Informed Consent
Item
subjects who are competent to provide written consent
boolean
C0021430 (UMLS CUI [1])
Age
Item
aged 35 to 85 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus | Chronic Kidney Disease | Systolic Pressure mean
Item
subjects with diabetes and/or chronic kidney disease must have a mean systolic blood pressure ≥130 mmhg
boolean
C0011849 (UMLS CUI [1])
C1561643 (UMLS CUI [2])
C0871470 (UMLS CUI [3,1])
C0444504 (UMLS CUI [3,2])
Systolic Pressure mean
Item
all other subjects must have a mean systolic blood pressure ≥140 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Antihypertensive Agents Dose Full | Antihypertensive Agents Class Quantity | Diuretics
Item
receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, including a diuretic
boolean
C0003364 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0443225 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2,1])
C1547013 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0012798 (UMLS CUI [3])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
female subjects of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at the time of randomization.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Sitting systolic blood pressure Average | Sitting diastolic blood pressure Average
Item
average sitting systolic blood pressure ≥180 mmhg or diastolic blood pressure ≥110 mmhg at screening
boolean
C1319893 (UMLS CUI [1,1])
C1510992 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C1510992 (UMLS CUI [2,2])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement
Item
serum alt or ast >2x uln
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable | Cerebrovascular accident | Sick Sinus Syndrome | Second degree atrioventricular block | Complete atrioventricular block | Chronic atrial fibrillation | Tachyarrhythmia Atrial Recurrent | Recurrent ventricular tachycardia | BRADYCARDIA SYMPTOMATIC
Item
subjects who have experienced myocardial infarction, unstable angina, or a cerebrovascular accident (cva) within 6 month of the screening visit; or sick sinus syndrome or second or third degree atrioventricular block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0037052 (UMLS CUI [4])
C0264906 (UMLS CUI [5])
C0151517 (UMLS CUI [6])
C0694539 (UMLS CUI [7])
C0080203 (UMLS CUI [8,1])
C0018792 (UMLS CUI [8,2])
C2945760 (UMLS CUI [8,3])
C1737264 (UMLS CUI [9])
C0741627 (UMLS CUI [10])
Implantable defibrillator | Cardiac Arrhythmia | pacemaker implant
Item
implanted cardioverter defibrillator (icd) that has fired for any arrhythmia within 3 months of screening or implanted pacemakers
boolean
C0162589 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
C0848753 (UMLS CUI [3])
Symptomatic congestive heart failure Requirement Therapeutic procedure
Item
symptomatic chf requiring treatment
boolean
C0742758 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Heart valve disease Hemodynamic Significant
Item
hemodynamically significant valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0019010 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
Hemodialysis | Peritoneal Dialysis | Kidney Transplantation
Item
hemodialysis or peritoneal dialysis; or history of renal transplant
boolean
C0019004 (UMLS CUI [1])
C0031139 (UMLS CUI [2])
C0022671 (UMLS CUI [3])
Malignant Neoplasms | Recurrent Malignant Neoplasm
Item
diagnosis or recurrence of malignancy within the past 3 years
boolean
C0006826 (UMLS CUI [1])
C1458156 (UMLS CUI [2])
Sleep Apnea
Item
sleep apnea
boolean
C0037315 (UMLS CUI [1])
shift work | night work
Item
subjects who perform alternating shift or night work
boolean
C1658633 (UMLS CUI [1])
C1659095 (UMLS CUI [2])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
subjects who have participated in a clinical study involving another investigational drug or device within 1 month of the screening visit
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])