ID
41348
Beskrivning
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 Medical History Form has to be filled in at the screening visit. It is used to record details of medical history and prior surgical and other invasive procedures. To be completed within 7 days before treatment initiation.
Länk
https://clinicaltrials.gov/ct2/show/NCT00039858
Nyckelord
Versioner (1)
- 2020-09-02 2020-09-02 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
2 september 2020
DOI
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Licens
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Medical History
- StudyEvent: ODM
Beskrivning
Medical / Surgical / Invasive Procedure History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Beskrivning
No significant medical history
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0750502
- UMLS CUI [1,3]
- C0332197
Beskrivning
Medical history: Ear, nose, and throat
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0395797
Beskrivning
Medical history: Ear, nose, and throat - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0395797
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Eyes
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
Beskrivning
Medical history: Eyes - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Respiratory
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035204
Beskrivning
Medical history: Respiratory - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035204
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Congenital Heart Disease
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0152021
Beskrivning
Medical history: Congenital Heart Disease - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0152021
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Cardiac Arrhythmia
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0003811
Beskrivning
Medical history: Cardiac Arrhythmia
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0003811
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Hypertension
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020538
Beskrivning
Medical history: Hypertension - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020538
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical histroy: Other cardiovascular diseases
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
Beskrivning
Medical histroy: Other cardiovascular diseases - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beskrivning
Medical histroy: Other cardiovascular diseases
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
Beskrivning
Medical histroy: Other cardiovascular diseases - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beskrivning
Medical history: Gastrointestinal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0017178
Beskrivning
Medical history: Gastrointestinal - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0017178
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Hepatobiliary and pancreas
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0267792
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0030286
Beskrivning
Medical history: Hepatobiliary and pancreas - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0267792
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0030286
- UMLS CUI [2,3]
- C1521902
Beskrivning
Medical history: Urinary system
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0042075
Beskrivning
Medical history: Urinary system - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0042075
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Reproductive system
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0178829
Beskrivning
Medical history: Reproductive system - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0178829
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Neurologic
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
Beskrivning
Medical history: Neurologic - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Blood and lymphatic
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0851353
Beskrivning
Medical history: Blood and lymphatic - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0851353
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Diabetes/Glucose Intolerance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0271650
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0011849
Beskrivning
Medical history: Diabetes/Glucose Intolerance - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0271650
- UMLS CUI [1,3]
- C1521902
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0011849
- UMLS CUI [2,3]
- C1521902
Beskrivning
Medical history: Other endocrine diseases
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0014130
- UMLS CUI [1,3]
- C0205394
Beskrivning
Medical history: Other endocrine diseases - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0014130
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Beskrivning
Medical history: Musculoskeletal
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0026857
- UMLS CUI [1,2]
- C0262926
Beskrivning
Medical history: Musculoskeletal - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0026857
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Skin
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0037274
Beskrivning
Medical history: Skin - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0037274
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Psychiatric
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
Beskrivning
Medical history: Psychiatric - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Allergies
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
Beskrivning
Medical history: Allergies - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C1521902
Beskrivning
Medical history: Other
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0205394
Beskrivning
Medical history: Other - specify
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1521902
Similar models
Medical History
- StudyEvent: ODM
C0019994 (UMLS CUI [1,2])
C0455610 (UMLS CUI-2)
C0750502 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0395797 (UMLS CUI [1,2])
C0395797 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0015397 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0035204 (UMLS CUI [1,2])
C0035204 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0152021 (UMLS CUI [1,2])
C0152021 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0003811 (UMLS CUI [1,2])
C0003811 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0020538 (UMLS CUI [1,2])
C0020538 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0007222 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0007222 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0007222 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0007222 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0017178 (UMLS CUI [1,2])
C0017178 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0267792 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0030286 (UMLS CUI [2,2])
C0267792 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0030286 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
C0042075 (UMLS CUI [1,2])
C0042075 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0178829 (UMLS CUI [1,2])
C0178829 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0027765 (UMLS CUI [1,2])
C0027765 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0851353 (UMLS CUI [1,2])
C0851353 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0271650 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0271650 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C1521902 (UMLS CUI [2,3])
C0014130 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0014130 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0262926 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0037274 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0004936 (UMLS CUI [1,2])
C0004936 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0020517 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])