[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635267":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":11,"responsibleParty":33,"collaborators":11,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":11,"eligibilityCriteria":41,"healthyVolunteers":37,"sex":42,"minAge":43,"maxAge":11,"enrollmentInfo":44,"targetDuration":11,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":11,"overallStatus":53,"whyStopped":11,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"QLS1410","EXPERIMENTAL",null,[13],"Drug: QLS1410",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","QLS1410 tablet administered orally, once daily (QD).",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Placebo tablet administered orally, once daily (QD).",[15],[28],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Ming Liu","CONTACT","+86-18322017516","mingliu@tmu.edu.cn",{"type":34,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100635267","phase-2-study-of-qls1410-in-the-treatment-of-primary-aldosteronism-100635267",false,"NCT07550465","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.","Inclusion Criteria:\n\n1. Male or female participants must be ≥ 18 years of age\n2. Participants with a documented diagnosis of primary aldosteronism (PA) that fulfils the criteria Guidelines.\n3. 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.\n4. eGFR ≥ 45 mL\u002Fmin\u002F1.73m2 at Screening\n5. Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomization\n\nExclusion Criteria:\n\n1. 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.\n2. Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.\n3. Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomization.","ALL","18 Years",{"count":45,"type":46},60,"ESTIMATED","INTERVENTIONAL",[49],"PHASE2","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.\n\nQLS1410 (or placebo) will be administered once daily, up-titrated after 2 weeks or 4 weeks based on clinical response and tolerability.",[52],"Primary Aldosteronism","NOT_YET_RECRUITING","2026-04-19",{"date":56,"type":57},"2026-04-24","ACTUAL",{"date":59,"type":46},"2026-06",{"date":61,"type":46},"2027-04",{"name":5,"class":6}]