ID
24079
Descripción
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
Palabras clave
Versiones (1)
- 25/7/17 25/7/17 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
25 de julio de 2017
DOI
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Licencia
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
Descripción
Visit Information
Alias
- UMLS CUI-1
- C0545082
Descripción
Investigator Instructions
Alias
- UMLS CUI-1
- C1442085
Descripción
Subject Continuation
Alias
- UMLS CUI-1
- C0805733
Descripción
Subject Continuation
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0805733
Descripción
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Descripción
Weight
Tipo de datos
float
Unidades de medida
- kg
Alias
- UMLS CUI [1]
- C0005910
Descripción
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Tipo de datos
float
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Descripción
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Tipo de datos
float
Unidades de medida
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Descripción
Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.
Tipo de datos
float
Unidades de medida
- beats/minute
Alias
- UMLS CUI [1]
- C0018810
Descripción
Neurological Examination
Alias
- UMLS CUI-1
- C0027853
Descripción
Neurological Examination
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0027853
Descripción
Central Laboratory (Fasting Samples)
Alias
- UMLS CUI-1
- C1880016
Descripción
Pregnancy Test
Alias
- UMLS CUI-1
- C0032976
Descripción
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Descripción
Date of ECG
Tipo de datos
date
Unidades de medida
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C2826640
Descripción
[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.
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C1623258
Descripción
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Descripción
Adverse Event
Alias
- UMLS CUI-1
- C0877248
Descripción
Adverse Event
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0877248
Descripción
Physical Examination
Alias
- UMLS CUI-1
- C0031809
Descripción
Physical Examination
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0031809
Descripción
Pedal Oedema
Alias
- UMLS CUI-1
- C0574002
Descripción
Pedal Oedema: depth
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C0205125
Descripción
Pedal Oedema: Site
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0574002
- UMLS CUI [1,2]
- C1515974
Descripción
The following scales should be completed at this visit: ADAS-cog, CIBIC+, NPI, DAD
Alias
- UMLS CUI-1
- C0681889
Descripción
ADAS-COG
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3539026
Descripción
CIBIC-Plus Summary
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0443172
- UMLS CUI [1,2]
- C0449820
Descripción
Neuropsychiatric Inventory (NPI)
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3539727
Descripción
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
Descripción
Investigational Product
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0304229
Descripción
Start Date
Tipo de datos
date
Unidades de medida
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C0808070
Descripción
Stop Date
Tipo de datos
date
Unidades de medida
- dd-mmm-yy
Alias
- UMLS CUI [1]
- C0806020
Descripción
Dose
Tipo de datos
integer
Unidades de medida
- mg
Descripción
IP Container Number
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0180098
Descripción
Total number of Tablets Dispensed
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C0805077
- UMLS CUI [1,2]
- C0039225
Descripción
Total number of Tablets Returned
Tipo de datos
float
Alias
- UMLS CUI [1,1]
- C2699071
- UMLS CUI [1,2]
- C0039225
Descripción
Discontinuation
Tipo de datos
boolean
Alias
- UMLS CUI [1]
- C0457454
Descripción
End of Visit Reminder
Alias
- UMLS CUI-1
- C1709896
- UMLS CUI-2
- C1320303
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Visit 6 GSK Rosiglitazone Alzheimer's disease 100468
- StudyEvent: ODM
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C1515974 (UMLS CUI [1,2])
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