0 Ratings
ID

32016

Description

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

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Versions (1)
  1. 10/12/18 10/12/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 12, 2018

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

    English

    Vital Signs and ECG - Screening

    1 forms  
    Vital Signs
    Description

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766
    Actual date/ time
    Description

    Date/Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Height
    Description

    Body Height

    Data type

    float

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

    Body Weight

    Data type

    float

    Measurement units
    • kg
    Alias
    UMLS CUI [1]
    C0005910
    kg
    Body Mass Index
    Description

    Body mass index

    Data type

    float

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

    Blood Pressure and Heart rate

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

    Date/Time

    Data type

    datetime

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

    Blood Pressure

    Data type

    text

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823
    mmHg
    Heart rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    12- Lead ECG
    Description

    12- Lead ECG

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

    Electrocardiogram Collection Date Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826846
    Heart rate
    Description

    heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810
    beats/min
    PR Interval
    Description

    Electrocardiogram: P-R interval

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS Duration
    Description

    QRS complex duration (observable entity)

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    Uncorrected QT Interval
    Description

    QT interval - finding

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1]
    C1287082
    msec
    Method of QTc Calculation
    Description

    Electrocardiogram QT corrected interval; Evaluation Method

    Data type

    integer

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

    Electrocardiogram QT corrected interval; Evaluation Method; Mechanical Methods

    Data type

    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.
    Description

    QTcB - Bazett's Correction Formula; Mechanical Methods

    Data type

    float

    Measurement units
    • 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.
    Description

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

    Data type

    float

    Measurement units
    • 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.
    Description

    Electrocardiogram QT corrected interval; Evaluation Method; Manual

    Data type

    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.
    Description

    Electrocardiogram QT corrected interval; Manual; Finding

    Data type

    float

    Measurement units
    • msec
    Alias
    UMLS CUI [1,1]
    C0855331
    UMLS CUI [1,2]
    C0175674
    UMLS CUI [1,3]
    C0243095
    msec
    Result of ECG
    Description

    EKG finding

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
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    Similar models

    Vital Signs and ECG - Screening

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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)
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