ID

21065

Beschreibung

A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents; ODM derived from: https://clinicaltrials.gov/show/NCT00389519

Link

https://clinicaltrials.gov/show/NCT00389519

Stichworte

Versionen (1)
  1. 07.04.17 07.04.17 -
Hochgeladen am

7. April 2017

DOI

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Creative Commons BY 4.0
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Eligibility Hypertension NCT00389519

Englisch

Eligibility Hypertension NCT00389519

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. previous, documented diagnosis of hypertension, or newly diagnosed hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (united states). sisbp greater than or equal to the 95th percentile for age, gender, and height.
Beschreibung

Hypertensive disease | Sitting systolic blood pressure | Age | Gender | Body Height

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C1319893
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0005890
2. the subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the investigator.
Beschreibung

Antihypertensive Agents Withdraw Possible | Placebo given

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003364
UMLS CUI [1,2]
C2349954
UMLS CUI [1,3]
C0332149
UMLS CUI [2]
C0420256
3. the subject is male or female age 6 to 16 years (inclusive), and weighs greater than or equal to 20 kg.
Beschreibung

Age | Body Weight

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
4. female subjects greater than or equal to 12 years of age, or who have had greater than or equal to 1 menstruation must: (a) have a negative serum pregnancy test at screening (i.e., subject is not pregnant), (b) not be lactating, and (c) use an acceptable method of contraception.
Beschreibung

Age | Gender Menstruation Quantity | Serum pregnancy test negative | Breast Feeding Absent | Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0025344
UMLS CUI [2,3]
C1265611
UMLS CUI [3]
C0430061
UMLS CUI [4,1]
C0006147
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0700589
5. parents/guardians are able to demonstrate their ability to (a) use a home blood pressure monitor supplied for the study to monitor their child's blood pressure, and (2) mix and administer a liquid dose of study drug if needed.
Beschreibung

Parent Ability Home Blood Pressure Monitoring | Guardian Ability Home Blood Pressure Monitoring | Child Blood pressure monitoring | Parent Ability Administration Investigational New Drugs | Guardian Ability Administration Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030551
UMLS CUI [1,2]
C0085732
UMLS CUI [1,3]
C1449681
UMLS CUI [2,1]
C1274041
UMLS CUI [2,2]
C0085732
UMLS CUI [2,3]
C1449681
UMLS CUI [3,1]
C0008059
UMLS CUI [3,2]
C0026426
UMLS CUI [4,1]
C0030551
UMLS CUI [4,2]
C0085732
UMLS CUI [4,3]
C1533734
UMLS CUI [4,4]
C0013230
UMLS CUI [5,1]
C1274041
UMLS CUI [5,2]
C0085732
UMLS CUI [5,3]
C1533734
UMLS CUI [5,4]
C0013230
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. bilateral renal artery stenosis.
Beschreibung

Bilateral renal artery stenosis

Datentyp

boolean

Alias
UMLS CUI [1]
C0856760
2. uncorrected coarctation of the aorta or corrected coarctation with a right arm/right leg blood pressure gradient greater than 10 mmhg.
Beschreibung

Aortic coarctation | Repair of coarctation of aorta | Blood pressure in right arm Blood pressure in right leg Gradient

Datentyp

boolean

Alias
UMLS CUI [1]
C0003492
UMLS CUI [2]
C0558326
UMLS CUI [3,1]
C2221330
UMLS CUI [3,2]
C2221328
UMLS CUI [3,3]
C0812409
3. severe hypertension.
Beschreibung

Hypertension, severe

Datentyp

boolean

Alias
UMLS CUI [1]
C4013784
4. renal transplantation or other previous solid organ transplantation less than 6 months prior to entering the study.
Beschreibung

Kidney Transplantation | Solid organ transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0022671
UMLS CUI [2]
C0730400
5. subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or cyclosporine.
Beschreibung

Nephrotic Syndrome | Maintenance therapy Stable Absent | Prednisone | Cyclosporine

Datentyp

boolean

Alias
UMLS CUI [1]
C0027726
UMLS CUI [2,1]
C0677908
UMLS CUI [2,2]
C0205360
UMLS CUI [2,3]
C0332197
UMLS CUI [3]
C0032952
UMLS CUI [4]
C0010592
6. a history of cardiomyopathy, clinically significant structural heart disease, or atrioventricular conduction disturbance, sick sinus syndrome, atrial flutter, atrial fibrillation, clinically significant bradycardia or an accessory bypass tract, or clinical symptoms of congestive heart failure.
Beschreibung

Cardiomyopathy | Structural disorder of heart | Atrioventricular conduction disorder | Sick Sinus Syndrome | Atrial Flutter | Atrial Fibrillation | Bradycardia | Accessory cardiac pathway | Congestive heart failure Symptoms Clinical

Datentyp

boolean

Alias
UMLS CUI [1]
C0878544
UMLS CUI [2]
C1290384
UMLS CUI [3]
C1627362
UMLS CUI [4]
C0037052
UMLS CUI [5]
C0004239
UMLS CUI [6]
C0004238
UMLS CUI [7]
C0428977
UMLS CUI [8]
C1963785
UMLS CUI [9,1]
C0018802
UMLS CUI [9,2]
C1457887
UMLS CUI [9,3]
C0205210
7. clinically significant hematologic, hepatobiliary, or renal disease including a schwartz formula gfr less than 40 ml/min/1.73 m2, and/or serum potassium (k+) greater than 5.5 meq/l.
Beschreibung

Hematological Disease | Hepatobiliary disease | Kidney Diseases | Formula Schwartz Glomerular Filtration Rate | Serum potassium measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0267792
UMLS CUI [3]
C0022658
UMLS CUI [4,1]
C1980037
UMLS CUI [4,2]
C0017654
UMLS CUI [5]
C0302353
8. history of pancreatitis (active or inactive).
Beschreibung

Pancreatitis | Pancreatitis inactive

Datentyp

boolean

Alias
UMLS CUI [1]
C0030305
UMLS CUI [2,1]
C0030305
UMLS CUI [2,2]
C0544452
9. known sensitivity to angiotensin converting enzyme inhibitors or a history of angioneurotic edema.
Beschreibung

Angiotensin-converting-enzyme inhibitor allergy | Angioedema

Datentyp

boolean

Alias
UMLS CUI [1]
C0571939
UMLS CUI [2]
C0002994
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Ähnliche Modelle

Eligibility Hypertension NCT00389519

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive disease | Sitting systolic blood pressure | Age | Gender | Body Height
Item
1. previous, documented diagnosis of hypertension, or newly diagnosed hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (united states). sisbp greater than or equal to the 95th percentile for age, gender, and height.
boolean
C0020538 (UMLS CUI [1])
C1319893 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0005890 (UMLS CUI [5])
Antihypertensive Agents Withdraw Possible | Placebo given
Item
2. the subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the investigator.
boolean
C0003364 (UMLS CUI [1,1])
C2349954 (UMLS CUI [1,2])
C0332149 (UMLS CUI [1,3])
C0420256 (UMLS CUI [2])
Age | Body Weight
Item
3. the subject is male or female age 6 to 16 years (inclusive), and weighs greater than or equal to 20 kg.
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Age | Gender Menstruation Quantity | Serum pregnancy test negative | Breast Feeding Absent | Contraceptive methods
Item
4. female subjects greater than or equal to 12 years of age, or who have had greater than or equal to 1 menstruation must: (a) have a negative serum pregnancy test at screening (i.e., subject is not pregnant), (b) not be lactating, and (c) use an acceptable method of contraception.
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0025344 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0430061 (UMLS CUI [3])
C0006147 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0700589 (UMLS CUI [5])
Parent Ability Home Blood Pressure Monitoring | Guardian Ability Home Blood Pressure Monitoring | Child Blood pressure monitoring | Parent Ability Administration Investigational New Drugs | Guardian Ability Administration Investigational New Drugs
Item
5. parents/guardians are able to demonstrate their ability to (a) use a home blood pressure monitor supplied for the study to monitor their child's blood pressure, and (2) mix and administer a liquid dose of study drug if needed.
boolean
C0030551 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C1449681 (UMLS CUI [1,3])
C1274041 (UMLS CUI [2,1])
C0085732 (UMLS CUI [2,2])
C1449681 (UMLS CUI [2,3])
C0008059 (UMLS CUI [3,1])
C0026426 (UMLS CUI [3,2])
C0030551 (UMLS CUI [4,1])
C0085732 (UMLS CUI [4,2])
C1533734 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
C1274041 (UMLS CUI [5,1])
C0085732 (UMLS CUI [5,2])
C1533734 (UMLS CUI [5,3])
C0013230 (UMLS CUI [5,4])
Item Group
C0680251 (UMLS CUI)
Bilateral renal artery stenosis
Item
1. bilateral renal artery stenosis.
boolean
C0856760 (UMLS CUI [1])
Aortic coarctation | Repair of coarctation of aorta | Blood pressure in right arm Blood pressure in right leg Gradient
Item
2. uncorrected coarctation of the aorta or corrected coarctation with a right arm/right leg blood pressure gradient greater than 10 mmhg.
boolean
C0003492 (UMLS CUI [1])
C0558326 (UMLS CUI [2])
C2221330 (UMLS CUI [3,1])
C2221328 (UMLS CUI [3,2])
C0812409 (UMLS CUI [3,3])
Hypertension, severe
Item
3. severe hypertension.
boolean
C4013784 (UMLS CUI [1])
Kidney Transplantation | Solid organ transplant
Item
4. renal transplantation or other previous solid organ transplantation less than 6 months prior to entering the study.
boolean
C0022671 (UMLS CUI [1])
C0730400 (UMLS CUI [2])
Nephrotic Syndrome | Maintenance therapy Stable Absent | Prednisone | Cyclosporine
Item
5. subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or cyclosporine.
boolean
C0027726 (UMLS CUI [1])
C0677908 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0032952 (UMLS CUI [3])
C0010592 (UMLS CUI [4])
Cardiomyopathy | Structural disorder of heart | Atrioventricular conduction disorder | Sick Sinus Syndrome | Atrial Flutter | Atrial Fibrillation | Bradycardia | Accessory cardiac pathway | Congestive heart failure Symptoms Clinical
Item
6. a history of cardiomyopathy, clinically significant structural heart disease, or atrioventricular conduction disturbance, sick sinus syndrome, atrial flutter, atrial fibrillation, clinically significant bradycardia or an accessory bypass tract, or clinical symptoms of congestive heart failure.
boolean
C0878544 (UMLS CUI [1])
C1290384 (UMLS CUI [2])
C1627362 (UMLS CUI [3])
C0037052 (UMLS CUI [4])
C0004239 (UMLS CUI [5])
C0004238 (UMLS CUI [6])
C0428977 (UMLS CUI [7])
C1963785 (UMLS CUI [8])
C0018802 (UMLS CUI [9,1])
C1457887 (UMLS CUI [9,2])
C0205210 (UMLS CUI [9,3])
Hematological Disease | Hepatobiliary disease | Kidney Diseases | Formula Schwartz Glomerular Filtration Rate | Serum potassium measurement
Item
7. clinically significant hematologic, hepatobiliary, or renal disease including a schwartz formula gfr less than 40 ml/min/1.73 m2, and/or serum potassium (k+) greater than 5.5 meq/l.
boolean
C0018939 (UMLS CUI [1])
C0267792 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C1980037 (UMLS CUI [4,1])
C0017654 (UMLS CUI [4,2])
C0302353 (UMLS CUI [5])
Pancreatitis | Pancreatitis inactive
Item
8. history of pancreatitis (active or inactive).
boolean
C0030305 (UMLS CUI [1])
C0030305 (UMLS CUI [2,1])
C0544452 (UMLS CUI [2,2])
Angiotensin-converting-enzyme inhibitor allergy | Angioedema
Item
9. known sensitivity to angiotensin converting enzyme inhibitors or a history of angioneurotic edema.
boolean
C0571939 (UMLS CUI [1])
C0002994 (UMLS CUI [2])
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