0 Evaluaciones
ID

21094

Descripción

Documentation Part: Treatment Phase Day 22 An Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets. ClinicalTrials.gov Identifier: NCT00460148 https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1 Responsible Party: GlaxoSmithKline

Link

https://clinicaltrials.gov/ct2/show/NCT00460148?term=NCT00460148&rank=1

Palabras clave

Versiones (4)
  1. 4/3/17 4/3/17 -
  2. 4/3/17 4/3/17 -
  3. 8/3/17 8/3/17 -
  4. 10/4/17 10/4/17 -
Subido en

10 de abril de 2017

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    Treatment Phase Day 22 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

    Inglés

    Treatment Phase Day 22 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

    1 formularios  
    Subject information
    Descripción

    Subject information

    Alias
    UMLS CUI-1
    C2707520
    Subject identifier
    Descripción

    Subject identifier

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348585
    Visit date
    Descripción

    Visit date

    Alias
    UMLS CUI-1
    C1320303
    Visit date
    Descripción

    Visit date

    Tipo de datos

    date

    Unidades de medida
    • Day Month Year
    Alias
    UMLS CUI [1]
    C1320303
    Day Month Year
    Vital signs
    Descripción

    Vital signs

    Alias
    UMLS CUI-1
    C0518766
    Date
    Descripción

    Date

    Tipo de datos

    date

    Unidades de medida
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0011008
    Day Month Year
    Planned Relative Time
    Descripción

    Planned Relative Time

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0439564
    Planned Absolute time
    Descripción

    Planned Absolute time

    Tipo de datos

    integer

    Unidades de medida
    • min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1552097
    min
    Actual time
    Descripción

    Actual time

    Tipo de datos

    time

    Unidades de medida
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0040223
    Hr : Min
    Systolic Blood Pressure
    Descripción

    Systolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0871470
    mmHg
    Diastolic Blood Pressure
    Descripción

    Diastolic Blood Pressure

    Tipo de datos

    integer

    Unidades de medida
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0428883
    mmHg
    Subject position
    Descripción

    Subject position

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C1262869
    Heart Rate
    Descripción

    Heart Rate

    Tipo de datos

    integer

    Unidades de medida
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0518766
    UMLS CUI [1,2]
    C0018810
    beats/min
    12-Lead-ECG
    Descripción

    12-Lead-ECG

    Alias
    UMLS CUI-1
    C0430456
    Start date of ECG
    Descripción

    Start date of ECG

    Tipo de datos

    date

    Unidades de medida
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0013798
    Day Month Year
    Planned Relative Time
    Descripción

    Planned Relative Time

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0439564
    Start Time of ECG
    Descripción

    Start Time of ECG

    Tipo de datos

    time

    Unidades de medida
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0013798
    Hr : Min
    Ventricular Rate
    Descripción

    Ventricular Rate

    Tipo de datos

    integer

    Unidades de medida
    • Beats/min
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C2189285
    Beats/min
    PR Interval
    Descripción

    PR Interval

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429087
    msec
    QRS Duration
    Descripción

    QRS Duration

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0429025
    msec
    Uncorrected QT Interval
    Descripción

    Uncorrected QT Interval

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1287082
    msec
    QTc Invertal
    Descripción

    QTc Invertal

    Tipo de datos

    integer

    Unidades de medida
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0860814
    msec
    Result of the ECG
    Descripción

    Enter code for result from the following list: 1=Normal 2=Abnormal - not clinically significant 3=Abnormal - clinically significant 4=No result (not available)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0438154
    Invesatigational product
    Descripción

    Invesatigational product

    Alias
    UMLS CUI-1
    C3898691
    Planned timepoint
    Descripción

    Planned timepoint

    Tipo de datos

    text

    Alias
    UMLS CUI [1]
    C2348792
    Date of dose
    Descripción

    Date of dose

    Tipo de datos

    date

    Unidades de medida
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0011008
    Day Month Year
    Time of dose
    Descripción

    Time of dose

    Tipo de datos

    time

    Unidades de medida
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C0013227
    UMLS CUI [1,2]
    C0040223
    Hr : Min
    Treatment confirmation
    Descripción

    Treatment confirmation

    Alias
    UMLS CUI-1
    C0750484
    UMLS CUI-2
    C0087111
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Descripción

    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0750484
    UMLS CUI [1,2]
    C0087111
    If No, record reason(s)
    Descripción

    If No, record reason(s)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0750484
    UMLS CUI [1,3]
    C0087111
    Ambulatory blood pressure monitoring
    Descripción

    Ambulatory blood pressure monitoring

    Alias
    UMLS CUI-1
    C0026426
    UMLS CUI-2
    C0439841
    Start date
    Descripción

    Start date

    Tipo de datos

    date

    Unidades de medida
    • Day Month Year
    Alias
    UMLS CUI [1,1]
    C0808070
    UMLS CUI [1,2]
    C0026426
    UMLS CUI [1,3]
    C0439841
    Day Month Year
    Start time
    Descripción

    Start time

    Tipo de datos

    time

    Unidades de medida
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C1301880
    UMLS CUI [1,2]
    C0026426
    UMLS CUI [1,3]
    C0439841
    Hr : Min
    Stop time
    Descripción

    Stop time

    Tipo de datos

    time

    Unidades de medida
    • Hr : Min
    Alias
    UMLS CUI [1,1]
    C1522314
    UMLS CUI [1,2]
    C0026426
    UMLS CUI [1,3]
    C0439841
    Hr : Min
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    Similar models

    Treatment Phase Day 22 Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole NCT00460148

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Subject information
    C2707520 (UMLS CUI-1)
    Subject identifier
    Item
    Subject identifier
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Visit date
    C1320303 (UMLS CUI-1)
    Visit date
    Item
    Visit date
    date
    C1320303 (UMLS CUI [1])
    Item Group
    Vital signs
    C0518766 (UMLS CUI-1)
    Date
    Item
    Date
    date
    C0518766 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Planned Relative Time
    text
    C0518766 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose (1)
    CL Item
    Unscheduled (2)
    Planned Absolute time
    Item
    Planned Absolute time
    integer
    C0518766 (UMLS CUI [1,1])
    C1552097 (UMLS CUI [1,2])
    Actual time
    Item
    Actual time
    time
    C0518766 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Systolic Blood Pressure
    Item
    Systolic Blood Pressure
    integer
    C0518766 (UMLS CUI [1,1])
    C0871470 (UMLS CUI [1,2])
    Diastolic Blood Pressure
    Item
    Diastolic Blood Pressure
    integer
    C0518766 (UMLS CUI [1,1])
    C0428883 (UMLS CUI [1,2])
    Item
    Subject position
    text
    C0518766 (UMLS CUI [1,1])
    C1262869 (UMLS CUI [1,2])
    Subject position
    Code List
    Subject position
    CL Item
    Supine (1)
    CL Item
    Standing (3)
    Heart Rate
    Item
    Heart Rate
    integer
    C0518766 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    Item Group
    12-Lead-ECG
    C0430456 (UMLS CUI-1)
    Start date of ECG
    Item
    Start date of ECG
    date
    C0808070 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Item
    Planned Relative Time
    text
    C0430456 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Planned Relative Time
    Code List
    Planned Relative Time
    CL Item
    Pre-dose (1)
    CL Item
    Unscheduled (2)
    Start Time of ECG
    Item
    Start Time of ECG
    time
    C1301880 (UMLS CUI [1,1])
    C0013798 (UMLS CUI [1,2])
    Ventricular Rate
    Item
    Ventricular Rate
    integer
    C0430456 (UMLS CUI [1,1])
    C2189285 (UMLS CUI [1,2])
    PR Interval
    Item
    PR Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C0429087 (UMLS CUI [1,2])
    QRS Duration
    Item
    QRS Duration
    integer
    C0430456 (UMLS CUI [1,1])
    C0429025 (UMLS CUI [1,2])
    Uncorrected QT Interval
    Item
    Uncorrected QT Interval
    integer
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    QTc Invertal
    Item
    QTc Invertal
    integer
    C0430456 (UMLS CUI [1,1])
    C0860814 (UMLS CUI [1,2])
    Result of the ECG
    Item
    Result of the ECG
    integer
    C0438154 (UMLS CUI [1])
    Item Group
    Invesatigational product
    C3898691 (UMLS CUI-1)
    Planned timepoint
    Item
    Planned timepoint
    text
    C2348792 (UMLS CUI [1])
    Date of dose
    Item
    Date of dose
    date
    C0013227 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Time of dose
    Item
    Time of dose
    time
    C0013227 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Item Group
    Treatment confirmation
    C0750484 (UMLS CUI-1)
    C0087111 (UMLS CUI-2)
    Item
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    text
    C0750484 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    Code List
    Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
    CL Item
    Yes (Y)
    CL Item
    No (N)
    If No, record reason(s)
    Item
    If No, record reason(s)
    text
    C0392360 (UMLS CUI [1,1])
    C0750484 (UMLS CUI [1,2])
    C0087111 (UMLS CUI [1,3])
    Item Group
    Ambulatory blood pressure monitoring
    C0026426 (UMLS CUI-1)
    C0439841 (UMLS CUI-2)
    Start date
    Item
    Start date
    date
    C0808070 (UMLS CUI [1,1])
    C0026426 (UMLS CUI [1,2])
    C0439841 (UMLS CUI [1,3])
    Start time
    Item
    Start time
    time
    C1301880 (UMLS CUI [1,1])
    C0026426 (UMLS CUI [1,2])
    C0439841 (UMLS CUI [1,3])
    Stop time
    Item
    Stop time
    time
    C1522314 (UMLS CUI [1,1])
    C0026426 (UMLS CUI [1,2])
    C0439841 (UMLS CUI [1,3])
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