ID

28401

Descripción

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Pharmacokinetics (Liver PK)

Palabras clave

Versiones (5)
  1. 11/10/2017 11/10/2017 -
  2. 16/10/2017 16/10/2017 -
  3. 16/10/2017 16/10/2017 -
  4. 23/10/2017 23/10/2017 -
  5. 11/01/2018 11/01/2018 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 janvier 2018

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Pharmacokinetics Liver GSK study Chronic Coronary Heart Disease NCT00799903

    Inglés

    Pharmacokinetics Liver GSK study Chronic Coronary Heart Disease NCT00799903

    1 formularios  
    An unscheduled PK blood sample must be obtained within 72 hours of last dose.
    Descripción

    An unscheduled PK blood sample must be obtained within 72 hours of last dose.

    1. Was a pharmacokinetic blood sample obtained?
    Descripción

    pharmacokinetic blood sample

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0031328
    UMLS CUI [1,2]
    C0178913
    If yes, date sample taken
    Descripción

    date blood sample taken

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C1277698
    UMLS CUI [1,2]
    C0011008
    If yes, time sample taken
    Descripción

    time blood sample taken

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0040223
    If Yes, date of last investigational product dose prior to PK sample
    Descripción

    date last investigational product dose prior to PK sample

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0678766
    If Yes, time of last investigational product dose prior to PK sample
    Descripción

    time last investigational product dose prior to PK sample

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0678766
    Sample Identifier/Sample Number
    Descripción

    Sample Identifier and Sample Number are conditional. The study team must choose one for inclusion on the eCRF form.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1299222
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    Similar models

    Pharmacokinetics Liver GSK study Chronic Coronary Heart Disease NCT00799903

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    An unscheduled PK blood sample must be obtained within 72 hours of last dose.
    pharmacokinetic blood sample
    Item
    1. Was a pharmacokinetic blood sample obtained?
    boolean
    C0031328 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    date blood sample taken
    Item
    If yes, date sample taken
    date
    C1277698 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    time blood sample taken
    Item
    If yes, time sample taken
    time
    C0005834 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    date last investigational product dose prior to PK sample
    Item
    If Yes, date of last investigational product dose prior to PK sample
    date
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0678766 (UMLS CUI [1,3])
    time last investigational product dose prior to PK sample
    Item
    If Yes, time of last investigational product dose prior to PK sample
    time
    C0011008 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0678766 (UMLS CUI [1,3])
    Sample Identifier/Sample Number
    Item
    Sample Identifier/Sample Number
    integer
    C1299222 (UMLS CUI [1])
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