Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Parent study
Male or female participants must be ≥ 18 years of age
Participants with a documented diagnosis of PA that fulfils the criteria defined in the 2016 or 2025 Endocrine Society Guidelines.
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.
eGFR ≥ 45 mL/min/1.73m2 at Screening
Serum potassium level ≥ 3.0 and \< 5.0 mmol/L at Screening determined as per the central laboratory.
Have a stable regimen of antihypertensive medications for at least 4 weeks prior to randomisation
Mean seated SBP on AOBPM of ≥ 135 mmHg and ≤ 170 mmHg and mean DBP of
≤ 105 mmHg.
Serum potassium (local lab) \> 3.0 mmol/L at randomization.
Completed the BaxPA main study through the End of Study visit and was randomised and treated during the Randomised Withdrawal period.
You may not be if
\- If not taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 170 mmHg or mean seated DBP \>105 mmHg (on AOBPM).
If taking an MRA or potassium sparing diuretic at Screening: Mean seated SBP \> 160 mmHg or mean seated DBP ≥ 100 mmHg.
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.
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.
Serum sodium level \< 135 mmol/L at Screening, determined as per central laboratory.
New York Heart Association functional HF class IV at Screening.
Persistent atrial fibrillation.
Treatment with any MRA or potassium-sparing diuretic within 2 weeks prior to Randomisation.
Substudy
Not applicable
Clareo Health | Parent Study: A Study to Assess Efficacy and Safety of Baxdrostat in Participants With Primary Aldosteronism Sub-study: A Follow-up Substudy After Completion of the BaxPA Main Study.
