ID

29725

Beschreibung

Study ID: 104257 Clinical Study ID: CRV104257 Study Title: A randomized, open-label, two period, period balanced, crossover study to estimate the relative bioavailability of an investigational drug compared to Coreg IR in healthy adult volunteers 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 Documentation part: Follow-up

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  1. 04.04.18 04.04.18 -
  2. 16.04.18 16.04.18 -
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GlaxoSmithKline

Hochgeladen am

16. April 2018

DOI

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Creative Commons BY-NC 3.0
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Bioavailability of an investigational drug compared to Coreg IR in healthy adults GSK104257

Englisch

Follow-up

1 Formulare  
  1. StudyEvent: ODM
    1. Follow-up
Vital signs
Beschreibung

Vital signs

Alias
UMLS CUI-1
C0518766
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Date of Vital signs
Beschreibung

Date of Vital signs

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Planned Relative Time of Vital Signs
Beschreibung

Planned Relative Time of Vital Signs

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual Time of Vital Signs
Beschreibung

Actual Time of Vital Signs

Datentyp

time

Alias
UMLS CUI [1]
C2826762
Blood pressure, systolic
Beschreibung

systolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure, diastolic
Beschreibung

diastolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Beschreibung

Orthostatic vital signs should be performed along with sitting blood pressure and heart rate. Orthostatic vital signs should be taken as follows; after the subject has been supine for 5 minutes, after the subject has been sitting for 2 minutes and at 1 and 3 minutes after subject has been standing.

Datentyp

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0518766
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-lead ECG
Beschreibung

12-lead ECG

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1623258
Planned Relative Time of ECG
Beschreibung

Planned Relative Time of ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Date of ECG
Beschreibung

Start Date of ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Start Time of ECG
Beschreibung

Start Time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Ventricular Rate
Beschreibung

Ventricular Rate

Datentyp

integer

Maßeinheiten
  • Beats/min
Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C0430456
Beats/min
PR Interval
Beschreibung

PR Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTc Interval
Beschreibung

QTc Interval

Datentyp

float

Maßeinheiten
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1,1]
C0438154
UMLS CUI [1,2]
C0430456
Electronically Transferred Lab Data
Beschreibung

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Planned Relative Time Haematology sample taken
Beschreibung

Planned Relative Time Haematology sample taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0439564
Date Haematology sample taken
Beschreibung

Date Haematology sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1302413
Time Haematology sample taken
Beschreibung

Time Haematology sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C0040223
Planned Relative Time Clinical Chemistry Sample taken
Beschreibung

Planned Relative Time Clinical Chemistry Sample taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0439564
Date Clinical Chemistry Sample taken
Beschreibung

Date Clinical Chemistry Sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0011008
Time Clinical Chemistry Sample taken
Beschreibung

Time Clinical Chemistry Sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0008000
UMLS CUI [1,3]
C0040223
Planned Relative Time Urinalysis sample taken
Beschreibung

Planned Relative Time Urinalysis sample taken

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200354
UMLS CUI [1,3]
C0439564
Date Urinalysis sample taken
Beschreibung

Date Urinalysis sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0011008
Time Urinalysis sample taken
Beschreibung

Time Urinalysis sample taken

Datentyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0040223
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Ähnliche Modelle

Follow-up

1 Formulare
  1. StudyEvent: ODM
    1. Follow-up
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Date of Vital signs
Item
Date of Vital signs
date
C2826644 (UMLS CUI [1])
Item
Planned Relative Time of Vital Signs
integer
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time of Vital Signs
Code List
Planned Relative Time of Vital Signs
CL Item
Follow-up (1)
Actual Time of Vital Signs
Item
Actual Time of Vital Signs
time
C2826762 (UMLS CUI [1])
systolic Blood pressure
Item
Blood pressure, systolic
integer
C0871470 (UMLS CUI [1])
diastolic Blood pressure
Item
Blood pressure, diastolic
integer
C0428883 (UMLS CUI [1])
Item
Subject Position
integer
C1262869 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Subject Position
Code List
Subject Position
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-lead ECG
C0430456 (UMLS CUI-1)
C1623258 (UMLS CUI-2)
Item
Planned Relative Time of ECG
integer
C0430456 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Timepoint of ECG
Code List
Planned Relative Time of ECG
CL Item
Follow-up (1)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Ventricular Rate
Item
Ventricular Rate
integer
C2189285 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
PR Interval
Item
PR Interval
float
C0429087 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
QTc Interval
Item
QTc Interval
float
C0489625 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant  (2)
CL Item
Abnormal- clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Electronically Transferred Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Item
Planned Relative Time Haematology sample taken
integer
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time of Vital Signs
Code List
Planned Relative Time Haematology sample taken
CL Item
Follow-up (1)
Date Haematology sample taken
Item
Date Haematology sample taken
date
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1302413 (UMLS CUI [1,3])
Time Haematology sample taken
Item
Time Haematology sample taken
time
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Clinical Chemistry Sample taken
integer
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time of Vital Signs
Code List
Planned Relative Time Clinical Chemistry Sample taken
CL Item
Follow-up (1)
Date Clinical Chemistry Sample taken
Item
Date Clinical Chemistry Sample taken
date
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Clinical Chemistry Sample taken
Item
Time Clinical Chemistry Sample taken
time
C0005834 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Item
Planned Relative Time Urinalysis sample taken
integer
C0042014 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Planned Relative Time of Vital Signs
Code List
Planned Relative Time Urinalysis sample taken
CL Item
Follow-up (1)
Date Urinalysis sample taken
Item
Date Urinalysis sample taken
date
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Time Urinalysis sample taken
Item
Time Urinalysis sample taken
time
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
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