Study of CS-3150 in Patients With Essential Hypertension

A Double Blind Study of CS-3150 to Evaluate Efficacy and Safety Compared to Eplerenone in Patients With Essential Hypertension (ESAX-HTN Study)

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

Primary objective is to evaluate antihypertensive effect and safety of CS-3150 2.5 mg compared to Eplerenone in patients with essential hypertension.

Secondary objective is to evaluate antihypertensive effect and safety of CS-3150 5.0 mg compared to 2.5 mg.

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