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Study of QLS1410 in the Treatment of Primary Aldosteronism.
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of QLS1410 versus placebo, on the reduction of Seated Blood Pressure (SBP) in participants ≥ 18 years of age with Primary Aldosteronism (PA) with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics. QLS1410 (or placebo) will be administered once daily, up-titrated after 2 weeks or 4 weeks based on clinical response and tolerability.
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS1410 Tablets in the Treatment of Patients With Primary Aldosteronism.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-06
Completion Date
2027-04
Last Updated
2026-04-24
Healthy Volunteers
No
Conditions
Interventions
QLS1410
QLS1410 tablet administered orally, once daily (QD).
Placebo
Placebo tablet administered orally, once daily (QD).