Study of QLS1410 in the Treatment of Primary Aldosteronism.
ConditionPrimary Aldosteronism
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
QLS1410
DrugQLS1410 tablet administered orally, once daily (QD).
Placebo
DrugPlacebo tablet administered orally, once daily (QD).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: QLS1410Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in seated Systolic Blood Pressure (SBP) at Week 12
To assess the effect of baxdrostat versus placebo on seated Systolic Blood Pressure (SBP) at Week 12
Time frame
at week 12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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