ID
38190
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 current stroke status form. It has to be filled in for Day 1.
Länk
https://clinicaltrials.gov/ct2/show/NCT00833989
Nyckelord
Versioner (1)
- 2019-09-25 2019-09-25 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
25 september 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
Current stroke status
- StudyEvent: ODM
Beskrivning
Current Stroke
Alias
- UMLS CUI-1
- C0038454
- UMLS CUI-2
- C0521116
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0011008
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0040223
Beskrivning
Sitting Balance
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0277814
- UMLS CUI [1,2]
- C0560184
Beskrivning
Check all that apply for current stroke intervention
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0348016
- UMLS CUI [2,2]
- C0032144
Beskrivning
Check all that apply for current stroke intervention
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0694634
- UMLS CUI [2,2]
- C0032144
Beskrivning
Check all that apply for current stroke intervention
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0190484
- UMLS CUI [2,2]
- C0443254
- UMLS CUI [2,3]
- C0995127
Beskrivning
Check all that apply for current stroke intervention
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0190484
- UMLS CUI [2,2]
- C0349707
- UMLS CUI [2,3]
- C0995127
Beskrivning
Check all that apply for current stroke intervention
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0035124
Beskrivning
Other Reperfusion Therapy Type, Specification
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0035124
- UMLS CUI [1,3]
- C2348235
Beskrivning
Check all that apply for current stroke intervention
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2]
- C0746919
Beskrivning
Current Stroke Risk Factors
Alias
- UMLS CUI-1
- C0038454
- UMLS CUI-2
- C0521116
- UMLS CUI-3
- C0035648
Beskrivning
Previous stroke(s)
Datatyp
text
Alias
- UMLS CUI [1]
- C0559159
Beskrivning
Previous transient ischemic attack(s)
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205156
- UMLS CUI [1,2]
- C0007787
Beskrivning
Atrial fibrilation
Datatyp
text
Alias
- UMLS CUI [1]
- C0004238
Beskrivning
Hypertension
Datatyp
text
Alias
- UMLS CUI [1]
- C0020538
Beskrivning
Diabetes
Datatyp
text
Alias
- UMLS CUI [1]
- C0011849
Beskrivning
Hypercholesterolemia
Datatyp
text
Alias
- UMLS CUI [1]
- C0020443
Beskrivning
(cigarette smoker only)
Datatyp
text
Alias
- UMLS CUI [1]
- C0337667
Beskrivning
( >2 drinks/ day)
Datatyp
text
Alias
- UMLS CUI [1]
- C0001948
Beskrivning
Previous myocardial infarction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205156
- UMLS CUI [1,2]
- C0027051
Similar models
Current stroke status
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0560184 (UMLS CUI [1,2])
C0348016 (UMLS CUI [2,1])
C0032144 (UMLS CUI [2,2])
C0694634 (UMLS CUI [2,1])
C0032144 (UMLS CUI [2,2])
C0190484 (UMLS CUI [2,1])
C0443254 (UMLS CUI [2,2])
C0995127 (UMLS CUI [2,3])
C0190484 (UMLS CUI [2,1])
C0349707 (UMLS CUI [2,2])
C0995127 (UMLS CUI [2,3])
C0035124 (UMLS CUI [1,2])
C0035124 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0746919 (UMLS CUI [2])
C0521116 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0007787 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,2])