A Phase 2 Exploratory Study to evaluate efficacy and safety of CS-3150 in Japanese Hypertensive Patients with Moderate Kidney Dysfunctio
- Conditions
- Hypertension with moderate kidney dysfunction
- Registration Number
- JPRN-jRCT2080222831
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
The efficacy and safety of CS-3150 titrated from 1. 25 mg, 2.5 mg to 5 mg were investigated in hypertensive patients with moderate kidney dysfunction for 12 weeks. The change in sitting blood pressure was significantly decreased in both systolic and diastolic blood pressures, and the change in sitting blood pressure decreased until Week 12 of the treatment period, demonstrating the hypotensive effects of CS-3150. No notable safety concerns were identified and tolerability was confirmed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 33
1)Male and female subjects aged 20 years or older and 80 years or younger at informed consent
2)Subjects with hypertension (Sitting SBP >= 140 mmHg and < 180 mmHg, Sitting DBP >= 80 mmHg and < 110 mmHg)
3) eGFR >= 30 mL/min/1.73 m2 and < 60 mL/min/1.73 m2
1)Secondary hypertension (except renoparenchymal hypertension) or malignant hypertension
2)Diabetes mellitus with albuminuria
3)Serum potassium level < 3.5 or >= 5.1 mEq/L
4)Subjects under Insulin treatment
5)Subjects under or pre-planned for hemodialysis
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<br>- Adverse events
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>- Time course of sitting systolic and diastolic blood pressure<br>- Proportion of patients achieving sitting blood pressure control<br>- Change from baseline in urinary albumin creatinine ratio<br>- Change in serum potassium