Severe Hypertension
Conditions
Keywords
severe hypertension, grade III hypertension, mineralocorticoid receptor antagonist
Brief summary
To examine antihypertensive effect and safety of administration of CS-3150 in patients with severe hypertension (Grade III).
Interventions
DRUGCS-3150
CS-3150 2.5 to 5mg, orally, once daily after breakfast
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female subjects aged 20 to 80 years at informed consent * Subjects with severe hypertension, who do not receive any antihypertensive drugs or receive antihypertensive drug (except for potassium-sparing diuretics) during run-in period (Sitting SBP ≥ 180 mmHg or Sitting DBP ≥ 110 mmHg)
Exclusion criteria
* Patients who are suspected hypertensive emergency * Secondary hypertension or malignant hypertension * Diabetes mellitus with albuminuria * Serum potassium level \< 3.5 or ≥ 5.1 mEq/L (≥ 4.8 mEq/L if receive RA inhibitor) * eGFR \< 60 mL/min/1.73 m\^2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in sitting systolic and diastolic blood pressure | Baseline to end of Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Time course of systolic and diastolic blood pressure | Baseline to end of Week 8 |
| Proportion of patients achieving blood pressure control | Baseline to end of Week 8 |
Countries
Japan
Outcome results
None listed