ID

17574

Description

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)

Mots-clés

  1. 11/09/2016 11/09/2016 -
  2. 25/09/2016 25/09/2016 -
Téléchargé le

25 septembre 2016

DOI

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Licence

Creative Commons BY-NC-ND 3.0

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REFELCT-1 Visit 6 NCT00428090

REFLECT-1 Visit 6 NCT00428090

Patient Information
Description

Patient Information

Alias
UMLS CUI-1
C1955348
Subject Identifier
Description

Patient Study ID

Type de données

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Type de données

date

Unités de mesure
  • dd/MMM/yy
Alias
UMLS CUI [1]
C1320303
dd/MMM/yy
Central Laboratory Instructions
Description

Central Laboratory Instructions

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C1442085
Laboratory samples are to be collected when the subject is the fasting state (No food or dring (except water) for at least 8 hours prior to sampling). If the subject is not in the fasted state, do not take samples. Schedule the subject to attend the clinical in the fasted state within the next 5 days for collection for laboratory samples.
Description

Central Laboratory Instructions

Type de données

text

Alias
UMLS CUI [1,1]
C1880016
UMLS CUI [1,2]
C1442085
Investigator Instructions
Description

Investigator Instructions

Alias
UMLS CUI-1
C1442085
Telephone the IVRS system to register the visit. (Note that if the subject is not continuiing in the study, you should make a Withdrawal call rather than a Visit Registration call). Review study medication compliance.
Description

Investigator Instructions

Type de données

text

Alias
UMLS CUI [1]
C1442085
Subject Continuation
Description

Subject Continuation

Alias
UMLS CUI-1
C0805733
If the subject is not continuing in the study, complete all assessments for this visit, ans also the Early Withdrawal ADAS-cog and CIBIC+ assessments in the Assessment Scale and CIBIC+ folders. The ADAS-cog and CIBIC+ results should then be recorded on the pages at the end of this visit. Esnure that all sections of the CRF (including the Study Conclusion page) are completed appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit. Make a Withdrawal call to the IVRS system.
Description

Subject Continuation

Type de données

text

Alias
UMLS CUI [1]
C0805733
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Systolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Description

Systolic Blood Pressure

Type de données

float

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Description

Diastolic Blood Pressure

Type de données

float

Unités de mesure
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Patient Position: Sitting. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Description

Patient Position

Type de données

boolean

Alias
UMLS CUI [1]
C0449850
Heart rate. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
Description

Heart Rate

Type de données

float

Unités de mesure
  • Beats/Min
Alias
UMLS CUI [1]
C0018810
Beats/Min
Neurologic Examination
Description

Neurologic Examination

Alias
UMLS CUI-1
C0027853
Perform a Neurologic examination on hte subject, including assessment of gait balance, coordination, cranial nerves and mtor and sensory systems. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the No-Serious Adverse Events page.
Description

Neurologic Examination

Type de données

text

Alias
UMLS CUI [1]
C0027853
Central Laboratory (Non Fasting Samples)
Description

Central Laboratory (Non Fasting Samples)

Alias
UMLS CUI-1
C1880016
Dates sample taken
Description

Dates sample taken

Type de données

date

Unités de mesure
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0460065
dd/MMM/yy
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
If Subject is female and of childbearing potential a serum pregnancy test must be performed.
Description

Pregnancy Test

Type de données

text

Alias
UMLS CUI [1]
C0032976
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
Date of ECG
Description

Date of ECG

Type de données

date

Unités de mesure
  • dd/MMM/yy
Alias
UMLS CUI [1]
C2826640
dd/MMM/yy
Result of the ECG
Description

Result of the ECG

Type de données

text

Alias
UMLS CUI [1]
C0438154
Concomitant Medication
Description

Concomitant Medication

Alias
UMLS CUI-1
C2347852
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the apporpriate Concomitant Medications sections.
Description

Concomitant medication

Type de données

text

Alias
UMLS CUI [1]
C2347852
Adverse Event
Description

Adverse Event

Alias
UMLS CUI-1
C0877248
Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
Description

Adverse Event

Type de données

text

Alias
UMLS CUI [1]
C0877248
Physical Examination
Description

Physical Examination

Alias
UMLS CUI-1
C0031809
Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.
Description

Physical Examination

Type de données

text

Alias
UMLS CUI [1]
C0031809
Pedal Oedema
Description

Pedal Oedema

Alias
UMLS CUI-1
C0574002
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 thoughout the study. Tick one:
Description

Pedal Oedema: depth

Type de données

text

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0205125
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 thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
Description

Pedal Oedema: Site

Type de données

text

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C1515974
Rating Scale Instrucitions - The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
Description

Rating Scale Instrucitions - The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD

Alias
UMLS CUI-1
C0681889
ADAS-cog Summary
Description

ADAS-cog Summary

Type de données

text

Alias
UMLS CUI [1]
C3539026
CIBIC-Plus Summary
Description

CIBIC-Plus Summary

Type de données

text

Neuropsychiatric Inventory (NPI)
Description

Neuropsychiatric Inventory (NPI)

Type de données

text

Alias
UMLS CUI [1]
C3539727
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).
Description

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
Investigational Product (e.g Bottle 1)
Description

Investigational Product

Type de données

text

Alias
UMLS CUI [1]
C0304229
Start Date
Description

Start Date

Type de données

date

Unités de mesure
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0808070
dd/MMM/yy
Stop Date
Description

Stop Date

Type de données

date

Unités de mesure
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0806020
dd/MMM/yy
Dose
Description

Dose

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1]
C3174092
mg
IP Container No.
Description

IP Container No.

Type de données

float

Alias
UMLS CUI [1]
C0180098
Has the subject missed investigational product for > 7 consecutive days?
Description

Discontinuation

Type de données

boolean

Alias
UMLS CUI [1]
C0457454
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).
Description

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
Total number of Tablets Dispensed
Description

Total number of Tablets Dispensed

Type de données

float

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Total number of Tablets Returned
Description

Total number of Tablets Returned

Type de données

float

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
End of Visit Reminder
Description

End of Visit Reminder

Alias
UMLS CUI-1
C1709896
UMLS CUI-2
C1320303
Schedule Visit 7 for 8 weeeks (+- 3 days) after this visit. It is not necessary for the subject to be fasted.
Description

End of Visit Reminder

Type de données

text

Alias
UMLS CUI [1,1]
C1709896
UMLS CUI [1,2]
C1320303

Similar models

REFLECT-1 Visit 6 NCT00428090

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Study ID
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Central Laboratory Instructions
C1880016 (UMLS CUI-1)
C1442085 (UMLS CUI-2)
Central Laboratory Instructions
Item
Laboratory samples are to be collected when the subject is the fasting state (No food or dring (except water) for at least 8 hours prior to sampling). If the subject is not in the fasted state, do not take samples. Schedule the subject to attend the clinical in the fasted state within the next 5 days for collection for laboratory samples.
text
C1880016 (UMLS CUI [1,1])
C1442085 (UMLS CUI [1,2])
Item Group
Investigator Instructions
C1442085 (UMLS CUI-1)
Investigator Instructions
Item
Telephone the IVRS system to register the visit. (Note that if the subject is not continuiing in the study, you should make a Withdrawal call rather than a Visit Registration call). Review study medication compliance.
text
C1442085 (UMLS CUI [1])
Item Group
Subject Continuation
C0805733 (UMLS CUI-1)
Subject Continuation
Item
If the subject is not continuing in the study, complete all assessments for this visit, ans also the Early Withdrawal ADAS-cog and CIBIC+ assessments in the Assessment Scale and CIBIC+ folders. The ADAS-cog and CIBIC+ results should then be recorded on the pages at the end of this visit. Esnure that all sections of the CRF (including the Study Conclusion page) are completed appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit. Make a Withdrawal call to the IVRS system.
text
C0805733 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0428883 (UMLS CUI [1])
Patient Position
Item
Patient Position: Sitting. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
boolean
C0449850 (UMLS CUI [1])
Heart Rate
Item
Heart rate. Blood Pressure and heart rate will be measured once, after the subject sits queitly for at least 5 minutes.
float
C0018810 (UMLS CUI [1])
Item Group
Neurologic Examination
C0027853 (UMLS CUI-1)
Neurologic Examination
Item
Perform a Neurologic examination on hte subject, including assessment of gait balance, coordination, cranial nerves and mtor and sensory systems. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the No-Serious Adverse Events page.
text
C0027853 (UMLS CUI [1])
Item Group
Central Laboratory (Non Fasting Samples)
C1880016 (UMLS CUI-1)
Dates sample taken
Item
Dates sample taken
date
C0460065 (UMLS CUI [1])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Pregnancy Test
Item
If Subject is female and of childbearing potential a serum pregnancy test must be performed.
text
C0032976 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (Normal)
CL Item
Abnormal - not clinically significant (Abnormal - not clinically significant)
CL Item
Abnormal - clinically significant (--> Complete an Adverse Event (AE) or Serious Adverse Event (SAE) page8s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. (Abnormal - clinically significant (--> Complete an Adverse Event (AE) or Serious Adverse Event (SAE) page8s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.)
Item Group
Concomitant Medication
C2347852 (UMLS CUI-1)
Concomitant medication
Item
Record any changes to the subject's concomitant medications or any new medications taken since the last visit in the apporpriate Concomitant Medications sections.
text
C2347852 (UMLS CUI [1])
Item Group
Adverse Event
C0877248 (UMLS CUI-1)
Adverse Event
Item
Record details of any new non-serious adverse events/serious adverse events observed or reported by the subject or any changes to ongoing non-serious adverse events in the appropriate Non-Serious Adverse Events/ Serious Adverse Events section.
text
C0877248 (UMLS CUI [1])
Item Group
Physical Examination
C0031809 (UMLS CUI-1)
Physical Examination
Item
Perform a physical examination on the subject, including auscultation of heart and lungs. Note: If any abnormalities are found as a result of the physical examination, these must be recorded on the Non-Serious Adverse Events page.
text
C0031809 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Pedal Oedema: depth
Item
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 thoughout the study. Tick one:
text
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Item
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 thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
text
C0574002 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
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 thoughout the study. Tick the appropriate box below to indicate which ankle was assessed at this visit:
CL Item
Right Ankle (Right Ankle)
CL Item
Left Ankle (Left Ankle)
Item Group
Rating Scale Instrucitions - The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
C0681889 (UMLS CUI-1)
ADAS-cog Summary
Item
ADAS-cog Summary
text
C3539026 (UMLS CUI [1])
CIBIC-Plus Summary
Item
CIBIC-Plus Summary
text
Neuropsychiatric Inventory (NPI)
Item
Neuropsychiatric Inventory (NPI)
text
C3539727 (UMLS CUI [1])
Item Group
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).
C0304229 (UMLS CUI-1)
Investigational Product
Item
Investigational Product (e.g Bottle 1)
text
C0304229 (UMLS CUI [1])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Dose
Item
Dose
float
C3174092 (UMLS CUI [1])
IP Container No.
Item
IP Container No.
float
C0180098 (UMLS CUI [1])
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
Item Group
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).
C1321605 (UMLS CUI-1)
Total number of Tablets Dispensed
Item
Total number of Tablets Dispensed
float
C0805077 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Total number of Tablets Returned
Item
Total number of Tablets Returned
float
C2699071 (UMLS CUI [1,1])
C0039225 (UMLS CUI [1,2])
Item Group
End of Visit Reminder
C1709896 (UMLS CUI-1)
C1320303 (UMLS CUI-2)
End of Visit Reminder
Item
Schedule Visit 7 for 8 weeeks (+- 3 days) after this visit. It is not necessary for the subject to be fasted.
text
C1709896 (UMLS CUI [1,1])
C1320303 (UMLS CUI [1,2])

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