Sitting systolic blood pressure mean | Age | Gender | Body Height
Item
mssbp (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at visit 2 (randomization), in study cspp100a2365
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0005890 (UMLS CUI [4])
Body Weight
Item
must be ≥ 20 kg and ≤ 150 kg at visit 2 (randomization), in study cspp100a2365
boolean
C0005910 (UMLS CUI [1])
Able to swallow Tablets | Administration Tablets Soft food
Item
must be able to swallow minitablets (2mm in diameter) administered in soft food
boolean
C2712086 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
C1533734 (UMLS CUI [2,1])
C0039225 (UMLS CUI [2,2])
C0453854 (UMLS CUI [2,3])
Dose Response Phase Completed | Participation Placebo Withdrawal Phase | Study Protocol Specified | Adverse reaction to drug Serious Absent
Item
successful completion of phase 1 (dose response phase) and at least 1 week of phase 2 (placebo withdrawal phase) of the cspp100a2365 protocol, with no serious drug-related adverse event(s).
boolean
C4055118 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0679823 (UMLS CUI [2,1])
C0032042 (UMLS CUI [2,2])
C2349954 (UMLS CUI [2,3])
C1710475 (UMLS CUI [2,4])
C2348563 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
C0041755 (UMLS CUI [4,1])
C0205404 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Immunosuppressive Agents | Cyclosporine | mycophenolate mofetil | Exception Steroids Oral | Exception Topical steroids
Item
patient receiving immunosuppressant medication (e.g. cyclosporine, mmf, etc) other than oral/topical steroids, for any medical condition
boolean
C0021081 (UMLS CUI [1])
C0010592 (UMLS CUI [2])
C0209368 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C1527415 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C2064827 (UMLS CUI [5,2])
Heart failure New York Heart Association Classification | Cardiomyopathy | Valvular disease Obstructive
Item
current diagnosis of heart failure (nyha class ii-iv) or history of cardiomyopathy or obstructive valvular disease
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0878544 (UMLS CUI [2])
C3258293 (UMLS CUI [3,1])
C0549186 (UMLS CUI [3,2])
Sitting systolic blood pressure mean
Item
mssbp ≥ 25% above the 95th percentile
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
Second degree atrioventricular block | Complete atrioventricular block | Pacemaker Absent
Item
second or third degree heart block without a pacemaker
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0810633 (UMLS CUI [3,1])
C0332197 (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])
Elevated total bilirubin
Item
total bilirubin > 2 times the upper limit of the reference range
boolean
C0741494 (UMLS CUI [1])
Creatinine clearance measurement | Estimated Glomerular Filtration Rate Creatinine-based formula (Schwartz)
Item
creatinine clearance < 30 ml/min/1.73m² (calculated using modified schwartz formula to estimate glomerular filtration rate [gfr]), based on the serum creatinine concentration obtained at the screening visit)
boolean
C0373595 (UMLS CUI [1])
C3811844 (UMLS CUI [2,1])
C1980037 (UMLS CUI [2,2])
White Blood Cell Count procedure
Item
wbc count < 3000/mm³
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 100,000/mm³
boolean
C0032181 (UMLS CUI [1])
Serum potassium measurement
Item
serum potassium > 5.2 meq/l
boolean
C0302353 (UMLS CUI [1])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])