ID
33918
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 12-Lead ECG . It has to be filled in for treatment period 1-4 at Day 1 and Day 7.
Link
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Trefwoorden
Versies (2)
- 21-12-18 21-12-18 -
- 07-01-19 07-01-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
7 januari 2019
DOI
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Licentie
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
Beschrijving
12-LEAD ECG
Alias
- UMLS CUI-1
- C0430456
Beschrijving
For TP1D1, TP2D1, TP3D1 and TP4D1 tick "pre-dose" and "1 hr post-dose" only. For both timepoints three measurements are mandatory. For TP1D7, TP2D7, TP3D7 and TP4D7 tick all five timepoints each. Please take three measurements for "pre-dose" and one measurement each for the remaining timepoints.
Datatype
integer
Alias
- UMLS CUI [1]
- C0439564
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C2826640
Beschrijving
00:00-23:59
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschrijving
Heart rate ECG
Datatype
integer
Maateenheden
- beats / min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C1623258
Beschrijving
PR Interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C4072785
Beschrijving
QTcF Calculation
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Method or QTc Calculatlon
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Machine record: QTcB (Bazett)
Datatype
boolean
Alias
- UMLS CUI [1]
- C1882512
Beschrijving
Machine record: QTcB (Bazett)
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C1882512
Beschrijving
Machine record: QTc Interval, unspecified method of correction
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0205370
- UMLS CUI [1,3]
- C2911685
Beschrijving
Machine record: QTc Interval, unspecified method of correction
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0205370
- UMLS CUI [1,3]
- C2911685
Beschrijving
RR interval
Datatype
integer
Alias
- UMLS CUI [1]
- C0489636
Beschrijving
Manual record: RR Interval
Datatype
float
Maateenheden
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C0175674
- UMLS CUI [1,3]
- C0243095
- UMLS CUI [2]
- C0489636
Beschrijving
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
Datatype
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])