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:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT04746495
Eligibility Criteria:
Inclusion Criteria:
* History of mild stage 1 systemic hypertension as defined by:
1. Systolic blood pressure (SBP) ≥ 140 millimeters of Mercury (mmHg) or diastolic blood pressure (DBP) ≥ 90 mmHg on 2 occasions and
2. Treatment with 1-2 antihypertensive medications (stable dose for 6 weeks)
Exclusion Criteria:
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Stage 2 hypertension (history of blood pressure ≥ 160/100 mmHg)
* History of hypertensive urgency, hypertensive crisis, or hospitalizations for hypertension
* Current mineralocorticoid antagonist use
* Type II Diabetes with microalbuminuria
* Primary adrenal insufficiency
* Current glucocorticoid use
* Electrolyte abnormality on baseline laboratory assessment
* Current potassium supplementation
* Positive test for leukocyte esterase on urinalysis
* Creatinine clearance \< 50 mL/min on baseline laboratory assessment
* Hyperkalemia
* Potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene)
* Serum potassium \>5.0 milliequivalents per liter (mEq/L) on baseline laboratory assessment
* Current use of strong CYP3A4 inhibitors (some include: ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir).
* Serum creatinine \> 1.5 mg/dL in males on baseline laboratory assessment
* Serum creatinine \> 1.3 mg/dL in females
* Current beta blocker use
* Any other condition thought by the Principal Investigator to place the participant at increased risk of injury during the clinical trial or compromise the scientific integrity of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT04746495
Study Brief:
Protocol Section:
NCT04746495