Study of CS-3150 in Patients With Primary Aldosteronism
- Registration Number
- NCT02885662
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief Summary
To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CS-3150 CS-3150 CS-3150 2.5 to 5.0 mg , orally, once daily after breakfast for 12 weeks.
- Primary Outcome Measures
Name Time Method Change from baseline in sitting blood pressure Baseline to end of Week 12 Change from baseline in sitting systolic and diastolic blood pressure
- Secondary Outcome Measures
Name Time Method Time course of sitting blood pressure Baseline to end of Week 12 Time course of sitting systolic and diastolic blood pressure
Proportion of patients achieving sitting blood pressure goal Baseline to end of Week 12
Trial Locations
- Locations (1)
Japan Organaization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
🇯🇵Yokohama, Kanagawa, Japan