A Long-term Study of CS-3150 as monotherapy or in combination with other antihypertensive drug in Japanese Patients with Essential Hypertensio
- Conditions
- Essential hypertension
- Registration Number
- JPRN-jRCT2080223121
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
CS-3150 was administered to patients with essential hypertension for Week 28 or Week 52. There were no safety issue, regardless of the concomitant use of antihypertensive drugs, and a stable antihypertensive effect was observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 368
1)Male and female subjects aged 20 years or older at informed consent
2) Subjects with essential hypertension, who do not receive any antihypertensive drugs or receive calcium channel blocker, ACE inhibitor, or ARB during run-in period (Sitting SBP >= 140 mmHg and < 180 mmHg, Sitting DBP >= 90 mmHg and < 110 mmHg, and mean 24hr SBP >= 130 and DBP >= 80 mmHg)
1)Secondary hypertension or malignant hypertension
2)Diabetes mellitus with albuminuria
3)Serum potassium level < 3.5 or >= 5.1 mEq/L (>= 4.8 mEq/L if receive ACE inhibitor, or ARB)
4)Reversed day-night life cycle including overnight workers
5)eGFR < 60 mL/min/1.73 m^2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>safety<br>-Change from baseline in sitting systolic and diastolic blood pressure (Baseline to end of Week 12, 28, 52)<br>-Adverse events, laboratory abnormalities, vital signs
- Secondary Outcome Measures
Name Time Method efficacy<br>Change from baseline in 24-hr blood pressure (ABPM) (Baseline to end of Week 12, 28, 52)