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36892

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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 12 LEAD ECG Monitoring form. It has to be filled in for Day 1, Day 6, Day 8, Day 12, Day 15 and Day 19.

Nyckelord

Versioner (2)
  1. 2017-09-02 2017-09-02 -
  2. 2019-06-19 2019-06-19 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

19 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

    12 LEAD ECG Monitoring 1

    1 Formulär  
    Administrative Data
    Beskrivning

    Administrative Data

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

    Subject number

    Datatyp

    integer

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

    Study Week

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0008972 (Clinical Research)
    UMLS CUI [1,2]
    C0439230 (week)
    SNOMED
    258705008
    Study Day
    Beskrivning

    Study Day

    Datatyp

    integer

    Alias
    UMLS CUI [1]
    C2826182 (Study Day)
    12 LEAD ECG MONITORING
    Beskrivning

    12 LEAD ECG MONITORING

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

    Note: Pre-dose only has to be measured for Day 1.

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C2348563 (Study Protocol)
    UMLS CUI [1,2]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    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
    Comments
    Beskrivning

    Comments

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
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    Similar models

    12 LEAD ECG Monitoring 1

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject number
    Item
    Subject number
    integer
    C2348585 (UMLS CUI [1])
    Item
    Study Week
    integer
    C0008972 (UMLS CUI [1,1])
    C0439230 (UMLS CUI [1,2])
    Study Week
    Code List
    Study Week
    CL Item
    Week 1 (1)
    CL Item
    Week 2 (2)
    CL Item
    Week 3 (3)
    Item
    Study Day
    integer
    C2826182 (UMLS CUI [1])
    Study Day
    Code List
    Study Day
    CL Item
    Day 1 (1)
    CL Item
    Day 6 (2)
    CL Item
    Day 8 (3)
    CL Item
    Day 12 (4)
    CL Item
    Day 15 (5)
    CL Item
    Day 19 (6)
    Item Group
    12 LEAD ECG MONITORING
    C0430456 (UMLS CUI-1)
    Item
    Study Time
    integer
    C2348563 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Study Time
    Code List
    Study Time
    CL Item
    Pre-dose  (1)
    CL Item
    +0.5 hr  (2)
    CL Item
    +1 hr  (3)
    CL Item
    +1.5 hrs (4)
    CL Item
    +2 hrs (5)
    CL Item
    +3 hrs  (6)
    CL Item
    +4 hrs  (7)
    CL Item
    +6 hrs (8)
    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)
    Comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Tillbaka till toppen 

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