ID
32615
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)
- 11/8/18 11/8/18 -
- 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 3: Vital Signs Form
- StudyEvent: ODM
Description
Dosing Date and Time
Description
Predose - Semi-supine
Description
Actual time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
Predose Orthostatic - Supine
Description
Actual time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
Predose Orthostatic - Standing
Description
Actual time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
Predose Orthostatic - Standing
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
15 Minutes - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
30 Minutes - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
45 Minutes - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
1 Hour - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
1.5 Hour - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
2 Hours - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
4 Hours - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
6 Hours - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
8 Hours - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
10 Hours - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
10 Hours - Orthostatic- Supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
10 Hours - Orthostatic- Sitting
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
10 Hours - Orthostatic- Standing
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
12 Hours - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
24 Hours - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
32 Hours - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Description
48 Hours - Semi-supine
Description
Actual Time
Data type
time
Description
Blood Pressure Systolic
Data type
integer
Measurement units
- mmHg
Description
Blood Pressure Diastolic
Data type
integer
Measurement units
- mmHg
Description
Heart Rate
Data type
integer
Measurement units
- bpm
Similar models
Session 3: Vital Signs Form
- StudyEvent: ODM