ID
33742
Beskrivning
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 treatment period 1-4 at Day 1 and Day 7.
Länk
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Nyckelord
Versioner (2)
- 2018-12-21 2018-12-21 -
- 2019-01-07 2019-01-07 - Sarah Riepenhausen
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
21 december 2018
DOI
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Licens
Creative Commons BY-NC 3.0
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Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026
12-Lead ECG treatment period 1-4.
- StudyEvent: ODM
Beskrivning
12-LEAD ECG
Alias
- UMLS CUI-1
- C0430456
Beskrivning
For TP1D1, TP2D1, TP3D1 and TP4D1 tick each 1 and 2. Please take for each three measurements. For TP1D7, TP2D7, TP3D7 and TP4D7 tick each 1-5. Please take for pre-dose each time three measurements.
Datatyp
integer
Alias
- UMLS CUI [1]
- C0439564
Beskrivning
day month year
Datatyp
date
Alias
- UMLS CUI [1]
- C2826640
Beskrivning
00:00-23:59
Datatyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beskrivning
Heart rate ECG
Datatyp
integer
Måttenheter
- beats / min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C1623258
Beskrivning
PR Interval
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
Uncorrected QT Interval
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C4072785
Beskrivning
QTcF Calculation
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beskrivning
Method or QTc Calculatlon
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beskrivning
Machine record: QTcB (Bazett)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1882512
Beskrivning
Machine record: QTcB (Bazett)
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1]
- C1882512
Beskrivning
Machine record: QTc Interval, unspecified method of correction
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0205370
- UMLS CUI [1,3]
- C2911685
Beskrivning
Machine record: QTc Interval, unspecified method of correction
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0205370
- UMLS CUI [1,3]
- C2911685
Beskrivning
RR interval
Datatyp
integer
Alias
- UMLS CUI [1]
- C0489636
Beskrivning
Manual record: RR Interval
Datatyp
float
Måttenheter
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C0175674
- UMLS CUI [1,3]
- C0243095
- UMLS CUI [2]
- C0489636
Beskrivning
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
Datatyp
integer
Alias
- UMLS CUI [1]
- C0438154
Similar models
12-Lead ECG treatment period 1-4.
- StudyEvent: ODM
C0013798 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,2])
C4072785 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
C0205370 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,3])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
C0489636 (UMLS CUI [2])