ID

17761

Description

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 the Early Withdrawal.

Mots-clés

Versions (2)
  1. 03/10/2016 03/10/2016 -
  2. 09/12/2016 09/12/2016 -
Téléchargé le

3 octobre 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
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NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Early Withdrawal

Anglais

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Early Withdrawal

1 Formulaires  
General Information
Description

General Information

Protocol Identifier: AVA100193
Description

Protocol Identifier

Type de données

boolean

Subject Identifier
Description

Subject Identifier

Type de données

integer

Visit Date
Description

Visit Date

Type de données

date

Visit Description: Early Withdrawal
Description

Visit Description

Type de données

boolean

Instructions
Description

Instructions

Instructions completed
Description

Instructions completed

Type de données

boolean

Vital signs
Description

Vital signs

Weight
Description

Weight

Type de données

float

Unités de mesure
  • kg
kg
Blood pressure: systolic
Description

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

Type de données

integer

Blood pressure: diastolic
Description

Blood pressure

Type de données

integer

Unités de mesure
  • mmHg
mmHg
Heart rate
Description

Heart rate

Type de données

integer

Unités de mesure
  • bpm
bpm
Central Laboratory (Non Fasting Samples)
Description

Central Laboratory (Non Fasting Samples)

Date samples taken
Description

Date samples taken

Type de données

date

Pregnancy test: pregnant
Description

If subject is female and of childbearing potential a serum pregnancy test must be performed.

Type de données

boolean

Concomitant Medications
Description

Concomitant Medications

Concomitant Medications
Description

Concomitant Medications

Type de données

text

Adverse Events
Description

Adverse Events

Non-Serious Adverse Events/Serious Adverse Events
Description

Non-Serious Adverse Events/Serious Adverse Events

Type de données

text

Physical Examination
Description

Physical Examination

Results from Physical Examination
Description

Results from Physical Examination

Type de données

text

Pedal Oedema
Description

Pedal Oedema

Depth of Indentation
Description

Depth of Indentation

Type de données

text

Indicate which ankle was assessed at this visit
Description

Ankle

Type de données

text

Further Instructions
Description

Further Instructions

Instructions followed and next visit scheduled?
Description

Instructions followed and next visit scheduled?

Type de données

boolean

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Similar models

NCT00334568/ GSK-AVA100193: M.Alzheimer GSK - Early Withdrawal

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
General Information
Protocol Identifier
Item
Protocol Identifier: AVA100193
boolean
Subject Identifier
Item
Subject Identifier
integer
Visit Date
Item
Visit Date
date
Visit Description
Item
Visit Description: Early Withdrawal
boolean
Item Group
Instructions
Instructions completed
Item
Instructions completed
boolean
Item Group
Vital signs
Weight
Item
Weight
float
Blood pressure
Item
Blood pressure: systolic
integer
Blood pressure
Item
Blood pressure: diastolic
integer
Heart rate
Item
Heart rate
integer
Item Group
Central Laboratory (Non Fasting Samples)
Date samples taken
Item
Date samples taken
date
Pregnancy test
Item
Pregnancy test: pregnant
boolean
Item Group
Concomitant Medications
Concomitant Medications
Item
Concomitant Medications
text
Item Group
Adverse Events
Non-Serious Adverse Events/Serious Adverse Events
Item
Non-Serious Adverse Events/Serious Adverse Events
text
Item Group
Physical Examination
Results from Physical Examination
Item
Results from Physical Examination
text
Item Group
Pedal Oedema
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
Further Instructions
Instructions followed and next visit scheduled?
Item
Instructions followed and next visit scheduled?
boolean
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