ID
17423
Description
An open label, dose titration study of sevelamer carbonate tablets dosed three times a day in hyperphosphatemic chronic kidney disease patients not on dialysis Name of Sponsor: Genzyme Europe BV Country: Netherlands https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A
Lien
https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A
Mots-clés
Versions (3)
- 13/09/2016 13/09/2016 -
- 13/09/2016 13/09/2016 -
- 16/09/2016 16/09/2016 -
Téléchargé le
13 septembre 2016
DOI
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Licence
Creative Commons BY-NC 3.0 Legacy
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Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41
Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41
- StudyEvent: ODM
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Description
age
Type de données
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
concomitant use of phosphate binders
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0357221
Description
fasting or dieting
Type de données
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C2945766
Description
Serum phosphorus measurement
Type de données
integer
Alias
- UMLS CUI [1]
- C0202178
Description
hydroxyvitamin D and iPTH
Type de données
boolean
Alias
- UMLS CUI [1]
- C0535968
- UMLS CUI [2]
- C0202159
Description
compliant to sevelamer carbonate
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1721288
Description
stable doses
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0042866
- UMLS CUI [1,3]
- C1337242
Description
contact to aluminium, magnesium, calcium or lanthanum
Type de données
boolean
Alias
- UMLS CUI [1]
- C0002367
- UMLS CUI [2]
- C0006675
- UMLS CUI [3]
- C0024467
- UMLS CUI [4]
- C0023031
Description
contraception
Type de données
integer
Alias
- UMLS CUI [1]
- C0700589
Description
dialysis
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011946
Description
compliant to phosphate binders
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C4020599
Description
informed consent
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
study participation status
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
study compliance
Type de données
boolean
Alias
- UMLS CUI [1]
- C1321605
Description
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Description
bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders
Type de données
boolean
Alias
- UMLS CUI [1]
- C0021843
- UMLS CUI [2]
- C0011168
- UMLS CUI [3]
- C0011168
- UMLS CUI [4,1]
- C0854121
- UMLS CUI [4,2]
- C0205082
Description
active substance abuse
Type de données
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
use of anti-arrhythmic or anti-seizure drugs
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0003195
- UMLS CUI [1,2]
- C0003286
Description
unstable comorbidity
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
pregnant or breast-feeding
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Description
malignant neoplasms
Type de données
boolean
Alias
- UMLS CUI [1]
- C0006826
Description
study protocol compliance
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C1321605
Description
hypersensitivity to study drug
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C071805
Description
comorbidity prohibiting study inclusion
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
date informed consent signed
Type de données
date
Alias
- UMLS CUI [1]
- C2985782
Description
Patient met all enrollment criteria?
Type de données
boolean
Alias
- UMLS CUI [1]
- C1302261
Description
Patient demographics
Alias
- UMLS CUI-1
- C1955348
Description
date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Ethnicity
Type de données
integer
Alias
- UMLS CUI [1]
- C0015031
Description
if previous answered with other, please specify
Type de données
text
Alias
- UMLS CUI [1]
- C0015031
Description
sex
Type de données
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Smoker
Type de données
boolean
Alias
- UMLS CUI [1]
- C0543414
Description
Diabetes mellitus
Type de données
boolean
Alias
- UMLS CUI [1]
- C0011849
Description
Vital signs
Alias
- UMLS CUI-1
- C0518766
Description
Heart Rate
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Respiratory Rate
Type de données
integer
Unités de mesure
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Systolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Weight and Height
Alias
- UMLS CUI-1
- C0005910
- UMLS CUI-3
- C0005890
Description
Medical/Surgical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Similar models
Screening Genzyme Chronic Kidney Disease EudraCT 2005-003233-41
- StudyEvent: ODM
C0357221 (UMLS CUI [1,2])
C2945766 (UMLS CUI [2])
C0202159 (UMLS CUI [2])
C1721288 (UMLS CUI [1,2])
C0042866 (UMLS CUI [1,2])
C1337242 (UMLS CUI [1,3])
C0006675 (UMLS CUI [2])
C0024467 (UMLS CUI [3])
C0023031 (UMLS CUI [4])
C4020599 (UMLS CUI [1,2])
C0011168 (UMLS CUI [2])
C0011168 (UMLS CUI [3])
C0854121 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0003286 (UMLS CUI [1,2])
C0006147 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
C071805 (UMLS CUI [1,2])
C0455610 (UMLS CUI-2)