ID
38187
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 Vital Signs form. It has to be filled in for: Day 1, Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, early withdrawal, if necessary as unscheduled form as well as for logs/repeats.
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
Vital Signs
- StudyEvent: ODM
Descripción
Dosing Date and Time
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C0011008
- UMLS CUI-4
- C0040223
Descripción
Height and Weight
Alias
- UMLS CUI-1
- C0005890
- UMLS CUI-2
- C0005910
Descripción
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descripción
For repeat measurements only.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C2348184
Descripción
Note: Time "0 min" is Immediately prior to start of infusion; Time "1 hr" is immediately after infusion has stopped. Day 1 and Week 2 only; up until 1 hour post start of infusion all times for both visits, on Day 1 additionally at 2, 4, 8, 12 and 24 hours post start of infusion, in Week 2 only the 3 hours measurement in addition
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0574032
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0011008
Descripción
00:00-23:59
Tipo de datos
time
Alias
- UMLS CUI [1]
- C0040223
Descripción
Vitals to be taken in supine position.
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Descripción
Vitals to be taken in supine position.
Tipo de datos
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Descripción
Vitals to be taken in supine position.
Tipo de datos
integer
Unidades de medida
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Similar models
Vital Signs
- StudyEvent: ODM
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0574032 (UMLS CUI [1,2])