ID

41637

Description

Study ID: 110106 Clinical Study ID: 110106 Study Title: A single centre, randomized, double-blind, dose ascending, placebo-controlled study, in two parts, to evaluate the safety, tolerability and pharmacokinetics of escalating single and repeat inhaled doses of GSK573719 and placebo formulated with the excipient magnesium stearate, in healthy subjects and in a healthy population of Cytochrome P450 Isoenzyme 2D6 poor metabolisers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00803673 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK573719, Placebo Study Indication: Pulmonary Disease, Chronic Obstructive

Keywords

Versions (1)
  1. 11/29/20 11/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 29, 2020

DOI

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License

Creative Commons BY 4.0
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Safety, tolerability and pharmacokinetics of GSK573719 and placebo formulated with the excipient magnesium stearate NCT00803673

English

Screening - ECG; Vital Signs

1 forms  
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
ECG (semi-recumbent position)
Description

ECG (semi-recumbent position)

Alias
UMLS CUI-1
C1623258
UMLS CUI-2
C0522019
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1]
C2826846
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Description

PR Interval

Data type

integer

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

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
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
Method of QTc Calculation
Description

Method of QTc Calculation

Data type

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs (semi-recumbent position)
Description

Vital Signs (semi-recumbent position)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
Vital Sigs - Actual date/time
Description

Vital Sigs - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

integer

Alias
UMLS CUI [1]
C1305855
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Vital Signs - Heart Rate
Description

Vital Signs - Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
Vital Signs (semi-recumbent position)
Description

Vital Signs (semi-recumbent position)

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0522019
Vital Sigs - Actual date/time
Description

Vital Sigs - Actual date/time

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Vital Signs - Heart Rate
Description

Vital Signs - Heart Rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0018810
beats/min
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Similar models

Screening - ECG; Vital Signs

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
ECG (semi-recumbent position)
C1623258 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (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
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
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 (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE)  (3)
CL Item
No result (not available) (4)
Item Group
Vital Signs (semi-recumbent position)
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
Vital Sigs - Actual date/time
Item
Vital Sigs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
integer
C1305855 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Vital Signs - Heart Rate
Item
Vital Signs - Heart Rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
Item Group
Vital Signs (semi-recumbent position)
C0518766 (UMLS CUI-1)
C0522019 (UMLS CUI-2)
Vital Sigs - Actual date/time
Item
Vital Sigs - Actual date/time
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Vital Signs - Heart Rate
Item
Vital Signs - Heart Rate
integer
C0518766 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
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