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ID

44255

Beschreibung

Study ID: 101468/205 Clinical Study ID: 101468/205 Study Title:A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197080 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Stichworte

  1. 19.02.19 19.02.19 -
  2. 20.09.21 20.09.21 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

20. September 2021

DOI

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Lizenz

Creative Commons BY-NC 3.0

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    Efficacy and Safety of Ropinirole XR (Extended Release) in Patients with Restless Legs Syndrome NCT00197080

    Ambulatory Blood Pressuure Monitoring Diary; Equipment Request

    When dispensed?
    Beschreibung

    When dispensed?

    Alias
    UMLS CUI-1
    C1880359
    Dispensed at the End of which Week Visit?
    Beschreibung

    Dispensed at the End of which Week Visit?

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1880359
    UMLS CUI [1,2]
    C0545082
    Administrative
    Beschreibung

    Administrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Beschreibung

    Subject Identifier

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Doctor’s Name:
    Beschreibung

    Doctor’s Name:

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2361125
    Telephone Number:
    Beschreibung

    Telephone Number:

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C1515258
    Study Contact:
    Beschreibung

    Study Contact:

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C0337611
    Ambulatory Blood Pressure Monitoring Diary
    Beschreibung

    Ambulatory Blood Pressure Monitoring Diary

    Alias
    UMLS CUI-1
    C0430452
    Date and time of dose:
    Beschreibung

    Date and time of dose:

    Datentyp

    datetime

    Alias
    UMLS CUI [1]
    C1986447
    Date of Assessment:
    Beschreibung

    Date of Assessment:

    Datentyp

    date

    Alias
    UMLS CUI [1]
    C2985720
    Blood Pressure Measurement
    Beschreibung

    Blood Pressure Measurement

    Alias
    UMLS CUI-1
    C0005823
    Time of Blood Pressure Measurement
    Beschreibung

    Time of Blood Pressure Measurement

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0005823
    UMLS CUI [1,2]
    C0040223
    Activity at time of Blood Pressure Measurement
    Beschreibung

    Check one activity level for each time point

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0005824
    UMLS CUI [1,2]
    C0040223
    UMLS CUI [1,3]
    C0026606
    Equipment Request
    Beschreibung

    Equipment Request

    Alias
    UMLS CUI-1
    C0014672
    UMLS CUI-2
    C1272683
    Date of Request:
    Beschreibung

    Date of Request:

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C0011008
    Investigator’s name:
    Beschreibung

    Investigator’s name:

    Datentyp

    text

    Alias
    UMLS CUI [1]
    C2826892
    Site Number:
    Beschreibung

    Site Number:

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C2825164
    UMLS CUI [1,2]
    C0237753
    Requestor’s name:
    Beschreibung

    Requestor’s name:

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C0027365
    Requestor’s phone number:
    Beschreibung

    Requestor’s phone number:

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C1272683
    UMLS CUI [1,2]
    C1515258
    Number of ABP 90207 monitors:
    Beschreibung

    Number of ABP 90207 monitors:

    Datentyp

    integer

    Alias
    UMLS CUI [1,1]
    C0237753
    UMLS CUI [1,2]
    C0181904
    Cuff Size(s):
    Beschreibung

    Cuff Size(s):

    Datentyp

    integer

    Alias
    UMLS CUI [1]
    C0489480
    Time Zone at the site:
    Beschreibung

    Time Zone at the site:

    Datentyp

    text

    Alias
    UMLS CUI [1,1]
    C2825194
    UMLS CUI [1,2]
    C2825164
    Equipment needed by:
    Beschreibung

    Equipment needed by:

    Datentyp

    date

    Alias
    UMLS CUI [1,1]
    C0014672
    UMLS CUI [1,2]
    C0686904

    Ähnliche Modelle

    Ambulatory Blood Pressuure Monitoring Diary; Equipment Request

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    When dispensed?
    C1880359 (UMLS CUI-1)
    Dispensed at the End of which Week Visit?
    Item
    Dispensed at the End of which Week Visit?
    integer
    C1880359 (UMLS CUI [1,1])
    C0545082 (UMLS CUI [1,2])
    Item Group
    Administrative
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Doctor’s Name:
    Item
    Doctor’s Name:
    text
    C2361125 (UMLS CUI [1])
    Telephone Number:
    Item
    Telephone Number:
    integer
    C1515258 (UMLS CUI [1])
    Study Contact:
    Item
    Study Contact:
    text
    C0337611 (UMLS CUI [1])
    Item Group
    Ambulatory Blood Pressure Monitoring Diary
    C0430452 (UMLS CUI-1)
    Date and time of dose:
    Item
    Date and time of dose:
    datetime
    C1986447 (UMLS CUI [1])
    Date of Assessment:
    Item
    Date of Assessment:
    date
    C2985720 (UMLS CUI [1])
    Item Group
    Blood Pressure Measurement
    C0005823 (UMLS CUI-1)
    Item
    Time of Blood Pressure Measurement
    integer
    C0005823 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Code List
    Time of Blood Pressure Measurement
    CL Item
    Pre-dose (1)
    CL Item
    1 Hour Post-dose (2)
    CL Item
    2 Hours Post-dose (3)
    CL Item
    3 Hours Post-dose (4)
    CL Item
    4 Hours Post-dose (5)
    CL Item
    5 Hours Post-dose (6)
    CL Item
    6 Hours Post-dose (7)
    CL Item
    7 Hours Post-dose (8)
    CL Item
    8 Hours Post-dose (9)
    CL Item
    9 Hours Post-dose (10)
    CL Item
    10 Hours Post-dose (11)
    Item
    Activity at time of Blood Pressure Measurement
    integer
    C0005824 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    C0026606 (UMLS CUI [1,3])
    Code List
    Activity at time of Blood Pressure Measurement
    CL Item
    Sedentary (or not very active) (1)
    CL Item
    (For example, napping, reading, watching TV, listening to music, etc.) (2)
    CL Item
    Low (activity) (2)
    CL Item
    (For example, using computer, cooking, eating, etc.) (4)
    CL Item
    Moderate (activity) (3)
    CL Item
    (For example, shopping at the mall, walking at a comfortable pace, etc.) (6)
    CL Item
    High (activity) (4)
    CL Item
    (For example, running, cycling, etc.) (8)
    CL Item
    Device not worn (5)
    Item Group
    Equipment Request
    C0014672 (UMLS CUI-1)
    C1272683 (UMLS CUI-2)
    Date of Request:
    Item
    Date of Request:
    date
    C1272683 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator’s name:
    Item
    Investigator’s name:
    text
    C2826892 (UMLS CUI [1])
    Site Number:
    Item
    Site Number:
    integer
    C2825164 (UMLS CUI [1,1])
    C0237753 (UMLS CUI [1,2])
    Requestor’s name:
    Item
    Requestor’s name:
    text
    C1272683 (UMLS CUI [1,1])
    C0027365 (UMLS CUI [1,2])
    Requestor’s phone number:
    Item
    Requestor’s phone number:
    integer
    C1272683 (UMLS CUI [1,1])
    C1515258 (UMLS CUI [1,2])
    Number of ABP 90207 monitors:
    Item
    Number of ABP 90207 monitors:
    integer
    C0237753 (UMLS CUI [1,1])
    C0181904 (UMLS CUI [1,2])
    Item
    Cuff Size(s):
    integer
    C0489480 (UMLS CUI [1])
    Code List
    Cuff Size(s):
    CL Item
    Small (17 - 24 cm) (1)
    CL Item
    Medium (24 - 32cm) (2)
    CL Item
    Large (32 - 42 cm) (3)
    CL Item
    Extra Large (38 - 50 cm) (4)
    Time Zone at the site:
    Item
    Time Zone at the site:
    text
    C2825194 (UMLS CUI [1,1])
    C2825164 (UMLS CUI [1,2])
    Equipment needed by:
    Item
    Equipment needed by:
    date
    C0014672 (UMLS CUI [1,1])
    C0686904 (UMLS CUI [1,2])

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