[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-hyperaldosteronism\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-hyperaldosteronism":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100593542","phase-3-a-study-to-assess-efficacy-and-safety-of-baxdrostat-in-participants-with-primary-aldosteronism-100593542",false,"NCT07007793","A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism","A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Baxdrostat in Adult Participants With Primary Aldosteronism","BaxPA","Inclusion Criteria:\n\n* Male or female participants must be ≥ 18 years of age\n* Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.\n* Participants willing and able to cease dosing of MRA or potassium sparing diuretics per study requirement for participants taking an MRA or potassium sparing diuretic at Screening.\n* eGFR ≥ 45 mL\u002Fmin\u002F1.73m2 at Screening\n* Serum potassium level ≥ 3.0 and \\\u003C 5.0 mmol\u002FL at Screening determined as per the central laboratory.\n* Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation\n* Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of\n\n  ≤ 105 mmHg.\n* Serum potassium (local lab) \\> 3.0 mmol\u002FL at randomization.\n\nExclusion Criteria:\n\n\\- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \\> 170 mmHg or mean seated DBP \\>105 mmHg (on AOBPM).\n\nIf taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \\> 160 mmHg or mean seated DBP ≥ 100 mmHg.\n\n* Previous surgical intervention for an adrenal adenoma or have a planned adrenalectomy, renal nerve denervation, or adrenal ablative procedure during the course of the study.\n* Has the following known secondary causes of HTN: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.\n* Serum sodium level \\\u003C 135 mmol\u002FL at Screening, determined as per central laboratory.\n* New York Heart Association functional HF class IV at Screening.\n* Persistent atrial fibrillation.\n* Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation.","ALL","18 Years",{"count":20,"type":21},250,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a Phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, and efficacy of baxdrostat versus placebo, on the reduction of Seated Blood Pressure (SBP) and achieving normalization of the Renin Angiotensin Aldosterone System (RAAS) in approximately 180 participants ≥ 18 years of age with Primary Aldosteronism (PA), with or without prior treatment with Mineralocorticoid Receptor Antagonists (MRAs) or potassium-sparing diuretics.\n\nBaxdrostat (or placebo) will be administered once daily, up-titrated after 2 weeks based on clinical response and tolerability.\n\nThe study is planned to be conducted globally in approximately 90 study centres and 12 countries.",[27],"Primary Hyperaldosteronism",[29,30,31,32,33,34],"Primary hyperaldosteronism","Primary aldosteronism","PA","Baxdrostat","CIN-107","Aldosterone","RECRUITING","2026-04-17",{"date":38,"type":39},"2026-04-20","ACTUAL",{"date":41,"type":39},"2025-08-07",{"date":43,"type":21},"2028-02-18",{"name":45,"class":46},"AstraZeneca","INDUSTRY",89,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study",true,"0 Years","20 Years",{"count":60,"type":21},5000,"OBSERVATIONAL","The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[64,65,66,67,68,69,27,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome","2026-03-31",{"date":90,"type":39},"2026-04-06",{"date":92,"type":39},"2020-03-05",{"date":94,"type":21},"2027-07",{"name":96,"class":97},"Duke University","OTHER",51]