Study of CS-3150 in Patients With Essential Hypertension

• Status: Completed
• Trial end date: 2017-07-11
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate antihypertensive effect and safety of CS-3150 compared to Eplerenone in patients with essential hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Eplerenone; Mineralocorticoid Receptor Antagonists; Spironolactone

Criteria

Inclusion Criteria:

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

• Subjects with essential hypertension satisfying the following blood pressure criteria;

• Sitting SBP: ≥ 140 mmHg and < 180 mmHg

• Sitting DBP: ≥ 90 mmHg and < 110 mmHg

• Mean 24 hr BP: SBP ≥ 130 and DBP ≥ 80 mmHg

Exclusion Criteria:

• Secondary hypertension or malignant hypertension

• Diabetic nephropathy or 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