Essential Hypertension
Conditions
Keywords
Essential hypertension, Mineralocorticoid receptor antagonist, Esaxerenone, Ambulatory blood pressure monitoring
Brief summary
To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.
Detailed description
Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension. Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.
Interventions
DRUGCS-3150
DRUGEplerenone
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female subjects aged 20 years or older at informed consent * Subjects with essential hypertension satisfying the following blood pressure criteria; * Sitting SBP: ≥ 140 mmHg and \< 180 mmHg * Sitting DBP: ≥ 90 mmHg and \< 110 mmHg * Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg
Exclusion criteria
* Secondary hypertension or malignant hypertension * Diabetic nephropathy or diabetes mellitus with albuminuria * Serum potassium level \< 3.5 or ≥ 5.1 mEq/L * Reversed day-night life cycle including overnight workers * eGFR \< 60 mL/min/1.73 m\^2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in sitting blood pressure | Baseline to end of Week 12 | Change from baseline in sitting systolic (SBP) and diastolic blood pressure (DBP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in 24 hour average blood pressure | Baseline to end of Week 12 | Change from baseline in 24 hour average systolic and diastolic blood pressure. |
Countries
Japan
Outcome results
None listed