ID

32619

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 (2)
  1. 11/8/18 11/8/18 -
  2. 1/9/19 1/9/19 -
Copyright Holder

GSK group of companies

Uploaded on

November 8, 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 4: Investigational Product

1 forms  
Administrative data
Description

Administrative data

Site
Description

Site

Data type

text

Patient
Description

Patient

Data type

text

Patient Number
Description

Patient Number

Data type

integer

Investigational Product - Regimen A - 40 mg Carvedilol CR
Description

Investigational Product - Regimen A - 40 mg Carvedilol CR

Date of dose
Description

Date of dose

Data type

date

Time of dose
Description

Time of dose

Data type

time

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

0 Hours, taken together with Carvedilol CR
Description

0 Hours, taken together with Carvedilol CR

Data type

text

Start Date
Description

Start Date

Data type

date

Start Time
Description

Start Time

Data type

time

Stop Date
Description

Stop Date

Data type

date

Stop Time
Description

Stop Time

Data type

time

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

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

2.5 Hours before Carvedilol CR
Description

2.5 Hours before Carvedilol CR

Data type

text

Start Date
Description

Start Date

Data type

date

Start Time
Description

Start Time

Data type

time

Stop Date
Description

Stop Date

Data type

date

Stop Time
Description

Stop Time

Data type

time

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

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

2 Hours after Cardivelol CR
Description

2 Hours after Cardivelol CR

Data type

text

Start Date
Description

Start Date

Data type

date

Start Time
Description

Start Time

Data type

time

Stop Date
Description

Stop Date

Data type

date

Stop Time
Description

Stop Time

Data type

time

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Similar models

Session 4: Investigational Product

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Site
Item
Site
text
Patient
Item
Patient
text
Patient Number
Item
Patient Number
integer
Item Group
Investigational Product - Regimen A - 40 mg Carvedilol CR
Date of dose
Item
Date of dose
date
Time of dose
Item
Time of dose
time
Item Group
Investigational Product - 40 mg Carvedilol Regimen B Alcohol Ingestion - 240 ml OF 20%EtOH
0 Hours, taken together with Carvedilol CR
Item
0 Hours, taken together with Carvedilol CR
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Item Group
Investigational Product - Regimen C Alcohol Ingestion - 240 ml OF 20% EtOH
2.5 Hours before Carvedilol CR
Item
2.5 Hours before Carvedilol CR
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Item Group
Investigational Product - Regimen D Alcohol Ingestion - 240 ml OF 20% EtOH
2 Hours after Cardivelol CR
Item
2 Hours after Cardivelol CR
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
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