Study of QLS1410 in the Treatment of Primary Aldosteronism.

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.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07550465

Enrollment

Registered

2026-04-24

Start date

2026-06-01

Completion date

2027-04-01

Last updated

2026-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism

Brief 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.

Interventions

DRUGQLS1410

QLS1410 tablet administered orally, once daily (QD).

DRUGPlacebo

Placebo tablet administered orally, once daily (QD).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female participants must be ≥ 18 years of age 2. Participants with a documented diagnosis of primary aldosteronism (PA) that fulfils the criteria Guidelines. 3. 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. 4. eGFR ≥ 45 mL/min/1.73m2 at Screening 5. Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomization

Exclusion criteria

1. 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. 2. Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation. 3. Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomization.

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 12	at week 12	To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 12

Contacts

CONTACTMing Liu

mingliu@tmu.edu.cn+86-18322017516

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026