A Phase 2 Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects
- Conditions
- Essential hypertension
- Registration Number
- JPRN-jRCT2080222720
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Sitting blood pressure, the primary endpoint, decreased dose-dependently with CS-3150, demonstrating the superiority of antihypertensive efficacy over placebo in the CS-3150 2.5 mg and 5 mg groups. The incidence of adverse events did not tend to increase in any treatment group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 426
1)Male and female subjects aged 20 years or older at informed consent
2)Subjects with essential hypertension (Sitting SBP >= 140 mmHg and < 180 mmHg, Sitting DBP >= 90 mmHg and < 110 mmHg, and 24hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)
1)Secondary hypertension or malignant hypertension
2)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 safety<br>efficacy<br>Change from baseline in sitting systolic and diastolic blood pressure<br>Adverse event
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>Change from baseline in 24-hr blood pressure (ABPM) Change in serum potassium