ID

29723

Description

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: Period 1

Keywords

Versions (2)
  1. 4/4/18 4/4/18 -
  2. 4/16/18 4/16/18 -
Copyright Holder

GlaxoSmithKline

Uploaded on

April 16, 2018

DOI

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License

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

English

Period 1

1 forms  
  1. StudyEvent: ODM
    1. Period 1
Randomisation
Description

Randomisation

Alias
UMLS CUI-1
C0034656
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Record randomisation number
Description

randomisation number

Data type

integer

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Date of randomisation
Description

Date of randomisation

Data type

date

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0011008
Investigational Product
Description

Investigational Product

Alias
UMLS CUI-1
C0304229
Planned Timepoint Investigational Product
Description

Planned Timepoint Investigational Product

Data type

integer

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C2348792
Date of Dose of Investigational Product
Description

Date of Dose of Investigational Product

Data type

date

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0011008
Time of Dose of Investigational Product
Description

Time of Dose of Investigational Product

Data type

time

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0040223
Pharmacokinetics - Blood
Description

Pharmacokinetics - Blood

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005767
UMLS CUI-3
C0304229
Planned Relative Time, Pharmacokinetics - Blood
Description

Time Relative to Dosing

Data type

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0439564
Date Blood Sample Taken
Description

Date Blood Sample Taken

Data type

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Time Blood Sample Taken
Description

Time Blood Sample Taken

Data type

time

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0040223
Blood Sample Number
Description

Blood Sample Number

Data type

integer

Alias
UMLS CUI [1]
C1299222
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Date of Vital signs
Description

Date of Vital signs

Data type

date

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

Planned Relative Time of Vital Signs

Data type

integer

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

Actual Time of Vital Signs

Data type

time

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

systolic Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood pressure, diastolic
Description

diastolic Blood pressure

Data type

integer

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject Position
Description

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.

Data type

integer

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

Heart rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
12-lead ECG
Description

12-lead ECG

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

Planned Relative Time of ECG

Data type

integer

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

Start Date of ECG

Data type

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time ECG
Description

Planned Relative Time ECG

Data type

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0439564
Start Time of ECG
Description

Start Time of ECG

Data type

time

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

Ventricular Rate

Data type

integer

Measurement units
  • Beats/min
Alias
UMLS CUI [1,1]
C2189285
UMLS CUI [1,2]
C0430456
Beats/min
PR Interval
Description

PR Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0429087
UMLS CUI [1,2]
C0430456
msec
QRS Duration
Description

QRS Duration

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0429025
UMLS CUI [1,2]
C0430456
msec
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C1287082
UMLS CUI [1,2]
C0430456
msec
QTc Interval
Description

QTc Interval

Data type

float

Measurement units
  • msec
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0430456
msec
Result of the ECG
Description

Result of the ECG

Data type

integer

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

Electronically Transferred Lab Data

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

Planned Relative Time Haematology sample taken

Data type

integer

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

Date Haematology sample taken

Data type

date

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

Time Haematology sample taken

Data type

time

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

Planned Relative Time Clinical Chemistry Sample taken

Data type

integer

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

Date Clinical Chemistry Sample taken

Data type

date

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

Time Clinical Chemistry Sample taken

Data type

time

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

Planned Relative Time Urinalysis sample taken

Data type

integer

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

Date Urinalysis sample taken

Data type

date

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

Time Urinalysis sample taken

Data type

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C0040223
Pregnancy Test
Description

Pregnancy Test

Alias
UMLS CUI-1
C0032976
Pregnancy Test positive?
Description

A serum pregnancy test should be performed. Exclude subject from study if results are positive

Data type

boolean

Alias
UMLS CUI [1]
C0032976
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Similar models

Period 1

1 forms
  1. StudyEvent: ODM
    1. Period 1
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Randomisation
C0034656 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
randomisation number
Item
Record randomisation number
integer
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date of randomisation
Item
Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Item
Planned Timepoint Investigational Product
integer
C0304229 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Planned Timepoint Investigational Product
Code List
Planned Timepoint Investigational Product
CL Item
0 hr (1)
CL Item
12 hrs (2)
Date of Dose of Investigational Product
Item
Date of Dose of Investigational Product
date
C0304229 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Dose of Investigational Product
Item
Time of Dose of Investigational Product
time
C0304229 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
Pharmacokinetics - Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
Item
Planned Relative Time, Pharmacokinetics - Blood
integer
C0005834 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time, Pharmacokinetics - Blood
CL Item
Pre-dose (1)
CL Item
+0,25 hrs (2)
CL Item
+0,5 hrs (3)
CL Item
+0,75 hrs (4)
CL Item
+1 hr (5)
CL Item
+1,5 hrs (6)
CL Item
+3 hrs (7)
CL Item
+4 hrs (8)
CL Item
+6 hrs (9)
CL Item
+8 hrs (10)
CL Item
+12 hrs (11)
CL Item
+12,25 hrs (12)
CL Item
+12,5 hrs (13)
CL Item
+12,75 hrs (14)
CL Item
+13 hrs (15)
CL Item
+13,5 hrs (16)
CL Item
+14 hrs (17)
CL Item
+15 hrs (18)
CL Item
+16 hrs (19)
CL Item
+18 hrs (20)
CL Item
+20 hrs (21)
CL Item
+24 hrs (22)
CL Item
+32 hrs (23)
CL Item
+48 hrs (24)
Date Blood Sample Taken
Item
Date Blood Sample Taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time Blood Sample Taken
Item
Time Blood Sample Taken
time
C0005834 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Blood Sample Number
Item
Blood Sample Number
integer
C1299222 (UMLS CUI [1])
Item Group
Vital signs
C0518766 (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
Predose (1)
CL Item
2hr (2)
CL Item
3hr (3)
CL Item
4hr (4)
CL Item
5hr (5)
CL Item
8hr (6)
CL Item
12hr (7)
CL Item
14hr (8)
CL Item
17hr (9)
CL Item
24hr (10)
CL Item
32hr (11)
CL Item
48hr (12)
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
Predose (1)
CL Item
48 hr (2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Planned Relative Time ECG
Item
Planned Relative Time ECG
text
C0430456 (UMLS CUI [1,1])
C0439564 (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 Haematology sample taken
Code List
Planned Relative Time Haematology sample taken
CL Item
Pre-dose (1)
CL Item
48 hr (2)
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 Haematology sample taken
Code List
Planned Relative Time Clinical Chemistry Sample taken
CL Item
Pre-dose (1)
CL Item
48 hr (2)
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 Haematology sample taken
Code List
Planned Relative Time Urinalysis sample taken
CL Item
Pre-dose (1)
CL Item
48 hr (2)
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])
Item Group
Pregnancy Test
C0032976 (UMLS CUI-1)
Pregnancy Test
Item
Pregnancy Test positive?
boolean
C0032976 (UMLS CUI [1])
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