ID

24444

Description

Study to Characterize the Long-term Clinical Experience of Atacand in Hypertensive Children Ages 1 to<11 Years (Hypertension in Pediatrics); ODM derived from: https://clinicaltrials.gov/show/NCT00690612

Lien

https://clinicaltrials.gov/show/NCT00690612

Mots-clés

Versions (1)
  1. 01/08/2017 01/08/2017 -
Téléchargé le

1 août 2017

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Hypertension NCT00690612

Anglais

Eligibility Hypertension NCT00690612

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
must have participated in protocol 328 (without discontinuation due to a study drug related ae).
Description

Study Subject Participation Status | Protocol Specified

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0205369
must sign an informed consent prior to initiating any stus dy procedures.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
have, in the opinion of the investigator, an on-going clinical indication for oral liquid formulation of candesartan cilexetil to control hypertension
Description

Indication for Candesartan cilexetil Formulation Liquid Oral | Hypertensive disease control

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0527379
UMLS CUI [1,3]
C0524527
UMLS CUI [1,4]
C1697794
UMLS CUI [1,5]
C1527415
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0243148
weight ≥ 10 kg and ≤ 40 kg.
Description

Body Weight

Type de données

boolean

Alias
UMLS CUI [1]
C0005910
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
any situation, clinical condition (such as clinically significant declining renal function) or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study.
Description

Situation Interferes with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Decreased renal function Interferes with Study Subject Participation Status | Laboratory test result abnormal Interferes with Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1,1]
C0748872
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C2348568
UMLS CUI [3,1]
C0232807
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0438215
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2348568
estimated glomerular filtration rate (gfr) <30 ml/min/1.73m2 for non-transplant patients and <40 ml/min/1.73m2 for transplant patients based on the schwartz formula (schwartz et al 1987) as determined at enrollment into study 328.
Description

Estimated Glomerular Filtration Rate Transplantation Absent | Estimated Glomerular Filtration Rate Transplantation | Formula Schwartz

Type de données

boolean

Alias
UMLS CUI [1,1]
C3811844
UMLS CUI [1,2]
C0040732
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C3811844
UMLS CUI [2,2]
C0040732
UMLS CUI [3]
C1980037
impaired liver function defined as either acute liver disease or chronic liver disease with persistently elevated liver enzyme values judged clinically significant by the investigator.
Description

Liver Dysfunction | Liver diseases | Chronic liver disease Associated with Elevated liver enzymes persistent

Type de données

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C0023895
UMLS CUI [3,1]
C0341439
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0235996
UMLS CUI [3,4]
C0205322
currently using any medications that, in the opinion of the investigator could negatively affect the subject when given together with candesartan cilexetil.
Description

Pharmaceutical Preparations Combination Candesartan cilexetil | Patient affected Negative

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0205195
UMLS CUI [1,3]
C0527379
UMLS CUI [2,1]
C0522476
UMLS CUI [2,2]
C1513916
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Similar models

Eligibility Hypertension NCT00690612

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Protocol Specified
Item
must have participated in protocol 328 (without discontinuation due to a study drug related ae).
boolean
C2348568 (UMLS CUI [1])
C2348563 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Informed Consent
Item
must sign an informed consent prior to initiating any stus dy procedures.
boolean
C0021430 (UMLS CUI [1])
Indication for Candesartan cilexetil Formulation Liquid Oral | Hypertensive disease control
Item
have, in the opinion of the investigator, an on-going clinical indication for oral liquid formulation of candesartan cilexetil to control hypertension
boolean
C0392360 (UMLS CUI [1,1])
C0527379 (UMLS CUI [1,2])
C0524527 (UMLS CUI [1,3])
C1697794 (UMLS CUI [1,4])
C1527415 (UMLS CUI [1,5])
C0020538 (UMLS CUI [2,1])
C0243148 (UMLS CUI [2,2])
Body Weight
Item
weight ≥ 10 kg and ≤ 40 kg.
boolean
C0005910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Situation Interferes with Study Subject Participation Status | Medical condition Interferes with Study Subject Participation Status | Decreased renal function Interferes with Study Subject Participation Status | Laboratory test result abnormal Interferes with Study Subject Participation Status
Item
any situation, clinical condition (such as clinically significant declining renal function) or laboratory abnormality that, in the opinion of the investigator or sponsor, may interfere with the subject's participation in the study.
boolean
C0748872 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0232807 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0438215 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
Estimated Glomerular Filtration Rate Transplantation Absent | Estimated Glomerular Filtration Rate Transplantation | Formula Schwartz
Item
estimated glomerular filtration rate (gfr) <30 ml/min/1.73m2 for non-transplant patients and <40 ml/min/1.73m2 for transplant patients based on the schwartz formula (schwartz et al 1987) as determined at enrollment into study 328.
boolean
C3811844 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3811844 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
C1980037 (UMLS CUI [3])
Liver Dysfunction | Liver diseases | Chronic liver disease Associated with Elevated liver enzymes persistent
Item
impaired liver function defined as either acute liver disease or chronic liver disease with persistently elevated liver enzyme values judged clinically significant by the investigator.
boolean
C0086565 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0341439 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0235996 (UMLS CUI [3,3])
C0205322 (UMLS CUI [3,4])
Pharmaceutical Preparations Combination Candesartan cilexetil | Patient affected Negative
Item
currently using any medications that, in the opinion of the investigator could negatively affect the subject when given together with candesartan cilexetil.
boolean
C0013227 (UMLS CUI [1,1])
C0205195 (UMLS CUI [1,2])
C0527379 (UMLS CUI [1,3])
C0522476 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
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