Primary Aldosteronism
Conditions
Keywords
Primary aldosteronism, Hypertension, mineralocorticoid receptor antagonist, Developmental Phase III
Brief summary
To examine antihypertensive effect and safety of CS-3150 in patients with primary aldosteronism.
Interventions
DRUGCS-3150
CS-3150 2.5 to 5.0 mg , orally.
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in sitting blood pressure | Baseline to end of Week 12 | Change from baseline in sitting systolic and diastolic blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Japan
Outcome results
None listed