0 Evaluaciones
ID

25704

Descripción

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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Versiones (2)
  1. 11/9/17 11/9/17 -
  2. 11/9/17 11/9/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

11 de septiembre de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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    visit period 1,2,3 & 4 cardiovascular monitoring day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

    Inglés

    visit period 1,2,3 & 4 cardiovascular monitoring day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 formularios  
    Administrative Data
    Descripción

    Administrative Data

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

    focus panel

    Tipo de datos

    integer

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

    patient number

    Tipo de datos

    integer

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

    date

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C0011008 (Date in time)
    SNOMED
    410671006
    Number of Visit
    Descripción

    visit number

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C1549755 (Visit Number)
    Treatment
    Descripción

    treatment

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    Cardiovascular Monitoring
    Descripción

    Cardiovascular Monitoring

    Alias
    UMLS CUI-1
    C0007226 (Cardiovascular system)
    SNOMED
    113257007
    LOINC
    LP7118-5
    Time relative to dosing
    Descripción

    time relative to dosing

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0439564 (Relative time)
    SNOMED
    118578006
    LOINC
    LP21276-8
    UMLS CUI [1,2]
    C3469597 (Administration of medication)
    SNOMED
    18629005
    UMLS CUI [1,3]
    C0304229 (Experimental drug)
    Actual Time
    Descripción

    actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Semi-supine BP: Systolic
    Descripción

    blood pressure systolic in semi-supine position

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    Semi-supine BP: Diastolic
    Descripción

    blood pressure diastolic in semi-supine position

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    Semi-supine Bts/min
    Descripción

    heart rate in semi-supine position

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [1,2]
    C0038846 (Supine Position)
    SNOMED
    40199007
    LOINC
    LP29600-1
    Actual Time
    Descripción

    actual time

    Tipo de datos

    time

    Alias
    UMLS CUI [1]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Erect BP: Systolic
    Descripción

    blood pressure systolic standing

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0871470 (Systolic Pressure)
    SNOMED
    271649006
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    Erecet BP: Diastolic
    Descripción

    blood pressure diastolic ins standing position

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0428883 (Diastolic blood pressure)
    SNOMED
    271650006
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    Erect pulse Bts/min
    Descripción

    heart rate in standing position

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0018810 (heart rate)
    SNOMED
    364075005
    LOINC
    LP29713-2
    UMLS CUI [1,2]
    C0231472 (Standing position)
    SNOMED
    10904000
    LOINC
    LP101862-3
    Comments
    Descripción

    Comments

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

    comments

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C0947611 (Comment)
    LOINC
    LP72293-1
    Volver a la parte superior de la página

    Similar models

    visit period 1,2,3 & 4 cardiovascular monitoring day 1 PK and tolerability of ropinirole as 5 new formulations 101468/197

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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])
    Item
    Number of Visit
    text
    C1549755 (UMLS CUI [1])
    visit number
    Code List
    Number of Visit
    CL Item
    Period 1 (Period 1)
    CL Item
    Period 2 (Period 2)
    CL Item
    Period 3 (Period 3)
    CL Item
    Period 4 (Period 4)
    treatment
    Item
    Treatment
    text
    C0087111 (UMLS CUI [1])
    Item Group
    Cardiovascular Monitoring
    C0007226 (UMLS CUI-1)
    Item
    Time relative to dosing
    text
    C0439564 (UMLS CUI [1,1])
    C3469597 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [1,3])
    time relative to dosing
    Code List
    Time relative to dosing
    CL Item
    predose (predose)
    CL Item
    +1hr (+1hr)
    CL Item
    +2hrs (+2hrs)
    CL Item
    +3hrs (+3hrs)
    CL Item
    +4hrs (+4hrs)
    CL Item
    +5hrs (+5hrs)
    CL Item
    +6hrs (+6hrs)
    CL Item
    +8hrs (+8hrs)
    CL Item
    +12hrs (+12hrs)
    actual time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    blood pressure systolic in semi-supine position
    Item
    Semi-supine BP: Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    blood pressure diastolic in semi-supine position
    Item
    Semi-supine BP: Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    heart rate in semi-supine position
    Item
    Semi-supine Bts/min
    integer
    C0018810 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    actual time
    Item
    Actual Time
    time
    C0040223 (UMLS CUI [1])
    blood pressure systolic standing
    Item
    Erect BP: Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    blood pressure diastolic ins standing position
    Item
    Erecet BP: Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    heart rate in standing position
    Item
    Erect pulse Bts/min
    integer
    C0018810 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    Item Group
    Comments
    C0947611 (UMLS CUI-1)
    comments
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Volver a la parte superior de la página 

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