ID

39956

Beschrijving

Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age; ODM derived from: https://clinicaltrials.gov/show/NCT01150357

Link

https://clinicaltrials.gov/show/NCT01150357

Trefwoorden

Versies (1)
  1. 05-03-20 05-03-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 maart 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hypertension NCT01150357

Engels

Eligibility Hypertension NCT01150357

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
documented diagnosis of hypertension as defined in the nhlbi 4th report, 2004
Beschrijving

Hypertensive disease

Datatype

boolean

Alias
UMLS CUI [1]
C0020538
mssbp (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at visit 2 (randomization) measurement as defined by the nhlbi 4th report, 2004
Beschrijving

Sitting systolic blood pressure mean | Age | Gender | Body Height

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0005890
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient receiving immunosuppressant medication (e.g. cyclosporine, mmf, etc) other than oral/topical steroids, for any medical condition
Beschrijving

Immunosuppressive Agents | Cyclosporine | mycophenolate mofetil | Exception Steroids Oral | Exception Topical steroids

Datatype

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0010592
UMLS CUI [3]
C0209368
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0038317
UMLS CUI [4,3]
C1527415
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C2064827
current diagnosis of heart failure (nyha class ii-iv) or history of cardiomyopathy or obstructive valvular disease
Beschrijving

Heart failure New York Heart Association Classification | Cardiomyopathy | Valvular disease Obstructive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C0878544
UMLS CUI [3,1]
C3258293
UMLS CUI [3,2]
C0549186
mssbp ≥ 25% above the 95th percentile
Beschrijving

Sitting systolic blood pressure mean

Datatype

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
second or third degree heart block without a pacemaker
Beschrijving

Second degree atrioventricular block | Complete atrioventricular block | Pacemaker Absent

Datatype

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C0810633
UMLS CUI [3,2]
C0332197
ast/sgot or alt/sgpt >3 times the upper limit of the reference range
Beschrijving

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
total bilirubin > 2 times the upper limit of the reference range
Beschrijving

Elevated total bilirubin

Datatype

boolean

Alias
UMLS CUI [1]
C0741494
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)
Beschrijving

Creatinine clearance measurement | Estimated Glomerular Filtration Rate Creatinine-based formula (Schwartz)

Datatype

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C1980037
wbc count < 3000/mm³
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Hypertension NCT01150357

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease
Item
documented diagnosis of hypertension as defined in the nhlbi 4th report, 2004
boolean
C0020538 (UMLS CUI [1])
Sitting systolic blood pressure mean | Age | Gender | Body Height
Item
mssbp (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at visit 2 (randomization) measurement as defined by the nhlbi 4th report, 2004
boolean
C1319893 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0005890 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
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])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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