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ID

28311

Beschrijving

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 - Repeating form (Scheduled visits)

Trefwoorden

  1. 05-10-17 05-10-17 -
  2. 16-10-17 16-10-17 -
  3. 23-10-17 23-10-17 -
  4. 03-01-18 03-01-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

3 januari 2018

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

    Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

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

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

    1. Was a pharmacokinetic blood sample obtained?
    Beschrijving

    pharmacokinetic blood sample

    Datatype

    boolean

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

    Date of blood sample

    Datatype

    date

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    If yes, time taken
    Beschrijving

    Time of blood sample

    Datatype

    time

    Alias
    UMLS CUI [1,1]
    C0200345
    UMLS CUI [1,2]
    C0040223
    If Yes, date of last investigational product dose prior to PK sample
    Beschrijving

    date of last investigational product dose prior to PK sample

    Datatype

    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
    Beschrijving

    time of last investigational product dose prior to PK sample

    Datatype

    time

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

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

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1299222

    Similar models

    Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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 of blood sample
    Item
    If yes, date taken
    date
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of blood sample
    Item
    If yes, time taken
    time
    C0200345 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    date of 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 of 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
    text
    C1299222 (UMLS CUI [1])

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