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41633

Beschreibung

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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  1. 09.11.20 09.11.20 -
  2. 29.11.20 29.11.20 -
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GlaxoSmithKline

Hochgeladen am

29. November 2020

DOI

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

    Englisch

    Day -1 - Admission Criteria; Vital Signs; Electrocardiogram; Central Laboratory

    1 Formulare  
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Site
    Beschreibung

    Site

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2825164
    Subject
    Beschreibung

    Subject

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Status
    Beschreibung

    Status

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0449438
    Doc#
    Beschreibung

    Doc#

    Datentyp

    integer

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

    Is Page Blank?

    Datentyp

    boolean

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

    Visit Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1320303
    Admission Criteria
    Beschreibung

    Admission Criteria

    Alias
    UMLS CUI-1
    C0030673
    UMLS CUI-2
    C0243161
    Protocol Date
    Beschreibung

    Protocol Date

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C2985700
    UMLS CUI [1,2]
    C0011008
    Does the subject continue to meet all eligibility criteria?
    Beschreibung

    Does the subject continue to meet all eligibility criteria?

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C1516637
    Vital Signs (sitting)
    Beschreibung

    Vital Signs (sitting)

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

    Vital Signs Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826644
    Vital Signs Time
    Beschreibung

    Vital Signs Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C2826762
    Systolic Blood Pressure
    Beschreibung

    Systolic Blood Pressure

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0871470
    mm[Hg]
    Diastolic Blood Pressure
    Beschreibung

    Diastolic Blood Pressure

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1]
    C0428883
    mm[Hg]
    Temperature
    Beschreibung

    Temperature

    Datentyp

    float

    Maßeinheiten
    • °C
    Alias
    UMLS CUI [1]
    C0005903
    °C
    Heart Rate
    Beschreibung

    Heart Rate

    Datentyp

    integer

    Maßeinheiten
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    Comment
    Beschreibung

    Comment

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    Electrocardiogram
    Beschreibung

    Electrocardiogram

    Alias
    UMLS CUI-1
    C0013798
    Date ECG Performed
    Beschreibung

    Date ECG Performed

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0011008
    Time ECG Performed
    Beschreibung

    Time ECG Performed

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0013798
    UMLS CUI [1,2]
    C0040223
    Heart Rate
    Beschreibung

    Heart Rate

    Datentyp

    integer

    Maßeinheiten
    • bmp
    Alias
    UMLS CUI [1]
    C0018810
    bmp
    PR Interval
    Beschreibung

    PR Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C0429087
    ms
    QRS Duration
    Beschreibung

    QRS Duration

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C0429025
    ms
    QT Interval
    Beschreibung

    QT Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C1287082
    ms
    QTcB Interval
    Beschreibung

    QTcB Interval

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1882512
    UMLS CUI [1,2]
    C0855331
    QTcF Interval
    Beschreibung

    QTcF Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C1882513
    ms
    RR Interval
    Beschreibung

    RR Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C0489636
    ms
    Normal Sinus Rhythmus?
    Beschreibung

    Normal Sinus Rhythmus?

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0232202
    Overall interpretation of ECG:
    Beschreibung

    Overall interpretation of ECG:

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1623258
    UMLS CUI [1,2]
    C0459471
    If abnormal, please specify
    Beschreibung

    If abnormal, please specify

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0243095
    UMLS CUI [1,2]
    C0205161
    UMLS CUI [1,3]
    C2348235
    Central Laboratory - Haematology
    Beschreibung

    Central Laboratory - Haematology

    Alias
    UMLS CUI-1
    C1880016
    UMLS CUI-2
    C0018941
    Was the laboratory sample collected? (Haematology)
    Beschreibung

    Was the laboratory sample collected? (Haematology)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    UMLS CUI [2]
    C0018941
    Sample Date (Haematology)
    Beschreibung

    Sample Date (Haematology)

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    UMLS CUI [2]
    C0018941
    Sample Time (Haematology)
    Beschreibung

    Sample Time (Haematology)

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0005834
    UMLS CUI [2]
    C0040223
    UMLS CUI [3]
    C0018941
    Comment (Haematology)
    Beschreibung

    Comment (Haematology)

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    UMLS CUI [2]
    C0018941
    Central Laboratory - Chemistry
    Beschreibung

    Central Laboratory - Chemistry

    Alias
    UMLS CUI-1
    C1880016
    UMLS CUI-2
    C0008000
    Was the laboratory sample collected? (Chemistry)
    Beschreibung

    Was the laboratory sample collected? (Chemistry)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    UMLS CUI [2]
    C0008000
    Sample Date (Chemistry)
    Beschreibung

    Sample Date (Chemistry)

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    UMLS CUI [2]
    C0008000
    Sample Time (Chemistry)
    Beschreibung

    Sample Time (Chemistry)

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0005834
    UMLS CUI [2]
    C0040223
    UMLS CUI [3]
    C0008000
    Comment (Chemistry)
    Beschreibung

    Comment (Chemistry)

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    UMLS CUI [2]
    C0008000
    Central Laboratory - UA/ UDS/ Urine HCG/ Urine Chem
    Beschreibung

    Central Laboratory - UA/ UDS/ Urine HCG/ Urine Chem

    Alias
    UMLS CUI-1
    C1880016
    UMLS CUI-2
    C0430056
    UMLS CUI-3
    C0864414
    Was the laboratory sample collected? (Urine)
    Beschreibung

    Was the laboratory sample collected? (Urine)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005834
    UMLS CUI [2]
    C0864414
    Sample Date (Urine)
    Beschreibung

    Sample Date (Urine)

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C1302413
    UMLS CUI [2]
    C0864414
    Sample Time (Urine)
    Beschreibung

    Sample Time (Urine)

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0005834
    UMLS CUI [2]
    C0040223
    UMLS CUI [3]
    C0864414
    Comment (Urine)
    Beschreibung

    Comment (Urine)

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0947611
    UMLS CUI [2]
    C0864414
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Day -1 - Admission Criteria; Vital Signs; Electrocardiogram; Central Laboratory

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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#
    integer
    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
    Admission Criteria
    C0030673 (UMLS CUI-1)
    C0243161 (UMLS CUI-2)
    Protocol Date
    Item
    Protocol Date
    date
    C2985700 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Does the subject continue to meet all eligibility criteria?
    Item
    Does the subject continue to meet all eligibility criteria?
    boolean
    C2348568 (UMLS CUI [1,1])
    C1516637 (UMLS CUI [1,2])
    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])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Electrocardiogram
    C0013798 (UMLS CUI-1)
    Date ECG Performed
    Item
    Date ECG Performed
    date
    C0013798 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time ECG Performed
    Item
    Time ECG Performed
    time
    C0013798 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    PR Interval
    Item
    PR Interval
    integer
    C0429087 (UMLS CUI [1])
    QRS Duration
    Item
    QRS Duration
    integer
    C0429025 (UMLS CUI [1])
    QT Interval
    Item
    QT Interval
    integer
    C1287082 (UMLS CUI [1])
    QTcB Interval
    Item
    QTcB Interval
    integer
    C1882512 (UMLS CUI [1,1])
    C0855331 (UMLS CUI [1,2])
    QTcF Interval
    Item
    QTcF Interval
    integer
    C0855331 (UMLS CUI [1,1])
    C1882513 (UMLS CUI [1,2])
    RR Interval
    Item
    RR Interval
    integer
    C0489636 (UMLS CUI [1])
    Normal Sinus Rhythmus?
    Item
    Normal Sinus Rhythmus?
    boolean
    C0232202 (UMLS CUI [1])
    Item
    Overall interpretation of ECG:
    integer
    C1623258 (UMLS CUI [1,1])
    C0459471 (UMLS CUI [1,2])
    Overall interpretation of ECG:
    Code List
    Overall interpretation of ECG:
    CL Item
    Normal  (1)
    CL Item
    Abnormal; Not Clinically Significant  (2)
    CL Item
    Abnormal; Clinically Significant (3)
    If abnormal, please specify
    Item
    If abnormal, please specify
    text
    C0243095 (UMLS CUI [1,1])
    C0205161 (UMLS CUI [1,2])
    C2348235 (UMLS CUI [1,3])
    Item Group
    Central Laboratory - Haematology
    C1880016 (UMLS CUI-1)
    C0018941 (UMLS CUI-2)
    Was the laboratory sample collected? (Haematology)
    Item
    Was the laboratory sample collected? (Haematology)
    boolean
    C0005834 (UMLS CUI [1])
    C0018941 (UMLS CUI [2])
    Sample Date (Haematology)
    Item
    Sample Date (Haematology)
    date
    C1302413 (UMLS CUI [1])
    C0018941 (UMLS CUI [2])
    Sample Time (Haematology)
    Item
    Sample Time (Haematology)
    time
    C0005834 (UMLS CUI [1])
    C0040223 (UMLS CUI [2])
    C0018941 (UMLS CUI [3])
    Comment (Haematology)
    Item
    Comment (Haematology)
    text
    C0947611 (UMLS CUI [1])
    C0018941 (UMLS CUI [2])
    Item Group
    Central Laboratory - Chemistry
    C1880016 (UMLS CUI-1)
    C0008000 (UMLS CUI-2)
    Was the laboratory sample collected? (Chemistry)
    Item
    Was the laboratory sample collected? (Chemistry)
    boolean
    C0005834 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    Sample Date (Chemistry)
    Item
    Sample Date (Chemistry)
    date
    C1302413 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    Sample Time (Chemistry)
    Item
    Sample Time (Chemistry)
    time
    C0005834 (UMLS CUI [1])
    C0040223 (UMLS CUI [2])
    C0008000 (UMLS CUI [3])
    Comment (Chemistry)
    Item
    Comment (Chemistry)
    text
    C0947611 (UMLS CUI [1])
    C0008000 (UMLS CUI [2])
    Item Group
    Central Laboratory - UA/ UDS/ Urine HCG/ Urine Chem
    C1880016 (UMLS CUI-1)
    C0430056 (UMLS CUI-2)
    C0864414 (UMLS CUI-3)
    Was the laboratory sample collected? (Urine)
    Item
    Was the laboratory sample collected? (Urine)
    boolean
    C0005834 (UMLS CUI [1])
    C0864414 (UMLS CUI [2])
    Sample Date (Urine)
    Item
    Sample Date (Urine)
    date
    C1302413 (UMLS CUI [1])
    C0864414 (UMLS CUI [2])
    Sample Time (Urine)
    Item
    Sample Time (Urine)
    time
    C0005834 (UMLS CUI [1])
    C0040223 (UMLS CUI [2])
    C0864414 (UMLS CUI [3])
    Comment (Urine)
    Item
    Comment (Urine)
    text
    C0947611 (UMLS CUI [1])
    C0864414 (UMLS CUI [2])
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