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ID

33973

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

Mots-clés

Versions (3)
  1. 08/11/2018 08/11/2018 -
  2. 13/12/2018 13/12/2018 -
  3. 09/01/2019 09/01/2019 -
Détendeur de droits

GSK group of companies

Téléchargé le

9 janvier 2019

DOI

Pour une demande vous connecter.

Licence

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

    Anglais

    Session 3: Investigational Product

    1 Formulaires  
    Administrative data
    Description

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Site
    Description

    Site

    Type de données

    text

    Alias
    UMLS CUI [1]
    C2825164
    Patient
    Description

    Patient

    Type de données

    text

    Alias
    UMLS CUI [1]
    C1299487
    Patient Number
    Description

    Patient Number

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1300638
    Investigational Product - Regimen A - 40 mg Carvedilol CR
    Description

    Investigational Product - Regimen A - 40 mg Carvedilol CR

    Alias
    UMLS CUI-1
    C0304229
    UMLS CUI-2
    C1276413
    UMLS CUI-3
    C0054836
    Date of dose
    Description

    Date of dose

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0011008
    Time of dose
    Description

    Time of dose

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C0178602
    UMLS CUI [1,3]
    C0040223
    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
    UMLS CUI-2
    C0054836
    UMLS CUI-3
    C1276413
    UMLS CUI-4
    C0001948
    Intake Start Date
    Description

    Taken together with Carvedilol CR

    Type de données

    date

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

    Start Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C1512806
    UMLS CUI [1,2]
    C1301880
    Intake Stop Date
    Description

    Stop Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1512806
    UMLS CUI [1,2]
    C0806020
    Intake Stop Time
    Description

    Stop Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C1512806
    UMLS CUI [1,2]
    C1522314
    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
    UMLS CUI-2
    C1276413
    UMLS CUI-3
    C0001948
    2.5 Hours before Carvedilol CR
    Description

    2.5 Hours before Carvedilol CR

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0439227
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [2]
    C0054836
    Intake Start Date
    Description

    Start Date

    Type de données

    date

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

    Start Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C1512806
    UMLS CUI [1,2]
    C1301880
    Intake Stop Date
    Description

    Stop Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1512806
    UMLS CUI [1,2]
    C0806020
    Intake Stop Time
    Description

    Stop Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C1512806
    UMLS CUI [1,2]
    C1522314
    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
    UMLS CUI-2
    C1276413
    UMLS CUI-3
    C0001948
    2 Hours after Cardivelol CR
    Description

    2 Hours after Cardivelol CR

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0439227
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [2]
    C0054836
    Intake Start Date
    Description

    Start Date

    Type de données

    date

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

    Start Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C1512806
    UMLS CUI [1,2]
    C1301880
    Intake Stop Date
    Description

    Stop Date

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C1512806
    UMLS CUI [1,2]
    C0806020
    Intake Stop Time
    Description

    Stop Time

    Type de données

    time

    Alias
    UMLS CUI [1,1]
    C1512806
    UMLS CUI [1,2]
    C1522314
    Retour au début de la page

    Similar models

    Session 3: Investigational Product

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Site
    Item
    Site
    text
    C2825164 (UMLS CUI [1])
    Patient
    Item
    Patient
    text
    C1299487 (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)
    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
    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])
    Retour au début de la page 

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