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ID

43928

Beschrijving

Study Part: Vital Signs Week 1 PK Visit (Visit 3). 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

Trefwoorden

  1. 16-10-17 16-10-17 -
  2. 20-09-21 20-09-21 -
Houder van rechten

GlaxoSmithKline

Geüploaded op

20 september 2021

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Vital Signs Week 1 PK Visit (Visit 3) Ropinirole Parkinson Disease 101468/165

    Vital Signs Week 1 PK Visit (Visit 3)

    VITAL SIGNS
    Beschrijving

    VITAL SIGNS

    Alias
    UMLS CUI-1
    C0518766
    Patient Number
    Beschrijving

    Patient Number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1830427
    Centre Number
    Beschrijving

    Centre Number

    Datatype

    integer

    Alias
    UMLS CUI [1,1]
    C0600091
    UMLS CUI [1,2]
    C0019994
    Reading/Set No.
    Beschrijving

    Set number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0150098
    Date and Time
    Beschrijving

    Date and Time

    Datatype

    datetime

    Alias
    UMLS CUI [1]
    C1264639
    Semi-supine BP Systolic
    Beschrijving

    systolic pressure

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0871470
    Semi-supine BP Diastolic
    Beschrijving

    diastolic pressure

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0428883
    Semi-supine HR
    Beschrijving

    Heart rate

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0018810
    Time
    Beschrijving

    Time

    Datatype

    time

    Alias
    UMLS CUI [1]
    C0040223
    Standing BP Systolic
    Beschrijving

    systolic pressure standing

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    Standing BP Diastolic
    Beschrijving

    diastolic pressure standing

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0231472
    Standing HR
    Beschrijving

    Heart rate standing

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2029905

    Similar models

    Vital Signs Week 1 PK Visit (Visit 3)

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    VITAL SIGNS
    C0518766 (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])
    Item
    Reading/Set No.
    text
    C0150098 (UMLS CUI [1])
    Code List
    Reading/Set No.
    CL Item
    Pre-dose 1 (Pre-dose 1)
    CL Item
    +4.5 hrs (+4.5 hrs)
    CL Item
    +12.5 hrs (+12.5 hrs)
    CL Item
    +24.5 hrs (+24.5 hrs)
    Date and Time
    Item
    Date and Time
    datetime
    C1264639 (UMLS CUI [1])
    systolic pressure
    Item
    Semi-supine BP Systolic
    text
    C0871470 (UMLS CUI [1])
    diastolic pressure
    Item
    Semi-supine BP Diastolic
    text
    C0428883 (UMLS CUI [1])
    Heart rate
    Item
    Semi-supine HR
    text
    C0018810 (UMLS CUI [1])
    Time
    Item
    Time
    time
    C0040223 (UMLS CUI [1])
    systolic pressure standing
    Item
    Standing BP Systolic
    text
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    diastolic pressure standing
    Item
    Standing BP Diastolic
    text
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Heart rate standing
    Item
    Standing HR
    text
    C2029905 (UMLS CUI [1])

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