ID

16802

Descripción

Olmesartan Pediatric Pharmacokinetic (PK) Study; ODM derived from: https://clinicaltrials.gov/show/NCT00151814

Link

https://clinicaltrials.gov/show/NCT00151814

Palabras clave

Versiones (1)
  1. 8/8/16 8/8/16 -
Subido en

8 de agosto de 2016

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Hypertension NCT00151814

Inglés

Eligibility Hypertension NCT00151814

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 12 months to 16 years inclusive
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
signed parental/guardian informed consent and assent from the subject
Descripción

parental consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0600634
current treatment for hypertension, or, if not currently treated for hypertension, systolic blood pressure (sbp) greater than or equal to 95th percentile for gender and height-for-age, or, if not currently treated for hypertension, systolic blood pressure or diastolic blood pressure greater than or equal to 90th percentile for gender and height-for-age and diabetic or having a family history of hypertension
Descripción

current treatment for hypertension, systolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0087111
UMLS CUI [2]
C0871470
glomerular filtration rate (gfr) greater than or equal to 30 ml/min/1.73 m2, estimated using the schwartz equation
Descripción

eGFR

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3811844
sexually active females of child-bearing potential must be practicing an acceptable method of birth control
Descripción

Contraception

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700589
negative serum beta-human chorionic gonadotropin at screening and at admission (female of child-bearing potential only)
Descripción

Serum pregnancy test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0430060
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically significant cardiac, gastrointestinal, hematologic, hepatic or hepatobiliary, neurologic, or pulmonary (except asthma) disorder
Descripción

cardiac, gastrointestinal, hematologic, hepatic or hepatobiliary, neurologic, or pulmonary (except asthma) disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0018939
UMLS CUI [4]
C0232741
UMLS CUI [5]
C0267792
UMLS CUI [6]
C0027765
UMLS CUI [7]
C0024115
history of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurologic findings within 1 year prior to screening
Descripción

hypertension associated with stroke, seizures, encephalopathy, or other significant neurologic findings

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020538
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0038454
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0036572
UMLS CUI [3,1]
C0020538
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0085584
UMLS CUI [4,1]
C0020538
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0422837
current treatment with more than 2 antihypertensive medications
Descripción

Antihypertensive medications

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0003364
secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney
Descripción

secondary hypertension from uncorrected coarctation of the aorta or renal artery stenosis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0155616
UMLS CUI [1,2]
C0003492
UMLS CUI [2,1]
C0155616
UMLS CUI [2,2]
C0035067
serum albumin < 2.5 g/dl
Descripción

Serum albumin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0523465
major organ or bone marrow transplantation except for prior kidney transplantation of at least 6 months and with stable renal function meeting the inclusion criteria
Descripción

major organ or bone marrow transplantation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0029216
UMLS CUI [2]
C0005961
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Similar models

Eligibility Hypertension NCT00151814

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 12 months to 16 years inclusive
boolean
C0001779 (UMLS CUI [1])
parental consent
Item
signed parental/guardian informed consent and assent from the subject
boolean
C0600634 (UMLS CUI [1])
current treatment for hypertension, systolic blood pressure
Item
current treatment for hypertension, or, if not currently treated for hypertension, systolic blood pressure (sbp) greater than or equal to 95th percentile for gender and height-for-age, or, if not currently treated for hypertension, systolic blood pressure or diastolic blood pressure greater than or equal to 90th percentile for gender and height-for-age and diabetic or having a family history of hypertension
boolean
C0020538 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
eGFR
Item
glomerular filtration rate (gfr) greater than or equal to 30 ml/min/1.73 m2, estimated using the schwartz equation
boolean
C3811844 (UMLS CUI [1])
Contraception
Item
sexually active females of child-bearing potential must be practicing an acceptable method of birth control
boolean
C0700589 (UMLS CUI [1])
Serum pregnancy test
Item
negative serum beta-human chorionic gonadotropin at screening and at admission (female of child-bearing potential only)
boolean
C0430060 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
cardiac, gastrointestinal, hematologic, hepatic or hepatobiliary, neurologic, or pulmonary (except asthma) disorder
Item
clinically significant cardiac, gastrointestinal, hematologic, hepatic or hepatobiliary, neurologic, or pulmonary (except asthma) disorder
boolean
C0232164 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0018939 (UMLS CUI [3])
C0232741 (UMLS CUI [4])
C0267792 (UMLS CUI [5])
C0027765 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
hypertension associated with stroke, seizures, encephalopathy, or other significant neurologic findings
Item
history of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurologic findings within 1 year prior to screening
boolean
C0020538 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,3])
C0020538 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0036572 (UMLS CUI [2,3])
C0020538 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0085584 (UMLS CUI [3,3])
C0020538 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0422837 (UMLS CUI [4,3])
Antihypertensive medications
Item
current treatment with more than 2 antihypertensive medications
boolean
C0003364 (UMLS CUI [1])
secondary hypertension from uncorrected coarctation of the aorta or renal artery stenosis
Item
secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney
boolean
C0155616 (UMLS CUI [1,1])
C0003492 (UMLS CUI [1,2])
C0155616 (UMLS CUI [2,1])
C0035067 (UMLS CUI [2,2])
Serum albumin
Item
serum albumin < 2.5 g/dl
boolean
C0523465 (UMLS CUI [1])
major organ or bone marrow transplantation
Item
major organ or bone marrow transplantation except for prior kidney transplantation of at least 6 months and with stable renal function meeting the inclusion criteria
boolean
C0029216 (UMLS CUI [1])
C0005961 (UMLS CUI [2])
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