ID
43025
Beskrivning
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
Nyckelord
Versioner (2)
- 2020-12-07 2020-12-07 -
- 2021-09-17 2021-09-17 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
17 september 2021
DOI
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Licens
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
Beskrivning
12-Lead /Holter/Telemetry ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0013801
- UMLS CUI-3
- C1623258
- UMLS CUI-4
- C0039451
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PR lnterval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
Uncorrected QT lnterval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
QTc Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
QTc (b) Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1882512
Beskrivning
Method of QTc Calculation
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beskrivning
Result of the ECG
Datatyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Actual date/time
Datatyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beskrivning
Systolic blood pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beskrivning
Diastolic blood pressure
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beskrivning
Heart rate
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
Blood pressure done?
Datatyp
text
Alias
- UMLS CUI [1]
- C0005823
Beskrivning
Heart rate done?
Datatyp
text
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beskrivning
Lead used for measurement
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0242485
- UMLS CUI [1,3]
- C0181586
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
Record clinically significant abnormalities
Datatyp
text
Alias
- UMLS CUI [1]
- C0232187
Beskrivning
A. If other abnormal rhythm, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Beskrivning
Record clinically significant abnormalities
Datatyp
text
Alias
- UMLS CUI [1]
- C2216025
Beskrivning
B. If other morphology, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
C. Conduction
Datatyp
text
Alias
- UMLS CUI [1]
- C0232217
Beskrivning
C. If other conduction, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
D. Myocardial Infarction
Datatyp
text
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
D. If other myocardial infarction, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beskrivning
E. Depolarisation/Repolarisation (QRS-T)
Datatyp
text
Alias
- UMLS CUI [1]
- C1395184
- UMLS CUI [2]
- C0948857
Beskrivning
E. If other depolarisation/ repolarisation, enter comment
Datatyp
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
Beskrivning
If other abnormalities, enter comment
Datatyp
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])