ID
41344
Beschrijving
Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. See https://clinicaltrials.gov/ct2/show/NCT00039858 The Urinalysis Form has to be filled in twice: first, at the screening visit (within 96 hours before treatment initiation) and second, within 24 hours of final infusion completion or at the 30-day follow-up visit, whichever comes first.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Trefwoorden
Versies (2)
- 31-08-20 31-08-20 -
- 02-09-20 02-09-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
2 september 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Urinalysis (pre-/post-treatment)
- StudyEvent: ODM
Beschrijving
Urinalysis
Alias
- UMLS CUI-1
- C0042014
Beschrijving
(dd-mmm-yyyy)
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0042014
Beschrijving
(0000-2359)
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0042014
Beschrijving
Laboratory procedures not performed - Urinalysis
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0445106
- UMLS CUI [1,3]
- C0042014
Beschrijving
(Lab name must match name on lab normals.)
Datatype
text
Alias
- UMLS CUI [1,1]
- C3258037
- UMLS CUI [1,2]
- C0042014
Beschrijving
Is a copy of the lab report attached?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0587081
Beschrijving
(numeric value only)
Datatype
float
Alias
- UMLS CUI [1]
- C0428541
Beschrijving
Protein in urine measurement - clinical significance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0428541
- UMLS CUI [1,2]
- C2826293
Beschrijving
Protein in urine measurement - comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0428541
- UMLS CUI [1,2]
- C0947611
Beschrijving
(numeric value only)
Datatype
float
Alias
- UMLS CUI [1]
- C0004076
Beschrijving
Urine glucose measurement - clinical significance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C2826293
Beschrijving
Urine glucose measurement - comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0004076
- UMLS CUI [1,2]
- C0947611
Beschrijving
(numeric value only)
Datatype
float
Alias
- UMLS CUI [1]
- C2188744
Beschrijving
Urine Occult Blood Measurement - clinical significance
Datatype
text
Alias
- UMLS CUI [1,1]
- C2188744
- UMLS CUI [1,2]
- C2826293
Beschrijving
Urine Occult Blood Measurement - comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C2188744
- UMLS CUI [1,2]
- C0947611
Beschrijving
(numeric value only)
Datatype
float
Alias
- UMLS CUI [1]
- C0042044
Beschrijving
Urine pH measurement - clinical significance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C2826293
Beschrijving
Urine pH measurement - comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042044
- UMLS CUI [1,2]
- C0947611
Beschrijving
(numeric value only)
Datatype
float
Alias
- UMLS CUI [1]
- C0202517
Beschrijving
Urine specific gravity measurement - clinical significance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202517
- UMLS CUI [1,2]
- C2826293
Beschrijving
Urine specific gravity measurement - comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0202517
- UMLS CUI [1,2]
- C0947611
Beschrijving
(numeric value only)
Datatype
float
Alias
- UMLS CUI [1]
- C1991100
Beschrijving
Urine ketones measurement - clinical significance
Datatype
text
Alias
- UMLS CUI [1,1]
- C1991100
- UMLS CUI [1,2]
- C2826293
Beschrijving
Urine ketones measurement - comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C1991100
- UMLS CUI [1,2]
- C0947611
Beschrijving
(numeric value only)
Datatype
float
Alias
- UMLS CUI [1]
- C0430397
Beschrijving
Urine microscopic analysis - specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C1521902
Beschrijving
Urine microscopic analysis - clinical significance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2826293
Beschrijving
Urine microscopic analysis - comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0947611
Beschrijving
(specify test name)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Beschrijving
(numeric value only)
Datatype
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other urinalysis test - clinical significance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C2826293
Beschrijving
Other urinalysis test - comment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Similar models
Urinalysis (pre-/post-treatment)
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,2])
C0445106 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C0042014 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])