ID

26045

Description

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)

Keywords

Versions (4)
  1. 10/5/17 10/5/17 -
  2. 10/16/17 10/16/17 -
  3. 10/23/17 10/23/17 -
  4. 1/3/18 1/3/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 5, 2017

DOI

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License

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

    English

    Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

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

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

    1. Was a pharmacokinetic blood sample obtained?
    Description

    pharmacokinetic blood sample

    Data type

    boolean

    If yes, date taken
    Description

    Date of blood sample

    Data type

    date

    If yes, time taken
    Description

    Time of blood sample

    Data type

    time

    If Yes, date of last investigational product dose prior to PK sample
    Description

    date of last investigational product dose prior to PK sample

    Data type

    date

    If Yes, time of last investigational product dose prior to PK sample
    Description

    time of last investigational product dose prior to PK sample

    Data type

    time

    Sample Identifier/Sample Number
    Description

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

    Data type

    text

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    Pharmacokinetics GSK study Chronic Coronary Heart Disease NCT00799903

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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
    Date of blood sample
    Item
    If yes, date taken
    date
    Time of blood sample
    Item
    If yes, time taken
    time
    date of last investigational product dose prior to PK sample
    Item
    If Yes, date of last investigational product dose prior to PK sample
    date
    time of last investigational product dose prior to PK sample
    Item
    If Yes, time of last investigational product dose prior to PK sample
    time
    Sample Identifier/Sample Number
    Item
    Sample Identifier/Sample Number
    text
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