Study of CS-3150 in Patients With Primary Aldosteronism

Daiichi Sankyo

Status: Completed

Conditions: Primary Aldosteronism

Treatments: Drug: CS-3150

Study type: Interventional

Funder types: Industry

Identifiers

NCT02885662

CS3150-A-J307

Details and patient eligibility

About

To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.

Enrollment: 44 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

• Patients diagnosed primary aldosteronism by screening test of plasma aldosterone concentration (PAC) and aldosterone to renin ratio (ARR), and confirmatory testing

• Patients satisfying following blood pressure;

  • sitting systolic blood pressure (SBP) ≥ 140 mmHg and <180 mmHg
  • sitting diastolic blood pressure (DBP) ≥ 90 mmHg and <110 mmHg

Exclusion criteria

• Secondary hypertension except primary aldosteronism or hypertensive emergency
• Patients diagnosed diabetic nephropathy
• Patients with type 1 diabetes
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2
• Serum potassium level < 3.0 or ≥ 5.1 milliequivalent (mEq)/L

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

CS-3150

Experimental group

Description:

CS-3150 2.5 to 5.0 mg , orally, once daily after breakfast for 12 weeks.

Treatment:

Drug: CS-3150