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36912

Beskrivning

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Unscheduled Vital Signs and ECG Monitoring for Screening and follow-up form.

Nyckelord

Versioner (2)
  1. 2019-06-18 2019-06-18 -
  2. 2019-06-21 2019-06-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21 juni 2019

DOI

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Creative Commons BY-NC 3.0
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    Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201

    Engelsk

    Vital Signs and ECG Monitoring for Screening and Follow-up

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Volunteer panel number
    Beskrivning

    Volunteer panel number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1300638 (Identification number)
    SNOMED
    396278008
    Subject number
    Beskrivning

    Subject number

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2348585 (Clinical Trial Subject Unique Identifier)
    Study Visit
    Beskrivning

    Study Visit

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0008972 (Clinical Research)
    UMLS CUI [1,2]
    C0545082 (Visit)
    12 LEAD ECG MONITORING
    Beskrivning

    12 LEAD ECG MONITORING

    Alias
    UMLS CUI-1
    C0430456 (Electrocardiography, 12-Lead)
    SNOMED
    268400002
    Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Actual Time
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Heart rate
    Beskrivning

    Heart rate

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    bpm
    PR
    Beskrivning

    PR

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0429087 (Electrocardiogram: P-R interval)
    SNOMED
    365411005
    msec
    QRS
    Beskrivning

    QRS

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C1880451 (Mean QRS Duration)
    msec
    QT
    Beskrivning

    QT

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C1287082 (QT interval - finding)
    SNOMED
    365417009
    msec
    QTc
    Beskrivning

    QTc

    Datatyp

    float

    Måttenheter
    • msec
    Alias
    UMLS CUI [1]
    C0489625 (QTC interval)
    LOINC
    LP31071-1
    msec
    ECG normal?
    Beskrivning

    ECG normal

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0522054 (ECG normal)
    SNOMED
    164854000
    Comment
    Beskrivning

    If the abnormality is clinically significant, please withdraw the subject

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Vital Signs
    Beskrivning

    Vital Signs

    Alias
    UMLS CUI-1
    C0518766 (Vital signs)
    LOINC
    LP30605-7
    Body position for blood pressure measurement
    Beskrivning

    Supine pulse and blood pressure will be made after the subject has been resting supine for a period of at least 10 minutes. Standing pulse and blood pressure will be made after the subject has been standing for 1 minute after the supine measurements.

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C1828063 (Body position for blood pressure measurement)
    SNOMED
    424724000
    Date
    Beskrivning

    day month year

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Actual Time
    Beskrivning

    00:00-23:59

    Datatyp

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Systolic Blood pressure
    Beskrivning

    Systolic Blood pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    mmHg
    Diastolic Blood pressure
    Beskrivning

    Diastolic Blood pressure

    Datatyp

    integer

    Måttenheter
    • mmHg
    Alias
    UMLS CUI [1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    mmHg
    Pulse
    Beskrivning

    Pulse

    Datatyp

    integer

    Måttenheter
    • bpm
    Alias
    UMLS CUI [1]
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    bpm
    Tillbaka till toppen

    Similar models

    Vital Signs and ECG Monitoring for Screening and Follow-up

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Volunteer panel number
    Item
    Volunteer panel number
    integer
    C1300638 (UMLS CUI [1])
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Study Visit
    integer
    C0008972 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    Study Visit
    Code List
    Study Visit
    CL Item
    Screening (1)
    CL Item
    Follow-up (2)
    Item Group
    12 LEAD ECG MONITORING
    C0430456 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    Heart rate
    Item
    Heart rate
    integer
    C0018810 (UMLS CUI [1])
    PR
    Item
    PR
    float
    C0429087 (UMLS CUI [1])
    QRS
    Item
    QRS
    float
    C1880451 (UMLS CUI [1])
    QT
    Item
    QT
    float
    C1287082 (UMLS CUI [1])
    QTc
    Item
    QTc
    float
    C0489625 (UMLS CUI [1])
    Item
    ECG normal?
    text
    C0522054 (UMLS CUI [1])
    ECG normal
    Code List
    ECG normal?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Vital Signs
    C0518766 (UMLS CUI-1)
    Item
    Body position for blood pressure measurement
    integer
    C1828063 (UMLS CUI [1])
    Body position for blood pressure measurement
    Code List
    Body position for blood pressure measurement
    CL Item
    Supine (1)
    CL Item
    Standing (2)
    Date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    Actual Time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    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])
    Tillbaka till toppen 

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