About this trial
This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in primary aldosteronism.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years , regardless of gender.
Diagnosed with primary aldosteronism (PA).
Mean seated office systolic blood pressure (msSBP) ≥145 mmHg.
Receiving stable background antihypertensive therapy.
Disqualifiers
Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and/or mean seated office diastolic blood pressure (msDBP) ≥110 mmHg.
History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.
History or diagnostic evidence of other secondary hypertension.
Prior surgical resection for adrenal adenoma.
Trial design
Parallel
Treatments tested in this trial
SAL0140 Tablets
DrugDrug: SAL0140 Tablets
SAL0140 Tablets
DrugSAL0140 Tablets
SAL0140 placebo
DrugPlacebo
Treatment groups
Trial outcomes
Primary outcomes
The baseline change in mean seated systolic blood pressure (msSBP)
Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment
Sponsors and contacts
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