ID

33513

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

Keywords

Versions (3)
  1. 11/8/18 11/8/18 -
  2. 11/8/18 11/8/18 -
  3. 12/11/18 12/11/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 11, 2018

DOI

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License

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 1: Investigational Product

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Description

Patient Number

Data type

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

Data type

date

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

Time of dose

Data type

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
C0001948
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
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

Data type

text

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0332152
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
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 Carvedilol CR
Description

2 Hours after Cardivelol CR

Data type

text

Alias
UMLS CUI [1,1]
C0054836
UMLS CUI [1,2]
C0687676
Start Date
Description

Start Date

Data type

date

Alias
UMLS CUI [1]
C0808070
Start Time
Description

Start Time

Data type

time

Alias
UMLS CUI [1]
C1301880
Stop Date
Description

Stop Date

Data type

date

Alias
UMLS CUI [1]
C0806020
Stop Time
Description

Stop Time

Data type

time

Alias
UMLS CUI [1]
C1522314
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Similar models

Session 1: 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
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)
C0001948 (UMLS CUI-3)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
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
C0001948 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
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 Carvedilol CR
text
C0054836 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1])
Start Time
Item
Start Time
time
C1301880 (UMLS CUI [1])
Stop Date
Item
Stop Date
date
C0806020 (UMLS CUI [1])
Stop Time
Item
Stop Time
time
C1522314 (UMLS CUI [1])
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