Hypertension With Moderate Renal Impairment
Conditions
Keywords
Mineralocorticoid receptor antagonist, Moderate renal impairment, Hypertension
Brief summary
To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with moderate renal impairment.
Interventions
DRUGCS-3150
CS-3150 1.25 to 2.5, 5mg, orally
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 or order to 80 or younger years at informed consent * Subjects with hypertension (Sitting SBP ≥ 140 mmHg, \<180 mmHg and Sitting DBP ≥ 80 mmHg, \<110 mmHg * Treatment with an ARB or ACE inhibitor * eGFR ≥ 30 mL/min/1.73 m2 and \< 60 mL/min/1.73 m2
Exclusion criteria
* Secondary hypertension or malignant hypertension * Diabetes mellitus with albuminuria * Subjects under Insulin treatment * Subjects under or pre-planned for hemodialysis * Serum potassium level \< 3.5 or ≥ 4.8 mEq/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in sitting systolic and diastolic blood pressure | Baseline to end of Week 12 | Change from baseline in sitting systolic and diastolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time course of systolic and diastolic blood pressure | Baseline to end of Week 12 | Time course of systolic and diastolic blood pressure |
| Proportion of patients achieving blood pressure control | Baseline to end of Week 12 | Proportion of patients achieving blood pressure control |
Countries
Japan
Outcome results
None listed