0 Evaluaciones
ID

32016

Descripción

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

Palabras clave

Versiones (1)
  1. 12/10/18 12/10/18 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

12 de octubre de 2018

DOI

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Licencia

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

    Inglés

    Vital Signs and ECG - Screening

    1 formularios  
    Vital Signs
    Descripción

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Actual date/ time
    Descripción

    Date/Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Height
    Descripción

    Body Height

    Tipo de datos

    float

    Unidades de medida
    • cm
    Alias
    UMLS CUI [1]
    C0005890 (Body Height)
    SNOMED
    50373000
    cm
    Weight
    Descripción

    Body Weight

    Tipo de datos

    float

    Unidades de medida
    • kg
    Alias
    UMLS CUI [1]
    C0005910 (Body Weight)
    SNOMED
    27113001
    kg
    Body Mass Index
    Descripción

    Body mass index

    Tipo de datos

    float

    Alias
    UMLS CUI [1]
    C1305855 (Body mass index)
    SNOMED
    60621009
    LOINC
    LP35925-4
    Blood Pressure and Heart rate
    Descripción

    Blood Pressure and Heart rate

    Alias
    UMLS CUI-1
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    UMLS CUI-2
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    Actual date/ time
    Descripción

    Date/Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C1264639 (Date/Time)
    SNOMED
    118575009
    Blood pressure (systolic/ diastolic)
    Descripción

    Blood Pressure

    Tipo de datos

    text

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    mmHg
    Heart rate
    Descripción

    heart rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    12- Lead ECG
    Descripción

    12- Lead ECG

    Alias
    UMLS CUI-1
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    Date and Time of ECG
    Descripción

    Electrocardiogram Collection Date Time

    Tipo de datos

    datetime

    Alias
    UMLS CUI [1]
    C2826846 (Electrocardiogram Collection Date Time)
    Heart rate
    Descripción

    heart rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    beats/min
    PR Interval
    Descripción

    Electrocardiogram: P-R interval

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429087 (Electrocardiogram: P-R interval)
    SNOMED
    365411005
    msec
    QRS Duration
    Descripción

    QRS complex duration (observable entity)

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429025 (QRS complex duration (observable entity))
    SNOMED
    251208001
    LOINC
    LP31031-5
    msec
    Uncorrected QT Interval
    Descripción

    QT interval - finding

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C1287082 (QT interval - finding)
    SNOMED
    365417009
    msec
    Method of QTc Calculation
    Descripción

    Electrocardiogram QT corrected interval; Evaluation Method

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0855331 (Electrocardiogram QT corrected interval)
    UMLS CUI [1,2]
    C2911685 (Evaluation Method)
    If QTc interval was calculated mechanical, check method of caluclation
    Descripción

    Electrocardiogram QT corrected interval; Evaluation Method; Mechanical Methods

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0855331 (Electrocardiogram QT corrected interval)
    UMLS CUI [1,2]
    C2911685 (Evaluation Method)
    UMLS CUI [1,3]
    C0443254 (Mechanical Methods)
    SNOMED
    261018001
    LOINC
    LA19743-6
    If QTc interval was calculated mechanically with Bazett's formula, enter finding.
    Descripción

    QTcB - Bazett's Correction Formula; Mechanical Methods

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C1882512 (QTcB - Bazett's Correction Formula)
    UMLS CUI [1,2]
    C0443254 (Mechanical Methods)
    SNOMED
    261018001
    LOINC
    LA19743-6
    msec
    If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
    Descripción

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

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C1882513 (QTcF - Fridericia's Correction Formula)
    UMLS CUI [1,2]
    C0443254 (Mechanical Methods)
    SNOMED
    261018001
    LOINC
    LA19743-6
    UMLS CUI [1,3]
    C0243095 (Finding)
    LOINC
    LA9042-8
    msec
    If QTc interval was calcualted manually, check method of caluclation.
    Descripción

    Electrocardiogram QT corrected interval; Evaluation Method; Manual

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0855331 (Electrocardiogram QT corrected interval)
    UMLS CUI [1,2]
    C2911685 (Evaluation Method)
    UMLS CUI [1,3]
    C0175674 (Manual)
    SNOMED
    87982008
    LOINC
    LP6376-0
    If QTc interval was calculated manually with RR interval, enter finding.
    Descripción

    Electrocardiogram QT corrected interval; Manual; Finding

    Tipo de datos

    float

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0855331 (Electrocardiogram QT corrected interval)
    UMLS CUI [1,2]
    C0175674 (Manual)
    SNOMED
    87982008
    LOINC
    LP6376-0
    UMLS CUI [1,3]
    C0243095 (Finding)
    LOINC
    LA9042-8
    msec
    Result of ECG
    Descripción

    EKG finding

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0438154 (Electrocardiogram finding)
    SNOMED
    271921002
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    Similar models

    Vital Signs and ECG - Screening

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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