Study of QLS1410 in the Treatment of Primary Aldosteronism.

Qilu Pharmaceutical

Status and phase: Begins enrollment this month; Phase 2

Conditions: Primary Aldosteronism

Treatments: Drug: Placebo; Drug: QLS1410

Study type: Interventional

Funder types: Industry

Identifiers

NCT07550465

QLS1410-202

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

QLS1410

Experimental group

Treatment:

Drug: QLS1410

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo