ID
43025
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 (2)
- 12/7/20 12/7/20 -
- 9/17/21 9/17/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
September 17, 2021
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
Logs/ Repeats - Concomitant Medication; 12-Lead/ Holter/ Telemetry ECG; Vital Signs; 12-Lead ECG Abnormalities
Description
12-Lead /Holter/Telemetry ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0013801
- UMLS CUI-3
- C1623258
- UMLS CUI-4
- C0039451
Description
Date and Time of ECG
Data type
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
PR lnterval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429087
Description
QRS Duration
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0429025
Description
Uncorrected QT lnterval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1287082
Description
QTc Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C0489625
Description
QTc (b) Interval
Data type
integer
Measurement units
- ms
Alias
- UMLS CUI [1]
- C1882512
Description
Method of QTc Calculation
Data type
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Description
Result of the ECG
Data type
integer
Alias
- UMLS CUI [1]
- C0438154
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Actual date/time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Description
Systolic blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic blood pressure
Data type
integer
Measurement units
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Alias
- UMLS CUI [1]
- C0018810
Description
Blood pressure done?
Data type
text
Alias
- UMLS CUI [1]
- C0005823
Description
Heart rate done?
Data type
text
Alias
- UMLS CUI [1]
- C0018810
Description
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Description
Lead used for measurement
Data type
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0242485
- UMLS CUI [1,3]
- C0181586
Description
Date and Time of ECG
Data type
datetime
Alias
- UMLS CUI [1]
- C2826846
Description
Record clinically significant abnormalities
Data type
text
Alias
- UMLS CUI [1]
- C0232187
Description
A. If other abnormal rhythm, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Description
Record clinically significant abnormalities
Data type
text
Alias
- UMLS CUI [1]
- C2216025
Description
B. If other morphology, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
C. Conduction
Data type
text
Alias
- UMLS CUI [1]
- C0232217
Description
C. If other conduction, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
D. Myocardial Infarction
Data type
text
Alias
- UMLS CUI [1]
- C0027051
Description
D. If other myocardial infarction, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Description
E. Depolarisation/Repolarisation (QRS-T)
Data type
text
Alias
- UMLS CUI [1]
- C1395184
- UMLS CUI [2]
- C0948857
Description
E. If other depolarisation/ repolarisation, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C1395184
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
- UMLS CUI [2,1]
- C0948857
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C0947611
Description
If other abnormalities, enter comment
Data type
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Similar models
Logs/ Repeats - Concomitant Medication; 12-Lead/ Holter/ Telemetry ECG; Vital Signs; 12-Lead ECG Abnormalities
C2348184 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C2826819 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0805701 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0439148 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1522314 (UMLS CUI [2])
C0013801 (UMLS CUI-2)
C1623258 (UMLS CUI-3)
C0039451 (UMLS CUI-4)
C2911685 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0242485 (UMLS CUI [1,2])
C0181586 (UMLS CUI [1,3])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0947611 (UMLS CUI [2,3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])