ID

34006

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. It has to be filled in for all treatment periods (1-4) for Day 1 and Day 7.

Link

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

Keywords

Versions (1)
  1. 1/10/19 1/10/19 -
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 combination on electrocardiographic parametersin healthy subjects, NCT01209026

English

Vital signs, TP1-4 Day 1 and 7

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
Treatment period and Day of treatment period
Description

Treatment period and Day of treatment period

Data type

integer

Alias
UMLS CUI [1]
C0087111
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Planned relative time
Description

For treatment period 1 Day 1 tick only for predose and 1 hr. For the measurements at Day 7 tick all. For each time take three measurements.

Data type

integer

Alias
UMLS CUI [1]
C0439564
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
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Similar models

Vital signs, TP1-4 Day 1 and 7

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
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Treatment period and Day of treatment period
integer
C0087111 (UMLS CUI [1])
Treatment period type
Code List
Treatment period and Day of treatment period
CL Item
TP1D1 (1)
CL Item
TP1D7 (2)
CL Item
TP2D1 (3)
CL Item
TP2D7 (4)
CL Item
TP3D1 (5)
CL Item
TP3D7 (6)
CL Item
TP4D1 (7)
CL Item
TP4D7 (8)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
Dosing type
Code List
Planned relative time
CL Item
Pre dose  (1)
CL Item
10 min post dose (2)
CL Item
1 hr post dose (3)
CL Item
2 hr post dose (4)
CL Item
6 hr post dose (5)
CL Item
1 hr post dose (3)
CL Item
12 hr post dose (6)
CL Item
24 hr post dose (7)
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])
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