ID
33740
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 12-Lead ECG . It has to be filled in for screening, follow-up and repeat. Use the repeat form if necessary.
Lien
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Mots-clés
Versions (1)
- 21/12/2018 21/12/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
21 décembre 2018
DOI
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Licence
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 (screening, follow-up, repeat)
- StudyEvent: ODM
Description
12-LEAD ECG
Alias
- UMLS CUI-1
- C0430456
Description
Please take for screening three measurements. For Follow-up just one measurement. For Repeat you can take as many as necessary.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C1623258
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C2826640
Description
00:00-23:59
Type de données
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Description
Heart rate ECG
Type de données
integer
Unités de mesure
- beats / min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C1623258
Description
PR Interval
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C4072785
Description
QTcF Calculation
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Method or QTc Calculatlon
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Machine record: QTcB (Bazett)
Type de données
boolean
Alias
- UMLS CUI [1]
- C1882512
Description
Machine record: QTcB (Bazett)
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1]
- C1882512
Description
Machine record: QTc Interval, unspecified method of correction
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0205370
- UMLS CUI [1,3]
- C2911685
Description
Machine record: QTc Interval, unspecified method of correction
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0205370
- UMLS CUI [1,3]
- C2911685
Description
RR interval
Type de données
integer
Alias
- UMLS CUI [1]
- C0489636
Description
Manual record: RR Interval
Type de données
float
Unités de mesure
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C0175674
- UMLS CUI [1,3]
- C0243095
- UMLS CUI [2]
- C0489636
Description
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
Type de données
integer
Alias
- UMLS CUI [1]
- C0438154
Similar models
12-Lead ECG (screening, follow-up, repeat)
- StudyEvent: ODM
C1623258 (UMLS CUI [1,2])
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])