Overview

Study of CS-3150 in Patients With Primary Aldosteronism

Status:
Completed
Trial end date:
2017-07-20
Target enrollment:
0
Participant gender:
All
Summary
To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Treatments:
Mineralocorticoid Receptor Antagonists
Criteria
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