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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT04714320
Eligibility Criteria:
Inclusion Criteria:
* Males or females aged 18-80 inclusive and weighing ≥ 50 kilograms (kg) at the time of informed consent
* Females: must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal
* Males must be abstinent, surgically sterile or if engaged in sexual relations with a woman of childbearing potential (WOCBP), a highly effective contraceptive method must be used
* Body mass index (BMI) ≤ 45.0 kilograms per square meter (kg/m\^2)
* At screening, the participant must have been on a stable, maximally tolerated regimen (per Investigator judgement) of 3 or more antihypertensive medications for at least 1 month prior to screening and will be required to maintain this regimen throughout the study. The combination of antihypertensive medications must be in the following categories: a) angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB), b) beta blocker: c) calcium channel blocker d) diuretic, e) alpha-1 blocker f) centrally acting sympatholytic agent or g) direct acting vasodilators (e.g. hydralazine)
Exclusion Criteria:
* Clinically significant abnormalities in screening laboratory results, medical history according to Investigator judgment
* History of secondary hypertension (HTN) including, but not limited to any of the following: renovascular HTN (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced HTN
* The use of the following at time of screening and during the course of the study:
* Other medications for the treatment of HTN (e.g., minoxidil, diazoxide, renin inhibitors)
* Medications that may cause hyperkalemia unless on a stable dose at least 1 month prior to the screening visit and no known history of hyperkalemia per Investigator judgement
* Use of oral anticoagulants, unless stable for 4 weeks prior to the first dose of study drug and regular monitoring must be performed per clinical practice during the study unless the participant is receiving vitamin K agonists. If the participant is receiving vitamin K antagonists (e.g., warfarin) international normalized ratio (INR) should be in therapeutic range, as established by the Investigator, for 4 weeks prior to the first dose
* Chronic administration of non-steroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase 2 (COX-2) inhibitors (except aspirin for cardiovascular disease provided the total daily dose does not exceed 325 mg)
* History of bleeding diathesis, coagulopathy, immune thrombocytopenic purpura (ITP), thrombotic cytopenic purpura (TTP), or any qualitative or quantitative platelet defect
* Unstable/underlying known cardiovascular disease defined as:
* Any history of congestive heart failure (New York Heart Association \[NYHA\] Class III-IV)
* Any history of previous myocardial infarction, coronary revascularization, unstable or stable angina pectoris ˂ 1 year prior to screening
* Any hemodynamically unstable atrial or ventricular arrhythmias
* Significant uncorrected valvular heart disease
* Any history of stroke or transient ischemic attack \< 1 year prior to screening
* A cardiac valve repair, cardiac device implantation, and/or a hospitalization for heart failure within 3 months of screening
* Participant works nighttime shifts (e.g., 11 PM to 7 AM)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04714320
Study Brief:
Protocol Section:
NCT04714320