ID

44186

Beskrivning

Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure; ODM derived from: https://clinicaltrials.gov/show/NCT00433836

Länk

https://clinicaltrials.gov/show/NCT00433836

Nyckelord

Versioner (3)
  1. 2018-04-25 2018-04-25 -
  2. 2018-04-25 2018-04-25 -
  3. 2021-09-20 2021-09-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypertension NCT00433836

Engelsk

Eligibility Hypertension NCT00433836

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, ages 6-17, with a documented history of hypertension
Beskrivning

Age | Hypertensive disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0020538
must be able to swallow a pill
Beskrivning

Able to swallow Pills

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0994475
must be ≥ 18 kg or ≤160 kg
Beskrivning

Body Weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0005910
mssbp (mean of 3 measurements) must be ≥ 95th percentile, for age, gender and height, at visit 2 (randomization), by office blood pressure measurement
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
patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. (an assent will be required for some patients depending upon their age and local requirements regarding assents)
Beskrivning

Study Subject Participation Status eligible | Informed Consent Parent | Informed Consent Guardian | Informed Consent Age dependent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548635
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030551
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1274041
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0001779
UMLS CUI [4,3]
C1701901
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
renal artery stenosis
Beskrivning

Renal Artery Stenosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0035067
current diagnosis of heart failure (nyha class ii-iv).
Beskrivning

Heart failure New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
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
second or third degree heart block without a pacemaker.
Beskrivning

Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C0030163
UMLS CUI [3,2]
C0332197
concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
Beskrivning

Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0741212
clinically significant valvular heart disease.
Beskrivning

Heart valve disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0018824
patient that demonstrates clinically significant ecg abnormalities other than those associated with left ventricular hypertrophy.
Beskrivning

ECG abnormality | Exception Left Ventricular Hypertrophy

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0149721
previous solid organ transplantation except renal, liver or heart transplantation. renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.
Beskrivning

Solid organ Transplantation | Exception Kidney Transplantation | Exception Transplantation of liver | Exception Heart Transplantation | Therapeutic immunosuppression Dosage Stable | Patient Stable status Clinical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0440790
UMLS CUI [1,2]
C0040732
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0022671
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0023911
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0018823
UMLS CUI [5,1]
C0021079
UMLS CUI [5,2]
C0178602
UMLS CUI [5,3]
C0205360
UMLS CUI [6,1]
C0030705
UMLS CUI [6,2]
C0205360
UMLS CUI [6,3]
C0205210
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
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Similar models

Eligibility Hypertension NCT00433836

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Hypertensive disease
Item
male or female, ages 6-17, with a documented history of hypertension
boolean
C0001779 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
Able to swallow Pills
Item
must be able to swallow a pill
boolean
C2712086 (UMLS CUI [1,1])
C0994475 (UMLS CUI [1,2])
Body Weight
Item
must be ≥ 18 kg or ≤160 kg
boolean
C0005910 (UMLS CUI [1])
Sitting systolic blood pressure mean Measurement Quantity | Age | Gender | Body Height
Item
mssbp (mean of 3 measurements) must be ≥ 95th percentile, for age, gender and height, at visit 2 (randomization), by office blood pressure measurement
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])
Study Subject Participation Status eligible | Informed Consent Parent | Informed Consent Guardian | Informed Consent Age dependent
Item
patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. (an assent will be required for some patients depending upon their age and local requirements regarding assents)
boolean
C2348568 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0030551 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3,1])
C1274041 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C0001779 (UMLS CUI [4,2])
C1701901 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Renal Artery Stenosis
Item
renal artery stenosis
boolean
C0035067 (UMLS CUI [1])
Heart failure New York Heart Association Classification
Item
current diagnosis of heart failure (nyha class ii-iv).
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
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 | Artificial cardiac pacemaker Absent
Item
second or third degree heart block without a pacemaker.
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0030163 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Cardiac Arrhythmia Life Threatening | ARRHYTHMIA SYMPTOMATIC
Item
concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
boolean
C0003811 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0741212 (UMLS CUI [2])
Heart valve disease
Item
clinically significant valvular heart disease.
boolean
C0018824 (UMLS CUI [1])
ECG abnormality | Exception Left Ventricular Hypertrophy
Item
patient that demonstrates clinically significant ecg abnormalities other than those associated with left ventricular hypertrophy.
boolean
C0522055 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0149721 (UMLS CUI [2,2])
Solid organ Transplantation | Exception Kidney Transplantation | Exception Transplantation of liver | Exception Heart Transplantation | Therapeutic immunosuppression Dosage Stable | Patient Stable status Clinical
Item
previous solid organ transplantation except renal, liver or heart transplantation. renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.
boolean
C0440790 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0022671 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0023911 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0018823 (UMLS CUI [4,2])
C0021079 (UMLS CUI [5,1])
C0178602 (UMLS CUI [5,2])
C0205360 (UMLS CUI [5,3])
C0030705 (UMLS CUI [6,1])
C0205360 (UMLS CUI [6,2])
C0205210 (UMLS CUI [6,3])
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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