ID
38190
Descripción
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
Palabras clave
Versiones (1)
- 25/9/19 25/9/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
25 de septiembre de 2019
DOI
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Licencia
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
Descripción
Current Stroke
Alias
- UMLS CUI-1
- C0038454
- UMLS CUI-2
- C0521116
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0011008
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1,1]
- C0038454
- UMLS CUI [1,2]
- C0040223
Descripción
Sitting Balance
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0277814
- UMLS CUI [1,2]
- C0560184
Descripción
Check all that apply for current stroke intervention
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0348016
- UMLS CUI [2,2]
- C0032144
Descripción
Check all that apply for current stroke intervention
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0694634
- UMLS CUI [2,2]
- C0032144
Descripción
Check all that apply for current stroke intervention
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0190484
- UMLS CUI [2,2]
- C0443254
- UMLS CUI [2,3]
- C0995127
Descripción
Check all that apply for current stroke intervention
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2,1]
- C0190484
- UMLS CUI [2,2]
- C0349707
- UMLS CUI [2,3]
- C0995127
Descripción
Check all that apply for current stroke intervention
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0035124
Descripción
Other Reperfusion Therapy Type, Specification
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0035124
- UMLS CUI [1,3]
- C2348235
Descripción
Check all that apply for current stroke intervention
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0035124
- UMLS CUI [2]
- C0746919
Descripción
Current Stroke Risk Factors
Alias
- UMLS CUI-1
- C0038454
- UMLS CUI-2
- C0521116
- UMLS CUI-3
- C0035648
Descripción
Previous stroke(s)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0559159
Descripción
Previous transient ischemic attack(s)
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0205156
- UMLS CUI [1,2]
- C0007787
Descripción
Atrial fibrilation
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0004238
Descripción
Hypertension
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0020538
Descripción
Diabetes
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0011849
Descripción
Hypercholesterolemia
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0020443
Descripción
(cigarette smoker only)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0337667
Descripción
( >2 drinks/ day)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0001948
Descripción
Previous myocardial infarction
Tipo de datos
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])