Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-25 @ 3:56 AM
NCT ID:
NCT05137002
Eligibility Criteria:
Inclusion Criteria:
* Is on a stable regimen of background antihypertensive agent(s) for at least 8 weeks and would be considered a candidate for an additional antihypertensive agent at the time of screening ;
* Has a mean seated systolic blood pressure (SBP) ≥ 140 mmHg or ≥ 130 mmHg if diabetic;
* Demonstrates ability to be adherent to the study drug and their anti-hypertensive medication during a run-in period
* If taking an SGLT2 inhibitor, the regimen must be stable for at least 8 weeks prior to randomization; and
* Agrees to comply with the contraception and reproduction restrictions of the study;
Exclusion Criteria:
* Has a mean seated systolic blood pressure (SBP) ≥180 mmHG;
* Has a body mass index (BMI) \>50 kg/m2;
* Is using alpha or beta blockers for any primary indication other than systemic hypertension (eg, migraine headache);
* Is not willing or not able to discontinue an MRA or potassium sparing diuretic as part of an existing antihypertensive regimen;
* Has documented estimated eGFR \<30 mL/min/1.73m2;
* Has known and documented New York Heart Association stage III or IV chronic heart failure;
* Has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening;
* Major cardiac surgery within 6 months before Screening;
* Has chronic permanent atrial fibrillation;
* Has uncontrolled diabetes with glycated hemoglobin \>10% at Screening;
* Has planned dialysis or kidney transplantation planned during the course of the study;
* Prior solid organ transplant and/or cell transplants;
* Sodium \<130 mEq/L;
* Potassium \<3.5 mEq/L;
* Potassium \>5 mEq/L;
* White blood cell count \>15 × E9/L or absolute neutrophil count \<1 × E9/L at Screening;
* Is positive for HIV antibody, hepatitis C virus RNA, or hepatitis B surface antigen;
* Has typical consumption of ≥14 alcoholic drinks weekly;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05137002
Study Brief:
Protocol Section:
NCT05137002