Study of QLS1410 in the Treatment of Primary Aldosteronism.
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Primary Aldosteronism
In brief
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.
Key facts
- Study ID
- NCT07550465
- Run by
- Qilu Pharmaceutical Co., Ltd.
- People needed
- 60
- Starts
- 2026-06-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-04-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female participants must be ≥ 18 years of age
- Participants with a documented diagnosis of primary aldosteronism (PA) that fulfils the criteria Guidelines.
- Participants willing and able to cease dosing of mineralocorticoid receptor antagonist (MRA) or potassium sparing diuretics per study requirement for participants taking an MRA or potassium sparing diuretic at Screening.
- eGFR ≥ 45 mL/min/1.73m2 at Screening
- Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomization
You may not qualify if…
- Had undergone surgery for adrenal adenoma in the past or planned to receive surgical treatments such as adrenalectomy, renal sympathetic denervation, or adrenal ablation during the course of the study.
- Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
- Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomization.
Full record on ClinicalTrials.gov
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