ID
41348
Descripción
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00039858
Palabras clave
Versiones (1)
- 2/9/20 2/9/20 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
2 de septiembre de 2020
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
Creative Commons BY-NC 4.0
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Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858
Medical History
- StudyEvent: ODM
Descripción
Medical / Surgical / Invasive Procedure History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0455610
Descripción
No significant medical history
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0750502
- UMLS CUI [1,3]
- C0332197
Descripción
Medical history: Ear, nose, and throat
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0395797
Descripción
Medical history: Ear, nose, and throat - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0395797
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Eyes
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
Descripción
Medical history: Eyes - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0015397
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Respiratory
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035204
Descripción
Medical history: Respiratory - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035204
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Congenital Heart Disease
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0152021
Descripción
Medical history: Congenital Heart Disease - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0152021
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Cardiac Arrhythmia
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0003811
Descripción
Medical history: Cardiac Arrhythmia
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0003811
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Hypertension
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020538
Descripción
Medical history: Hypertension - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020538
- UMLS CUI [1,3]
- C1521902
Descripción
Medical histroy: Other cardiovascular diseases
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
Descripción
Medical histroy: Other cardiovascular diseases - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Descripción
Medical histroy: Other cardiovascular diseases
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
Descripción
Medical histroy: Other cardiovascular diseases - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0007222
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Descripción
Medical history: Gastrointestinal
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0017178
Descripción
Medical history: Gastrointestinal - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0017178
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Hepatobiliary and pancreas
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0267792
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0030286
Descripción
Medical history: Hepatobiliary and pancreas - specify
Tipo de datos
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
Descripción
Medical history: Urinary system
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0042075
Descripción
Medical history: Urinary system - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0042075
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Reproductive system
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0178829
Descripción
Medical history: Reproductive system - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0178829
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Neurologic
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
Descripción
Medical history: Neurologic - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0027765
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Blood and lymphatic
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0851353
Descripción
Medical history: Blood and lymphatic - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0851353
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Diabetes/Glucose Intolerance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0271650
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0011849
Descripción
Medical history: Diabetes/Glucose Intolerance - specify
Tipo de datos
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
Descripción
Medical history: Other endocrine diseases
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0014130
- UMLS CUI [1,3]
- C0205394
Descripción
Medical history: Other endocrine diseases - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0014130
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C1521902
Descripción
Medical history: Musculoskeletal
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0026857
- UMLS CUI [1,2]
- C0262926
Descripción
Medical history: Musculoskeletal - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0026857
- UMLS CUI [1,2]
- C0262926
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Skin
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0037274
Descripción
Medical history: Skin - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0037274
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Psychiatric
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
Descripción
Medical history: Psychiatric - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0004936
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Allergies
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
Descripción
Medical history: Allergies - specify
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0020517
- UMLS CUI [1,3]
- C1521902
Descripción
Medical history: Other
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0205394
Descripción
Medical history: Other - specify
Tipo de datos
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])