ID
24079
Beskrivning
Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 6
Nyckelord
Versioner (1)
- 2017-07-25 2017-07-25 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
25 juli 2017
DOI
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Licens
Creative Commons BY-NC-ND 3.0
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Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
Beskrivning
Visit Information
Alias
- UMLS CUI-1
- C0545082
Beskrivning
Investigator Instructions
Alias
- UMLS CUI-1
- C1442085
Beskrivning
Subject Continuation
Alias
- UMLS CUI-1
- C0805733
Beskrivning
Subject Continuation
Datatyp
text
Alias
- UMLS CUI [1]
- C0805733
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Weight
Datatyp
float
Måttenheter
- kg
Alias
- UMLS CUI [1]
- C0005910
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
float
Måttenheter
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatyp
float
Måttenheter
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beskrivning
Neurological Examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0027853
Beskrivning
Central Laboratory (Fasting Samples)
Alias
- UMLS CUI-1
- C1880016
Beskrivning
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beskrivning
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beskrivning
Date of ECG
Datatyp
date
Måttenheter
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
[3] abnormal - clinically significant: Complete an Adverse Event (AE) or Serious Adverse Event (SAE) ge(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Datatyp
integer
Alias
- UMLS CUI [1]
- C1623258
Beskrivning
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Adverse Event
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beskrivning
Physical Examination
Datatyp
text
Alias
- UMLS CUI [1]
- C0031809
Beskrivning
Pedal Oedema
Alias
- UMLS CUI-1
- C0574002
Beskrivning
Pedal Oedema: depth
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beskrivning
Pedal Oedema: Site
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C1515974
Beskrivning
The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
Alias
- UMLS CUI-1
- C0681889
Beskrivning
ADAS-COG
Datatyp
text
Alias
- UMLS CUI [1]
- C3539026
Beskrivning
CIBIC-Plus Summary
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C0449820
Beskrivning
Neuropsychiatric Inventory (NPI)
Datatyp
text
Alias
- UMLS CUI [1]
- C3539727
Beskrivning
Investigational Product/ Compliance - Dispense Weeks 25 - 32 study medication as specified by the IVRS system. Record start date, container number and number of tablets dispensed below (stop date and tablets returned will be completed when the bottle is returned).
Alias
- UMLS CUI-1
- C0304229
- UMLS CUI-2
- C1321605
Beskrivning
Investigational Product
Datatyp
text
Alias
- UMLS CUI [1]
- C0304229
Beskrivning
Start Date
Datatyp
date
Måttenheter
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C0808070
Beskrivning
Stop Date
Datatyp
date
Måttenheter
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C0806020
Beskrivning
Dose
Datatyp
integer
Måttenheter
- mg
Beskrivning
IP Container Number
Datatyp
text
Alias
- UMLS CUI [1]
- C0180098
Beskrivning
Total number of Tablets Dispensed
Datatyp
float
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Beskrivning
Total number of Tablets Returned
Datatyp
float
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Beskrivning
Discontinuation
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0457454
Beskrivning
End of Visit Reminder
Alias
- UMLS CUI-1
- C1709896
- UMLS CUI-2
- C1320303
Similar models
Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
C1442085 (UMLS CUI-2)
C1442085 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,2])
C1321605 (UMLS CUI-2)
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C1320303 (UMLS CUI [1,2])