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ID

26377

Description

Study Part: Pregnancy Test Week 1 Pre-dose (Visit 1). An open-label, up-titration study to assess the dose proportionality of ropinirole controlled release (CR) and to demonstrate the bioequivalence of ropinirole CR (1 x 8 mg) compared to the ropinirole CR (4 x 2 mg) in Parkinson's Disease patients not receiving other dopaminergic therapies. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Phase: phase 2. Study Recruitment Status: Completed. Generic Name: ropinirole. Trade Name: Modutab, ZIPEREVE, ZEPREVE, REPREVE, ADARTREL, REQUIP,Zygara. Study Indication: Parkinson Disease. Study ID: 101468/165. Clinical Study ID: 101468/165

Keywords

  1. 10/16/17 10/16/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 2017

DOI

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License

Creative Commons BY-NC 3.0

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    Pregnancy Test Week 1 Pre-dose (Visit 1) Ropinirole Parkinson Disease 101468/165

    Pregnancy Test Week 1 Pre-dose (Visit 1)

    URINE PREGNANCY TEST (Females only)
    Description

    URINE PREGNANCY TEST (Females only)

    Alias
    UMLS CUI-1
    C0430056
    Patient Number
    Description

    Patient Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C1830427
    Centre Number
    Description

    Centre Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Visit Date
    Description

    Visit Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1320303
    Was a pregnancy test carried out?
    Description

    pregnancy test

    Data type

    text

    Alias
    UMLS CUI [1]
    C0032976
    If ’No’, please specify reason
    Description

    reason

    Data type

    text

    Alias
    UMLS CUI [1]
    C0566251
    Date of pregnancy test:
    Description

    Date of pregnancy test

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0032976
    UMLS CUI [1,2]
    C0011008
    Pregnancy test
    Description

    If ’Positive’, withdraw the subject from the stud

    Data type

    text

    Alias
    UMLS CUI [1]
    C0430056

    Similar models

    Pregnancy Test Week 1 Pre-dose (Visit 1)

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    URINE PREGNANCY TEST (Females only)
    C0430056 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Centre Number
    Item
    Centre Number
    integer
    C0600091 (UMLS CUI [1,1])
    C0019994 (UMLS CUI [1,2])
    Visit Date
    Item
    Visit Date
    date
    C1320303 (UMLS CUI [1])
    Item
    Was a pregnancy test carried out?
    text
    C0032976 (UMLS CUI [1])
    Code List
    Was a pregnancy test carried out?
    CL Item
    Yes (Yes)
    CL Item
    No (No)
    CL Item
    Not Applicable (Not Applicable)
    reason
    Item
    If ’No’, please specify reason
    text
    C0566251 (UMLS CUI [1])
    Date of pregnancy test
    Item
    Date of pregnancy test:
    date
    C0032976 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Pregnancy test
    text
    C0430056 (UMLS CUI [1])
    Code List
    Pregnancy test
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)

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