ID

33501

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

  1. 2018-11-08 2018-11-08 -
  2. 2018-12-11 2018-12-11 -
  3. 2018-12-11 2018-12-11 -
Rättsinnehavare

GSK group of companies

Uppladdad den

11 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

12-lead ECG Form

  1. StudyEvent: ODM
    1. 12-lead ECG Form
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Site
Beskrivning

Site

Datatyp

text

Alias
UMLS CUI [1]
C2825164
Patient
Beskrivning

Patient

Datatyp

text

Alias
UMLS CUI [1]
C1299487
Patient Number
Beskrivning

Patient Number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1300638
Screening ECG
Beskrivning

Screening ECG

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0220908
Date of ECG
Beskrivning

Date of ECG

Datatyp

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Beskrivning

Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
PR Interval
Beskrivning

PR Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
QTc Interval
Beskrivning

QTc Interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0489625
msec
Result of the ECG
Beskrivning

Result of the ECG

Datatyp

text

Alias
UMLS CUI [1]
C0438154

Similar models

12-lead ECG Form

  1. StudyEvent: ODM
    1. 12-lead ECG Form
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
Screening ECG
C1623258 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1])
Item
Result of the ECG
text
C0438154 (UMLS CUI [1])
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
CL Item
No result (not available) (4)

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