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ID

30497

Descrizione

This ODM file contains 12-Lead ECG Findings. To be filled at Screening, Session 1 and 2 (Day 1, several times), Early Withdrawal and Follow-Up. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

collegamento

https://clinicaltrials.gov/ct2/show/NCT01039454

Keywords

  1. 08/06/18 08/06/18 - Sarah Riepenhausen
Titolare del copyright

GlaxoSmithKline

Caricato su

8 giugno 2018

DOI

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Licenza

Creative Commons BY-NC 3.0

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    Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454

    12-Lead-ECG (All Part A Visits)

    Administrative Data
    Descrizione

    Administrative Data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descrizione

    Subject Identifier

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C2348585
    Type of Visit
    Descrizione

    Visit

    Tipo di dati

    text

    Alias
    UMLS CUI [1]
    C0545082
    12-Lead ECG
    Descrizione

    12-Lead ECG

    Alias
    UMLS CUI-1
    C0430456
    Planned relative Time on Session Days 1.
    Descrizione

    Not to be filled at Screening, Early Withdrawal or Follow-Up Visit.

    Tipo di dati

    text

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0439564
    Start Date of ECG
    Descrizione

    Start Date of ECG

    Tipo di dati

    date

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C0808070
    Start Time of ECG
    Descrizione

    Start Time of ECG

    Tipo di dati

    time

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1301880
    Heart Rate
    Descrizione

    Heart Rate

    Tipo di dati

    integer

    Unità di misura
    • beats/min
    Alias
    UMLS CUI [1,1]
    C0018810
    UMLS CUI [1,2]
    C0430456
    beats/min
    PR Interval
    Descrizione

    PR Interval

    Tipo di dati

    float

    Unità di misura
    • msec
    Alias
    UMLS CUI [1]
    C0429087
    msec
    QRS Duration
    Descrizione

    QRS Duration

    Tipo di dati

    float

    Unità di misura
    • msec
    Alias
    UMLS CUI [1,1]
    C0429025
    UMLS CUI [1,2]
    C0430456
    msec
    uncorrected QT interval
    Descrizione

    uncorrected QT interval

    Tipo di dati

    float

    Unità di misura
    • msec
    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1287082
    UMLS CUI [1,3]
    C4072785
    msec
    QTc interval
    Descrizione

    QTc interval

    Tipo di dati

    float

    Unità di misura
    • msec
    Alias
    UMLS CUI [1]
    C0855331
    msec
    Result of ECG
    Descrizione

    Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete additional ECG abnormalities pages if clinically abnormalities are present.

    Tipo di dati

    integer

    Alias
    UMLS CUI [1,1]
    C0430456
    UMLS CUI [1,2]
    C1274040

    Similar models

    12-Lead-ECG (All Part A Visits)

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    Administrative Data
    C1320722 (UMLS CUI-1)
    Subject Identifier
    Item
    Subject Identifier
    text
    C2348585 (UMLS CUI [1])
    Item
    Type of Visit
    text
    C0545082 (UMLS CUI [1])
    Code List
    Type of Visit
    CL Item
    Screening (Screening)
    (Comment:en)
    CL Item
    Session 1 (Day 1) (Session 1 (Day 1))
    (Comment:en)
    CL Item
    Early Withdrawal (Early Withdrawal)
    (Comment:en)
    CL Item
    Follow-Up (Follow-Up)
    (Comment:en)
    CL Item
    Session 2 (Day 1) (Session 2 (Day 1))
    (Comment:en)
    CL Item
    Unscheduled (Unscheduled)
    (Comment:en)
    Item Group
    12-Lead ECG
    C0430456 (UMLS CUI-1)
    Item
    Planned relative Time on Session Days 1.
    text
    C0430456 (UMLS CUI [1,1])
    C0439564 (UMLS CUI [1,2])
    Code List
    Planned relative Time on Session Days 1.
    CL Item
    Pre-dose (Pre-dose)
    CL Item
    1hrs (1hrs)
    CL Item
    2hrs (2hrs)
    CL Item
    5hrs (5hrs)
    CL Item
    6hrs (6hrs)
    CL Item
    8hrs (8hrs)
    CL Item
    12hrs (12hrs)
    CL Item
    24hrs (24hrs)
    CL Item
    48hrs (48hrs)
    Start Date of ECG
    Item
    Start Date of ECG
    date
    C0430456 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start Time of ECG
    Item
    Start Time of ECG
    time
    C0430456 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Heart Rate
    Item
    Heart Rate
    integer
    C0018810 (UMLS CUI [1,1])
    C0430456 (UMLS CUI [1,2])
    PR Interval
    Item
    PR Interval
    float
    C0429087 (UMLS CUI [1])
    QRS Duration
    Item
    QRS Duration
    float
    C0429025 (UMLS CUI [1,1])
    C0430456 (UMLS CUI [1,2])
    uncorrected QT interval
    Item
    uncorrected QT interval
    float
    C0430456 (UMLS CUI [1,1])
    C1287082 (UMLS CUI [1,2])
    C4072785 (UMLS CUI [1,3])
    QTc interval
    Item
    QTc interval
    float
    C0855331 (UMLS CUI [1])
    Item
    Result of ECG
    integer
    C0430456 (UMLS CUI [1,1])
    C1274040 (UMLS CUI [1,2])
    Code List
    Result of ECG
    CL Item
    Normal (1)
    CL Item
    Abnormal - not clinically significant (2)
    CL Item
    abnormal - clinically significant (3)
    CL Item
    no result (not available) (4)

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