ID
33703
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 the study conclusion form and the pregnancy information. It has to be filled in for the end of study.
Lien
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Mots-clés
Versions (2)
- 20/12/2018 20/12/2018 -
- 20/12/2018 20/12/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
20 décembre 2018
DOI
Pour une demande vous connecter.
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
Study conclusion, pregnancy information
- StudyEvent: ODM
Description
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Description
day month year
Type de données
date
Alias
- UMLS CUI [1]
- C0805839
Description
If yes complete the following items for withdrawing information
Type de données
text
Alias
- UMLS CUI [1]
- C0422727
Description
day month year
Type de données
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0011008
Description
If you tick 1: Record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. To 5: Select this reason if none of the other primary reasons are appropriate. 5, 7 and 8 are optional.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Description
Investigator discretion
Type de données
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0022423
Description
Data owner should check the box when data cleaning is complete. Item Is not required
Type de données
text
Alias
- UMLS CUI [1]
- C1519316
Description
Office Use 1
Type de données
text
Alias
- UMLS CUI [1]
- C0442603
Description
Office Use 2
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0442603
- UMLS CUI [1,2]
- C0237753
Description
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
For females. If Yes, complete the paper Pregnancy Notification form
Type de données
text
Alias
- UMLS CUI [1]
- C3828490
Description
For males. If Yes, complete the paper Pregnancy Notification form. Check Not Applicable if female partner not of childbearing potential or no female partner.
Type de données
text
Alias
- UMLS CUI [1]
- C3828490
- UMLS CUI [2,1]
- C0919624
- UMLS CUI [2,2]
- C0086287
Similar models
Study conclusion, pregnancy information
- StudyEvent: ODM
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,2])
C0919624 (UMLS CUI [2,1])
C0086287 (UMLS CUI [2,2])