ID

44188

Description

Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure; ODM derived from: https://clinicaltrials.gov/show/NCT00435162

Link

https://clinicaltrials.gov/show/NCT00435162

Keywords

Versions (2)
  1. 4/25/18 4/25/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension NCT00435162

English

Eligibility Hypertension NCT00435162

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
children aged 6 months - 5 years at visit 1, with a documented history of hypertension
Description

Children | Age | Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0020538
must be able to swallow liquid formulation
Description

Able to swallow Liquid Dosage Form

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C1697794
must be ≥ 6 kg or ≤ 40 kg at randomization
Description

Body Weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
must have documented history mssbp (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at randomization
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C0242485
UMLS CUI [1,4]
C1265611
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0005890
if patients enter with uncontrolled bp they can remain on background antihypertensives with an unchanged dosing regimen
Description

Blood Pressure Uncontrolled | Antihypertensive Agents Dosage unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0003364
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0442739
if patients have had a solid organ transplant more than 1 year ago they must be on stable doses of immunosuppressive therapy
Description

Solid organ Transplantation | Therapeutic immunosuppression Dosage Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0440790
UMLS CUI [1,2]
C0040732
UMLS CUI [2,1]
C0021079
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language
Description

Parent Language comprehension Instructions | Guardian Language comprehension Instructions

Data type

boolean

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C0233733
UMLS CUI [1,3]
C1442085
UMLS CUI [2,1]
C1274041
UMLS CUI [2,2]
C0233733
UMLS CUI [2,3]
C1442085
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with background arb therapy
Description

Angiotensin II receptor antagonist

Data type

boolean

Alias
UMLS CUI [1]
C0521942
patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function)
Description

Abnormality Clinical Significance | Laboratory test result abnormal | Exception Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2826293
UMLS CUI [2]
C0438215
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0232804
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
glomerular filtration rate < 30 ml/min/1.73m²
Description

Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1]
C0017654
serum potassium > upper limit of the reference range
Description

Serum potassium increased

Data type

boolean

Alias
UMLS CUI [1]
C0553704
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
patients exhibiting clinically significant ecg abnormalities
Description

ECG abnormality

Data type

boolean

Alias
UMLS CUI [1]
C0522055
patients that have coarctation of the aorta with a gradient of ≥ 30 mm hg, or renal artery stenosis
Description

Aortic coarctation Gradient | Renal Artery Stenosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0003492
UMLS CUI [1,2]
C0812409
UMLS CUI [2]
C0035067
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 NCT00435162

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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
C0522055 (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])
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