ID
33703
Descripción
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.
Link
https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026
Palabras clave
Versiones (2)
- 20/12/18 20/12/18 -
- 20/12/18 20/12/18 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
20 de diciembre de 2018
DOI
Para solicitar uno, por favor iniciar sesión.
Licencia
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
Descripción
Study conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0805839
Descripción
If yes complete the following items for withdrawing information
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0422727
Descripción
day month year
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0011008
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Descripción
Investigator discretion
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0008961
- UMLS CUI [1,2]
- C0022423
Descripción
Data owner should check the box when data cleaning is complete. Item Is not required
Tipo de datos
text
Alias
- UMLS CUI [1]
- C1519316
Descripción
Office Use 1
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0442603
Descripción
Office Use 2
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0442603
- UMLS CUI [1,2]
- C0237753
Descripción
Pregnancy information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
For females. If Yes, complete the paper Pregnancy Notification form
Tipo de datos
text
Alias
- UMLS CUI [1]
- C3828490
Descripción
For males. If Yes, complete the paper Pregnancy Notification form. Check Not Applicable if female partner not of childbearing potential or no female partner.
Tipo de datos
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])