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ID

32016

Beschrijving

Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

Trefwoorden

Versies (1)
  1. 12-10-18 12-10-18 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

12 oktober 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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    Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125

    Engels

    Vital Signs and ECG - Screening

    1 Formulieren  
    Vital Signs
    Beschrijving

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Actual date/ time
    Beschrijving

    Date/Time

    Datatype

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Height
    Beschrijving

    Body Height

    Datatype

    float

    Maateenheden
    • cm
    Alias
    UMLS CUI [1]
    C0005890
    cm
    Weight
    Beschrijving

    Body Weight

    Datatype

    float

    Maateenheden
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body Mass Index
    Beschrijving

    Body mass index

    Datatype

    float

    Alias
    UMLS CUI [1]
    C1305855
    Blood Pressure and Heart rate
    Beschrijving

    Blood Pressure and Heart rate

    Alias
    UMLS CUI-1
    C0005823
    UMLS CUI-2
    C0018810
    Actual date/ time
    Beschrijving

    Date/Time

    Datatype

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Blood pressure (systolic/ diastolic)
    Beschrijving

    Blood Pressure

    Datatype

    text

    Maateenheden
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Heart rate
    Beschrijving

    heart rate

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    12- Lead ECG
    Beschrijving

    12- Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Date and Time of ECG
    Beschrijving

    Electrocardiogram Collection Date Time

    Datatype

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    Heart rate
    Beschrijving

    heart rate

    Datatype

    integer

    Maateenheden
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Beschrijving

    Electrocardiogram: P-R interval

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS Duration
    Beschrijving

    QRS complex duration (observable entity)

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Beschrijving

    QT interval - finding

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    Method of QTc Calculation
    Beschrijving

    Electrocardiogram QT corrected interval; Evaluation Method

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C2911685
    If QTc interval was calculated mechanical, check method of caluclation
    Beschrijving

    Electrocardiogram QT corrected interval; Evaluation Method; Mechanical Methods

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C2911685
    UMLS CUI [1,3]
    C0443254
    If QTc interval was calculated mechanically with Bazett's formula, enter finding.
    Beschrijving

    QTcB - Bazett's Correction Formula; Mechanical Methods

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1,1]
    C1882512
    UMLS CUI [1,2]
    C0443254
    msec
    If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
    Beschrijving

    QTcF - Fridericia's Correction Formula; Mechanical Methods; Finding

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1,1]
    C1882513
    UMLS CUI [1,2]
    C0443254
    UMLS CUI [1,3]
    C0243095
    msec
    If QTc interval was calcualted manually, check method of caluclation.
    Beschrijving

    Electrocardiogram QT corrected interval; Evaluation Method; Manual

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C2911685
    UMLS CUI [1,3]
    C0175674
    If QTc interval was calculated manually with RR interval, enter finding.
    Beschrijving

    Electrocardiogram QT corrected interval; Manual; Finding

    Datatype

    float

    Maateenheden
    • msec
    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C0175674
    UMLS CUI [1,3]
    C0243095
    msec
    Result of ECG
    Beschrijving

    EKG finding

    Datatype

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Terug naar het begin van de pagina

    Similar models

    Vital Signs and ECG - Screening

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Date/Time
    Item
    Actual date/ time
    datetime
    C1264639 (UMLS CUI [1])
    Body Height
    Item
    Height
    float
    C0005890 (UMLS CUI [1])
    Body Weight
    Item
    Weight
    float
    C0005910 (UMLS CUI [1])
    Body mass index
    Item
    Body Mass Index
    float
    C1305855 (UMLS CUI [1])
    Item Group
    Blood Pressure and Heart rate
    C0005823 (UMLS CUI-1)
    C0018810 (UMLS CUI-2)
    Date/Time
    Item
    Actual date/ time
    datetime
    C1264639 (UMLS CUI [1])
    Blood Pressure
    Item
    Blood pressure (systolic/ diastolic)
    text
    C0005823 (UMLS CUI [1])
    heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Item Group
    12- Lead ECG
    C0430456 (UMLS CUI-1)
    Electrocardiogram Collection Date Time
    Item
    Date and Time of ECG
    datetime
    C2826846 (UMLS CUI [1])
    heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    Electrocardiogram: P-R interval
    Item
    PR Interval
    float
    C0429087 (UMLS CUI [1])
    QRS complex duration (observable entity)
    Item
    QRS Duration
    float
    C0429025 (UMLS CUI [1])
    QT interval - finding
    Item
    Uncorrected QT Interval
    float
    C1287082 (UMLS CUI [1])
    Item
    Method of QTc Calculation
    integer
    C0855331 (UMLS CUI [1,1])
    C2911685 (UMLS CUI [1,2])
    Electrocardiogram QT corrected interval; Evaluation Method
    Code List
    Method of QTc Calculation
    CL Item
    Machine; record QTc value(s) generated by the machine (1)
    CL Item
    Manual; record the RR interval that precedes the measured QT interval (2)
    Item
    If QTc interval was calculated mechanical, check method of caluclation
    text
    C0855331 (UMLS CUI [1,1])
    C2911685 (UMLS CUI [1,2])
    C0443254 (UMLS CUI [1,3])
    undefined item
    Code List
    If QTc interval was calculated mechanical, check method of caluclation
    CL Item
    QTcB (Bazett) (B)
    CL Item
    QTcF (Fridericia) (F)
    QTcB - Bazett's Correction Formula; Mechanical Methods
    Item
    If QTc interval was calculated mechanically with Bazett's formula, enter finding.
    float
    C1882512 (UMLS CUI [1,1])
    C0443254 (UMLS CUI [1,2])
    QTcF - Fridericia's Correction Formula; Mechanical Methods; Finding
    Item
    If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
    float
    C1882513 (UMLS CUI [1,1])
    C0443254 (UMLS CUI [1,2])
    C0243095 (UMLS CUI [1,3])
    Item
    If QTc interval was calcualted manually, check method of caluclation.
    text
    C0855331 (UMLS CUI [1,1])
    C2911685 (UMLS CUI [1,2])
    C0175674 (UMLS CUI [1,3])
    undefined item
    Code List
    If QTc interval was calcualted manually, check method of caluclation.
    CL Item
    RR interval (RR)
    CL Item
    RR interval not available (NA)
    Electrocardiogram QT corrected interval; Manual; Finding
    Item
    If QTc interval was calculated manually with RR interval, enter finding.
    float
    C0855331 (UMLS CUI [1,1])
    C0175674 (UMLS CUI [1,2])
    C0243095 (UMLS CUI [1,3])
    Item
    Result of ECG
    integer
    C0438154 (UMLS CUI [1])
    EKG finding
    Code List
    Result of ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - Not clinically significant (2)
    CL Item
    Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
    CL Item
    No result (not available) (4)
    Terug naar het begin van de pagina 

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