Ensayos clínicos

Inclusion Criteria:

1. Have been diagnosed with PA.

2. Are taking mineralocorticoid receptor antagonist (MRA) to control BP; or are newly
diagnosed with PA and have not started MRA treatment.

3. Are willing and able to cease dosing of MRA for up to 4 weeks in patients taking MRA.

4. Are willing to be compliant with the contraception and reproduction restrictions of
the study.

5. Have increased SBP by ≥ 20 mmHg or have SBP ≥ 160 mmHg after dosing of MRA treatment
is ceased for up to 4 weeks duration, or have SBP ≥ 150 mmHg for patients who are
newly diagnosed with PA and have not taken an MRA in the past 12 weeks.

Exclusion Criteria:

1. At Screening Visit, have a single occurrence of mean seated SBP > 180 mmHg or DBP >
110 mmHg if not taking an MRA; or have a mean seated SBP ≥ 160 mmHg or DBP ≥ 100 mmHg
if currently taking an MRA.

2. Have a body mass index > 45 kg/m2.

3. Have had a previous surgical intervention for an adrenal adenoma or have a planned
adrenal carcinoma, adrenalectomy, renal nerve denervation, or adrenal ablative
procedure during the course of the study.

4. Have a documented estimated glomerular filtration rate < 45 mL/min/1.73 m2.

5. Have a planned dialysis, kidney transplantation or any major surgical procedure during
the course of the study.

6. Have known documented New York Heart Association class III or IV chronic heart
failure.

7. Have had a stroke, transient ischemic attack, hypertensive encephalopathy, acute
coronary syndrome, or hospitalization for heart failure within 6 months before the
Screening Visit.

8. Have known current severe left ventricular outflow obstruction.

9. Have had major cardiac surgery within 6 months before the Screening Visit.

10. Have a history of, or currently experiencing, clinically significant arrhythmias.

11. Have had a prior solid organ transplant or cell transplant.

12. Are positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen.

13. Have typical consumption of > 14 alcoholic drinks weekly.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 10/18/22. Questions regarding updates should be directed to the study team contact.