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ID

41634

Description

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

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Versions (2)
  1. 11/9/20 11/9/20 -
  2. 11/29/20 11/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 29, 2020

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License

Creative Commons BY 4.0
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    Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

    English

    Screening - Vital Signs; General Medical History; Physical Exam

    1 forms  
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Site
    Description

    Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164
    Subject
    Description

    Subject

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Status
    Description

    Status

    Data type

    text

    Alias
    UMLS CUI [1]
    C0449438
    Doc #
    Description

    Doc #

    Data type

    text

    Alias
    UMLS CUI [1]
    C1301746
    Is Page Blank?
    Description

    Is Page Blank?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1704732
    UMLS CUI [1,2]
    C0750479
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Vital Signs (sitting)
    Description

    Vital Signs (sitting)

    Alias
    UMLS CUI-1
    C0518766
    UMLS CUI-2
    C0277814
    Vital Signs Date
    Description

    Vital Signs Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826644
    Vital Signs Time
    Description

    Vital Signs Time

    Data type

    time

    Alias
    UMLS CUI [1]
    C2826762
    Systolic Blood Pressure
    Description

    Systolic Blood Pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Description

    Diastolic Blood Pressure

    Data type

    integer

    Measurement units
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Temperature
    Description

    Temperature

    Data type

    float

    Measurement units
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Heart Rate
    Description

    Heart Rate

    Data type

    integer

    Measurement units
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Height
    Description

    Height

    Data type

    integer

    Measurement units
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Description

    Weight

    Data type

    integer

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    BMI
    Description

    BMI

    Data type

    integer

    Measurement units
    • kg/m^2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m^2
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    General Medical History
    Description

    General Medical History

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0031809
    Body System
    Description

    Body System

    Data type

    text

    Alias
    UMLS CUI [1]
    C0460002
    Specific Condition
    Description

    Specific Condition

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348235
    Condition Status
    Description

    Condition Status

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3176928
    Condition Start Date
    Description

    Condition Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0808070
    Condition End Date
    Description

    Condition End Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0806020
    Physical Exam
    Description

    Physical Exam

    Alias
    UMLS CUI-1
    C0031809
    Date of Physical Exam
    Description

    Date of Physical Exam

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826643
    Physical Exam
    Description

    Physical Exam

    Alias
    UMLS CUI-1
    C0031809
    Physical Exam - Assessment
    Description

    Physical Exam - Assessment

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809
    UMLS CUI [2]
    C1516048
    Physical Exam - Result
    Description

    Physical Exam - Result

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0031809
    UMLS CUI [2]
    C1274040
    Physical Exam - Only Specify Abnormality
    Description

    Physical Exam - Only Specify Abnormality

    Data type

    text

    Alias
    UMLS CUI [1]
    C0031809
    UMLS CUI [2]
    C1704258
    UMLS CUI [3]
    C2348235
    Back to the top of the page

    Similar models

    Screening - Vital Signs; General Medical History; Physical Exam

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Subject
    Item
    Subject
    text
    C2348585 (UMLS CUI [1])
    Status
    Item
    Status
    text
    C0449438 (UMLS CUI [1])
    Doc #
    Item
    Doc #
    text
    C1301746 (UMLS CUI [1])
    Is Page Blank?
    Item
    Is Page Blank?
    boolean
    C1704732 (UMLS CUI [1,1])
    C0750479 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Vital Signs (sitting)
    C0518766 (UMLS CUI-1)
    C0277814 (UMLS CUI-2)
    Vital Signs Date
    Item
    Vital Signs Date
    date
    C2826644 (UMLS CUI [1])
    Vital Signs Time
    Item
    Vital Signs Time
    time
    C2826762 (UMLS CUI [1])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0428883 (UMLS CUI [1])
    Temperature
    Item
    Temperature
    float
    C0005903 (UMLS CUI [1])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    integer
    C0005910 (UMLS CUI [1])
    BMI
    Item
    BMI
    integer
    C1305855 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    General Medical History
    C0262926 (UMLS CUI-1)
    C0031809 (UMLS CUI-2)
    Item
    Body System
    text
    C0460002 (UMLS CUI [1])
    Body System
    Code List
    Body System
    CL Item
    Blood and lymphatic system disorders (1)
    CL Item
    Ear and labyrinth disorders (2)
    CL Item
    Endocrine disorders (3)
    CL Item
    Eye disorders (4)
    CL Item
    Immune system disorders (including allergies) (5)
    CL Item
    Metabolism and nutrition disorders (6)
    CL Item
    Musculoskeletal and connective tissue disorders (7)
    CL Item
    Neoplasms benign, malignant and unspecified (including cysts and polyps) (8)
    CL Item
    Nervous system disorders (9)
    CL Item
    Psychiatric disorders (10)
    CL Item
    Renal and urinary disorders (11)
    CL Item
    Reproductive system and breast disorders (12)
    CL Item
    Respiratory, thoracic, and mediastinal disorders (including asthma) (13)
    CL Item
    Infections and infestations (14)
    CL Item
    Congenital, familial and genetic disorders (15)
    CL Item
    General disorders and administration site conditions (16)
    CL Item
    Injury, poisoning, and procedural complications (17)
    CL Item
    Cardiovascular disorder (18)
    CL Item
    Gastrointestinal disorder (19)
    CL Item
    Hepatobiliary disorders (20)
    CL Item
    Skin and subcutaneous tissue disorders (21)
    CL Item
    Vascular disorders (22)
    CL Item
    Other (Z)
    Specific Condition
    Item
    Specific Condition
    text
    C0012634 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Item
    Condition Status
    integer
    C3176928 (UMLS CUI [1])
    Condition Status
    Code List
    Condition Status
    CL Item
    Current (1)
    CL Item
    Past (2)
    CL Item
    No medical condition (3)
    Condition Start Date
    Item
    Condition Start Date
    date
    C0012634 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Condition End Date
    Item
    Condition End Date
    date
    C0012634 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Item Group
    Physical Exam
    C0031809 (UMLS CUI-1)
    Date of Physical Exam
    Item
    Date of Physical Exam
    date
    C2826643 (UMLS CUI [1])
    Item Group
    Physical Exam
    C0031809 (UMLS CUI-1)
    Item
    Physical Exam - Assessment
    integer
    C0031809 (UMLS CUI [1])
    C1516048 (UMLS CUI [2])
    Physical Exam - Assessment
    Code List
    Physical Exam - Assessment
    CL Item
    Skin including Injection Site (1)
    CL Item
    Head, Eyes, Ears, Nose, Throat (2)
    CL Item
    Thyroid (3)
    CL Item
    Central Nervous System (4)
    CL Item
    Resoiratory System (5)
    CL Item
    Cardiovascular System (6)
    CL Item
    Abdomen (Liver and Spleen) (7)
    Item
    Physical Exam - Result
    integer
    C0031809 (UMLS CUI [1])
    C1274040 (UMLS CUI [2])
    Physical Exam - Result
    Code List
    Physical Exam - Result
    CL Item
    Normal (1)
    CL Item
    Abnormal (2)
    CL Item
    Not Done (3)
    Physical Exam - Only Specify Abnormality
    Item
    Physical Exam - Only Specify Abnormality
    text
    C0031809 (UMLS CUI [1])
    C1704258 (UMLS CUI [2])
    C2348235 (UMLS CUI [3])
    Back to the top of the page 

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