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
Link
https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-003233-41/DE#A
Keywords
Versions (3)
- 9/13/16 9/13/16 -
- 9/13/16 9/13/16 -
- 9/16/16 9/16/16 -
Uploaded on
September 13, 2016
DOI
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License
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0001779
Description
concomitant use of phosphate binders
Data type
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0357221
Description
fasting or dieting
Data type
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C2945766
Description
Serum phosphorus measurement
Data type
integer
Alias
- UMLS CUI [1]
- C0202178
Description
hydroxyvitamin D and iPTH
Data type
boolean
Alias
- UMLS CUI [1]
- C0535968
- UMLS CUI [2]
- C0202159
Description
compliant to sevelamer carbonate
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1721288
Description
stable doses
Data type
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0002367
- UMLS CUI [2]
- C0006675
- UMLS CUI [3]
- C0024467
- UMLS CUI [4]
- C0023031
Description
contraception
Data type
integer
Alias
- UMLS CUI [1]
- C0700589
Description
dialysis
Data type
boolean
Alias
- UMLS CUI [1]
- C0011946
Description
compliant to phosphate binders
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C4020599
Description
informed consent
Data type
boolean
Alias
- UMLS CUI [1]
- C0021430
Description
study participation status
Data type
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
study compliance
Data type
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
Data type
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
Data type
boolean
Alias
- UMLS CUI [1]
- C0038586
Description
use of anti-arrhythmic or anti-seizure drugs
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0003195
- UMLS CUI [1,2]
- C0003286
Description
unstable comorbidity
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
pregnant or breast-feeding
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Description
malignant neoplasms
Data type
boolean
Alias
- UMLS CUI [1]
- C0006826
Description
study protocol compliance
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C1321605
Description
hypersensitivity to study drug
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C071805
Description
comorbidity prohibiting study inclusion
Data type
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
date informed consent signed
Data type
date
Alias
- UMLS CUI [1]
- C2985782
Description
Patient met all enrollment criteria?
Data type
boolean
Alias
- UMLS CUI [1]
- C1302261
Description
Patient demographics
Alias
- UMLS CUI-1
- C1955348
Description
date of birth
Data type
date
Alias
- UMLS CUI [1]
- C0421451
Description
Ethnicity
Data type
integer
Alias
- UMLS CUI [1]
- C0015031
Description
if previous answered with other, please specify
Data type
text
Alias
- UMLS CUI [1]
- C0015031
Description
sex
Data type
integer
Alias
- UMLS CUI [1]
- C0079399
Description
Smoker
Data type
boolean
Alias
- UMLS CUI [1]
- C0543414
Description
Diabetes mellitus
Data type
boolean
Alias
- UMLS CUI [1]
- C0011849
Description
Vital signs
Alias
- UMLS CUI-1
- C0518766
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Respiratory Rate
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- 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)