ID
33740
Beschreibung
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
Stichworte
Versionen (1)
- 21.12.18 21.12.18 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
21. Dezember 2018
DOI
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Lizenz
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
Beschreibung
12-LEAD ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Please take for screening three measurements. For Follow-up just one measurement. For Repeat you can take as many as necessary.
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0237753
- UMLS CUI [1,2]
- C1623258
Beschreibung
day month year
Datentyp
date
Alias
- UMLS CUI [1]
- C2826640
Beschreibung
00:00-23:59
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschreibung
Heart rate ECG
Datentyp
integer
Maßeinheiten
- beats / min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C1623258
Beschreibung
PR Interval
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Duration
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschreibung
Uncorrected QT Interval
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C1287082
- UMLS CUI [1,2]
- C4072785
Beschreibung
QTcF Calculation
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschreibung
Method or QTc Calculatlon
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschreibung
Machine record: QTcB (Bazett)
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1882512
Beschreibung
Machine record: QTcB (Bazett)
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1]
- C1882512
Beschreibung
Machine record: QTc Interval, unspecified method of correction
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0205370
- UMLS CUI [1,3]
- C2911685
Beschreibung
Machine record: QTc Interval, unspecified method of correction
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0205370
- UMLS CUI [1,3]
- C2911685
Beschreibung
RR interval
Datentyp
integer
Alias
- UMLS CUI [1]
- C0489636
Beschreibung
Manual record: RR Interval
Datentyp
float
Maßeinheiten
- msec
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C0175674
- UMLS CUI [1,3]
- C0243095
- UMLS CUI [2]
- C0489636
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Ähnliche Modelle
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])