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.
Link
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Keywords
Versions (1)
- 12/21/18 12/21/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
December 21, 2018
DOI
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License
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.
Data type
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C1623258
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C2826640
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Description
Heart rate ECG
Data type
integer
Measurement units
- beats / min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C1623258
Description
PR Interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT Interval
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C4072785
Description
QTcF Calculation
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Method or QTc Calculatlon
Data type
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Machine record: QTcB (Bazett)
Data type
boolean
Alias
- UMLS CUI [1]
- C1882512
Description
Machine record: QTcB (Bazett)
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1]
- C1882512
Description
Machine record: QTc Interval, unspecified method of correction
Data type
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
Data type
float
Measurement units
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0205370
- UMLS CUI [1,3]
- C2911685
Description
RR interval
Data type
integer
Alias
- UMLS CUI [1]
- C0489636
Description
Manual record: RR Interval
Data type
float
Measurement units
- 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
Data type
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])