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38828

Beschreibung

Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

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  1. 07.11.19 07.11.19 -
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GlaxoSmithKline

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7. November 2019

DOI

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Creative Commons BY-NC 3.0
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    Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597

    Englisch

    Screening - Administrative; Demography; Vital Signs; 12-Lead ECG; Summary Holter

    1 Formulare  
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Volunteer Identifier
    Beschreibung

    Volunteer Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1300638
    UMLS CUI [1,2]
    C0020155
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    Centre Number
    Beschreibung

    Centre Number

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Demography
    Beschreibung

    Demography

    Alias
    UMLS CUI-1
    C0011298
    Date of birth
    Beschreibung

    Date of birth

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0421451
    Sex
    Beschreibung

    Sex

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0079399
    Ethnicity
    Beschreibung

    Check one

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0015031
    Geographic Ancestry
    Beschreibung

    Check all that apply

    Datentyp

    integer

    Vital Signs
    Beschreibung

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Height
    Beschreibung

    Height

    Datentyp

    integer

    Maßeinheiten
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Beschreibung

    Weight

    Datentyp

    float

    Maßeinheiten
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body mass index
    Beschreibung

    Body mass index

    Datentyp

    float

    Maßeinheiten
    • kg/m2
    Alias
    UMLS CUI [1]
    C1305855
    kg/m2
    Vital Signs
    Beschreibung

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Beschreibung

    Date

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C0011008
    Planned Relative Time - Vital Signs
    Beschreibung

    Planned Relative Time - Vital Signs

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0439564
    UMLS CUI [1,2]
    C1301732
    UMLS CUI [1,3]
    C0518766
    Actual Time
    Beschreibung

    Actual Time

    Datentyp

    time

    Alias
    UMLS CUI [1]
    C0040223
    Systolic Blood Pressure Semi-recumbent
    Beschreibung

    Systolic Blood Pressure Semi-recumbent

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0522019
    mm[Hg]
    Diastolic Blood Pressure Semi-recumbent
    Beschreibung

    Diastolic Blood Pressure Semi-recumbent

    Datentyp

    integer

    Maßeinheiten
    • mm[Hg]
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0522019
    mm[Hg]
    Heart Rate
    Beschreibung

    Heart Rate

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    12-Lead ECG
    Beschreibung

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    ECG Number
    Beschreibung

    ECG Number

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0237753
    Start Date of ECG
    Beschreibung

    Start Date of ECG

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0808070
    Planned Relative Time - ECG
    Beschreibung

    Planned Relative Time - ECG

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301732
    UMLS CUI [1,3]
    C0439564
    Start Time of ECG
    Beschreibung

    Start Time of ECG

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301880
    Heart Rate
    Beschreibung

    Heart Rate

    Datentyp

    integer

    Maßeinheiten
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    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
    Uncorrected QT Interval
    Beschreibung

    Uncorrected QT Interval

    Datentyp

    integer

    Maßeinheiten
    • ms
    Alias
    UMLS CUI [1]
    C1287082
    ms
    Result of the ECG
    Beschreibung

    Result of the ECG

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Summary Holter
    Beschreibung

    Summary Holter

    Alias
    UMLS CUI-1
    C0013801
    UMLS CUI-2
    C0242482
    Start date of Holter
    Beschreibung

    Start date of Holter

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C0808070
    Start time of Holter
    Beschreibung

    Start time of Holter

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C1301880
    Stop date of Holter
    Beschreibung

    Stop date of Holter

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C0806020
    Stop time of Holter
    Beschreibung

    Stop time of Holter

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C1522314
    Interpretation of Holter
    Beschreibung

    Check one

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0013801
    UMLS CUI [1,2]
    C0438154
    Holter monitoring method
    Beschreibung

    Check one

    Datentyp

    integer

    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Screening - Administrative; Demography; Vital Signs; 12-Lead ECG; Summary Holter

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Volunteer Identifier
    Item
    Volunteer Identifier
    text
    C1300638 (UMLS CUI [1,1])
    C0020155 (UMLS CUI [1,2])
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    text
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Item Group
    Demography
    C0011298 (UMLS CUI-1)
    Date of birth
    Item
    Date of birth
    date
    C0421451 (UMLS CUI [1])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Sex
    Code List
    Sex
    CL Item
    Female (F)
    CL Item
    Male (M)
    Item
    Ethnicity
    integer
    C0015031 (UMLS CUI [1])
    Ethnicity
    Code List
    Ethnicity
    CL Item
    Hispanic or Latino (1)
    CL Item
    Not Hispanic or Latino (2)
    Item
    Geographic Ancestry
    integer
    Geographic Ancestry
    Code List
    Geographic Ancestry
    CL Item
    African American/African Heritage (11)
    CL Item
    American Indian or Alaskan Native (12)
    CL Item
    Asian - Central/South Asian Heritage (13)
    CL Item
    Asian - East Asian Heritage (14)
    CL Item
    Asian - Japanese Heritage (15)
    CL Item
    Asian - South East Asian Heritage (16)
    CL Item
    Native Hawaiian or Other Pacific Islander (17)
    CL Item
    White - Arabic/North African Heritage (18)
    CL Item
    White - White/Caucasian/European Heritage (19)
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Height
    Item
    Height
    integer
    C0005890 (UMLS CUI [1])
    Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body mass index
    Item
    Body mass index
    float
    C1305855 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Planned Relative Time - Vital Signs
    Item
    Planned Relative Time - Vital Signs
    text
    C0439564 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C0518766 (UMLS CUI [1,3])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Systolic Blood Pressure Semi-recumbent
    Item
    Systolic Blood Pressure Semi-recumbent
    integer
    C0871470 (UMLS CUI [1,1])
    C0522019 (UMLS CUI [1,2])
    Diastolic Blood Pressure Semi-recumbent
    Item
    Diastolic Blood Pressure Semi-recumbent
    integer
    C0428883 (UMLS CUI [1,1])
    C0522019 (UMLS CUI [1,2])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    Item
    ECG Number
    integer
    C0430456 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    ECG Number
    Code List
    ECG Number
    CL Item
    ECG 1 (1)
    CL Item
    ECG 2 (2)
    CL Item
    ECG 3 (3)
    Start Date of ECG
    Item
    Start Date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Planned Relative Time - ECG
    Item
    Planned Relative Time - ECG
    text
    C0430456 (UMLS CUI [1,1])
    C1301732 (UMLS CUI [1,2])
    C0439564 (UMLS CUI [1,3])
    Start Time of ECG
    Item
    Start Time of ECG
    time
    C0430456 (UMLS CUI [1,1])
    C1301880 (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])
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    integer
    C1287082 (UMLS CUI [1])
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    Result of the ECG
    Code List
    Result of the ECG
    CL Item
    Normal  (1)
    CL Item
    Abnormal - not clinically significant  (2)
    CL Item
    Abnormal- clinically significant  (3)
    CL Item
    No result (not available) (4)
    Item Group
    Summary Holter
    C0013801 (UMLS CUI-1)
    C0242482 (UMLS CUI-2)
    Start date of Holter
    Item
    Start date of Holter
    date
    C0013801 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start time of Holter
    Item
    Start time of Holter
    time
    C0013801 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Stop date of Holter
    Item
    Stop date of Holter
    date
    C0013801 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Stop time of Holter
    Item
    Stop time of Holter
    time
    C0013801 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item
    Interpretation of Holter
    text
    C0013801 (UMLS CUI [1,1])
    C0438154 (UMLS CUI [1,2])
    Interpretation of Holter
    Code List
    Interpretation of Holter
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant 1 (3)
    CL Item
    No result (4)
    CL Item
    Unable to evaluate (5)
    Item
    Holter monitoring method
    integer
    Holter monitoring method
    Code List
    Holter monitoring method
    CL Item
    12 Lead 1000Hz (1)
    CL Item
    12 lead 180Hz (2)
    CL Item
    3 Lead 180 Hz (3)
    CL Item
    Telemetry (4)
    CL Item
    5 Lead 512Hz (5)
    CL Item
    4 Lead 0.05-40 Hz (6)
    CL Item
    6 Lead 0.05-40 Hz (7)
    CL Item
    7 Lead 0.05-100 Hz-3dB (8)
    CL Item
    7 Lead 3 channel 133 Hz (9)
    CL Item
    2 Lead 200 Hz (10)
    CL Item
    Other (11)
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