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ID

25853

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: Unscheduled visit

Keywords

Versions (3)
  1. 9/21/17 9/21/17 -
  2. 10/23/17 10/23/17 -
  3. 12/22/17 12/22/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 21, 2017

DOI

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License

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

    English

    Unscheduled visit GSK study Chronic Coronary Heart Disease NCT00799903

    1 forms  
    Status of visit
    Description

    Status of visit

    1. Which assessments were performed at this unscheduled visit?
    Description

    PK sample collection performed at GSK request for sentinel event

    Data type

    integer

    PK sample collection performed at GSK request for sentinel event
    Description

    PK sample collection performed at GSK request for sentinel event

    1. Was a pharmacokinetic blood sample obtained?
    Description

    pharmacokinetic blood sample obtained

    Data type

    boolean

    If yes, date sample taken
    Description

    date sample taken

    Data type

    date

    if yes, time sample taken
    Description

    time sample taken

    Data type

    time

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

    date of last investigational product dose

    Data type

    date

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

    time of last investigational product dose

    Data type

    time

    Sample Identifier/Sample Number
    Description

    Sample Identifier/Sample Number

    Data type

    text

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    Similar models

    Unscheduled visit GSK study Chronic Coronary Heart Disease NCT00799903

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Status of visit
    Item
    1. Which assessments were performed at this unscheduled visit?
    integer
    Assessments
    Code List
    1. Which assessments were performed at this unscheduled visit?
    CL Item
    Vital signs (1)
    CL Item
    ECG (2)
    CL Item
    Lab - blood sample (3)
    CL Item
    Urine dipstick (4)
    CL Item
    PK (5)
    Item Group
    PK sample collection performed at GSK request for sentinel event
    pharmacokinetic blood sample obtained
    Item
    1. Was a pharmacokinetic blood sample obtained?
    boolean
    date sample taken
    Item
    If yes, date sample taken
    date
    time sample taken
    Item
    if yes, time sample taken
    time
    date of last investigational product dose
    Item
    If Yes, date of last investigational product dose prior to PK sample
    date
    time of last investigational product dose
    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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