0 Ratings
ID

27197

Description

Study ID: 101468/168 Clinical Study ID: 101468/168 Study Title: A Randomised, Double Blind, Three Period, Cross-Over Study of Ropinirole CR and Ropinirole IR Monotherapy Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara Study Indication: Parkinson Disease

Keywords

Versions (3)
  1. 9/20/17 9/20/17 -
  2. 9/20/17 9/20/17 -
  3. 11/3/17 11/3/17 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 3, 2017

DOI

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License

Creative Commons BY-NC 3.0
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    visit week 12 physical examination Ropinirole CR Ropinirole IR Monotherapy 101468/168

    English

    visit week 12 physical examination Ropinirole CR Ropinirole IR Monotherapy 101468/168

    1 forms  
    Administrative Data
    Description

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    subject number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    VITAL SIGNS
    Description

    VITAL SIGNS

    Alias
    UMLS CUI-1
    C0518766
    Semi-Supine Blood Pressure Systolic
    Description

    semi-supine blood pressure systolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0038846
    mmHg
    Semi-Supine Blood Pressure Diastolic
    Description

    semi-supine blood pressure diastolic

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0038846
    beats/min
    Semi-Supine Heart Rate
    Description

    semi-supine heart rate

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0522019
    UMLS CUI [1,2]
    C0018810
    beats/min
    Standing Blood Pressure Systolic
    Description

    standing blood pressure systolic

    Data type

    integer

    Measurement units
    • mmHg
    Alias
    UMLS CUI [1,1]
    C0871470
    UMLS CUI [1,2]
    C0231472
    mmHg
    Standing Blood Pressure Diastolic
    Description

    standing blood pressure diastolic

    Data type

    integer

    Measurement units
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0428883
    UMLS CUI [1,2]
    C0231472
    beats/min
    Standing Heart Rate
    Description

    standing heart rate

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2029905
    12-LEAD ECG
    Description

    12-LEAD ECG

    Alias
    UMLS CUI-1
    C0430456
    Date of ECG
    Description

    date of ECG

    Data type

    date

    Alias
    UMLS CUI [1]
    C2826640
    Result of ECG
    Description

    ECG Finding

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0438154
    CENTRAL LABORATORY
    Description

    CENTRAL LABORATORY

    Alias
    UMLS CUI-1
    C1880016
    Date sample taken
    Description

    date sample taken

    Data type

    date

    Alias
    UMLS CUI [1]
    C1302413
    CLINICAL GLOBAL IMPRESSION (CGI-S)
    Description

    CLINICAL GLOBAL IMPRESSION (CGI-S)

    Alias
    UMLS CUI-1
    C3639708
    CLINICAL GLOBAL IMPRESSION (CGI-S)
    Description

    clinical global impression questionnaire

    Data type

    text

    Alias
    UMLS CUI [1]
    C3639708
    UNIFIED PARKINSONS DISEASE RATING SCALE
    Description

    UNIFIED PARKINSONS DISEASE RATING SCALE

    Alias
    UMLS CUI-1
    C3639721
    UNIFIED PARKINSONS DISEASE RATING SCALE
    Description

    unified parkinson's disease rating scale questionnaire

    Data type

    text

    Alias
    UMLS CUI [1]
    C3639721
    PARKINSON’S DISEASE SLEEP SCALE (PDSS)
    Description

    PARKINSON’S DISEASE SLEEP SCALE (PDSS)

    Alias
    UMLS CUI-1
    C0030567
    UMLS CUI-2
    C0037313
    PARKINSON’S DISEASE SLEEP SCALE (PDSS)
    Description

    parkinson's disease sleep scale

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0851578
    UMLS CUI [1,2]
    C0681889
    BECK DEPRESSION INVENTORY
    Description

    BECK DEPRESSION INVENTORY

    Ensure the subject has completed the week 12 Beck Depression Inventory
    Description

    Beck Depression Inventory completion

    Data type

    boolean

    Epworth Sleepiness Scale
    Description

    Epworth Sleepiness Scale

    Ensure the subject has completed the week 12 Epworth Sleepiness Scale
    Description

    Epworth Sleepiness Scale completion

    Data type

    boolean

    Stable UPDRS motor score
    Description

    Stable UPDRS motor score

    Stable UPDRS motor score
    Description

    A subject must have a stable UPDRS motor score in order to proceed into the next phase of the study. A stable UPDRS motor score is defined as a score which does not change by more than +/- 2 points during at least the final two visits of the titration phase (Weeks 10 and 12).

    Data type

    boolean

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    Similar models

    visit week 12 physical examination Ropinirole CR Ropinirole IR Monotherapy 101468/168

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    subject number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    VITAL SIGNS
    C0518766 (UMLS CUI-1)
    semi-supine blood pressure systolic
    Item
    Semi-Supine Blood Pressure Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    semi-supine blood pressure diastolic
    Item
    Semi-Supine Blood Pressure Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0038846 (UMLS CUI [1,2])
    semi-supine heart rate
    Item
    Semi-Supine Heart Rate
    integer
    C0522019 (UMLS CUI [1,1])
    C0018810 (UMLS CUI [1,2])
    standing blood pressure systolic
    Item
    Standing Blood Pressure Systolic
    integer
    C0871470 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    standing blood pressure diastolic
    Item
    Standing Blood Pressure Diastolic
    integer
    C0428883 (UMLS CUI [1,1])
    C0231472 (UMLS CUI [1,2])
    standing heart rate
    Item
    Standing Heart Rate
    integer
    C2029905 (UMLS CUI [1])
    Item Group
    12-LEAD ECG
    C0430456 (UMLS CUI-1)
    date of ECG
    Item
    Date of ECG
    date
    C2826640 (UMLS CUI [1])
    Item
    Result of ECG
    integer
    C0438154 (UMLS CUI [1])
    ECG Finding
    Code List
    Result of ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant (2)
    CL Item
    Abnormal - clinically significant -> Complete an Adverse Event (AE) or Serious Adverse Event  (3)
    CL Item
    (SAE) page(s) if clinically significant abnormalities meet the (4)
    CL Item
    protocol definition for an AE or SAE. (5)
    Item Group
    CENTRAL LABORATORY
    C1880016 (UMLS CUI-1)
    date sample taken
    Item
    Date sample taken
    date
    C1302413 (UMLS CUI [1])
    Item Group
    CLINICAL GLOBAL IMPRESSION (CGI-S)
    C3639708 (UMLS CUI-1)
    clinical global impression questionnaire
    Item
    CLINICAL GLOBAL IMPRESSION (CGI-S)
    text
    C3639708 (UMLS CUI [1])
    Item Group
    UNIFIED PARKINSONS DISEASE RATING SCALE
    C3639721 (UMLS CUI-1)
    unified parkinson's disease rating scale questionnaire
    Item
    UNIFIED PARKINSONS DISEASE RATING SCALE
    text
    C3639721 (UMLS CUI [1])
    Item Group
    PARKINSON’S DISEASE SLEEP SCALE (PDSS)
    C0030567 (UMLS CUI-1)
    C0037313 (UMLS CUI-2)
    parkinson's disease sleep scale
    Item
    PARKINSON’S DISEASE SLEEP SCALE (PDSS)
    text
    C0851578 (UMLS CUI [1,1])
    C0681889 (UMLS CUI [1,2])
    Item Group
    BECK DEPRESSION INVENTORY
    Beck Depression Inventory completion
    Item
    Ensure the subject has completed the week 12 Beck Depression Inventory
    boolean
    Item Group
    Epworth Sleepiness Scale
    Epworth Sleepiness Scale completion
    Item
    Ensure the subject has completed the week 12 Epworth Sleepiness Scale
    boolean
    Item Group
    Stable UPDRS motor score
    Stable UPDRS motor score
    Item
    Stable UPDRS motor score
    boolean
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