A Study to Evaluate Efficacy and Safety of CS-3150 in Japanese Hypertensive Subjects

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, placebo-controlled, double-blind, multi-center study to evaluate efficacy and safety of different doses of CS-3150 compared to placebo in Japanese hypertensive subjects. 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: Eplerenone; Mineralocorticoid Receptor Antagonists

Criteria

Inclusion Criteria:

• Male and female subjects aged 20 years or older at informed consent

• Subjects with essential hypertension (Sitting SBP ≥ 140 mmHg and < 180 mmHg, Sitting DBP ≥ 90 mmHg and < 110 mmHg,and 24h-hr blood pressure more than 130 mmHg in SBP and 80 mmHg in DBP)

Exclusion Criteria:

• Secondary hypertension or malignant hypertension

• Diabetes mellitus with albuminuria

• Serum potassium level < 3.5 or ≥ 5.1 mEq/L

• Reversed day-night life cycle including overnight workers

• eGFR < 60 mL/min/1.73 m^2