ID

29897

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00435162

Nyckelord

Versioner (2)
  1. 2018-04-25 2018-04-25 -
  2. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

25 april 2018

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Hypertension NCT00435162

Engelsk

Eligibility Hypertension NCT00435162

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Children | Age | Hypertensive disease

Datatyp

boolean

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

Able to swallow Liquid Dosage Form

Datatyp

boolean

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

Body Weight

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Blood Pressure Uncontrolled | Antihypertensive Agents Dosage unchanged

Datatyp

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
Beskrivning

Solid organ Transplantation | Therapeutic immunosuppression Dosage Stable

Datatyp

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
Beskrivning

Parent Language comprehension Instructions | Guardian Language comprehension Instructions

Datatyp

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
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with background arb therapy
Beskrivning

Angiotensin II receptor antagonist

Datatyp

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)
Beskrivning

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

Datatyp

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
Beskrivning

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
glomerular filtration rate < 30 ml/min/1.73m²
Beskrivning

Glomerular Filtration Rate

Datatyp

boolean

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

Serum potassium increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0553704
mssbp ≥ 25% above the 95th percentile
Beskrivning

Sitting systolic blood pressure mean

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1319893
UMLS CUI [1,2]
C0444504
patients exhibiting clinically significant ecg abnormalities
Beskrivning

ECG abnormality

Datatyp

boolean

Alias
UMLS CUI [1]
C1832603
patients that have coarctation of the aorta with a gradient of ≥ 30 mm hg, or renal artery stenosis
Beskrivning

Aortic coarctation Gradient | Renal Artery Stenosis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003492
UMLS CUI [1,2]
C0812409
UMLS CUI [2]
C0035067
other protocol-defined inclusion/exclusion criteria may apply
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Tillbaka till toppen

Similar models

Eligibility Hypertension NCT00435162

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
C1832603 (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])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial