ID

39957

Description

An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age; ODM derived from: https://clinicaltrials.gov/show/NCT01151410

Link

https://clinicaltrials.gov/show/NCT01151410

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 NCT01151410

English

Eligibility Hypertension NCT01151410

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
mssbp (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at visit 2 (randomization), in study cspp100a2365
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
must be ≥ 20 kg and ≤ 150 kg at visit 2 (randomization), in study cspp100a2365
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
must be able to swallow minitablets (2mm in diameter) administered in soft food
Description

Able to swallow Tablets | Administration Tablets Soft food

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0039225
UMLS CUI [2,1]
C1533734
UMLS CUI [2,2]
C0039225
UMLS CUI [2,3]
C0453854
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).
Description

Dose Response Phase Completed | Participation Placebo Withdrawal Phase | Study Protocol Specified | Adverse reaction to drug Serious Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C4055118
UMLS CUI [1,2]
C1710475
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0679823
UMLS CUI [2,2]
C0032042
UMLS CUI [2,3]
C2349954
UMLS CUI [2,4]
C1710475
UMLS CUI [3,1]
C2348563
UMLS CUI [3,2]
C0205369
UMLS CUI [4,1]
C0041755
UMLS CUI [4,2]
C0205404
UMLS CUI [4,3]
C0332197
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
platelet count < 100,000/mm³
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
serum potassium > 5.2 meq/l
Description

Serum potassium measurement

Data type

boolean

Alias
UMLS CUI [1]
C0302353
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 NCT01151410

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
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