0 Ratings
ID

40858

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. 26-05-20 26-05-20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

26 mei 2020

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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

    PK Blood Sampling

    1 forms  
    1. StudyEvent: ODM
      1. PK Blood Sampling
    Administrative
    Description

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    PK Blood Sampling
    Description

    PK Blood Sampling

    Alias
    UMLS CUI-1
    C0031327
    UMLS CUI-2
    C0178913
    Time relative to start of dose
    Description

    Time relative to start of dose

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0178602
    PK blood sampling - Date
    Description

    PK blood sampling - Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0031327
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0011008
    PK blood sampling - Actual Time
    Description

    PK blood sampling - Actual Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0031327
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0040223
    PK blood sampling - Sample Taken
    Description

    PK blood sampling - Sample Taken

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0031327
    UMLS CUI [1,2]
    C0178913
    PK Blood Sampling - Comments
    Description

    PK Blood Sampling - Comments

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0031327
    UMLS CUI [1,2]
    C0178913
    UMLS CUI [1,3]
    C0947611
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    Similar models

    PK Blood Sampling

    1 forms
    1. StudyEvent: ODM
      1. PK Blood Sampling
    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
    PK Blood Sampling
    C0031327 (UMLS CUI-1)
    C0178913 (UMLS CUI-2)
    Item
    Time relative to start of dose
    integer
    C1301880 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Time relative to start of dose
    Code List
    Time relative to start of dose
    CL Item
    Pre-dose (1)
    CL Item
    +0.25 hr (2)
    CL Item
    +0.50 hr (3)
    CL Item
    +0.75 hr (4)
    CL Item
    +1 hrs (5)
    CL Item
    +1.25 hrs (6)
    CL Item
    +1.5 hrs (7)
    CL Item
    +2 hrs (8)
    CL Item
    +3 hrs (9)
    CL Item
    +4 hrs (10)
    CL Item
    +6 hrs (11)
    CL Item
    +8 hrs (12)
    CL Item
    +16-18 hrs (13)
    PK blood sampling - Date
    Item
    PK blood sampling - Date
    date
    C0031327 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    PK blood sampling - Actual Time
    Item
    PK blood sampling - Actual Time
    time
    C0031327 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    PK blood sampling - Sample Taken
    Item
    PK blood sampling - Sample Taken
    boolean
    C0031327 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    PK Blood Sampling - Comments
    Item
    PK Blood Sampling - Comments
    text
    C0031327 (UMLS CUI [1,1])
    C0178913 (UMLS CUI [1,2])
    C0947611 (UMLS CUI [1,3])
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