A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment
- Registration Number
- NCT02448628
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
This study is a multi-center, open label, dose titration, exploratory study to evaluate efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood pressure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- Men and women Aged 20 years or older and 80 years or younger at informed consent
- Subjects with hypertension (Sitting systolic blood pressure SBP >= 140 mmHg and < 180 mmHg, Sitting diastolic blood pressure DBP >= 80 mmHg and < 110 mmHg)
- estimated glomerular filtration rate 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
- Serum potassium level < 3.5 or >= 5.1 mEq/L
- Subjects under Insulin treatment
- Subjects under or pre-planned for hemodialysis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CS-3150 CS-3150 CS-3150 1.25 to 5.0 mg , 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
- Secondary Outcome Measures
Name Time Method Change from baseline in UACR Baseline to end of Week 12 Urine Albumin Creatinine Ratio (UACR)