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临床试验/JPRN-jRCT2080223232
JPRN-jRCT2080223232已完成3 期

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

DAIICHI SANKYO Co.,Ltd.0 个研究点目标入组 20 人开始时间: 2016年6月6日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
20

研究概览

简要总结

The efficacy and safety of CS-3150 titrated from 2.5 mg to 5 mg were investigated in patients with hypertension of grade III after 8 weeks. The change in sitting blood pressure was significantly reduced in both systolic blood pressure and diastolic blood pressure, confirming a clear antihypertensive effect. There were no safety issues.

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 hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drugs (except for potassium-sparing diuretics) during run-in period (Sitting SBP >= 180 mmHg or Sitting DBP >= 110 mmHg)

排除标准

  • 1)Suspected Hypertensive emergency
  • 2)Secondary hypertension or malignant hypertension
  • 3)Diabetic nephropathy
  • 4)Serum potassium level < 3.5 or >= 5.1 mEq/L (< 3.5 or>= 4.8 mEq/L if receive RA inhibitor)
  • 5)eGFR < 60 mL/min/1.73 m^2.

研究者

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