ID

23031

Beschrijving

Study ID: 100468 Clinical Study ID: AVA100468 Study Title: An open-label extension to study AVA100193, to assess the long-term safety and efficacy of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's disease Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 2 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Avandia XR,Rosiglitazone XR,Avandia Study Indication: Alzheimer's Disease Visit 1

Trefwoorden

Versies (1)
  1. 20-06-17 20-06-17 -
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GlaxoSmithKline

Geüploaded op

20 juni 2017

DOI

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Licentie

Creative Commons BY-NC-ND 3.0
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Visit 1 GSK Rosiglitazone Alzheimer's disease 100468

Engels

Visit 1 GSK Rosiglitazone Alzheimer's disease 100468

1 Formulieren  
Visit Information
Beschrijving

Visit Information

Alias
UMLS CUI-1
C0545082
Subject Identifier
Beschrijving

Subject Identifier

Datatype

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschrijving

Visit Date

Datatype

date

Maateenheden
  • dd-mmm-yy
Alias
UMLS CUI [1]
C1320303
dd-mmm-yy
Previous Clinical Trial Participation
Beschrijving

Previous Clinical Trial Participation

Alias
UMLS CUI-1
C2348568
Did the subject participate in AVA100 clinical study 193?
Beschrijving

Study Subject Participation Status

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
IF YES, complete the following: Previous Centre ID
Beschrijving

Previous Centre Number

Datatype

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
UMLS CUI [1,3]
C0205156
If YES, complete the following: Previous Subject Identifier
Beschrijving

Previous Subject Identifier

Datatype

text

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

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Beschrijving

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.

Datatype

boolean

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Male or female subject who has successfully completed Visit 8 of AVA100193 (24 weeks of treatment) without tolerability issues, where in the opinion of te subject and of the investigator, it will be beneficial to continue treatment with RSG XR.
Beschrijving

Tick the boxes corresponding to any of the inclusion criteria the subject failed.

Datatype

boolean

Alias
UMLS CUI [1]
C3274448
2. Female subjects must be post menopausal (i.e. > 6 monthhs without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norpplant, Dep-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 continuoulsy use contraceptive measures thoughout the duration of the study.
Beschrijving

Tick the boxes corresponding to any of the inclusion criteria the subject failed.

Datatype

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
3. Subject is willing to participate in the extention study and has provided full written informed consent prio 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 subjet has been provided by a legally acceptable representative.
Beschrijving

Tick the boxes corresponding to any of the inclusion criteria the subject failed.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C2348568
4. Caregiver has provided full wirtten informed consent on his or her own behalf prior to the performance of any protocol-specified procedure.
Beschrijving

Tick the boxes corresponding to any of the inclusion criteria the subject failed.

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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 AVA00193.
Beschrijving

Tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datatype

boolean

Alias
UMLS CUI [1]
C1519255
UMLS CUI [2]
C0438215
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.
Beschrijving

Tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datatype

boolean

Alias
UMLS CUI [1]
C2828389
3. The subject experienced a significant cardiovascular event during AVA100193 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary sydrome [non 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 noct have congestive heart failure, and is clinically stable.
Beschrijving

Tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datatype

boolean

Alias
UMLS CUI [1]
C1320716
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.
Beschrijving

Tick the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.

Datatype

boolean

Alias
UMLS CUI [1]
C0013216
Investigational Product/ 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).
Beschrijving

Investigational Product/ 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
C0304229
UMLS CUI-3
C1321605
Investigational Product (e.g., Bottle 1)
Beschrijving

Investigational Product

Datatype

text

Alias
UMLS CUI [1]
C0304229
Start Date
Beschrijving

Start Date

Datatype

date

Maateenheden
  • dd-mmm-yy
Alias
UMLS CUI [1]
C0808070
dd-mmm-yy
Stop Date
Beschrijving

Stop Date

Datatype

date

Maateenheden
  • dd-mmm-yy
Alias
UMLS CUI [1]
C0806020
dd-mmm-yy
Dose
Beschrijving

Dose

Datatype

integer

Maateenheden
  • mg
Alias
UMLS CUI [1]
C3174092
IP Container No.
Beschrijving

IP Container Number

Datatype

text

Alias
UMLS CUI [1]
C0180098
Total Number of Tablets Dispensed
Beschrijving

Total Number of Tablets Dispensed

Datatype

float

Alias
UMLS CUI [1,1]
C0805077
UMLS CUI [1,2]
C0039225
Total Number of Tablets Returned
Beschrijving

Total Number of Tablets Returned

Datatype

float

Alias
UMLS CUI [1,1]
C2699071
UMLS CUI [1,2]
C0039225
Has the subject missed investigational product for > 7 consecutive days?
Beschrijving

Discontinuation

Datatype

boolean

Alias
UMLS CUI [1]
C0457454
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Similar models

Visit 1 GSK Rosiglitazone Alzheimer's disease 100468

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Visit Information
C0545082 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
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 AVA100 clinical study 193?
boolean
C2348568 (UMLS CUI [1])
Previous Centre Number
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 Subject Identifier
Item
If YES, complete the following: Previous Subject Identifier
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?
boolean
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Tolerability Study
Item
1. Male or female subject who has successfully completed Visit 8 of AVA100193 (24 weeks of treatment) without tolerability issues, where in the opinion of te subject and of the investigator, it will be beneficial to continue treatment with RSG XR.
boolean
C3274448 (UMLS CUI [1])
Gynaecological Status
Item
2. Female subjects must be post menopausal (i.e. > 6 monthhs without menstrual period), surgically sterile, or if of child-bearing potential, using effective contraceptive measures (oral contraceptives, Norpplant, Dep-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 continuoulsy use contraceptive measures thoughout the duration of the study.
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Willing to participate
Item
3. Subject is willing to participate in the extention study and has provided full written informed consent prio 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 subjet has been provided by a legally acceptable representative.
boolean
C0600109 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Informed Consent
Item
4. Caregiver has provided full wirtten informed consent on his or her own behalf prior to the performance of any protocol-specified procedure.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Serious Adverse Event, clinically significant laboratory abnormality
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 AVA00193.
boolean
C1519255 (UMLS CUI [1])
C0438215 (UMLS CUI [2])
Exclusion Criteria
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
C2828389 (UMLS CUI [1])
Cardiovascular Event
Item
3. The subject experienced a significant cardiovascular event during AVA100193 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary sydrome [non 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 noct have congestive heart failure, and is clinically stable.
boolean
C1320716 (UMLS CUI [1])
Pharmacotherapy
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
C0013216 (UMLS CUI [1])
Item Group
Investigational Product/ 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).
C0304229 (UMLS CUI-1)
C1321605 (UMLS CUI-3)
Item
Investigational Product (e.g., Bottle 1)
text
C0304229 (UMLS CUI [1])
Investigational Product
Code List
Investigational Product (e.g., Bottle 1)
CL Item
Bottle 1 (Bottle 1)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Item
Dose
integer
C3174092 (UMLS CUI [1])
Dose
Code List
Dose
CL Item
4 (1)
IP Container Number
Item
IP Container No.
text
C0180098 (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])
Discontinuation
Item
Has the subject missed investigational product for > 7 consecutive days?
boolean
C0457454 (UMLS CUI [1])
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