ID
25883
Beschreibung
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.
Stichworte
Versionen (3)
- 21.09.17 21.09.17 -
- 21.09.17 21.09.17 -
- 25.09.17 25.09.17 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
25. September 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Visit 6-8 plus Follow-up
Visit 6-8 plus Follow-up
- StudyEvent: ODM
Beschreibung
Visit 7
Alias
- UMLS CUI-1
- C0545082
Beschreibung
Subject Identifier
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Visit Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1320303
Beschreibung
Subject Continuation
Datentyp
text
Alias
- UMLS CUI [1]
- C0805733
Beschreibung
Weight
Datentyp
float
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Central Laboratory (fasting samples)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0015663
Beschreibung
Collection Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1317250
Beschreibung
Concomitant Medications
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Adverse Events
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschreibung
Pedal edema
Datentyp
integer
Alias
- UMLS CUI [1]
- C0574002
Beschreibung
ADAS-cog CIBIC+ NPI DAD
Datentyp
text
Alias
- UMLS CUI [1]
- C0681889
Beschreibung
Alzheimer Disease Assessment Scale
Datentyp
text
Alias
- UMLS CUI [1]
- C0450989
Beschreibung
Clinician Interview-Based Impression of Change
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641327
Beschreibung
NPI
Datentyp
text
Alias
- UMLS CUI [1]
- C3539727
Beschreibung
Disability Assessment for Dementia Questionnaire
Datentyp
text
Alias
- UMLS CUI [1]
- C3641946
Beschreibung
Monitor Data Validation Checks
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519941
- UMLS CUI [1,2]
- C0030695
Beschreibung
Investigator Instructions
Datentyp
text
Alias
- UMLS CUI [1]
- C1442085
Beschreibung
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).
Datentyp
text
Alias
- UMLS CUI [1]
- C0304229
Beschreibung
Investigational Product
Datentyp
text
Alias
- UMLS CUI [1]
- C0304229
Beschreibung
Investigational Product
Datentyp
text
Alias
- UMLS CUI [1]
- C0304229
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beschreibung
Start Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0304229
Beschreibung
Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beschreibung
Stop Date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0304229
Beschreibung
IP Container Number
Datentyp
text
Alias
- UMLS CUI [1]
- C0180098
Beschreibung
IP Container Number
Datentyp
text
Alias
- UMLS CUI [1]
- C0180098
Beschreibung
Compliance
Datentyp
text
Alias
- UMLS CUI [1]
- C1321605
Beschreibung
Total number of Tablets Dispensed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Beschreibung
Total number of Tablets Dispensed
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Beschreibung
Total number of Tablets Returned
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Beschreibung
Total number of Tablets Returned
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Beschreibung
Discontinuation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457454
Beschreibung
End of Visit Reminder
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1709896
- UMLS CUI [1,2]
- C2827036
Beschreibung
Visit 8
Alias
- UMLS CUI-1
- C0545082
Beschreibung
Investigator Instructions
Datentyp
text
Alias
- UMLS CUI [1]
- C1442085
Beschreibung
Subject Identifier
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Visit Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1320303
Beschreibung
Weight
Datentyp
float
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Neurological Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0027853
Beschreibung
Gait assessment
Datentyp
text
Alias
- UMLS CUI [1]
- C2459822
Beschreibung
Balance assessment
Datentyp
text
Alias
- UMLS CUI [1]
- C0560184
Beschreibung
Coordination
Datentyp
text
Alias
- UMLS CUI [1]
- C0242414
Beschreibung
Cranial nerves
Datentyp
text
Alias
- UMLS CUI [1]
- C0010268
Beschreibung
Motor system
Datentyp
text
Alias
- UMLS CUI [1]
- C0026606
Beschreibung
Sensory system
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0682648
- UMLS CUI [1,2]
- C0031809
Beschreibung
Central Laboratory ( fasting samples)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0015663
Beschreibung
Collection Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1317250
Beschreibung
If subject is female and of childbearing potential a serum pregnancy test must be performed.
Datentyp
text
Alias
- UMLS CUI [1]
- C0032976
Beschreibung
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.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C2347501
Beschreibung
Blood sample collection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Time and date of blood sampling
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0178913
Beschreibung
Blood sample collection
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0005834
Beschreibung
Time and date of blood sampling
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0178913
Beschreibung
(only one aliquot volume required since all are equal)
Datentyp
float
Maßeinheiten
- mL
Alias
- UMLS CUI [1]
- C2700258
Beschreibung
Centrifugation time
Datentyp
integer
Maßeinheiten
- minutes
Alias
- UMLS CUI [1,1]
- C0179834
- UMLS CUI [1,2]
- C0040223
Beschreibung
Centrifuge temperature
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0039476
- UMLS CUI [1,2]
- C0179834
Beschreibung
Centrifugation speed
Datentyp
integer
Maßeinheiten
- r.p.m
Alias
- UMLS CUI [1,1]
- C0678536
- UMLS CUI [1,2]
- C0179834
Beschreibung
Centrifuge rotor radius
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2720577
- UMLS CUI [1,2]
- C1306504
Beschreibung
Time in freezer
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0175738
- UMLS CUI [1,2]
- C0040223
Beschreibung
Temperature of freezer
Datentyp
integer
Maßeinheiten
- -°C
Alias
- UMLS CUI [1]
- C2957069
Beschreibung
Date of 12 lead ECG
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C2584899
Beschreibung
ECG result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beschreibung
ECG result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0456984
Beschreibung
Concomitant Medications
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Adverse Events
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschreibung
Pedal edema
Datentyp
integer
Alias
- UMLS CUI [1]
- C0574002
Beschreibung
ADAS-cog CIBIC+ NPI DAD
Datentyp
text
Alias
- UMLS CUI [1]
- C0681889
Beschreibung
Alzheimer Disease Assessment Scale
Datentyp
text
Alias
- UMLS CUI [1]
- C0450989
Beschreibung
Clinician Interview-Based Impression of Change
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3641327
Beschreibung
NPI
Datentyp
text
Alias
- UMLS CUI [1]
- C3539727
Beschreibung
Disability Assessment for Dementia Questionnaire
Datentyp
text
Alias
- UMLS CUI [1]
- C3641946
Beschreibung
Investigational Product Compliance
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1321605
Beschreibung
End of Visit Reminder
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1709896
- UMLS CUI [1,2]
- C2827036
Beschreibung
Study End Follow-up
Alias
- UMLS CUI-1
- C2827036
- UMLS CUI-2
- C3274571
Beschreibung
Investigator Instructions
Datentyp
text
Alias
- UMLS CUI [1]
- C1442085
Beschreibung
Subject Identifier
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348585
Beschreibung
Visit Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1320303
Beschreibung
Weight
Datentyp
float
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datentyp
integer
Maßeinheiten
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Central Laboratory (Non fasting samples)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2585491
Beschreibung
Collection Date
Datentyp
date
Alias
- UMLS CUI [1]
- C1317250
Beschreibung
Concomitant Medications
Datentyp
text
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Adverse Events
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the NonSerious Adverse Events page.
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschreibung
Pedal edema
Datentyp
integer
Alias
- UMLS CUI [1]
- C0574002
Ähnliche Modelle
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])