ID

42299

Beschreibung

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

Stichworte

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  1. 12.05.21 12.05.21 -
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GlaxoSmithKline

Hochgeladen am

12. Mai 2021

DOI

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Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533)

Englisch

Pharmacogenetics

1 Formulare  
  1. StudyEvent: ODM
    1. Pharmacogenetics
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beschreibung

Patient

Datentyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beschreibung

Patient Number

Datentyp

text

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

Date of visit/assessment

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

Date of visit/assessment

Datentyp

date

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

PGx-Pharmacogenetic Research Consent

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

Has informed consent been otained for PGx-Pharmacogenetic research?

Datentyp

boolean

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

Date informed consent obtained for PGx-Pharmacogenetic research

Datentyp

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?
Beschreibung

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

Datentyp

boolean

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

Record Date sample taken

Datentyp

date

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

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

Datentyp

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
Beschreibung

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

Datentyp

text

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

Genetics Type

Datentyp

text

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

Pharmacogenetic Research Withdrawal of Consent

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

Has subject withdrawn consent for PGx-Pharmacogenetic research?

Datentyp

boolean

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

Has a request been made for sample destruction?

Datentyp

boolean

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

If request for sample destruction has been made, check reason

Datentyp

integer

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

Specify other reason for sample destruction

Datentyp

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
Beschreibung

Genetics Type

Datentyp

text

Alias
UMLS CUI [1,1]
C0017399
UMLS CUI [1,2]
C0332307
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Ähnliche Modelle

Pharmacogenetics

1 Formulare
  1. StudyEvent: ODM
    1. Pharmacogenetics
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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