Essential Hypertension | Secondary hypertension | Sitting diastolic blood pressure | Age | Gender | Body Height | Chronic Kidney Diseases | Diabetes Mellitus | Heart failure | Target Organ Damage Hypertensive
Item
the subject has hypertension (primary or secondary) defined as clinic seated diastolic bp ≥95th percentile (by age, gender, and height) or ≥90th percentile (by age, gender, height) if chronic renal disease, diabetes, heart failure or hypertensive target organ damage is present
boolean
C0085580 (UMLS CUI [1])
C0155616 (UMLS CUI [2])
C1319894 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0079399 (UMLS CUI [5])
C0005890 (UMLS CUI [6])
C1561643 (UMLS CUI [7])
C0011849 (UMLS CUI [8])
C0018801 (UMLS CUI [9])
C1521840 (UMLS CUI [10,1])
C0178784 (UMLS CUI [10,2])
C1883709 (UMLS CUI [10,3])
C0857121 (UMLS CUI [10,4])
Patients Treated | Hypertensive disease | Status post Washout Period | Sitting diastolic blood pressure
Item
1. if currently treated: the subject has a documented historical diagnosis of hypertension and a post-washout clinic seated diastolic bp meeting the above criteria on day -1 (or day 1 for subjects not participating in ambulatory blood pressure monitoring)
boolean
C0030705 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1710661 (UMLS CUI [3,2])
C1319894 (UMLS CUI [4])
Patients Untreated | Sitting diastolic blood pressure Elevated | Measurement Quantity
Item
2. if currently untreated: the subject has elevated seated diastolic bp meeting the above criteria on 3 separate occasions before randomization, including on day -1 (or day 1 for subjects not participating in ambulatory blood pressure monitoring)
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1319894 (UMLS CUI [2,1])
C3163633 (UMLS CUI [2,2])
C0242485 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
Age | Body Weight
Item
the subject is male or female and aged 6 to <18 years at baseline and weighs at least 25 kg
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Life Style Modification Continue | Pharmacotherapy Absent | Participation Weight Reduction Programs | Body Weight Maintenance
Item
the subject agrees to continue their previously implemented nonpharmacological life style modifications if begun prior to screening. note: for subjects participating in a weight loss program, the weight maintenance
boolean
C0023676 (UMLS CUI [1,1])
C3840684 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
C0013216 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0679823 (UMLS CUI [3,1])
C3179079 (UMLS CUI [3,2])
C4042910 (UMLS CUI [4])
Sitting diastolic blood pressure | Age | Gender | Body Height | Average Measurement Quantity
Item
the subject has a clinic seated diastolic bp greater than 15 mm hg and/or seated diastolic bp greater than 10 mm hg above the 99th percentile for age, gender, and height as confirmed by the average (arithmetic mean) of 3 serial clinic seated bp measurements at screening/visit 1
boolean
C1319894 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0005890 (UMLS CUI [4])
C1510992 (UMLS CUI [5,1])
C0242485 (UMLS CUI [5,2])
C1265611 (UMLS CUI [5,3])
Accelerated Hypertension
Item
the subject has a diagnosis of malignant or accelerated hypertension
boolean
C0020540 (UMLS CUI [1])
Antihypertensive Agents Quantity
Item
the subject is currently treated with more than 2 antihypertensive agents
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Antihypertensive Agents To be stopped Unwilling | Antihypertensive Agents To be stopped Parent Unwilling | Antihypertensive Agents To be stopped Legal Guardian Unwilling
Item
the subject or parent/legal guardian is not willing for the subject's previous antihypertensive medications to be stopped
boolean
C0003364 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0003364 (UMLS CUI [2,1])
C1272691 (UMLS CUI [2,2])
C0030551 (UMLS CUI [2,3])
C0558080 (UMLS CUI [2,4])
C0003364 (UMLS CUI [3,1])
C1272691 (UMLS CUI [3,2])
C0023226 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
Participation Weight Reduction Program With intensity
Item
the subject has participated in the intensive, active weight-loss phase of a weight-loss program within 30 days prior to screening/visit 1
boolean
C0679823 (UMLS CUI [1,1])
C3179079 (UMLS CUI [1,2])
C0522510 (UMLS CUI [1,3])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate Creatinine-based formula (Schwartz) | Dialysis | Renal vascular disorder Affecting Both kidneys | Renal vascular disorder Affecting Kidney Solitary | Nephrotic Syndrome Severe | Remission Lacking | Serum albumin measurement
Item
the subject has any of the following: severe renal impairment (egfr <30 ml/min/1.73 m2 by the schwartz formula); is currently undergoing dialysis treatment; renovascular disease affecting both kidneys or a solitary kidney; severe nephrotic syndrome not in remission; or serum albumin <2.5 g/dl
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2,1])
C1980037 (UMLS CUI [2,2])
C0011946 (UMLS CUI [3])
C0268790 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0227665 (UMLS CUI [4,3])
C0268790 (UMLS CUI [5,1])
C0392760 (UMLS CUI [5,2])
C0022646 (UMLS CUI [5,3])
C0205171 (UMLS CUI [5,4])
C0027726 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0544452 (UMLS CUI [7,1])
C0332268 (UMLS CUI [7,2])
C0523465 (UMLS CUI [8])
Cardiovascular Diseases Severe | Hepatobiliary disease Severe | Gastrointestinal Diseases Severe | Endocrine System Diseases Severe | Metabolic Diseases Severe | Hyperthyroidism | Cushing Syndrome | Hematological Disease Severe | Immune System Diseases Severe | Disorder of the genitourinary system Severe | Mental Disorders, Severe | Malignant Neoplasms | Condition Interferes with Study Subject Participation Status | Condition compromises Clinical Trial Integrity
Item
the subject has a history or clinical manifestations of severe cardiovascular, hepato-biliary, gastrointestinal, endocrine-metabolic (e.g., hyperthyroidism, cushing's syndrome), hematologic, immunologic, genito-urinary, or psychiatric disease, cancer, and/or any conditions that would interfere with the health status of the subject through study participation, or would jeopardize study integrity in the opinion of the investigator
boolean
C0007222 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0267792 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0017178 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0014130 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0025517 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0020550 (UMLS CUI [6])
C0010481 (UMLS CUI [7])
C0018939 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0021053 (UMLS CUI [9,1])
C0205082 (UMLS CUI [9,2])
C0080276 (UMLS CUI [10,1])
C0205082 (UMLS CUI [10,2])
C4046029 (UMLS CUI [11])
C0006826 (UMLS CUI [12])
C0348080 (UMLS CUI [13,1])
C0521102 (UMLS CUI [13,2])
C2348568 (UMLS CUI [13,3])
C0348080 (UMLS CUI [14,1])
C2945640 (UMLS CUI [14,2])
C0008976 (UMLS CUI [14,3])
C1947912 (UMLS CUI [14,4])
Aortic coarctation uncorrected | Left ventricular outflow tract obstruction Due to Eosinophilic gastroenteritis | Aortic valve disorder | Procedure Affecting Blood Pressure | Repair Arterial malformation
Item
the subject is suffering from uncorrected coarctation of the aorta, or hemodynamically significant left ventricular outflow tract obstruction due to eg, aortic valvular disease, or is likely to undergo a procedure known to affect blood pressure (eg, repair of arterial anomalies) during the course of the study
boolean
C0003492 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0344917 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C1262481 (UMLS CUI [2,3])
C1260873 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0005823 (UMLS CUI [4,3])
C4319951 (UMLS CUI [5,1])
C0151489 (UMLS CUI [5,2])
Poorly controlled diabetes mellitus | Hemoglobin A1c measurement
Item
the subject is poorly controlled diabetic defined as having a glycosylated hemoglobin value >8.5% at screening/visit 1
boolean
C0554876 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Hyperkalemia | Disorder of electrolytes
Item
the subject has hyperkalemia as defined by the central laboratory's normal reference range or any pertinent electrolyte disorders at screening/visit
boolean
C0020461 (UMLS CUI [1])
C1704431 (UMLS CUI [2])