ID
43025
Beschreibung
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
Stichworte
Versionen (2)
- 07.12.20 07.12.20 -
- 17.09.21 17.09.21 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
17. September 2021
DOI
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Lizenz
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
Beschreibung
12-Lead /Holter/Telemetry ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0013801
- UMLS CUI-3
- C1623258
- UMLS CUI-4
- C0039451
Beschreibung
Date and Time of ECG
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
PR lnterval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Duration
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschreibung
Uncorrected QT lnterval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschreibung
QTc Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
QTc (b) Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1882512
Beschreibung
Method of QTc Calculation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschreibung
Result of the ECG
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschreibung
Actual date/time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beschreibung
Systolic blood pressure
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
Diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
Heart rate
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
Blood pressure done?
Datentyp
text
Alias
- UMLS CUI [1]
- C0005823
Beschreibung
Heart rate done?
Datentyp
text
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beschreibung
Lead used for measurement
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0242485
- UMLS CUI [1,3]
- C0181586
Beschreibung
Date and Time of ECG
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschreibung
Record clinically significant abnormalities
Datentyp
text
Alias
- UMLS CUI [1]
- C0232187
Beschreibung
A. If other abnormal rhythm, enter comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0232187
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Beschreibung
Record clinically significant abnormalities
Datentyp
text
Alias
- UMLS CUI [1]
- C2216025
Beschreibung
B. If other morphology, enter comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschreibung
C. Conduction
Datentyp
text
Alias
- UMLS CUI [1]
- C0232217
Beschreibung
C. If other conduction, enter comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschreibung
D. Myocardial Infarction
Datentyp
text
Alias
- UMLS CUI [1]
- C0027051
Beschreibung
D. If other myocardial infarction, enter comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschreibung
E. Depolarisation/Repolarisation (QRS-T)
Datentyp
text
Alias
- UMLS CUI [1]
- C1395184
- UMLS CUI [2]
- C0948857
Beschreibung
E. If other depolarisation/ repolarisation, enter comment
Datentyp
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
Beschreibung
If other abnormalities, enter comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Ähnliche Modelle
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])