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ID

25711

Description

Study ID: 101468/197 Clinical Study ID: SKF-101468/197 Study Title:An open study to compare the PK and tolerability of ropinirole administered as 5 different new formulations with the standard, marketed formulation in healthy volunteers 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: Requip Study Indication : Restless Legs Syndrome

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Versions (1)
  1. 9/12/17 9/12/17 -
Copyright Holder

GlaxoSmithKline

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September 12, 2017

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Creative Commons BY-NC 3.0
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    final examination cardiovascular monitoring PK and tolerability of ropinirole as 5 new formulations 101468/197

    English

    final examination cardiovascular monitoring PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Focus Panel ID
    Description

    focus panel

    Data type

    integer

    Alias
    UMLS CUI [1]
    C3846158 (Other Coding)
    LOINC
    LA4728-7
    Patient No
    Description

    patient number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427 (undefined)
    Date
    Description

    date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Treatment
    Description

    treatment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    BLOOD PRESSURE AND PULSE RATE: semi-supine position
    Description

    BLOOD PRESSURE AND PULSE RATE: semi-supine position

    Alias
    UMLS CUI-1
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    UMLS CUI-2
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    UMLS CUI-4
    C0232117 (Pulse Rate)
    SNOMED
    78564009
    UMLS CUI-5
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    Time
    Description

    time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood pressure: Systolic
    Description

    blood pressure systolic in semi-supine position

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Blood pressure: Diastolic
    Description

    blood pressure diastolic in semi-supine position

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Pulse
    Description

    heart rate

    Data type

    integer

    Measurement units
    • Bts/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    Bts/min
    Initials
    Description

    initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    BLOOD PRESSURE AND PULSE RATE: erect position
    Description

    BLOOD PRESSURE AND PULSE RATE: erect position

    Alias
    UMLS CUI-1
    C0005823 (Blood Pressure)
    SNOMED
    75367002
    UMLS CUI-2
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    UMLS CUI-4
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI-5
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    Time
    Description

    time

    Data type

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Blood pressure: Systolic
    Description

    blood pressure systolic in semi-supine position

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Blood pressure: Diastolic
    Description

    blood pressure diastolic in semi-supine position

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    mmHg
    Pulse
    Description

    heart rate

    Data type

    integer

    Measurement units
    • Bts/min
    Alias
    UMLS CUI [1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    Bts/min
    Initials
    Description

    initials

    Data type

    text

    Alias
    UMLS CUI [1]
    C2986440 (Person Initials)
    Comments
    Description

    Comments

    Alias
    UMLS CUI-1
    C0947611 (Comment)
    LOINC
    LP72293-1
    Comments
    Description

    comments

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Back to the top of the page

    Similar models

    final examination cardiovascular monitoring PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    focus panel
    Item
    Focus Panel ID
    integer
    C3846158 (UMLS CUI [1])
    patient number
    Item
    Patient No
    integer
    C1830427 (UMLS CUI [1])
    date
    Item
    Date
    date
    C0011008 (UMLS CUI [1])
    treatment
    Item
    Treatment
    text
    C0087111 (UMLS CUI [1])
    Item Group
    BLOOD PRESSURE AND PULSE RATE: semi-supine position
    C0005823 (UMLS CUI-1)
    C0038846 (UMLS CUI-2)
    C0232117 (UMLS CUI-4)
    C0038846 (UMLS CUI-5)
    time
    Item
    Time
    time
    C0040223 (UMLS CUI [1])
    blood pressure systolic in semi-supine position
    Item
    Blood pressure: Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    blood pressure diastolic in semi-supine position
    Item
    Blood pressure: Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    heart rate
    Item
    Pulse
    integer
    C0018810 (UMLS CUI [1])
    initials
    Item
    Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    BLOOD PRESSURE AND PULSE RATE: erect position
    C0005823 (UMLS CUI-1)
    C0231472 (UMLS CUI-2)
    C0018810 (UMLS CUI-4)
    C0231472 (UMLS CUI-5)
    time
    Item
    Time
    time
    C0040223 (UMLS CUI [1])
    blood pressure systolic in semi-supine position
    Item
    Blood pressure: Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    blood pressure diastolic in semi-supine position
    Item
    Blood pressure: Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    heart rate
    Item
    Pulse
    integer
    C0018810 (UMLS CUI [1])
    initials
    Item
    Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Comments
    C0947611 (UMLS CUI-1)
    comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Back to the top of the page 

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