Study of CS-3150 in Patients With Essential Hypertension (ESAX-HTN)

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: CS-3150; Drug: Eplerenone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02890173

CS3150-A-J301

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,001 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,001 participants in 3 patient groups

CS-3150 2.5 mg

Experimental group

Description:

CS-3150 2.5 mg, orally, once daily after breakfast for 12 weeks

Treatment:

Drug: CS-3150

CS-3150 5.0 mg

Experimental group

Description:

CS-3150 5 mg, orally, once daily after breakfast for 12 weeks

Treatment:

Drug: CS-3150

Eplerenone

Active Comparator group

Description:

Eplerenone 50 mg, orally, once daily after breakfast for 12 weeks

Treatment:

Drug: Eplerenone