ID

33984

Beschrijving

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, 8 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 Vital signs and body measurements of subject. Both has to be filled in for screening. Vital signs also has to be filled in at Day-1 and at follow-up. Day-1 is part of the treatment periods.

Link

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

Trefwoorden

Versies (2)
  1. 21-12-18 21-12-18 -
  2. 10-01-19 10-01-19 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

Geüploaded op

10 januari 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY-NC 3.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

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

Engels

Vital signs (screening, Day-1, Follow-up)

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Visit type
Beschrijving

The itemgroup "body measurement" is only for screening.

Datatype

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Measurement number
Beschrijving

Measurement number

Datatype

integer

Alias
UMLS CUI [1,1]
C0242485
UMLS CUI [1,2]
C0237753
Actual date
Beschrijving

day month year

Datatype

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Actual time
Beschrijving

00:00-23:59

Datatype

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Blood pressure: Systolic
Beschrijving

Blood pressure: systolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure: diastolic
Beschrijving

Blood pressure: diastolic

Datatype

integer

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beschrijving

Heart rate

Datatype

integer

Maateenheden
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body measurement
Beschrijving

Body measurement

Alias
UMLS CUI-1
C1268086
UMLS CUI-2
C0242485
Height
Beschrijving

only for measurement 1

Datatype

integer

Maateenheden
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschrijving

only for measurement 1

Datatype

float

Maateenheden
  • kg
Alias
UMLS CUI [1]
C0005910
kg
BMI
Beschrijving

only for measurement 1

Datatype

float

Maateenheden
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Terug naar het begin van de pagina

Similar models

Vital signs (screening, Day-1, Follow-up)

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of visit/assessment
Item
Date of visit
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item
Visit type
integer
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
screening (1)
CL Item
TP1 Day-1 (2)
CL Item
TP2 Day-1 (3)
CL Item
TP3 Day-1 (4)
CL Item
TP4 Day-1 (5)
CL Item
Follow-up (6)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Measurement number
integer
C0242485 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Measurement number
Code List
Measurement number
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Actual date
Item
Actual date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure: systolic
Item
Blood pressure: Systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure: diastolic
Item
Blood pressure: diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Body measurement
C1268086 (UMLS CUI-1)
C0242485 (UMLS CUI-2)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
BMI
Item
BMI
float
C1305855 (UMLS CUI [1])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial