ID
17387
Beschreibung
NCT00428090 / GSK-AVA105640 A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer’s disease. (REFLECT-1) Schedule Visit 6 for 8 weks (+- 3 days) Visit 4, in the morning, and remind the subject to attend in the fasted state (no food or dring (except water) for at least 8 hours prior to the visit.
Stichworte
Versionen (2)
- 11.09.16 11.09.16 -
- 25.09.16 25.09.16 -
Hochgeladen am
11. September 2016
DOI
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Lizenz
Creative Commons BY-NC-ND 3.0
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GSK Visit 6 NCT00428090
GSK Visit 6 NCT00428090
- StudyEvent: ODM
Beschreibung
Central Laboratory Instructions
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C1442085
Beschreibung
Central Laboratory Instructions
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C1442085
Beschreibung
Investigator Instructions
Alias
- UMLS CUI-1
- C1442085
Beschreibung
Subject Continuation
Alias
- UMLS CUI-1
- C0805733
Beschreibung
Subject Continuation
Datentyp
text
Alias
- UMLS CUI [1]
- C0805733
Beschreibung
Vital signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Systolic Blood Pressure
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic Blood Pressure
Datentyp
float
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Patient Position
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0449850
Beschreibung
Heart Rate
Datentyp
float
Maßeinheiten
- Beats/Min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Neurologic Examination
Alias
- UMLS CUI-1
- C0027853
Beschreibung
Neurologic Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0027853
Beschreibung
Central Laboratory (Non Fasting Samples)
Alias
- UMLS CUI-1
- C1880016
Beschreibung
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Beschreibung
Adverse Event
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Physical Examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Pedal Oedema
Alias
- UMLS CUI-1
- C0574002
Beschreibung
Pedal Oedema: depth
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschreibung
Pedal Oedema: Site
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C1515974
Beschreibung
Rating Scale Instrucitions - The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
Alias
- UMLS CUI-1
- C0681889
Beschreibung
Investigational Product - 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
Beschreibung
Investigational Product
Datentyp
text
Alias
- UMLS CUI [1]
- C0304229
Beschreibung
Start Date
Datentyp
date
Maßeinheiten
- dd/MMM/yy
Alias
- UMLS CUI [1]
- C0808070
Beschreibung
Stop Date
Datentyp
date
Maßeinheiten
- dd/MMM/yy
Alias
- UMLS CUI [1]
- C0806020
Beschreibung
Dose
Datentyp
float
Maßeinheiten
- mg
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
IP Container No.
Datentyp
float
Alias
- UMLS CUI [1]
- C0180098
Beschreibung
Discontinuation
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457454
Beschreibung
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
- C1321605
Ähnliche Modelle
GSK Visit 6 NCT00428090
- StudyEvent: ODM
C1442085 (UMLS CUI-2)
C1442085 (UMLS CUI [1,2])
C0205125 (UMLS CUI [1,2])
C1515974 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,2])