Information:
Error:
ID
21934
Description
This is an open-label extension to study 49653/461, to assess the long-term safety of rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's Disease. GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00381238?term=NCT00381238&rank=1
Link
https://clinicaltrials.gov/ct2/show/NCT00381238?term=NCT00381238&rank=1
Keywords
Versions (1)
- 5/9/17 5/9/17 -
Uploaded on
May 9, 2017
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Eligibility Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238
Eligibility Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238
Similar models
Eligibility Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease NCT00381238
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Eligibility Question
Item
Did the subject meet all the entry criteria? If No, check all boxes corresponding to violations of any inclusion/exclusion criteria. Do NOT enter the subject into the study if this failed any inclusion or exclusion criteria below.
boolean
C1516637 (UMLS CUI [1])
Item
Inclusion Criteria Check the boxes corresponding to any of the inclusion criteria the subject failed.
integer
C1512693 (UMLS CUI [1])
Code List
Inclusion Criteria Check the boxes corresponding to any of the inclusion criteria the subject failed.
CL Item
Male or female subject who has successfully completed the 12 Month Visit of 49653/461 (12 months of treatment) without tolerability issues, where in the opinion of the subject an 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 sterile, or if of childbearing 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 extension study and has proved full written informed consent prior to the performance of any protocol-specifier 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 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-specifies procedure. (4)
Item
Exclusion Criteria check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
integer
C0680251 (UMLS CUI [1])
Code List
Exclusion Criteria check the boxes corresponding to any of the exclusion criteria that disqualified the subject from entry.
CL Item
Subject had a serious adverse experience (SAE) or clinically significant laboratory abnormality during 49653/461, which in the opinion of the investigator could have been attributable to study medication, and which is ongoing at the end of 49653/461. (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 person) for inclusion in the study based on the entry criteria for the primary study, 49653/461 (exclusive of the age criteria which may not be applicable to some of the subjects). (2)
CL Item
The subject experienced a significant cardiovascular event during 49653/461 (e.g. intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome (non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrhythmia), unless a thorough cardiovascular evaluation has been performed which conforms that the subject does 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 is initiated at the end of 49653/461. (4)