ID
24079
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 6
Trefwoorden
Versies (1)
- 25-07-17 25-07-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 juli 2017
DOI
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Licentie
Creative Commons BY-NC-ND 3.0
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Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
Beschrijving
Visit Information
Alias
- UMLS CUI-1
- C0545082
Beschrijving
Investigator Instructions
Alias
- UMLS CUI-1
- C1442085
Beschrijving
Subject Continuation
Alias
- UMLS CUI-1
- C0805733
Beschrijving
Subject Continuation
Datatype
text
Alias
- UMLS CUI [1]
- C0805733
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
float
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Datatype
float
Maateenheden
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Beschrijving
Neurological Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0027853
Beschrijving
Central Laboratory (Fasting Samples)
Alias
- UMLS CUI-1
- C1880016
Beschrijving
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Beschrijving
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Date of ECG
Datatype
date
Maateenheden
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C2826640
Beschrijving
[3] abnormal - clinically significant: Complete an Adverse Event (AE) or Serious Adverse Event (SAE) ge(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE.
Datatype
integer
Alias
- UMLS CUI [1]
- C1623258
Beschrijving
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschrijving
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Beschrijving
Adverse Event
Datatype
text
Alias
- UMLS CUI [1]
- C0877248
Beschrijving
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Physical Examination
Datatype
text
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Pedal Oedema
Alias
- UMLS CUI-1
- C0574002
Beschrijving
Pedal Oedema: depth
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Beschrijving
Pedal Oedema: Site
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C1515974
Beschrijving
The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
Alias
- UMLS CUI-1
- C0681889
Beschrijving
ADAS-COG
Datatype
text
Alias
- UMLS CUI [1]
- C3539026
Beschrijving
CIBIC-Plus Summary
Datatype
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C0449820
Beschrijving
Neuropsychiatric Inventory (NPI)
Datatype
text
Alias
- UMLS CUI [1]
- C3539727
Beschrijving
Investigational Product/ 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
- C0304229
- UMLS CUI-2
- C1321605
Beschrijving
Investigational Product
Datatype
text
Alias
- UMLS CUI [1]
- C0304229
Beschrijving
Start Date
Datatype
date
Maateenheden
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C0808070
Beschrijving
Stop Date
Datatype
date
Maateenheden
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C0806020
Beschrijving
Dose
Datatype
integer
Maateenheden
- mg
Beschrijving
IP Container Number
Datatype
text
Alias
- UMLS CUI [1]
- C0180098
Beschrijving
Total number of Tablets Dispensed
Datatype
float
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Beschrijving
Total number of Tablets Returned
Datatype
float
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Beschrijving
Discontinuation
Datatype
boolean
Alias
- UMLS CUI [1]
- C0457454
Beschrijving
End of Visit Reminder
Alias
- UMLS CUI-1
- C1709896
- UMLS CUI-2
- C1320303
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- StudyEvent: ODM
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