ID

41252

Description

Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Versions (1)
  1. 7/24/20 7/24/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

July 24, 2020

DOI

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License

Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

English

24 Hrs Holter ECG; 12-Lead ECG

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
24 Hrs Holter ECG (Screening)
Description

24 Hrs Holter ECG (Screening)

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0220908
Start Date of Holter
Description

Start Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start Time of Holter
Description

Start Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
End Date of Holter
Description

End Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
End Time of Holter
Description

End Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Mean HR
Description

Mean HR

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C1881634
beats/min
Result of the Holter
Description

Check one

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1274040
24 Hrs Holter ECG (Lead II Monitoring) - 0 hr - 6 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)
Description

24 Hrs Holter ECG (Lead II Monitoring) - 0 hr - 6 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C2347804
Start Date of Holter
Description

Start Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start Time of Holter
Description

Start Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
End Date of Holter
Description

End Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
End Time of Holter
Description

End Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Mean HR
Description

Mean HR

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C1881634
beats/min
Result of the Holter
Description

Check one

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1274040
24 Hrs Holter ECG - 0 hr - 24 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)
Description

24 Hrs Holter ECG - 0 hr - 24 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0439568
UMLS CUI-3
C2347804
Start Date of Holter
Description

Start Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start Time of Holter
Description

Start Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
End Date of Holter
Description

End Date of Holter

Data type

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
End Time of Holter
Description

End Time of Holter

Data type

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Mean HR
Description

Mean HR

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C1881634
beats/min
Result of the Holter
Description

Check one

Data type

integer

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1274040
12-Lead ECG (Screening)
Description

12-Lead ECG (Screening)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0220908
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
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1]
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]
C2189285
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval
Description

QRS Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1880451
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG (Mean Calculation) (Screening)
Description

12-Lead ECG (Mean Calculation) (Screening)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C0444504
UMLS CUI-3
C0220908
Screening - QTc Interval
Description

Screening - QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0489625
UMLS CUI [1,2]
C0220908
ms
Screening - Is the reading within acceptable limits?
Description

Screening - Is the reading within acceptable limits?

Data type

boolean

Alias
UMLS CUI [1]
C0220908
UMLS CUI [2,1]
C0456984
UMLS CUI [2,2]
C1879533
Mean screening - QTc Interval
Description

Mean screening - QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0444504
UMLS CUI [1,2]
C0220908
UMLS CUI [2]
C0489625
ms
Mean screening - QTc Interval - 10%
Description

Mean screening - QTc Interval - 10%

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0489625
UMLS CUI [2,2]
C0439165
ms
Mean screening - QTc Interval + 10%
Description

Mean screening - QTc Interval + 10%

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0220908
UMLS CUI [1,2]
C0444504
UMLS CUI [2,1]
C0489625
UMLS CUI [2,2]
C0439165
ms
12-Lead ECG (Treatment Period 1, 2, 3, 4, 5)
Description

12-Lead ECG (Treatment Period 1, 2, 3, 4, 5)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C2347804
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
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1]
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]
C2189285
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval
Description

QRS Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1880451
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
12-Lead ECG (Follow-Up)
Description

12-Lead ECG (Follow-Up)

Alias
UMLS CUI-1
C0430456
UMLS CUI-2
C1522577
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
Description

Planned Relative Time

Data type

integer

Alias
UMLS CUI [1]
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]
C2189285
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Interval
Description

QRS Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1880451
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

24 Hrs Holter ECG; 12-Lead ECG

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
24 Hrs Holter ECG (Screening)
C0013801 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of Holter
Item
Start Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End Date of Holter
Item
End Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time of Holter
Item
End Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Mean HR
Item
Mean HR
integer
C1881634 (UMLS CUI [1])
Item
Result of the Holter
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of the Holter
Code List
Result of the Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Item Group
24 Hrs Holter ECG (Lead II Monitoring) - 0 hr - 6 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)
C0013801 (UMLS CUI-1)
C2347804 (UMLS CUI-2)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of Holter
Item
Start Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End Date of Holter
Item
End Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time of Holter
Item
End Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Mean HR
Item
Mean HR
integer
C1881634 (UMLS CUI [1])
Item
Result of the Holter
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of the Holter
Code List
Result of the Holter
CL Item
Normal  (1)
CL Item
Abnormal - Not clinically significant  (2)
CL Item
Abnormal - Clinically significant (3)
Item Group
24 Hrs Holter ECG - 0 hr - 24 hrs post-dose (Treatment Period 1, 2, 3, 4, 5)
C0013801 (UMLS CUI-1)
C0439568 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
Start Date of Holter
Item
Start Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start Time of Holter
Item
Start Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
End Date of Holter
Item
End Date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
End Time of Holter
Item
End Time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Mean HR
Item
Mean HR
integer
C1881634 (UMLS CUI [1])
Item
Result of the Holter
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of the Holter
Code List
Result of the Holter
CL Item
Normal  (1)
CL Item
Abnormal - Not clinically significant  (2)
CL Item
Abnormal - Clinically significant (3)
Item Group
12-Lead ECG (Screening)
C0430456 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Unscheduled (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])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
integer
C1880451 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
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
12-Lead ECG (Mean Calculation) (Screening)
C0430456 (UMLS CUI-1)
C0444504 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
Screening - QTc Interval
Item
Screening - QTc Interval
integer
C0489625 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Screening - Is the reading within acceptable limits?
Item
Screening - Is the reading within acceptable limits?
boolean
C0220908 (UMLS CUI [1])
C0456984 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
Mean screening - QTc Interval
Item
Mean screening - QTc Interval
integer
C0444504 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2])
Mean screening - QTc Interval - 10%
Item
Mean screening - QTc Interval - 10%
integer
C0220908 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Mean screening - QTc Interval + 10%
Item
Mean screening - QTc Interval + 10%
integer
C0220908 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
Item Group
12-Lead ECG (Treatment Period 1, 2, 3, 4, 5)
C0430456 (UMLS CUI-1)
C2347804 (UMLS CUI-2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-dose (1)
CL Item
15 mins (2)
CL Item
45 mins (3)
CL Item
1.5 hrs (4)
CL Item
4 hrs (5)
CL Item
8 hrs (6)
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])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
integer
C1880451 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
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
12-Lead ECG (Follow-Up)
C0430456 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Follow-Up (1)
CL Item
Unscheduled (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])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Interval
Item
QRS Interval
integer
C1880451 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
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)
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