ID

39956

Description

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

Keywords

Versions (1)
  1. 3/5/20 3/5/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 5, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT01150357

English

Eligibility Hypertension NCT01150357

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Hypertensive disease

Data type

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
Description

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

Data type

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
Description

Exclusion Criteria

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

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

Data type

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
Description

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

Data type

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
Description

Sitting systolic blood pressure mean

Data type

boolean

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

Second degree atrioventricular block | Complete atrioventricular block | Pacemaker Absent

Data type

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
Description

Aspartate aminotransferase increased | Alanine aminotransferase increased

Data type

boolean

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

Elevated total bilirubin

Data type

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)
Description

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

Data type

boolean

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

White Blood Cell Count procedure

Data type

boolean

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

Eligibility Criteria Study Protocol

Data type

boolean

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

Eligibility Hypertension NCT01150357

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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