ID

17575

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)

Stichworte

Versionen (2)
  1. 11.09.16 11.09.16 -
  2. 25.09.16 25.09.16 -
Hochgeladen am

25. September 2016

DOI

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REFLECT-1 Visit 1 NCT00428090

Englisch

REFLECT-1 Visit 1 NCT00428090

1 Formulare  
Patient Information
Beschreibung

Patient Information

Alias
UMLS CUI-1
C1955348
Patient ID
Beschreibung

Patient Study ID

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Maßeinheiten
  • dd/MMM/yy
Alias
UMLS CUI [1]
C1320303
dd/MMM/yy
Previous Clinical Trial Participation
Beschreibung

Previous Clinical Trial Participation

Alias
UMLS CUI-1
C2348568
Did the subject participate in AVA 100 clinical study 193?
Beschreibung

Study Subject Participation Status

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
If "Yes", complete the following: Previous Centre ID
Beschreibung

Previous Centre ID

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
UMLS CUI [1,3]
C0205156
If "Yes", complete the following: Previous Subject Identifie
Beschreibung

Previous Patient Study ID

Datentyp

text

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Eligibility Question
Beschreibung

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria? (If "No", tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do NOT enter the subject into the study if they failed any inclusion or exclusion criteria below.)
Beschreibung

Eligibility Criteria

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria - tick all boxes corresponding to any of any of the inclusion criteria the subject failed.
Beschreibung

Inclusion Criteria - tick all boxes corresponding to any of any of the inclusion criteria the subject failed.

Alias
UMLS CUI-1
C1512693
1. Male or female subject who has successfully completed Visit 8 of AVA 100193 (24 weeks of treatment) without tolerability issues, where in the opinion of the subject and of the investigator, it will be beneficial to continue treatment with RSG XR.
Beschreibung

Completion of previous study and treatment with RSG XR

Datentyp

boolean

Alias
UMLS CUI [1]
C2732579
UMLS CUI [2,1]
C0289313
UMLS CUI [2,2]
C0013216
2. Female subjects must be post-menopausal (i.e. > 6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD), a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures throughout the study and for 30 days after discontinuing study medication. The subject and their caregiver must ensure that the subject will continously use contraceptive measures throughout the duration of the study.
Beschreibung

Gynaecological status

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3]
C0700589
3. Subject is willing to participate in the extention study and has provided full wirtten informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full wirtten informed consent on behalf of the subject has been provided by a legally acceptable representative.
Beschreibung

Informed Consent: Study Participation and Cognitive Status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C2348568
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0945985
4. Caregiver has provided full written informed consent on his or her won behalf prior to the performance of any protocol-specified procedure.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria - tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
Beschreibung

Exclusion Criteria - tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Alias
UMLS CUI-1
C0680251
1. Subject had a serious adverse experience or clinically significant laboratory abnormality during AVA100193, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at the end of AVA100193.
Beschreibung

Adverse Event or laboratory abnormality due to study drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C0304229
2. The subject is felt by the investigator to be unsuitable (on the basis of health, compliance, caregiver availability, or for any other reason) for inclusion in the study.
Beschreibung

Health status, Compliance, Caregiver availability, Other reason

Datentyp

boolean

Alias
UMLS CUI [1]
C0018759
UMLS CUI [2]
C1321605
UMLS CUI [3,1]
C0470187
UMLS CUI [3,2]
C0085537
UMLS CUI [4]
C3840932
3. The subject experienced a significant cardiovascular event during AVA100193 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome (on Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrhythmia), unless a thorough cardiovascular evaluation has been performed which confirms that the subject does not have congestive heart failure, and is clinically stable
Beschreibung

Cardiovascular status

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
4. Treatment with a cholinesterase inhibitor, selegiline, memantine or any other treatment for cognitive symptoms/AD (including but not limited to papaverin, cinnarisin, cerebrolysin) is initiated at the end of AVA100193.
Beschreibung

Concomitant medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
Investiagional Product - dispense the first bottle of study medication (Weeks 1 - 4) 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 at Visit 3).
Beschreibung

Investiagional Product - dispense the first bottle of study medication (Weeks 1 - 4) 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 at Visit 3).

Alias
UMLS CUI-1
C0304229
Investigational Product (e.g Bottle 1)
Beschreibung

Investigational Product

Datentyp

text

Alias
UMLS CUI [1]
C0304229
Start Date
Beschreibung

Start Date

Datentyp

date

Maßeinheiten
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0808070
dd/MMM/yy
Stop Date
Beschreibung

Stop Date

Datentyp

date

Maßeinheiten
  • dd/MMM/yy
Alias
UMLS CUI [1]
C0806020
dd/MMM/yy
Dose
Beschreibung

Dose

Datentyp

float

Maßeinheiten
  • mg
Alias
UMLS CUI [1]
C3174092
mg
IP Container No.
Beschreibung

IP Container No.

Datentyp

float

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

Discontinuation

Datentyp

boolean

Alias
UMLS CUI [1]
C0457454
Compliance - dispense the first bottle of study medication (Weeks 1 - 4) 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 at Visit 3).
Beschreibung

Compliance - dispense the first bottle of study medication (Weeks 1 - 4) 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 at Visit 3).

Alias
UMLS CUI-1
C1321605
Total number of Tablets Dispensed
Beschreibung

Total number of Tablets Dispensed

Datentyp

float

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

Total number of Tablets Returned

Datentyp

float

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

End of Visit Reminder

Alias
UMLS CUI-1
C1709896
UMLS CUI-2
C1320303
Schedule Visit 2 for 14 days (+- 3 days) after this visit. It is not necessary for the subject to be fasted.
Beschreibung

End of Visit Reminder

Datentyp

text

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

REFLECT-1 Visit 1 NCT00428090

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Patient Information
C1955348 (UMLS CUI-1)
Patient Study ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Previous Clinical Trial Participation
C2348568 (UMLS CUI-1)
Study Subject Participation Status
Item
Did the subject participate in AVA 100 clinical study 193?
boolean
C2348568 (UMLS CUI [1])
Previous Centre ID
Item
If "Yes", complete the following: Previous Centre ID
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Previous Patient Study ID
Item
If "Yes", complete the following: Previous Subject Identifie
text
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Eligibility Criteria
Item
Did the subject meet all the entry criteria? (If "No", tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do NOT enter the subject into the study if they failed any inclusion or exclusion criteria below.)
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria - tick all boxes corresponding to any of any of the inclusion criteria the subject failed.
C1512693 (UMLS CUI-1)
Completion of previous study and treatment with RSG XR
Item
1. Male or female subject who has successfully completed Visit 8 of AVA 100193 (24 weeks of treatment) without tolerability issues, where in the opinion of the subject and of the investigator, it will be beneficial to continue treatment with RSG XR.
boolean
C2732579 (UMLS CUI [1])
C0289313 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
Gynaecological status
Item
2. Female subjects must be post-menopausal (i.e. > 6 months without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norplant, Depo-Provera, an intra-uterine device (IUD), a diaphragm with spermicide or a condom with spermicide). Women of childbearing potential must use effective contraceptive measures throughout the study and for 30 days after discontinuing study medication. The subject and their caregiver must ensure that the subject will continously use contraceptive measures throughout the duration of the study.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3])
Informed Consent: Study Participation and Cognitive Status
Item
3. Subject is willing to participate in the extention study and has provided full wirtten informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full wirtten informed consent on behalf of the subject has been provided by a legally acceptable representative.
boolean
C0021430 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0945985 (UMLS CUI [2,2])
Informed Consent
Item
4. Caregiver has provided full written informed consent on his or her won behalf prior to the performance of any protocol-specified procedure.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria - tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
C0680251 (UMLS CUI-1)
Adverse Event or laboratory abnormality due to study drug
Item
1. Subject had a serious adverse experience or clinically significant laboratory abnormality during AVA100193, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at the end of AVA100193.
boolean
C0877248 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
Health status, Compliance, Caregiver availability, Other reason
Item
2. The subject is felt by the investigator to be unsuitable (on the basis of health, compliance, caregiver availability, or for any other reason) for inclusion in the study.
boolean
C0018759 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
C0470187 (UMLS CUI [3,1])
C0085537 (UMLS CUI [3,2])
C3840932 (UMLS CUI [4])
Cardiovascular status
Item
3. The subject experienced a significant cardiovascular event during AVA100193 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome (on Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrhythmia), unless a thorough cardiovascular evaluation has been performed which confirms that the subject does not have congestive heart failure, and is clinically stable
boolean
C0007222 (UMLS CUI [1])
Concomitant medication
Item
4. Treatment with a cholinesterase inhibitor, selegiline, memantine or any other treatment for cognitive symptoms/AD (including but not limited to papaverin, cinnarisin, cerebrolysin) is initiated at the end of AVA100193.
boolean
C2347852 (UMLS CUI [1])
Item Group
Investiagional Product - dispense the first bottle of study medication (Weeks 1 - 4) 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 at Visit 3).
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 the first bottle of study medication (Weeks 1 - 4) 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 at Visit 3).
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 2 for 14 days (+- 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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