

相似试验

已完成

3 期

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

JPRN-jRCT2080223233DAIICHI SANKYO Co.,Ltd.58

已完成

3 期

A Study of CS-3150 to Evaluate Efficacy and Safety in Patients with Primary AldosteronismPrimary aldosteronism

JPRN-jRCT2080223294DAIICHI SANKYO Co.,Ltd.44

已完成

3 期

A Study to Evaluate Efficacy and Safety of CS-3150 in Patients With Severe Hypertension (Grade III)Severe hypertension (Grade III)

JPRN-jRCT2080223232DAIICHI SANKYO Co.,Ltd.20

已完成

3 期

Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal ImpairmentHypertension With Moderate Renal Impairment

NCT02807987Daiichi Sankyo Co., Ltd.58

已完成

3 期

Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and AlbuminuriaHypertension

NCT02807974Daiichi Sankyo Co., Ltd.51