ID

42299

Descrição

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

Palavras-chave

Versões (1)
  1. 12/05/2021 12/05/2021 -
Titular dos direitos

GlaxoSmithKline

Transferido a

12 de maio de 2021

DOI

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Licença

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

    Inglês

    Pharmacogenetics

    1 Formulários  
    1. StudyEvent: ODM
      1. Pharmacogenetics
    Administrative
    Descrição

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Site
    Descrição

    Site

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C2825164
    Patient
    Descrição

    Patient

    Tipo de dados

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient Number
    Descrição

    Patient Number

    Tipo de dados

    text

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

    Date of visit/assessment

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

    Date of visit/assessment

    Tipo de dados

    date

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

    PGx-Pharmacogenetic Research Consent

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

    Has informed consent been otained for PGx-Pharmacogenetic research?

    Tipo de dados

    boolean

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

    Date informed consent obtained for PGx-Pharmacogenetic research

    Tipo de dados

    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?
    Descrição

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

    Tipo de dados

    boolean

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

    Record Date sample taken

    Tipo de dados

    date

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

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

    Tipo de dados

    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
    Descrição

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

    Tipo de dados

    text

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

    Genetics Type

    Tipo de dados

    text

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

    Pharmacogenetic Research Withdrawal of Consent

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

    Has subject withdrawn consent for PGx-Pharmacogenetic research?

    Tipo de dados

    boolean

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

    Has a request been made for sample destruction?

    Tipo de dados

    boolean

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

    If request for sample destruction has been made, check reason

    Tipo de dados

    integer

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

    Specify other reason for sample destruction

    Tipo de dados

    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
    Descrição

    Genetics Type

    Tipo de dados

    text

    Alias
    UMLS CUI [1,1]
    C0017399
    UMLS CUI [1,2]
    C0332307
    Voltar ao início da página

    Similar models

    Pharmacogenetics

    1 Formulários
    1. StudyEvent: ODM
      1. Pharmacogenetics
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    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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