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38954

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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. 15.11.19 15.11.19 -
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GlaxoSmithKline

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15. November 2019

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    Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597

    Englisch

    Screening - 12-Lead ECG Abnormalities

    1 Formulare  
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2348585
    12-Lead ECG Abnormalities
    Beschreibung

    12-Lead ECG Abnormalities

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C1704258
    ECG Number
    Beschreibung

    Transcribe from the 12 Lead ECG result page.

    Datentyp

    integer

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

    Date of ECG

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2826640
    Time of ECG
    Beschreibung

    Time of ECG

    Datentyp

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301880
    12-Lead ECG Abnormalities
    Beschreibung

    12-Lead ECG Abnormalities

    Alias
    UMLS CUI-1
    C0430456
    UMLS CUI-2
    C1704258
    A. Rhythm
    Beschreibung

    A. Rhythm

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0199556
    A. Rhythm - Comment
    Beschreibung

    A. Rhythm - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0199556
    UMLS CUI [1,2]
    C0947611
    B. P-Wave and QRS Morphology
    Beschreibung

    B. P-Wave and QRS Morphology

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2216025
    UMLS CUI [1,2]
    C0429098
    B. P-Wave and QRS Morphology - Comment
    Beschreibung

    B. P-Wave and QRS Morphology - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2216025
    UMLS CUI [1,2]
    C0429098
    UMLS CUI [1,3]
    C0947611
    C. Conduction
    Beschreibung

    C. Conduction

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0264886
    C. Conduction - Comment
    Beschreibung

    C. Conduction - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0264886
    D. Myocardial Infarction
    Beschreibung

    D. Myocardial Infarction

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0027051
    D. Myocardial Infarction - Comment
    Beschreibung

    D. Myocardial Infarction - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0027051
    UMLS CUI [1,2]
    C0947611
    E. Depolarisation/Repolarisation (QRS-T)
    Beschreibung

    E. Depolarisation/Repolarisation (QRS-T)

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1331539
    UMLS CUI [1,2]
    C0948857
    E. Depolarisation/Repolarisation (QRS-T) - Comment
    Beschreibung

    E. Depolarisation/Repolarisation (QRS-T) - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1331539
    UMLS CUI [1,2]
    C0948857
    UMLS CUI [1,3]
    C0947611
    Other Abnormalities
    Beschreibung

    Other Abnormalities

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    Other Abnormalities - Comment
    Beschreibung

    Other Abnormalities - Comment

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C0522055
    UMLS CUI [1,2]
    C0205394
    UMLS CUI [1,3]
    C0947611
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Screening - 12-Lead ECG Abnormalities

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    12-Lead ECG Abnormalities
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    ECG Number
    Item
    ECG Number
    integer
    C0430456 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Time of ECG
    Item
    Time of ECG
    time
    C0430456 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Item Group
    12-Lead ECG Abnormalities
    C0430456 (UMLS CUI-1)
    C1704258 (UMLS CUI-2)
    Item
    A. Rhythm
    text
    C0199556 (UMLS CUI [1])
    A. Rhythm
    Code List
    A. Rhythm
    CL Item
    Sinus bradycardia (A1)
    CL Item
    Sinus bradycardia (heart rate 40-50 beats/min) (A21)
    CL Item
    Sinus bradycardia (heart rate 30-39 beats/min) (A22)
    CL Item
    Sinus bradycardia (heart rate < 30 beats/min) (A23)
    CL Item
    Sinus pause (A3)
    CL Item
    Sinus tachycardia (heart rate >100 beats/min) (A2)
    CL Item
    Ectopic supraventricular beats (A4)
    CL Item
    Ectopic supraventricular rhythm (A20)
    CL Item
    Wandering atrial pacemaker (A17)
    CL Item
    Multifocal atrial tachycardia (Wandering atrial pacemaker with heart rate >100 beats/min) (A26)
    CL Item
    Supraventricular tachycardia (heart rate >100 beats/min) (A6)
    CL Item
    Atrial flutter (A7)
    CL Item
    Atrial fibrillation (A8)
    CL Item
    Junctional rhythm (heart rate 100 beats/min) (A5)
    CL Item
    Junctional rhythm (A25)
    CL Item
    Junctional tachycardia (heart rate > 100 beats/min) (A24)
    CL Item
    Ectopic ventricular beats (A 9)
    CL Item
    Ventricular couplets (A12)
    CL Item
    Bigeminy (A13)
    CL Item
    Trigeminy (A28)
    CL Item
    Electrical alternans (A14)
    CL Item
    R on T phenomenon (A29)
    CL Item
    Ventricular fibrillation (A18)
    CL Item
    Idioventricular rhythm (heart rate < 100 beats/min) (A19)
    CL Item
    Sustained ventricular tachycardia (A10)
    CL Item
    Non-sustained ventricular tachycardia (A11)
    CL Item
    Wide QRS Tachycardia (diagnosis unknown) (A32)
    CL Item
    Sinus arrhythmia (A33)
    CL Item
    Ventricular tachycardia (A27)
    CL Item
    Monomorphic ventricular tachycardia (A30)
    CL Item
    Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (A15)
    CL Item
    Polymorphic (sustained and non-sustained) ventricular tachycardia (A31)
    CL Item
    Artificial pacemaker (A16)
    CL Item
    Atrial premature complex (A35)
    CL Item
    Other abnormal rhythm (A99)
    A. Rhythm - Comment
    Item
    A. Rhythm - Comment
    text
    C0199556 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item
    B. P-Wave and QRS Morphology
    text
    C2216025 (UMLS CUI [1,1])
    C0429098 (UMLS CUI [1,2])
    B. P-Wave and QRS Morphology
    Code List
    B. P-Wave and QRS Morphology
    CL Item
    Right ventricular hypertrophy (B3)
    CL Item
    Intraatrial conduction delay (B5)
    CL Item
    Poor R wave progression (B7)
    CL Item
    Left atrial abnormality (B9)
    CL Item
    Right atrial abnormality (B10)
    CL Item
    Late R wave transition (B16)
    CL Item
    Increased voltage consistent with left ventricular hypertrophy (D14)
    CL Item
    Other morphology (B99)
    B. P-Wave and QRS Morphology - Comment
    Item
    B. P-Wave and QRS Morphology - Comment
    text
    C2216025 (UMLS CUI [1,1])
    C0429098 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    C. Conduction
    text
    C0264886 (UMLS CUI [1])
    C. Conduction
    Code List
    C. Conduction
    CL Item
    First degree AV block (PR interval > 200 msec) (C1)
    CL Item
    Short PR interval (C20)
    CL Item
    Second degree AV block (Mobitz type 1) (C2)
    CL Item
    Second degree AV block (Mobitz type 2) (C3)
    CL Item
    2:1 AV block (C16)
    CL Item
    Third degree AV block (C4)
    CL Item
    Left axis deviation (QRS axis more negative than -30°) (C5)
    CL Item
    Right axis deviation (QRS axis morepositive than +110°) (C6)
    CL Item
    Incomplete right bundle branch block (C7)
    CL Item
    Incomplete left bundle branch block (C13)
    CL Item
    Right bundle branch block (C8)
    CL Item
    Left anterior hemiblock (synonymous to left anterior fascicular block) (C14)
    CL Item
    Left posterior hemiblock (synonymous to left posterior fascicular block) (C15)
    CL Item
    Left bundle branch block (C9)
    CL Item
    Bifascicular block (C17)
    CL Item
    Non-specific intraventricular conduction delay (QRS 120 msec) (C10)
    CL Item
    Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (C11)
    CL Item
    AV dissociation (C18)
    CL Item
    Prolonged QT 450-500 (C28)
    CL Item
    Prolonged QT >500 (C29)
    CL Item
    Prolonged QTc Interval 450-500 (C30)
    CL Item
    Prolonged QTc Interval >500 (C31)
    CL Item
    Other conduction (C99)
    C. Conduction - Comment
    Item
    C. Conduction - Comment
    text
    C0264886 (UMLS CUI [1])
    Item
    D. Myocardial Infarction
    text
    C0027051 (UMLS CUI [1])
    D. Myocardial Infarction
    Code List
    D. Myocardial Infarction
    CL Item
    Myocardial infarction, old (D1)
    CL Item
    Myocardial infarction, anterior (D2)
    CL Item
    Myocardial infarction, lateral (D3)
    CL Item
    Myocardial infarction, posterior (D4)
    CL Item
    Myocardial infarction, inferior (D5)
    CL Item
    Myocardial infarction, septal (D6)
    CL Item
    Myocardial infarction, Non-Q wave (D20)
    CL Item
    Juvenile Twave pattern, early repolarization (D22)
    CL Item
    Other myocardial infarction (D98)
    D. Myocardial Infarction - Comment
    Item
    D. Myocardial Infarction - Comment
    text
    C0027051 (UMLS CUI [1,1])
    C0947611 (UMLS CUI [1,2])
    Item
    E. Depolarisation/Repolarisation (QRS-T)
    text
    C1331539 (UMLS CUI [1,1])
    C0948857 (UMLS CUI [1,2])
    E. Depolarisation/Repolarisation (QRS-T)
    Code List
    E. Depolarisation/Repolarisation (QRS-T)
    CL Item
    Non-specific ST-T changes (D7)
    CL Item
    J point elevation (D19)
    CL Item
    ST elevation (D8)
    CL Item
    ST elevation-pericarditis (D21)
    CL Item
    ST depression (D9)
    CL Item
    ST segment abnormality, not specified (D96)
    CL Item
    U waves abnormal (D10)
    CL Item
    T wave inversion (D11)
    CL Item
    T wave peaked (D12)
    CL Item
    T waves flat (D15)
    CL Item
    T waves biphasic (D16)
    CL Item
    Notched T-waves (D18)
    CL Item
    Low QRS voltage (D13)
    CL Item
    T-wave flattening/inversion (D17)
    CL Item
    T wave abnormality, not specified (D97)
    CL Item
    Other depolarisation/repolarisation (D99)
    E. Depolarisation/Repolarisation (QRS-T) - Comment
    Item
    E. Depolarisation/Repolarisation (QRS-T) - Comment
    text
    C1331539 (UMLS CUI [1,1])
    C0948857 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Item
    Other Abnormalities
    text
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Other Abnormalities
    Code List
    Other Abnormalities
    CL Item
    Other abnormalities (E99)
    Other Abnormalities - Comment
    Item
    Other Abnormalities - Comment
    text
    C0522055 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
    Zum Seitenanfang zurückkehren 

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