Essential hypertension
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1)Male and female subjects aged 20 years or older at informed consent 2) Subjects with essential hypertension during run-in period (mean 24 hr SBP >= 130 and DBP >= 80 mmHg , and Sitting SBP >= 140 mmHg and = 90 mmHg and < 110 mmHg)
Exclusion criteria
Exclusion criteria: 1)Secondary hypertension or malignant hypertension 2)Diabetes mellitus with albuminuria 3)Serum potassium level = 5.1 mEq/L 4)Reversed day-night life cycle including overnight workers 5)eGFR < 60 mL/min/1.73 m^2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy exploratory - Relationship between the change from baseline in 24 hr blood pressure (systolic, diastolic, and avarage blood pressure) and baseline factors. - Adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy -Relationship between the change from baseline in morning, evening, and night blood pressure (systolic, diastolic, and avarage blood pressure) and baseline factors. -Relationship between the change from baseline in sitting blood pressure (systolic and diastolic blood pressure) and baseline factors. -Change from baseline in sitting blood pressure (systolic and diastolic blood pressure) and baseline factors. -Time course of 24 hr blood pressure and sitting blood pressure (systolic, diastolic, and avarage blood pressure) -Proportion of patients achieving 24 hr and sitting blood pressure control | — |
Countries
Japan