A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN study)
- Conditions
- Essential hypertension
- Registration Number
- JPRN-jRCT2080223293
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
CS-3150 was administrated once daily for 12 weeks to patients with essential hypertension. The change in sitting blood pressure as the primary efficacy endpoint, was evaluated. The non-inferiority of CS-3150 2.5 mg to eplerenone 50 mg was verified, and the antihypertensive effect of CS-3150 5 mg was statistically significantly superior to that of 2. 5 mg. The incidence of adverse events was similar between 2.5 mg and 5 mg of CS-3150 and 50-mg of eplerenone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1001
1) Male and female subjects aged 20 years or older at informed consent
2) Subjects with essential hypertension and satisfied the following blood pressure criteria during run-in period;
-Sitting BP: SBP >= 140 mmHg and < 180 mmHg, DBP >= 90 mmHg and < 110 mmHg
-Mean 24 hr BP: SBP >= 130 and DBP >= 80 mmHg
1)Secondary hypertension or malignant hypertension
2)Diabetic nephropathy or diabetes mellitus with albuminuria
3)Serum potassium level < 3.5 or >= 5.1 mEq/L
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<br>- Adverse events
- Secondary Outcome Measures
Name Time Method efficacy<br>Change from baseline in 24 hr systolic and diastolic blood pressure