0 Ratings
ID

33972

Description

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

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Versions (2)
  1. 11/8/18 11/8/18 -
  2. 1/9/19 1/9/19 -
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GSK group of companies

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January 9, 2019

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Creative Commons BY-NC 3.0
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    A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904

    English

    Session 4: Investigational Product

    1 forms  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722 (Administrative documentation)
    SNOMED
    405624007
    Site
    Description

    Site

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164 (Study Site)
    Patient
    Description

    Patient

    Data type

    text

    Alias
    UMLS CUI [1]
    C2825164 (Study Site)
    Patient Number
    Description

    Patient Number

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [1,2]
    C1300638 (Identification number)
    SNOMED
    396278008
    Investigational Product - Regimen A - 40 mg Carvedilol CR
    Description

    Investigational Product - Regimen A - 40 mg Carvedilol CR

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C1276413 (Therapeutic regimen)
    SNOMED
    133877004
    UMLS CUI-3
    C0054836 (carvedilol)
    SNOMED
    108551001
    Date of dose
    Description

    Date of dose

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C0011008 (Date in time)
    SNOMED
    410671006
    Time of dose
    Description

    Time of dose

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C0304229 (Experimental drug)
    UMLS CUI [1,2]
    C0178602 (Dosage)
    SNOMED
    260911001
    LOINC
    LP7180-5
    UMLS CUI [1,3]
    C0040223 (Time)
    SNOMED
    410670007
    LOINC
    LP73517-2
    Investigational Product - 40 mg Carvedilol Regimen B Alcohol Ingestion - 240 ml OF 20%EtOH
    Description

    Investigational Product - 40 mg Carvedilol Regimen B Alcohol Ingestion - 240 ml OF 20%EtOH

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C0054836 (carvedilol)
    SNOMED
    108551001
    UMLS CUI-3
    C1276413 (Therapeutic regimen)
    SNOMED
    133877004
    UMLS CUI-4
    C0001948 (Alcohol consumption)
    SNOMED
    897148007
    LOINC
    MTHU047472
    0 Hours, taken together with Carvedilol CR
    Description

    0 Hours, taken together with Carvedilol CR

    Data type

    text

    Alias
    UMLS CUI [1]
    C0439227 (Hour)
    SNOMED
    258702006
    UMLS CUI [2]
    C0054836 (carvedilol)
    SNOMED
    108551001
    Intake Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Intake Start Time
    Description

    Start Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    Intake Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Intake Stop Time
    Description

    Stop Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C1522314 (End Time)
    SNOMED
    397898000
    Investigational Product - Regimen C Alcohol Ingestion - 240 ml OF 20% EtOH
    Description

    Investigational Product - Regimen C Alcohol Ingestion - 240 ml OF 20% EtOH

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C1276413 (Therapeutic regimen)
    SNOMED
    133877004
    UMLS CUI-3
    C0001948 (Alcohol consumption)
    SNOMED
    897148007
    LOINC
    MTHU047472
    2.5 Hours before Carvedilol CR
    Description

    2.5 Hours before Carvedilol CR

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439227 (Hour)
    SNOMED
    258702006
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [2]
    C0054836 (carvedilol)
    SNOMED
    108551001
    Intake Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Intake Start Time
    Description

    Start Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    Intake Stop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Intake Stop Time
    Description

    Stop Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C1522314 (End Time)
    SNOMED
    397898000
    Investigational Product - Regimen D Alcohol Ingestion - 240 ml OF 20% EtOH
    Description

    Investigational Product - Regimen D Alcohol Ingestion - 240 ml OF 20% EtOH

    Alias
    UMLS CUI-1
    C0304229 (Experimental drug)
    UMLS CUI-2
    C1276413 (Therapeutic regimen)
    SNOMED
    133877004
    UMLS CUI-3
    C0001948 (Alcohol consumption)
    SNOMED
    897148007
    LOINC
    MTHU047472
    2 Hours after Cardivelol CR
    Description

    2 Hours after Cardivelol CR

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0439227 (Hour)
    SNOMED
    258702006
    UMLS CUI [1,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [2]
    C0054836 (carvedilol)
    SNOMED
    108551001
    Intake Start Date
    Description

    Start Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C0808070 (Start Date)
    Intake Start Time
    Description

    Start Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C1301880 (Start time)
    SNOMED
    398201009
    LOINC
    LP102339-1
    IntakeStop Date
    Description

    Stop Date

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C0806020 (End date)
    SNOMED
    454551000124105
    LOINC
    MTHU008302
    Intake Stop Time
    Description

    Stop Time

    Data type

    time

    Alias
    UMLS CUI [1,1]
    C1512806 (Intake)
    UMLS CUI [1,2]
    C1522314 (End Time)
    SNOMED
    397898000
    Back to the top of the page

    Similar models

    Session 4: Investigational Product

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Patient
    Item
    Patient
    text
    C2825164 (UMLS CUI [1])
    Patient Number
    Item
    Patient Number
    integer
    C0030705 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Item Group
    Investigational Product - Regimen A - 40 mg Carvedilol CR
    C0304229 (UMLS CUI-1)
    C1276413 (UMLS CUI-2)
    C0054836 (UMLS CUI-3)
    Date of dose
    Item
    Date of dose
    date
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0011008 (UMLS CUI [1,3])
    Time of dose
    Item
    Time of dose
    time
    C0304229 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item Group
    Investigational Product - 40 mg Carvedilol Regimen B Alcohol Ingestion - 240 ml OF 20%EtOH
    C0304229 (UMLS CUI-1)
    C0054836 (UMLS CUI-2)
    C1276413 (UMLS CUI-3)
    C0001948 (UMLS CUI-4)
    0 Hours, taken together with Carvedilol CR
    Item
    0 Hours, taken together with Carvedilol CR
    text
    C0439227 (UMLS CUI [1])
    C0054836 (UMLS CUI [2])
    Start Date
    Item
    Intake Start Date
    date
    C1512806 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start Time
    Item
    Intake Start Time
    time
    C1512806 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Stop Date
    Item
    Intake Stop Date
    date
    C1512806 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Stop Time
    Item
    Intake Stop Time
    time
    C1512806 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item Group
    Investigational Product - Regimen C Alcohol Ingestion - 240 ml OF 20% EtOH
    C0304229 (UMLS CUI-1)
    C1276413 (UMLS CUI-2)
    C0001948 (UMLS CUI-3)
    2.5 Hours before Carvedilol CR
    Item
    2.5 Hours before Carvedilol CR
    text
    C0439227 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0054836 (UMLS CUI [2])
    Start Date
    Item
    Intake Start Date
    date
    C1512806 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start Time
    Item
    Intake Start Time
    time
    C1512806 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Stop Date
    Item
    Intake Stop Date
    date
    C1512806 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Stop Time
    Item
    Intake Stop Time
    time
    C1512806 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Item Group
    Investigational Product - Regimen D Alcohol Ingestion - 240 ml OF 20% EtOH
    C0304229 (UMLS CUI-1)
    C1276413 (UMLS CUI-2)
    C0001948 (UMLS CUI-3)
    2 Hours after Cardivelol CR
    Item
    2 Hours after Cardivelol CR
    text
    C0439227 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0054836 (UMLS CUI [2])
    Start Date
    Item
    Intake Start Date
    date
    C1512806 (UMLS CUI [1,1])
    C0808070 (UMLS CUI [1,2])
    Start Time
    Item
    Intake Start Time
    time
    C1512806 (UMLS CUI [1,1])
    C1301880 (UMLS CUI [1,2])
    Stop Date
    Item
    IntakeStop Date
    date
    C1512806 (UMLS CUI [1,1])
    C0806020 (UMLS CUI [1,2])
    Stop Time
    Item
    Intake Stop Time
    time
    C1512806 (UMLS CUI [1,1])
    C1522314 (UMLS CUI [1,2])
    Back to the top of the page 

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