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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