A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Mineralocorticoid Receptor Antagonists

Criteria

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