0 Ratings
ID

40874

Description

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline 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

Keywords

Versions (1)
  1. 5/29/20 5/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 29, 2020

DOI

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License

Creative Commons BY-NC 4.0
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    Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

    English

    Concomitant Medication

    1 forms  
    1. StudyEvent: ODM
      1. Concomitant Medication
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Are there any concomitant medication CHANGES since the start of the study?
    Description

    If ’YES’, please record all medications used below. Where appropriate, medical conditions should be recorded on the Adverse Events Form, utilizing the same terminology. If a medication has had a dosage change it must be recorded with the start and stop date.

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0443172
    Concomitant Medication
    Description

    Concomitant Medication

    Alias
    UMLS CUI-1
    C2347852
    Drug Name
    Description

    (Trade Name Preferred)

    Data type

    text

    Alias
    UMLS CUI [1]
    C2360065
    SINGLE Dose/Unit
    Description

    (eg.500mg)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1960417
    UMLS CUI [1,2]
    C0869039
    Frequency of this Dose
    Description

    (e.g.BID,PRN)

    Data type

    text

    Alias
    UMLS CUI [1]
    C3476109
    Concomitant Medication Route
    Description

    Concomitant Medication Route

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826730
    Concomitant Medication Indication
    Description

    Concomitant Medication Indication

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826696
    Concomitant Medication Start Date/Time
    Description

    Concomitant Medication Start Date/Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826825
    Concomitant Medication End Date/Time
    Description

    Concomitant Medication End Date/Time

    Data type

    datetime

    Alias
    UMLS CUI [1]
    C2826815
    Concomitant Medication continuing at end of Study?
    Description

    Concomitant Medication continuing at end of Study?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2826666
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    Similar models

    Concomitant Medication

    1 forms
    1. StudyEvent: ODM
      1. Concomitant Medication
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Are there any concomitant medication CHANGES since the start of the study?
    Item
    Are there any concomitant medication CHANGES since the start of the study?
    boolean
    C2347852 (UMLS CUI [1,1])
    C0443172 (UMLS CUI [1,2])
    Item Group
    Concomitant Medication
    C2347852 (UMLS CUI-1)
    Drug Name
    Item
    Drug Name
    text
    C2360065 (UMLS CUI [1])
    SINGLE Dose/Unit
    Item
    SINGLE Dose/Unit
    text
    C1960417 (UMLS CUI [1,1])
    C0869039 (UMLS CUI [1,2])
    Frequency of this Dose
    Item
    Frequency of this Dose
    text
    C3476109 (UMLS CUI [1])
    Concomitant Medication Route
    Item
    Concomitant Medication Route
    text
    C2826730 (UMLS CUI [1])
    Concomitant Medication Indication
    Item
    Concomitant Medication Indication
    text
    C2826696 (UMLS CUI [1])
    Concomitant Medication Start Date/Time
    Item
    Concomitant Medication Start Date/Time
    datetime
    C2826825 (UMLS CUI [1])
    Concomitant Medication End Date/Time
    Item
    Concomitant Medication End Date/Time
    datetime
    C2826815 (UMLS CUI [1])
    Concomitant Medication continuing at end of Study?
    Item
    Concomitant Medication continuing at end of Study?
    boolean
    C2826666 (UMLS CUI [1])
    Back to the top of the page 

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