A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment
Overview
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.
Full Title of Study: “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.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2015
Interventions
- Drug: CS-3150
Arms, Groups and Cohorts
- Experimental: CS-3150
- CS-3150 1.25 to 5.0 mg , orally, once daily after breakfast for 12 weeks
Clinical Trial Outcome Measures
Primary Measures
- Change from baseline in sitting systolic and diastolic blood pressure
- Time Frame: Baseline to end of Week 12
Secondary Measures
- Change from baseline in UACR
- Time Frame: Baseline to end of Week 12
- Urine Albumin Creatinine Ratio (UACR)
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Daiichi Sankyo
- Provider of Information About this Clinical Study
- Sponsor
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