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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT04519658
Eligibility Criteria:
Inclusion Criteria:
* Is on a stable regimen of ≥ 3 antihypertensive agents (one of which is a diuretic) for at least 4 weeks prior to randomization;
* Be at least 70% compliant to their anti-hypertensive medication regimen;
* Has a seated BP ≥ 130/80 mmHg;
* Agrees to comply with the contraception and reproduction restrictions of the study; and
* Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.
Exclusion Criteria:
* Has a seated SBP ≥ 180 mmHg or DBP ≥ 110 mmHg;
* Has a body mass index (BMI) \> 40 kg/m2;
* Has an upper arm circumference \< 7 or \> 17 inches;
* Has been on night shifts at any time during the 4 weeks before Screening;
* Is using a beta blocker for any primary indication other than systemic hypertension (eg, migraine headache);
* Is not willing or not able to discontinue an MRA or a potassium sparing diuretic as part of an existing antihypertensive regimen;
* Is not willing or not able to discontinue taking a potassium supplement;
* Has documented estimated glomerular filtration rate (eGFR) \< 45 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;
* Has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease diagnosed from a prior echocardiogram;
* Major cardiac surgery (eg, CABG, valve replacement), peripheral arterial bypass surgery, or PCI within 6 months before Screening;
* Has chronic permanent atrial fibrillation;
* Has uncontrolled diabetes with glycosylated hemoglobin \> 9.5% at Screening;
* Has planned dialysis or kidney transplant during the course of this study;
* Potassium \< 3.5 mEq/L;
* Potassium \> 5.0 mEq/L;
* 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:
NCT04519658
Study Brief:
Protocol Section:
NCT04519658