Children | Age | Hypertensive disease
Item
children aged 6 months - 5 years at visit 1, with a documented history of hypertension
boolean
C0008059 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0020538 (UMLS CUI [3])
Able to swallow Liquid Dosage Form
Item
must be able to swallow liquid formulation
boolean
C2712086 (UMLS CUI [1,1])
C1697794 (UMLS CUI [1,2])
Body Weight
Item
must be ≥ 6 kg or ≤ 40 kg at randomization
boolean
C0005910 (UMLS CUI [1])
Sitting systolic blood pressure mean Measurement Quantity | Age | Gender | Body Height
Item
must have documented history mssbp (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at randomization
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0005890 (UMLS CUI [4])
Blood Pressure Uncontrolled | Antihypertensive Agents Dosage unchanged
Item
if patients enter with uncontrolled bp they can remain on background antihypertensives with an unchanged dosing regimen
boolean
C0005823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0442739 (UMLS CUI [2,3])
Solid organ Transplantation | Therapeutic immunosuppression Dosage Stable
Item
if patients have had a solid organ transplant more than 1 year ago they must be on stable doses of immunosuppressive therapy
boolean
C0440790 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0021079 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Parent Language comprehension Instructions | Guardian Language comprehension Instructions
Item
parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language
boolean
C0030551 (UMLS CUI [1,1])
C0233733 (UMLS CUI [1,2])
C1442085 (UMLS CUI [1,3])
C1274041 (UMLS CUI [2,1])
C0233733 (UMLS CUI [2,2])
C1442085 (UMLS CUI [2,3])
Angiotensin II receptor antagonist
Item
patients with background arb therapy
boolean
C0521942 (UMLS CUI [1])
Abnormality Clinical Significance | Laboratory test result abnormal | Exception Renal function
Item
patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function)
boolean
C1704258 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0232804 (UMLS CUI [3,2])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
ast/sgot or alt/sgpt > 3 times the upper limit of the reference range
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Glomerular Filtration Rate
Item
glomerular filtration rate < 30 ml/min/1.73m²
boolean
C0017654 (UMLS CUI [1])
Serum potassium increased
Item
serum potassium > upper limit of the reference range
boolean
C0553704 (UMLS CUI [1])
Sitting systolic blood pressure mean
Item
mssbp ≥ 25% above the 95th percentile
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
ECG abnormality
Item
patients exhibiting clinically significant ecg abnormalities
boolean
C1832603 (UMLS CUI [1])
Aortic coarctation Gradient | Renal Artery Stenosis
Item
patients that have coarctation of the aorta with a gradient of ≥ 30 mm hg, or renal artery stenosis
boolean
C0003492 (UMLS CUI [1,1])
C0812409 (UMLS CUI [1,2])
C0035067 (UMLS CUI [2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])