ID

33932

Description

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 4 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains the Pharmacokinetic (PGx) research withdrawl of consent (PGx withdrawl) form. It has to be filled in for the end of study.

Lien

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Mots-clés

Versions (3)
  1. 08/01/2019 08/01/2019 -
  2. 10/01/2019 10/01/2019 - Sarah Riepenhausen
  3. 10/01/2019 10/01/2019 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

8 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

Anglais

Pharmacokinetic (PGx) research withdrawl of consent (PGx withdrawl)

1 Formulaires  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Type de données

text

Alias
UMLS CUI [1]
C2348585
C2347500 C1707492
Description

C2347500 C1707492

Has subject withdrawn consent for PGx research?
Description

Withdrawl of consent for PGx

Type de données

text

Alias
UMLS CUI [1]
C1707492
If consent for PGx was withdrawn, please note the date of informed consent withdrawn
Description

day month year

Type de données

date

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C0011008
Has a request been made for sample destruction?
Description

Request to sample destruction

Type de données

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
If request to sample destruction was made, please check reasons
Description

Screen failure is an optional choice. Please replace 'insert sample type' with the appropriate sample type as specified in the protocol.

Type de données

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
If other reason for request sample destruction, please specify
Description

Other reason for request to sample destruction

Type de données

text

Alias
UMLS CUI [1,1]
C1948029
UMLS CUI [1,2]
C0178913
UMLS CUI [1,3]
C1272683
UMLS CUI [1,4]
C0392360
UMLS CUI [1,5]
C0205394
Design Notes
Description

Design Notes

Alias
UMLS CUI-1
C0947611
Withdrawl of consent for PGx (DNA) sample destruction
Description

For PGx (DNA) is optional.

Type de données

boolean

Alias
UMLS CUI [1,1]
C1707492
UMLS CUI [1,2]
C1948029
UMLS CUI [1,3]
C0178913
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Similar models

Pharmacokinetic (PGx) research withdrawl of consent (PGx withdrawl)

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Has subject withdrawn consent for PGx research?
text
C1707492 (UMLS CUI [1])
Withdrawl of consent for PGx
Code List
Has subject withdrawn consent for PGx research?
CL Item
Yes (Y)
CL Item
No (N)
Date of informed consent withdrawn
Item
If consent for PGx was withdrawn, please note the date of informed consent withdrawn
date
C1707492 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Has a request been made for sample destruction?
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
Request to sample destruction
Code List
Has a request been made for sample destruction?
CL Item
Yes (Y)
CL Item
No (N)
Item
If request to sample destruction was made, please check reasons
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
Request to sample destruction
Code List
If request to sample destruction was made, please check reasons
CL Item
Subject withdrew consent for PGx (1)
CL Item
Screen failure (2)
CL Item
Other (Z)
Item
If other reason for request sample destruction, please specify
text
C1948029 (UMLS CUI [1,1])
C0178913 (UMLS CUI [1,2])
C1272683 (UMLS CUI [1,3])
C0392360 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,5])
Request to sample destruction
Code List
If other reason for request sample destruction, please specify
Item Group
Design Notes
C0947611 (UMLS CUI-1)
Withdrawl of consent for PGx (DNA) sample destruction
Item
Withdrawl of consent for PGx (DNA) sample destruction
boolean
C1707492 (UMLS CUI [1,1])
C1948029 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
Retour au début de la page 

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