ID

32010

Description

Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

Keywords

Versions (1)
  1. 10/11/18 10/11/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 11, 2018

DOI

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License

Creative Commons BY-NC 3.0
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Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125

English

Inform Screening, Enrolment, Date of visit, Demography

1 forms  
Inform Screening
Description

Inform Screening

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C1710032
Subject initials
Description

Person Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Date of birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Inform Enrolment
Description

Inform Enrolment

Alias
UMLS CUI-1
C1552002
UMLS CUI-2
C4041024
Subject number
Description

Clinical Trial Subject Unique Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Alias
UMLS CUI-1
C1320303
Date of Visit/ Assessment
Description

Date of visit | Assessment Date

Data type

date

Alias
UMLS CUI [1]
C1320303
UMLS CUI [2]
C2985720
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Description

Patient date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
If female, record child- bearing potential
Description

Female of child bearing age

Data type

integer

Alias
UMLS CUI [1]
C1960468
Ethnicity
Description

Ethnic group

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry - check all that apply.
Description

Your ancestry or national origin

Data type

integer

Alias
UMLS CUI [1]
C3841890
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Similar models

Inform Screening, Enrolment, Date of visit, Demography

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inform Screening
C1552002 (UMLS CUI-1)
C1710032 (UMLS CUI-2)
Person Initials
Item
Subject initials
text
C2986440 (UMLS CUI [1])
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item Group
Inform Enrolment
C1552002 (UMLS CUI-1)
C4041024 (UMLS CUI-2)
Clinical Trial Subject Unique Identifier
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Date of visit
C1320303 (UMLS CUI-1)
Date of visit | Assessment Date
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1])
C2985720 (UMLS CUI [2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Patient date of birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
If female, record child- bearing potential
integer
C1960468 (UMLS CUI [1])
Female of child bearing age
Code List
If female, record child- bearing potential
CL Item
Post- menopausal (2)
CL Item
Sterile (of child- bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnic group
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic ancestry - check all that apply.
integer
C3841890 (UMLS CUI [1])
Your ancestry or national origin
Code List
Geographic ancestry - check all that apply.
CL Item
African American/ African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/ South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/ North African Heritage (18)
CL Item
White - White/ Caucasian/ European Heritage (19)
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