ID
38187
Descrição
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
Palavras-chave
Versões (1)
- 25/09/2019 25/09/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
25 de setembro de 2019
DOI
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Licença
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
Descrição
Dosing Date and Time
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C0011008
- UMLS CUI-4
- C0040223
Descrição
Height and Weight
Alias
- UMLS CUI-1
- C0005890
- UMLS CUI-2
- C0005910
Descrição
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descrição
For repeat measurements only.
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C2348184
Descrição
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 dados
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0574032
Descrição
day month year
Tipo de dados
date
Alias
- UMLS CUI [1]
- C0011008
Descrição
00:00-23:59
Tipo de dados
time
Alias
- UMLS CUI [1]
- C0040223
Descrição
Vitals to be taken in supine position.
Tipo de dados
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Descrição
Vitals to be taken in supine position.
Tipo de dados
integer
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Descrição
Vitals to be taken in supine position.
Tipo de dados
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])