ID
38190
Beschrijving
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Trefwoorden
Versies (1)
- 25-09-19 25-09-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 september 2019
DOI
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Licentie
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
Beschrijving
Current Stroke
Alias
- UMLS CUI-1
- C0038454
- UMLS CUI-2
- C0521116
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0040223
Beschrijving
Sitting Balance
Datatype
text
Alias
- UMLS CUI [1,1]
- C0277814
- UMLS CUI [1,2]
- C0560184
Beschrijving
Check all that apply for current stroke intervention
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0348016
- UMLS CUI [2,2]
- C0032144
Beschrijving
Check all that apply for current stroke intervention
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0694634
- UMLS CUI [2,2]
- C0032144
Beschrijving
Check all that apply for current stroke intervention
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0190484
- UMLS CUI [2,2]
- C0443254
- UMLS CUI [2,3]
- C0995127
Beschrijving
Check all that apply for current stroke intervention
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0190484
- UMLS CUI [2,2]
- C0349707
- UMLS CUI [2,3]
- C0995127
Beschrijving
Check all that apply for current stroke intervention
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0035124
Beschrijving
Other Reperfusion Therapy Type, Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0035124
- UMLS CUI [1,3]
- C2348235
Beschrijving
Check all that apply for current stroke intervention
Datatype
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2]
- C0746919
Beschrijving
Current Stroke Risk Factors
Alias
- UMLS CUI-1
- C0038454
- UMLS CUI-2
- C0521116
- UMLS CUI-3
- C0035648
Beschrijving
Previous stroke(s)
Datatype
text
Alias
- UMLS CUI [1]
- C0559159
Beschrijving
Previous transient ischemic attack(s)
Datatype
text
Alias
- UMLS CUI [1,1]
- C0205156
- UMLS CUI [1,2]
- C0007787
Beschrijving
Atrial fibrilation
Datatype
text
Alias
- UMLS CUI [1]
- C0004238
Beschrijving
Hypertension
Datatype
text
Alias
- UMLS CUI [1]
- C0020538
Beschrijving
Diabetes
Datatype
text
Alias
- UMLS CUI [1]
- C0011849
Beschrijving
Hypercholesterolemia
Datatype
text
Alias
- UMLS CUI [1]
- C0020443
Beschrijving
(cigarette smoker only)
Datatype
text
Alias
- UMLS CUI [1]
- C0337667
Beschrijving
( >2 drinks/ day)
Datatype
text
Alias
- UMLS CUI [1]
- C0001948
Beschrijving
Previous myocardial infarction
Datatype
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])