ID
25883
Description
A 24 week double-blind, randomised, placebo-controlled, parallel-group dose-ranging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer's disease.
Mots-clés
Versions (3)
- 21/09/2017 21/09/2017 -
- 21/09/2017 21/09/2017 -
- 25/09/2017 25/09/2017 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
25 septembre 2017
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Visit 6-8 plus Follow-up
Visit 6-8 plus Follow-up
- StudyEvent: ODM
Description
Visit 7
Alias
- UMLS CUI-1
- C0545082
Description
Subject Identifier
Type de données
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Visit Date
Type de données
date
Alias
- UMLS CUI [1]
- C1320303
Description
Subject Continuation
Type de données
text
Alias
- UMLS CUI [1]
- C0805733
Description
Weight
Type de données
float
Alias
- UMLS CUI [1]
- C0005910
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Central Laboratory (fasting samples)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0015663
Description
Collection Date
Type de données
date
Alias
- UMLS CUI [1]
- C1317250
Description
Concomitant Medications
Type de données
text
Alias
- UMLS CUI [1]
- C2347852
Description
Adverse Events
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Type de données
text
Alias
- UMLS CUI [1]
- C0031809
Description
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle throughout the study
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Description
Pedal edema
Type de données
integer
Alias
- UMLS CUI [1]
- C0574002
Description
ADAS-cog CIBIC+ NPI DAD
Type de données
text
Alias
- UMLS CUI [1]
- C0681889
Description
Alzheimer Disease Assessment Scale
Type de données
text
Alias
- UMLS CUI [1]
- C0450989
Description
Clinician Interview-Based Impression of Change
Type de données
boolean
Alias
- UMLS CUI [1]
- C3641327
Description
NPI
Type de données
text
Alias
- UMLS CUI [1]
- C3539727
Description
Disability Assessment for Dementia Questionnaire
Type de données
text
Alias
- UMLS CUI [1]
- C3641946
Description
Monitor Data Validation Checks
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519941
- UMLS CUI [1,2]
- C0030695
Description
Investigator Instructions
Type de données
text
Alias
- UMLS CUI [1]
- C1442085
Description
Previous bottle: turn to the lnvestigational Product/Compliance section for the previous visit to record the stop date and number of tablets returned, and to answer the question 'Has the subject missed taking investigation al product for >7 consecutive days?' New bottle: dispense two bottles of study medication as specified by the IVRS system. Record start date (for bottle 5), container numbers and number of tablets dispensed below (start date for bottle 6, stop dates and tablets returned will be completed when the bottle is returned).
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Investigational Product
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Investigational Product
Type de données
text
Alias
- UMLS CUI [1]
- C0304229
Description
Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Description
Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Description
Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Description
Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Description
IP Container Number
Type de données
text
Alias
- UMLS CUI [1]
- C0180098
Description
IP Container Number
Type de données
text
Alias
- UMLS CUI [1]
- C0180098
Description
Compliance
Type de données
text
Alias
- UMLS CUI [1]
- C1321605
Description
Total number of Tablets Dispensed
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Description
Total number of Tablets Dispensed
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Description
Total number of Tablets Returned
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Description
Total number of Tablets Returned
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Description
Discontinuation
Type de données
boolean
Alias
- UMLS CUI [1]
- C0457454
Description
End of Visit Reminder
Type de données
text
Alias
- UMLS CUI [1,1]
- C1709896
- UMLS CUI [1,2]
- C2827036
Description
Visit 8
Alias
- UMLS CUI-1
- C0545082
Description
Investigator Instructions
Type de données
text
Alias
- UMLS CUI [1]
- C1442085
Description
Subject Identifier
Type de données
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Visit Date
Type de données
date
Alias
- UMLS CUI [1]
- C1320303
Description
Weight
Type de données
float
Alias
- UMLS CUI [1]
- C0005910
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Neurological Examination
Type de données
text
Alias
- UMLS CUI [1]
- C0027853
Description
Gait assessment
Type de données
text
Alias
- UMLS CUI [1]
- C2459822
Description
Balance assessment
Type de données
text
Alias
- UMLS CUI [1]
- C0560184
Description
Coordination
Type de données
text
Alias
- UMLS CUI [1]
- C0242414
Description
Cranial nerves
Type de données
text
Alias
- UMLS CUI [1]
- C0010268
Description
Motor system
Type de données
text
Alias
- UMLS CUI [1]
- C0026606
Description
Sensory system
Type de données
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0031809
Description
Central Laboratory ( fasting samples)
Type de données
text
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0015663
Description
Collection Date
Type de données
date
Alias
- UMLS CUI [1]
- C1317250
Description
If subject is female and of childbearing potential a serum pregnancy test must be performed.
Type de données
text
Alias
- UMLS CUI [1]
- C0032976
Description
Check whether informed consent for pharmacogenetic and pharmacogenomic research was obtained for this subject. Only for those subjects for whom consent was obtained, take blood samples for pharmacogenomic assessments and record the details in the following two sections.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347501
Description
Blood sample collection
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005834
Description
Time and date of blood sampling
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0178913
Description
Blood sample collection
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005834
Description
Time and date of blood sampling
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0178913
Description
(only one aliquot volume required since all are equal)
Type de données
float
Unités de mesure
- mL
Alias
- UMLS CUI [1]
- C2700258
Description
Centrifugation time
Type de données
integer
Unités de mesure
- minutes
Alias
- UMLS CUI [1,1]
- C0179834
- UMLS CUI [1,2]
- C0040223
Description
Centrifuge temperature
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0039476
- UMLS CUI [1,2]
- C0179834
Description
Centrifugation speed
Type de données
integer
Unités de mesure
- r.p.m
Alias
- UMLS CUI [1,1]
- C0678536
- UMLS CUI [1,2]
- C0179834
Description
Centrifuge rotor radius
Type de données
integer
Alias
- UMLS CUI [1,1]
- C2720577
- UMLS CUI [1,2]
- C1306504
Description
Time in freezer
Type de données
time
Alias
- UMLS CUI [1,1]
- C0175738
- UMLS CUI [1,2]
- C0040223
Description
Temperature of freezer
Type de données
integer
Unités de mesure
- -°C
Alias
- UMLS CUI [1]
- C2957069
Description
Date of 12 lead ECG
Type de données
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2584899
Description
ECG result
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Description
ECG result
Type de données
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Description
Concomitant Medications
Type de données
text
Alias
- UMLS CUI [1]
- C2347852
Description
Adverse Events
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Type de données
text
Alias
- UMLS CUI [1]
- C0031809
Description
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle throughout the study
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Description
Pedal edema
Type de données
integer
Alias
- UMLS CUI [1]
- C0574002
Description
ADAS-cog CIBIC+ NPI DAD
Type de données
text
Alias
- UMLS CUI [1]
- C0681889
Description
Alzheimer Disease Assessment Scale
Type de données
text
Alias
- UMLS CUI [1]
- C0450989
Description
Clinician Interview-Based Impression of Change
Type de données
boolean
Alias
- UMLS CUI [1]
- C3641327
Description
NPI
Type de données
text
Alias
- UMLS CUI [1]
- C3539727
Description
Disability Assessment for Dementia Questionnaire
Type de données
text
Alias
- UMLS CUI [1]
- C3641946
Description
Investigational Product Compliance
Type de données
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1321605
Description
End of Visit Reminder
Type de données
text
Alias
- UMLS CUI [1,1]
- C1709896
- UMLS CUI [1,2]
- C2827036
Description
Study End Follow-up
Alias
- UMLS CUI-1
- C2827036
- UMLS CUI-2
- C3274571
Description
Investigator Instructions
Type de données
text
Alias
- UMLS CUI [1]
- C1442085
Description
Subject Identifier
Type de données
integer
Alias
- UMLS CUI [1]
- C2348585
Description
Visit Date
Type de données
date
Alias
- UMLS CUI [1]
- C1320303
Description
Weight
Type de données
float
Alias
- UMLS CUI [1]
- C0005910
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
integer
Unités de mesure
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Type de données
integer
Unités de mesure
- bpm
Alias
- UMLS CUI [1]
- C0018810
Description
Central Laboratory (Non fasting samples)
Type de données
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2585491
Description
Collection Date
Type de données
date
Alias
- UMLS CUI [1]
- C1317250
Description
Concomitant Medications
Type de données
text
Alias
- UMLS CUI [1]
- C2347852
Description
Adverse Events
Type de données
text
Alias
- UMLS CUI [1]
- C0877248
Description
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Type de données
text
Alias
- UMLS CUI [1]
- C0031809
Description
Press firmly with thumb anterior to the worst affected ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle throughout the study
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Description
Pedal edema
Type de données
integer
Alias
- UMLS CUI [1]
- C0574002
Similar models
Visit 6-8 plus Follow-up
- StudyEvent: ODM
C2585491 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C0030695 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C2827036 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C0030695 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C2827036 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,2])
C0015663 (UMLS CUI [1,2])
C2347501 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0179834 (UMLS CUI [1,2])
C0179834 (UMLS CUI [1,2])
C1306504 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C2584899 (UMLS CUI [1,2])
C0456984 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,2])
C2827036 (UMLS CUI [1,2])
C2585491 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])