Study of CS-3150 in Combination With ARB or ACE Inhibitor in Hypertensive Patients With Moderate Renal Impairment
- Registration Number
- NCT02807987
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CS-3150 CS-3150 CS-3150 1.25 to 2.5, 5mg, orally, once daily after breakfast for 12 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Proportion of patients achieving blood pressure control Baseline to end of Week 12 Proportion of patients achieving blood pressure control
Time course of systolic and diastolic blood pressure Baseline to end of Week 12 Time course of systolic and diastolic blood pressure