ID

33984

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, 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

Keywords

Versions (2)
  1. 12/21/18 12/21/18 -
  2. 1/10/19 1/10/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

January 10, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026

English

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

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

day month year

Data type

date

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

The itemgroup "body measurement" is only for screening.

Data type

integer

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

Vital Signs

Alias
UMLS CUI-1
C0518766
Measurement number
Description

Measurement number

Data type

integer

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

day month year

Data type

date

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

00:00-23:59

Data type

time

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

Blood pressure: systolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure: diastolic
Description

Blood pressure: diastolic

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Body measurement
Description

Body measurement

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

only for measurement 1

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

only for measurement 1

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
BMI
Description

only for measurement 1

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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