ID

42299

Description

Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension

Keywords

Versions (1)
  1. 5/12/21 5/12/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 12, 2021

DOI

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License

Creative Commons BY 4.0
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Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533)

English

Pharmacogenetics

1 forms  
  1. StudyEvent: ODM
    1. Pharmacogenetics
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit/assessment
Description

Date of visit/assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-3
C2985720
Date of visit/assessment
Description

Date of visit/assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
PGx-Pharmacogenetic Research Consent
Description

PGx-Pharmacogenetic Research Consent

Alias
UMLS CUI-1
C2347500
UMLS CUI-3
C0021430
Has informed consent been otained for PGx-Pharmacogenetic research?
Description

Has informed consent been otained for PGx-Pharmacogenetic research?

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2347500
Date informed consent obtained for PGx-Pharmacogenetic research
Description

Date informed consent obtained for PGx-Pharmacogenetic research

Data type

date

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2347500
UMLS CUI [3]
C0011008
Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research?
Description

Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research?

Data type

boolean

Alias
UMLS CUI [1,1]
C2347500
UMLS CUI [1,2]
C0005834
Record Date sample taken
Description

Record Date sample taken

Data type

date

Alias
UMLS CUI [1]
C1302413
If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason
Description

If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason

Data type

integer

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C2347500
UMLS CUI [3]
C0392360
If other reason for informed consent has not been obtained, specify
Description

If other reason for informed consent has not been obtained, specify

Data type

text

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0566251
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C2348235
Genetics Type
Description

Genetics Type

Data type

text

Alias
UMLS CUI [1,1]
C0017399
UMLS CUI [1,2]
C0332307
Pharmacogenetic Research Withdrawal of Consent
Description

Pharmacogenetic Research Withdrawal of Consent

Alias
UMLS CUI-1
C1707492
UMLS CUI-3
C0031325
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Description

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Data type

boolean

Alias
UMLS CUI [1]
C2347500
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C2349954
Has a request been made for sample destruction?
Description

Has a request been made for sample destruction?

Data type

boolean

Alias
UMLS CUI [1]
C1948029
UMLS CUI [2]
C0178913
UMLS CUI [3]
C1272683
If request for sample destruction has been made, check reason
Description

If request for sample destruction has been made, check reason

Data type

integer

Alias
UMLS CUI [1]
C1948029
UMLS CUI [2]
C0178913
UMLS CUI [3]
C1272683
UMLS CUI [4]
C0392360
Specify other reason for sample destruction
Description

Specify other reason for sample destruction

Data type

text

Alias
UMLS CUI [1]
C1948029
UMLS CUI [2]
C0178913
UMLS CUI [3]
C0392360
UMLS CUI [4,1]
C0205394
UMLS CUI [4,2]
C2348235
Genetics Type
Description

Genetics Type

Data type

text

Alias
UMLS CUI [1,1]
C0017399
UMLS CUI [1,2]
C0332307
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Similar models

Pharmacogenetics

1 forms
  1. StudyEvent: ODM
    1. Pharmacogenetics
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-3)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
PGx-Pharmacogenetic Research Consent
C2347500 (UMLS CUI-1)
C0021430 (UMLS CUI-3)
Has informed consent been otained for PGx-Pharmacogenetic research?
Item
Has informed consent been otained for PGx-Pharmacogenetic research?
boolean
C0021430 (UMLS CUI [1])
C2347500 (UMLS CUI [2])
Date informed consent obtained for PGx-Pharmacogenetic research
Item
Date informed consent obtained for PGx-Pharmacogenetic research
date
C0021430 (UMLS CUI [1])
C2347500 (UMLS CUI [2])
C0011008 (UMLS CUI [3])
Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research?
Item
Has a blood sample been collected for PGx-Pharmacogenetic (DNA) research?
boolean
C2347500 (UMLS CUI [1,1])
C0005834 (UMLS CUI [1,2])
Record Date sample taken
Item
Record Date sample taken
date
C1302413 (UMLS CUI [1])
Item
If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason
integer
C0021430 (UMLS CUI [1])
C2347500 (UMLS CUI [2])
C0392360 (UMLS CUI [3])
If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason
Code List
If no informed consent has been obtained for PGx-Pharmacogenetic research, check reason
CL Item
Subject declined (1)
CL Item
Subject not asked by Investigator (2)
CL Item
Other, specify (3)
If other reason for informed consent has not been obtained, specify
Item
If other reason for informed consent has not been obtained, specify
text
C0021430 (UMLS CUI [1])
C0566251 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C2348235 (UMLS CUI [2,3])
Genetics Type
Item
Genetics Type
text
C0017399 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Item Group
Pharmacogenetic Research Withdrawal of Consent
C1707492 (UMLS CUI-1)
C0031325 (UMLS CUI-3)
Has subject withdrawn consent for PGx-Pharmacogenetic research?
Item
Has subject withdrawn consent for PGx-Pharmacogenetic research?
boolean
C2347500 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C2349954 (UMLS CUI [2,2])
Has a request been made for sample destruction?
Item
Has a request been made for sample destruction?
boolean
C1948029 (UMLS CUI [1])
C0178913 (UMLS CUI [2])
C1272683 (UMLS CUI [3])
Item
If request for sample destruction has been made, check reason
integer
C1948029 (UMLS CUI [1])
C0178913 (UMLS CUI [2])
C1272683 (UMLS CUI [3])
C0392360 (UMLS CUI [4])
If request for sample destruction has been made, check reason
Code List
If request for sample destruction has been made, check reason
CL Item
Subject requested (1)
CL Item
Screen failure (2)
CL Item
Other, specify (3)
Specify other reason for sample destruction
Item
Specify other reason for sample destruction
text
C1948029 (UMLS CUI [1])
C0178913 (UMLS CUI [2])
C0392360 (UMLS CUI [3])
C0205394 (UMLS CUI [4,1])
C2348235 (UMLS CUI [4,2])
Genetics Type
Item
Genetics Type
text
C0017399 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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