ID
38267
Beskrivning
Study ID: 111539 Clinical Study ID: 111539 Study Title: A Single-Blind Study of the Safety, Pharmacokinetics and Pharmacodynamics of scalating Repeat Doses of GSK249320 in Patients With Stroke Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00833989 https://clinicaltrials.gov/ct2/show/NCT00833989 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Refanezumab, Placebo Trade Name: N/A Study Indication: Ischaemic Attack, Transient The study consists of 8 visits: Day 1, Week 1 (Day 5), Week 2 (Day 10), Week 4 (Day 30), Week 8 (Day 60), Week 12 (Day 90), Week 16 (Day 112), Follow-up (F/U). All subjects will receive two doses. The first dose within 24-72 hrs after stroke the second dose 9 +/- 1 days after the first one. Each dose will be given as an intravenous infusion over 60 minutes. This document contains the Logs and Repeats Form.
Länk
https://clinicaltrials.gov/ct2/show/NCT00833989
Nyckelord
Versioner (2)
- 2019-09-18 2019-09-18 -
- 2019-10-05 2019-10-05 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
5 oktober 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Safety, Pharmacokinetics and Pharmacodynamics of Refanezumab in Patients with Stroke, NCT00833989
Logs and Repeats
- StudyEvent: ODM
Beskrivning
Date of visit/assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Beskrivning
AE/Concomitant medication/Repeat an assessment check question
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C0205341
- UMLS CUI-4
- C0220825
Beskrivning
Concomitant medications during the study
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beskrivning
Non serious AE during the study
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beskrivning
SAE during the study
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Beskrivning
Repeat ECG
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beskrivning
Repeat vital signs
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beskrivning
Repeat PK blood sample
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205341
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005767
Beskrivning
Liver event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beskrivning
If Yes to Liver Events, go to the LE DETAILS visit and complete the Liver Event forms
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0023884
- UMLS CUI [1,2]
- C0022885
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C2746065
- UMLS CUI [1,5]
- C0243161
Similar models
Logs and Repeats
- StudyEvent: ODM
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C0205341 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,3])
C0022885 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2746065 (UMLS CUI [1,4])
C0243161 (UMLS CUI [1,5])