ID

32599

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

  1. 11/8/18 11/8/18 -
  2. 12/13/18 12/13/18 -
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

Session 1: Vital Signs Form

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

Dosing Date and Time
Description

Dosing Date and Time

Dosing date
Description

Dosing date

Data type

date

Dosing time
Description

Dosing time

Data type

time

Predose - Semi-supine
Description

Predose - Semi-supine

Actual time
Description

Actual time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
Predose Orthostatic - Supine
Description

Predose Orthostatic - Supine

Actual time
Description

Actual time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
Predose Orthostatic - Standing
Description

Predose Orthostatic - Standing

Actual time
Description

Actual time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
Predose Orthostatic - Standing
Description

Predose Orthostatic - Standing

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
15 Minutes - Semi-supine
Description

15 Minutes - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
30 Minutes - Semi-supine
Description

30 Minutes - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
45 Minutes - Semi-supine
Description

45 Minutes - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
1 Hour - Semi-supine
Description

1 Hour - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
1.5 Hour - Semi-supine
Description

1.5 Hour - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
2 Hours - Semi-supine
Description

2 Hours - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
4 Hours - Semi-supine
Description

4 Hours - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
6 Hours - Semi-supine
Description

6 Hours - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
8 Hours - Semi-supine
Description

8 Hours - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
10 Hours - Semi-supine
Description

10 Hours - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
10 Hours - Orthostatic- Supine
Description

10 Hours - Orthostatic- Supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
10 Hours - Orthostatic- Sitting
Description

10 Hours - Orthostatic- Sitting

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
10 Hours - Orthostatic- Standing
Description

10 Hours - Orthostatic- Standing

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
12 Hours - Semi-supine
Description

12 Hours - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
24 Hours - Semi-supine
Description

24 Hours - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
32 Hours - Semi-supine
Description

32 Hours - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm
48 Hours - Semi-supine
Description

48 Hours - Semi-supine

Actual Time
Description

Actual Time

Data type

time

Blood Pressure Systolic
Description

Blood Pressure Systolic

Data type

integer

Measurement units
  • mmHg
mmHg
Blood Pressure Diastolic
Description

Blood Pressure Diastolic

Data type

integer

Measurement units
  • mmHg
mmHg
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
bpm

Similar models

Session 1: Vital Signs Form

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
Dosing Date and Time
Dosing date
Item
Dosing date
date
Dosing time
Item
Dosing time
time
Item Group
Predose - Semi-supine
Actual time
Item
Actual time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
Predose Orthostatic - Supine
Actual time
Item
Actual time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
Predose Orthostatic - Standing
Actual time
Item
Actual time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
Predose Orthostatic - Standing
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
15 Minutes - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
30 Minutes - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
45 Minutes - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
1 Hour - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
1.5 Hour - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
2 Hours - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
4 Hours - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
6 Hours - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
8 Hours - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
10 Hours - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
10 Hours - Orthostatic- Supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
10 Hours - Orthostatic- Sitting
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
10 Hours - Orthostatic- Standing
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
12 Hours - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
24 Hours - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
32 Hours - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
48 Hours - Semi-supine
Actual Time
Item
Actual Time
time
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
Heart Rate
Item
Heart Rate
integer

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