ID

17447

Descripción

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK A 24 week double-blind, randomized, placebo-controlled, parallel-group dose-raging study to investigate the effects of rosiglitazone (extended release tablets) on cognition in subjects with mild to moderate Alzheimer´s disease. Medicine: rosiglitazone, Condition: Alzheimer´s Disease, Phase: 2, Clinical Study ID: AVA 100193, Sponsor: GSK. This ODM contains Book 3/Visit 3.

Palabras clave

Versiones (3)
  1. 14/9/16 14/9/16 -
  2. 2/10/16 2/10/16 -
  3. 14/12/16 14/12/16 -
Subido en

14 de septiembre de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 3

Inglés

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 3

1 formularios  
General information
Descripción

General information

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

integer

Visit Date
Descripción

Visit Date

Tipo de datos

date

Visit Description: Visit 3
Descripción

Visit Description

Tipo de datos

boolean

Investigator Instructions (See Description)
Descripción

Telephone the IVRS system to register the visit. (Note that if the subject is not continuing in the study, you should make a withdrawal call rather that a Visit Registration call).

Tipo de datos

boolean

Subject Continuation (See Description)
Descripción

If the subject is not continuing in the study, complete all assessments and ensure that all sections of the CRF (including the Study Conclusion section) are completely appropriately. Schedule an early withdrawal follow-up visit for 14 +/- 7 days after this visit.

Tipo de datos

boolean

Vital Signs
Descripción

Vital Signs

Weight
Descripción

Weight

Tipo de datos

float

Unidades de medida
  • kg
kg
Blood pressure (See Description): Systolic
Descripción

Blood pressure and heart rate will be measured once, after the subject sits quietly for at least 5 minutes.

Tipo de datos

integer

Blood pressure: Diastolic
Descripción

Blood pressure

Tipo de datos

integer

Unidades de medida
  • mmHg
mmHg
Heart Rate
Descripción

Heart Rate

Tipo de datos

integer

Unidades de medida
  • bpm
bpm
Concomitant Medications (See Description)
Descripción

Concomitant Medications (See Description)

Adverse Events (See Description)
Descripción

Adverse Events (See Description)

Physical Examination (See Description)
Descripción

Physical Examination (See Description)

Pedal Oedema (See Description)
Descripción

Pedal Oedema (See Description)

Depth of Indentation
Descripción

Depth of Indentation

Tipo de datos

text

Indicate which ankle was assessed at this visit
Descripción

Ankle

Tipo de datos

text

End of visit reminder (See Description)
Descripción

End of visit reminder (See Description)

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Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Book 3

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General information
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description: Visit 3
boolean
Investigator Instructions (See Description)
Item
Investigator Instructions (See Description)
boolean
Subject Continuation (See Description)
Item
Subject Continuation (See Description)
boolean
Item Group
Vital Signs
Weight
Item
Weight
float
Blood pressure (See Description)
Item
Blood pressure (See Description): Systolic
integer
Blood pressure
Item
Blood pressure: Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
Concomitant Medications (See Description)
Item Group
Adverse Events (See Description)
Item Group
Physical Examination (See Description)
Item Group
Pedal Oedema (See Description)
Item
Depth of Indentation
text
Depth of Indentation
Code List
Depth of Indentation
CL Item
< 1 mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
> 10 mm (5)
Item
Indicate which ankle was assessed at this visit
text
Ankle
Code List
Indicate which ankle was assessed at this visit
CL Item
Right Ankle (1)
CL Item
Left Ankle (2)
Item Group
End of visit reminder (See Description)
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