ID

33740

Descripción

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 12-Lead ECG . It has to be filled in for screening, follow-up and repeat. Use the repeat form if necessary.

Link

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

Palabras clave

Versiones (1)
  1. 21/12/18 21/12/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

21 de diciembre de 2018

DOI

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Licencia

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

Inglés

12-Lead ECG (screening, follow-up, repeat)

1 formularios  
Administrative data
Descripción

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Descripción

Subject number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit type
Descripción

Visit type

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
Date of visit
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
12-LEAD ECG
Descripción

12-LEAD ECG

Alias
UMLS CUI-1
C0430456
Measurement number ECG
Descripción

Please take for screening three measurements. For Follow-up just one measurement. For Repeat you can take as many as necessary.

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0237753
UMLS CUI [1,2]
C1623258
Date of ECG
Descripción

day month year

Tipo de datos

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Descripción

00:00-23:59

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Heart rate ECG
Descripción

Heart rate ECG

Tipo de datos

integer

Unidades de medida
  • beats / min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C1623258
beats / min
PR Interval
Descripción

PR Interval

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Descripción

QRS Duration

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Descripción

Uncorrected QT Interval

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C4072785
msec
QTcF Calculation
Descripción

QTcF Calculation

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
msec
Method or QTc Calculatlon
Descripción

Method or QTc Calculatlon

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Machine record: QTcB (Bazett)
Descripción

Machine record: QTcB (Bazett)

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1882512
If you tick in "Method QTc Calculation Machine record" Machine record, please note QTcB (Bazett)
Descripción

Machine record: QTcB (Bazett)

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C1882512
msec
Machine record: QTc Interval, unspecified method of correction
Descripción

Machine record: QTc Interval, unspecified method of correction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0205370
UMLS CUI [1,3]
C2911685
If you tick in "Method QTc Calculation Machine record" Machine record, please note QTc Interval, unspecified method of correction
Descripción

Machine record: QTc Interval, unspecified method of correction

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0205370
UMLS CUI [1,3]
C2911685
msec
RR interval
Descripción

RR interval

Tipo de datos

integer

Alias
UMLS CUI [1]
C0489636
If you tick in "Method QTc Calculation Machine record" manual record, please note RR Interval
Descripción

Manual record: RR Interval

Tipo de datos

float

Unidades de medida
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C0175674
UMLS CUI [1,3]
C0243095
UMLS CUI [2]
C0489636
msec
Result of the ECG
Descripción

If clinically significant complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

12-Lead ECG (screening, follow-up, repeat)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Visit type
Code List
Visit type
CL Item
screening (1)
CL Item
Follow-up (2)
CL Item
Repeat (3)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
12-LEAD ECG
C0430456 (UMLS CUI-1)
Item
Measurement number ECG
integer
C0237753 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
Measurement number
Code List
Measurement number ECG
CL Item
Measurement 1 (1)
CL Item
Measurement 2 (2)
CL Item
Measurement 3 (3)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart rate ECG
Item
Heart rate ECG
integer
C0018810 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
QTcF Calculation
Item
QTcF Calculation
float
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Item
Method or QTc Calculatlon
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method or QTc Galculatlon
Code List
Method or QTc Calculatlon
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR Interval that precedes the measured QT Interval (2)
Machine record: QTcB (Bazett)
Item
Machine record: QTcB (Bazett)
boolean
C1882512 (UMLS CUI [1])
Machine record: QTcB (Bazett)
Item
If you tick in "Method QTc Calculation Machine record" Machine record, please note QTcB (Bazett)
float
C1882512 (UMLS CUI [1])
Machine record: QTc Interval, unspecified method of correction
Item
Machine record: QTc Interval, unspecified method of correction
boolean
C0489625 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
Machine record: QTc Interval, unspecified method of correction
Item
If you tick in "Method QTc Calculation Machine record" Machine record, please note QTc Interval, unspecified method of correction
float
C0489625 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
Item
RR interval
integer
C0489636 (UMLS CUI [1])
RR interval
Code List
RR interval
CL Item
available (1)
CL Item
not available (2)
Manual record: RR Interval
Item
If you tick in "Method QTc Calculation Machine record" manual record, please note RR Interval
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0489636 (UMLS CUI [2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
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