ID

34006

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 Vital signs. It has to be filled in for all treatment periods (1-4) for Day 1 and Day 7.

Länk

https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026

Nyckelord

  1. 2019-01-10 2019-01-10 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

10 januari 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY-NC 3.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Effect of inhaled fluticasone furoate combination on electrocardiographic parametersin healthy subjects, NCT01209026

Vital signs, TP1-4 Day 1 and 7

Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Treatment period and Day of treatment period
Beskrivning

Treatment period and Day of treatment period

Datatyp

integer

Alias
UMLS CUI [1]
C0087111
Vital Signs
Beskrivning

Vital Signs

Alias
UMLS CUI-1
C0518766
Planned relative time
Beskrivning

For treatment period 1 Day 1 tick only for predose and 1 hr. For the measurements at Day 7 tick all. For each time take three measurements.

Datatyp

integer

Alias
UMLS CUI [1]
C0439564
Actual date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Actual time
Beskrivning

00:00-23:59

Datatyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Blood pressure: systolic
Beskrivning

Blood pressure: systolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure: diastolic
Beskrivning

Blood pressure: diastolic

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Heart rate
Beskrivning

Heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min

Similar models

Vital signs, TP1-4 Day 1 and 7

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Treatment period and Day of treatment period
integer
C0087111 (UMLS CUI [1])
Code List
Treatment period and Day of treatment period
CL Item
TP1D1 (1)
CL Item
TP1D7 (2)
CL Item
TP2D1 (3)
CL Item
TP2D7 (4)
CL Item
TP3D1 (5)
CL Item
TP3D7 (6)
CL Item
TP4D1 (7)
CL Item
TP4D7 (8)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Item
Planned relative time
integer
C0439564 (UMLS CUI [1])
Code List
Planned relative time
CL Item
Pre dose  (1)
CL Item
10 min post dose (2)
CL Item
1 hr post dose (3)
CL Item
2 hr post dose (4)
CL Item
6 hr post dose (5)
CL Item
1 hr post dose (3)
CL Item
12 hr post dose (6)
CL Item
24 hr post dose (7)
Actual date
Item
Actual date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood pressure: systolic
Item
Blood pressure: systolic
integer
C0871470 (UMLS CUI [1])
Blood pressure: diastolic
Item
Blood pressure: diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial