A Study to Evaluate Efficacy and Safety of CS-3150 in Patients With Severe Hypertension (Grade III)
- Conditions
- Severe hypertension (Grade III)
- Registration Number
- JPRN-jRCT2080223232
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 20
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)
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.
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 efficacy<br>Time course of sitting systolic and diastolic blood pressure<br>Proportion of patients achieving sitting blood pressure control