A Study of CS-3150 to Evaluate Efficacy and Safety to in combination with ARB or ACE inhibitor in Hypertensive Patients with Moderate Kidney Dysfunctio
- Conditions
- Hypertension with moderate renal impairment
- Registration Number
- JPRN-jRCT2080223233
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 58
) 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
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/
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>- Change from baseline in sitting systolic and diastolic blood pressure at the end of treatment<br>- Adverse events
- Secondary Outcome Measures
Name Time Method efficacy<br>-Time course of sitting systolic and diastolic blood pressure<br>-Proportion of patients achieving sitting blood pressure control