A Study of CS-3150 to Evaluate Efficacy and Safety in Hypertensive Patients with Type 2 Diabetes and Albuminuria
- Conditions
- Hypertension with type 2 diabetes and albuminuria.
- Registration Number
- JPRN-jRCT2080223238
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 51
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
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/
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 safety<br>-Time course of sitting systolic and diastolic blood pressure<br>-Proportion of patients achieving sitting blood pressure control<br>-Change rate from baseline in urine-albumin-to-creatinine ratio. <br>-Time course of urine-albumin-to-creatinine.