Information:
Fel:
ID
33562
Beskrivning
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
Nyckelord
Versioner (2)
- 2018-11-08 2018-11-08 -
- 2018-12-13 2018-12-13 -
Rättsinnehavare
GSK group of companies
Uppladdad den
13 december 2018
DOI
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Licens
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
- StudyEvent: ODM
Similar models
Session 1: Vital Signs Form
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
C1300638 (UMLS CUI [1,2])
Item Group
Dosing Date and Time
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0178602 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0013227 (UMLS CUI-4)
C0178602 (UMLS CUI-5)
C0040223 (UMLS CUI-6)
Dosing date
Item
Dosing date
date
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Dosing time
Item
Dosing time
time
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Predose Orthostatic - Supine
C1095971 (UMLS CUI-1)
C0232117 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
C0038846 (UMLS CUI-4)
C0232117 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
C0038846 (UMLS CUI-4)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Predose Orthostatic - Standing
C1095971 (UMLS CUI-1)
C0232117 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
C0231472 (UMLS CUI-4)
C0232117 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
C0231472 (UMLS CUI-4)
Actual time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Predose Orthostatic - Standing
C1095971 (UMLS CUI-1)
C0232117 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
C0231472 (UMLS CUI-4)
C0232117 (UMLS CUI-2)
C3812758 (UMLS CUI-3)
C0231472 (UMLS CUI-4)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
15 Minutes - Semi-supine
C0040223 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0522019 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
30 Minutes - Semi-supine
C0040223 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0522019 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
45 Minutes - Semi-supine
C0040223 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0522019 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
1.5 Hour - Semi-supine
C0040223 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0522019 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
10 Hours - Semi-supine
C0040223 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
C0522019 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
10 Hours - Orthostatic- Supine
C0040223 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0018810 (UMLS CUI-3)
C0038846 (UMLS CUI-4)
C1095971 (UMLS CUI-2)
C0018810 (UMLS CUI-3)
C0038846 (UMLS CUI-4)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
10 Hours - Orthostatic- Sitting
C0040223 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0018810 (UMLS CUI-3)
C0277814 (UMLS CUI-4)
C1095971 (UMLS CUI-2)
C0018810 (UMLS CUI-3)
C0277814 (UMLS CUI-4)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
10 Hours - Orthostatic- Standing
C0040223 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0018810 (UMLS CUI-3)
C0231472 (UMLS CUI-4)
C1095971 (UMLS CUI-2)
C0018810 (UMLS CUI-3)
C0231472 (UMLS CUI-4)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
12 Hours - Semi-supine
C0522019 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
C0040223 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
24 Hours - Semi-supine
C0522019 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
C0040223 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
32 Hours - Semi-supine
C0522019 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
C0040223 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
48 Hours - Semi-supine
C0522019 (UMLS CUI-1)
C0040223 (UMLS CUI-2)
C0040223 (UMLS CUI-2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Blood Pressure Systolic
Item
Blood Pressure Systolic
integer
C0871470 (UMLS CUI [1])
Blood Pressure Diastolic
Item
Blood Pressure Diastolic
integer
C0428883 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])