ID
17423
Beschreibung
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
Stichworte
Versionen (3)
- 13.09.16 13.09.16 -
- 13.09.16 13.09.16 -
- 16.09.16 16.09.16 -
Hochgeladen am
13. September 2016
DOI
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Lizenz
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
Beschreibung
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschreibung
age
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschreibung
concomitant use of phosphate binders
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0357221
Beschreibung
fasting or dieting
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015663
- UMLS CUI [2]
- C2945766
Beschreibung
Serum phosphorus measurement
Datentyp
integer
Alias
- UMLS CUI [1]
- C0202178
Beschreibung
hydroxyvitamin D and iPTH
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0535968
- UMLS CUI [2]
- C0202159
Beschreibung
compliant to sevelamer carbonate
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C1721288
Beschreibung
stable doses
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0678766
- UMLS CUI [1,2]
- C0042866
- UMLS CUI [1,3]
- C1337242
Beschreibung
contact to aluminium, magnesium, calcium or lanthanum
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0002367
- UMLS CUI [2]
- C0006675
- UMLS CUI [3]
- C0024467
- UMLS CUI [4]
- C0023031
Beschreibung
contraception
Datentyp
integer
Alias
- UMLS CUI [1]
- C0700589
Beschreibung
dialysis
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011946
Beschreibung
compliant to phosphate binders
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1321605
- UMLS CUI [1,2]
- C4020599
Beschreibung
informed consent
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschreibung
study participation status
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschreibung
study compliance
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1321605
Beschreibung
Exclusion criteria
Alias
- UMLS CUI-1
- C0680251
Beschreibung
bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal motility (GI) disorders
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0021843
- UMLS CUI [2]
- C0011168
- UMLS CUI [3]
- C0011168
- UMLS CUI [4,1]
- C0854121
- UMLS CUI [4,2]
- C0205082
Beschreibung
active substance abuse
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0038586
Beschreibung
use of anti-arrhythmic or anti-seizure drugs
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0003195
- UMLS CUI [1,2]
- C0003286
Beschreibung
unstable comorbidity
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
pregnant or breast-feeding
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0032961
- UMLS CUI [1,2]
- C0006147
Beschreibung
malignant neoplasms
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0006826
Beschreibung
study protocol compliance
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2348563
- UMLS CUI [1,2]
- C1321605
Beschreibung
hypersensitivity to study drug
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C071805
Beschreibung
comorbidity prohibiting study inclusion
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0009488
Beschreibung
date informed consent signed
Datentyp
date
Alias
- UMLS CUI [1]
- C2985782
Beschreibung
Patient met all enrollment criteria?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1302261
Beschreibung
Patient demographics
Alias
- UMLS CUI-1
- C1955348
Beschreibung
date of birth
Datentyp
date
Alias
- UMLS CUI [1]
- C0421451
Beschreibung
Ethnicity
Datentyp
integer
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
if previous answered with other, please specify
Datentyp
text
Alias
- UMLS CUI [1]
- C0015031
Beschreibung
sex
Datentyp
integer
Alias
- UMLS CUI [1]
- C0079399
Beschreibung
Smoker
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0543414
Beschreibung
Diabetes mellitus
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0011849
Beschreibung
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Heart Rate
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Respiratory Rate
Datentyp
integer
Maßeinheiten
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Beschreibung
Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Weight and Height
Alias
- UMLS CUI-1
- C0005910
- UMLS CUI-3
- C0005890
Beschreibung
Medical/Surgical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Ähnliche Modelle
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)