0 Evaluaciones
ID

36012

Descripción

Study ID: 101468/198 Clinical Study ID: 101468/198 Study Title:An open, randomised, crossover, healthy volunteer study to compare the PK and tolerability of ropinirole as 3 different new formulations with the standard marketed formulation and to study the effects of a high fat meal on a new formulation Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of a Screening, 5 Sessions each with 2 days and a Follow-up. This document contains the Electrocardiography/ Cardiovascular Monitoring form. It has to be filled in for screening and follow-up.

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Versiones (1)
  1. 9/4/19 9/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

9 de abril de 2019

DOI

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Licencia

Creative Commons BY-NC 3.0
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    Comparison of pharmacokinetic and tolerability of ropinirole in healthy adults, 101468/198

    Inglés

    Electrocardiography/ Cardiovascular Monitoring for Screening and Follow-up

    1 formularios  
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject No.
    Descripción

    Subject No.

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Panel ID
    Descripción

    Panel ID

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C3846158
    Visit date
    Descripción

    day month year

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C1320303
    Visit type
    Descripción

    Visit type

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    12 LEAD ECG
    Descripción

    12 LEAD ECG

    Alias
    UMLS CUI-1
    C0430456
    ECG Time
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301880
    Heart rate
    Descripción

    Heart rate

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0018810
    bpm
    PR interval
    Descripción

    PR interval

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS duration
    Descripción

    QRS duration

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0429025
    msec
    QT duration
    Descripción

    QT duration

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C1880452
    msec
    QTc interval
    Descripción

    QTc interval

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1]
    C0489625
    msec
    Is the ECG normal?
    Descripción

    ECG normal

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0522054
    Comments (Include Clinically Significant ECG Abnormalities)
    Descripción

    Comments

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
    Blood pressure measurement
    Descripción

    Blood pressure measurement

    Alias
    UMLS CUI-1
    C0005823
    Body position
    Descripción

    Body position

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C1262869
    UMLS CUI [1,2]
    C0005823
    Time of measurement
    Descripción

    00:00-23:59

    Tipo de datos

    time

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0005823
    Systolic blood pressure
    Descripción

    Systolic blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470
    mmHg
    Diastolic blood pressure
    Descripción

    Diastolic blood pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883
    mmHg
    Pulse
    Descripción

    Pulse

    Tipo de datos

    integer

    Unidades de medida
    • bpm
    Alias
    UMLS CUI [1]
    C0232117
    bpm
    Comments
    Descripción

    Comments

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611
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    Similar models

    Electrocardiography/ Cardiovascular Monitoring for Screening and Follow-up

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Subject No.
    Item
    Subject No.
    text
    C2348585 (UMLS CUI [1])
    Panel ID
    Item
    Panel ID
    text
    C3846158 (UMLS CUI [1])
    Visit date
    Item
    Visit date
    date
    C1320303 (UMLS CUI [1])
    Item
    Visit type
    integer
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Visit type
    Code List
    Visit type
    CL Item
    Screening (1)
    CL Item
    Follow-up (2)
    Item Group
    12 LEAD ECG
    C0430456 (UMLS CUI-1)
    ECG Time
    Item
    ECG Time
    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])
    QT duration
    Item
    QT duration
    integer
    C1880452 (UMLS CUI [1])
    QTc interval
    Item
    QTc interval
    integer
    C0489625 (UMLS CUI [1])
    Item
    Is the ECG normal?
    text
    C0522054 (UMLS CUI [1])
    ECG normal
    Code List
    Is the ECG normal?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Comments
    Item
    Comments (Include Clinically Significant ECG Abnormalities)
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Blood pressure measurement
    C0005823 (UMLS CUI-1)
    Item
    Body position
    integer
    C1262869 (UMLS CUI [1,1])
    C0005823 (UMLS CUI [1,2])
    Body position
    Code List
    Body position
    CL Item
    semi-supine (1)
    CL Item
    standing (2)
    Time of measurement
    Item
    Time of measurement
    time
    C0040223 (UMLS CUI [1,1])
    C0005823 (UMLS CUI [1,2])
    Systolic blood pressure
    Item
    Systolic blood pressure
    integer
    C0871470 (UMLS CUI [1])
    Diastolic blood pressure
    Item
    Diastolic blood pressure
    integer
    C0428883 (UMLS CUI [1])
    Pulse
    Item
    Pulse
    integer
    C0232117 (UMLS CUI [1])
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
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