NCT02885662CompletedNot Applicable
A Study of CS-3150 to Evaluate Efficacy and Safety in Patients With Primary Aldosteronism
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Daiichi Sankyo Co., Ltd.
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change from baseline in sitting blood pressure
Study Overview
Brief Summary
To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
CS-3150
Experimental
CS-3150 2.5 to 5.0 mg , orally, once daily after breakfast for 12 weeks.
Intervention: CS-3150 (Drug)
Outcomes
Primary Outcomes
Change from baseline in sitting blood pressure
Time Frame: Baseline to end of Week 12
Change from baseline in sitting systolic and diastolic blood pressure
Secondary Outcomes
- Time course of sitting blood pressure(Baseline to end of Week 12)
- Proportion of patients achieving sitting blood pressure goal(Baseline to end of Week 12)
Investigators
Study Sites (1)
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