ID
17423
Beschrijving
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
Link
https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A
Trefwoorden
Versies (3)
- 13-09-16 13-09-16 -
- 13-09-16 13-09-16 -
- 16-09-16 16-09-16 -
Geüploaded op
13 september 2016
DOI
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Licentie
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
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
age
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
concomitant use of phosphate binders
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0357221
Beschrijving
fasting or dieting
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C2945766
Beschrijving
Serum phosphorus measurement
Datatype
integer
Alias
- UMLS CUI [1]
- C0202178
Beschrijving
hydroxyvitamin D and iPTH
Datatype
boolean
Alias
- UMLS CUI [1]
- C0535968
- UMLS CUI [2]
- C0202159
Beschrijving
compliant to sevelamer carbonate
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1721288
Beschrijving
stable doses
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0042866
- UMLS CUI [1,3]
- C1337242
Beschrijving
contact to aluminium, magnesium, calcium or lanthanum
Datatype
boolean
Alias
- UMLS CUI [1]
- C0002367
- UMLS CUI [2]
- C0006675
- UMLS CUI [3]
- C0024467
- UMLS CUI [4]
- C0023031
Beschrijving
contraception
Datatype
integer
Alias
- UMLS CUI [1]
- C0700589
Beschrijving
dialysis
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011946
Beschrijving
compliant to phosphate binders
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C4020599
Beschrijving
informed consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
study participation status
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
study compliance
Datatype
boolean
Alias
- UMLS CUI [1]
- C1321605
Beschrijving
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021843
- UMLS CUI [2]
- C0011168
- UMLS CUI [3]
- C0011168
- UMLS CUI [4,1]
- C0854121
- UMLS CUI [4,2]
- C0205082
Beschrijving
active substance abuse
Datatype
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschrijving
use of anti-arrhythmic or anti-seizure drugs
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0003195
- UMLS CUI [1,2]
- C0003286
Beschrijving
unstable comorbidity
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
pregnant or breast-feeding
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beschrijving
malignant neoplasms
Datatype
boolean
Alias
- UMLS CUI [1]
- C0006826
Beschrijving
study protocol compliance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C1321605
Beschrijving
hypersensitivity to study drug
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C071805
Beschrijving
comorbidity prohibiting study inclusion
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschrijving
date informed consent signed
Datatype
date
Alias
- UMLS CUI [1]
- C2985782
Beschrijving
Patient met all enrollment criteria?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1302261
Beschrijving
Patient demographics
Alias
- UMLS CUI-1
- C1955348
Beschrijving
date of birth
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Ethnicity
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
if previous answered with other, please specify
Datatype
text
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
sex
Datatype
integer
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Smoker
Datatype
boolean
Alias
- UMLS CUI [1]
- C0543414
Beschrijving
Diabetes mellitus
Datatype
boolean
Alias
- UMLS CUI [1]
- C0011849
Beschrijving
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Respiratory Rate
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Weight and Height
Alias
- UMLS CUI-1
- C0005910
- UMLS CUI-3
- C0005890
Beschrijving
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)