ID
38187
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 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
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
Vital Signs
- StudyEvent: ODM
Beschrijving
Dosing Date and Time
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0178602
- UMLS CUI-3
- C0011008
- UMLS CUI-4
- C0040223
Beschrijving
Height and Weight
Alias
- UMLS CUI-1
- C0005890
- UMLS CUI-2
- C0005910
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
For repeat measurements only.
Datatype
integer
Alias
- UMLS CUI [1]
- C2348184
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C0574032
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
Beschrijving
Vitals to be taken in supine position.
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Vitals to be taken in supine position.
Datatype
integer
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Vitals to be taken in supine position.
Datatype
integer
Maateenheden
- 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])