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Informações:
Falhas:
ID
18471
Descrição
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 Medicine: rosiglitazone, Condition: Alzheimer's Disease, Phase: 2, Clinical Study ID: AVA100468, Sponsor: GSK
Palavras-chave
Versões (2)
- 07/11/2016 07/11/2016 -
- 06/02/2017 06/02/2017 -
Transferido a
7 de novembro de 2016
DOI
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Licença
Creative Commons BY-NC 3.0
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Visit 1 GSK-AVA100468 NCT00381238
Visit 1 GSK-AVA100468 NCT00381238
- StudyEvent: ODM
Similar models
Visit 1 GSK-AVA100468 NCT00381238
- StudyEvent: ODM
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Protocol Identifier
Item
Protocol Identifier: AVA100468
boolean
Subject Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Previous Clinical Trial Participation
Item
Did the subject participate in AVA100 study 193?
boolean
C2348568 (UMLS CUI [1])
Centre ID
Item
Previous Centre Number:
text
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
C0019994 (UMLS CUI [1,2])
Patient ID
Item
Previous Subject Identifier
text
C2348585 (UMLS CUI [1])
Eligibility
Item
Did the subject meet all the entry criteria?
boolean
C0013893 (UMLS CUI [1])
Item
Tick the boxes corresponding to any of the inclusion criteria the subject failed:
integer
C1512693 (UMLS CUI [1])
Code List
Tick the boxes corresponding to any of the inclusion criteria the subject failed:
CL Item
Male or female subject who has successfully completed Visit 8 of AVA100193 (24 weeks of treatment) without tolerability issues, where in the opinion of the subject and the investigator, it will be beneficial to continue treatment with RSG XR. (1)
CL Item
Female subjects must be post-menopausal (i.e. >6 months without menstrual period), surgically sterlie, 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 continuously use contraceptive measures throughout the duration of the study. (2)
CL Item
Subject is willing to participate in the extention study and has provided full written informed consent prior to the performance of any protocol-specified procedure; or if unable to provide informed consent due to cognitive status, full written informed consent on behalf of the subject has been provided by a legally acceptable representative. (3)
CL Item
Caregiver has provided full written informed consent on his or her own behalf prior to the performance of any protocol-specified procedure. (4)
Item
Tick the boxes corresponding to any of the exlusion criteria that disqualified the subject from entry.
integer
C0680251 (UMLS CUI [1])
Code List
Tick the boxes corresponding to any of the exlusion criteria that disqualified the subject from entry.
CL Item
Subject had a serious adverse experience or clinically significant laboratory abnormality during AVA100193, which in the opinion of the investigator could have been attributabe to study medication, and which is ongoin at the end of AVA100193. (1)
CL Item
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. (2)
CL Item
The subject experienced a significant cardiovascular event during AVA100193 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome (non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrythmia), unless a thorough cardiovascular evaluation has been performed which confirms that the subject doas not have congestive heart failure, and is clinically stable. (3)
CL Item
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. (4)
Pharmaceutical Preparations
Item
Investigational Product
text
C0013227 (UMLS CUI [1])
Pharmaceutical Preparations Start date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Pharmaceutical Preparations Start date
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Pharmaceutical Preparations Dosev
Item
Dose
integer
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
Pharmaceutical Preparations Dosev
Item
IP container No.
integer
C0013227 (UMLS CUI [1,1])
C2348343 (UMLS CUI [1,2])
C2348343 (UMLS CUI [1,2])
Compliance
Item
Total number of Tablets dispensed:
integer
C1321605 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Compliance
Item
Total number of Tablets returned:
integer
C1321605 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
Compliance
Item
Has the subject missed investigational product for >7 consecutive days?
boolean
C1321605 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])