ID
38343
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 Investigational Product - IV Dosing and the Randomisation form. It has to be filled in for Day 1 and Week 2.
Länk
https://clinicaltrials.gov/ct2/show/NCT00833989
Nyckelord
Versioner (2)
- 2019-09-25 2019-09-25 -
- 2019-10-11 2019-10-11 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
11 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
Investigational Product Dosing, Randomisation
- StudyEvent: ODM
Beskrivning
Randomisation
Alias
- UMLS CUI-1
- C0034656
Beskrivning
If you tick yes, please fill in the Number and the Date of Randomisation in the following items.
Datatyp
text
Alias
- UMLS CUI [1]
- C0034656
Beskrivning
Randomisation number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Beskrivning
Investigational Product - IV Dosing
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0178602
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beskrivning
00:00-23:59 Time is optional
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0304229
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beskrivning
00:00-23:59 Time is optional
Datatyp
time
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0304229
Beskrivning
Investigational product container number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0180098
- UMLS CUI [1,3]
- C0600091
Beskrivning
If you tick yes, please select appropriate reason in the following item.
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1512900
Beskrivning
Reason for dose interruption
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1512900
- UMLS CUI [1,3]
- C0566251
Beskrivning
Other reason for dose interruption, specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C1512900
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0566251
- UMLS CUI [1,5]
- C2348235
Beskrivning
Total volume of infusion
Datatyp
float
Måttenheter
- ml
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C2700258
Similar models
Investigational Product Dosing, Randomisation
- StudyEvent: ODM
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0178602 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,2])
C1512900 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,3])
C1512900 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0566251 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
C2700258 (UMLS CUI [1,2])