ID
38113
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 Study conclusion Form. It has to be filled in for the end of study.
Link
https://clinicaltrials.gov/ct2/show/NCT00833989
Trefwoorden
Versies (2)
- 18-09-19 18-09-19 -
- 05-10-19 05-10-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
18 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, 111539
Study conclusion
- StudyEvent: ODM
Beschrijving
Status of treatment blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beschrijving
If you tick yes, complete the following items and the Adverse Event form and/or Investigational Product forms as appropriate.
Datatype
text
Alias
- UMLS CUI [1]
- C3897431
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Beschrijving
00:00-23:59
Datatype
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0040223
Beschrijving
Reason blind broken
Datatype
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0566251
Beschrijving
Other Reason, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [1,3]
- C2348235
Beschrijving
Investigational Product discontinuation
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C0457454
Beschrijving
If you tick yes, please complete in the following item the primary reason.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0444930
- UMLS CUI [1,2]
- C0304229
Beschrijving
Item is not required If you tick "Adverse Event", please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate
Datatype
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0444930
- UMLS CUI [1,3]
- C0304229
Beschrijving
Other reason, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C3840932
- UMLS CUI [1,2]
- C0444930
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [1,4]
- C2348235
Beschrijving
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
Beschrijving
If you tick yes, please complete details in the following items.
Datatype
text
Alias
- UMLS CUI [1]
- C2349954
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0011008
Beschrijving
If you tick " Adverse Event", record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate.
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
Beschrijving
Withdrawal, Investigator discretion, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0008961
- UMLS CUI [1,4]
- C0022423
- UMLS CUI [1,5]
- C0008961
Beschrijving
Death
Alias
- UMLS CUI-1
- C0011065
Beschrijving
If you tick no, please enter the date of death and the primary cause of death in the following items.
Datatype
text
Alias
- UMLS CUI [1,1]
- C2584946
- UMLS CUI [1,2]
- C2348568
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
For both causes, please specify in the following item.
Datatype
integer
Alias
- UMLS CUI [1]
- C0007465
Beschrijving
Cause of death, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0007465
Beschrijving
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
This is an optional form but is conditional upon females in the trial; This form will be dynamically generated to appear at the End visit if Female is selected on the Demographics form. If Yes, complete the paper Pregnancy Notification form.
Datatype
text
Alias
- UMLS CUI [1]
- C3828490
Beschrijving
This is an optional form, but is conditional upon males in the trial. This form will be dynamically generated if the male is selected on the Demography form. If Yes, complete the paper Pregnancy Notification form. Check "Not Applicable" if female partner not of childbearing potential or no female partner.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0086287
- UMLS CUI [1,2]
- C3887537
- UMLS CUI [1,3]
- C3828490
Similar models
Study conclusion
- StudyEvent: ODM
C2347038 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0457454 (UMLS CUI-2)
C0304229 (UMLS CUI [1,2])
C0444930 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0444930 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,3])
C0022423 (UMLS CUI [1,4])
C0008961 (UMLS CUI [1,5])
C0007465 (UMLS CUI [1,2])
C3887537 (UMLS CUI [1,2])
C3828490 (UMLS CUI [1,3])