ID
41252
Beschreibung
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)
Stichworte
Versionen (1)
- 24.07.20 24.07.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
24. Juli 2020
DOI
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Lizenz
Creative Commons BY 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)
24 Hrs Holter ECG; 12-Lead ECG
- StudyEvent: ODM
Beschreibung
24 Hrs Holter ECG (Screening)
Alias
- UMLS CUI-1
- C0013801
- UMLS CUI-2
- C0220908
Beschreibung
Start Date of Holter
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
Beschreibung
Start Time of Holter
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1301880
Beschreibung
End Date of Holter
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
Beschreibung
End Time of Holter
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1522314
Beschreibung
Mean HR
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C1881634
Beschreibung
Check one
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1274040
Beschreibung
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
Beschreibung
Start Date of Holter
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
Beschreibung
Start Time of Holter
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1301880
Beschreibung
End Date of Holter
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
Beschreibung
End Time of Holter
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1522314
Beschreibung
Mean HR
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C1881634
Beschreibung
Check one
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1274040
Beschreibung
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
Beschreibung
Start Date of Holter
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
Beschreibung
Start Time of Holter
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1301880
Beschreibung
End Date of Holter
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
Beschreibung
End Time of Holter
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1522314
Beschreibung
Mean HR
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C1881634
Beschreibung
Check one
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1274040
Beschreibung
12-Lead ECG (Screening)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0220908
Beschreibung
Start Date of ECG
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschreibung
Planned Relative Time
Datentyp
integer
Alias
- UMLS CUI [1]
- C0439564
Beschreibung
Start Time of ECG
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschreibung
Ventricular Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C2189285
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1880451
Beschreibung
Uncorrected QT Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschreibung
QTc Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
Result of the ECG
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
12-Lead ECG (Mean Calculation) (Screening)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C0444504
- UMLS CUI-3
- C0220908
Beschreibung
Screening - QTc Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C0489625
- UMLS CUI [1,2]
- C0220908
Beschreibung
Screening - Is the reading within acceptable limits?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0220908
- UMLS CUI [2,1]
- C0456984
- UMLS CUI [2,2]
- C1879533
Beschreibung
Mean screening - QTc Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C0444504
- UMLS CUI [1,2]
- C0220908
- UMLS CUI [2]
- C0489625
Beschreibung
Mean screening - QTc Interval - 10%
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C0220908
- UMLS CUI [1,2]
- C0444504
- UMLS CUI [2,1]
- C0489625
- UMLS CUI [2,2]
- C0439165
Beschreibung
Mean screening - QTc Interval + 10%
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1,1]
- C0220908
- UMLS CUI [1,2]
- C0444504
- UMLS CUI [2,1]
- C0489625
- UMLS CUI [2,2]
- C0439165
Beschreibung
12-Lead ECG (Treatment Period 1, 2, 3, 4, 5)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C2347804
Beschreibung
Start Date of ECG
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschreibung
Planned Relative Time
Datentyp
integer
Alias
- UMLS CUI [1]
- C0439564
Beschreibung
Start Time of ECG
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschreibung
Ventricular Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C2189285
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1880451
Beschreibung
Uncorrected QT Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschreibung
QTc Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
Result of the ECG
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
12-Lead ECG (Follow-Up)
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1522577
Beschreibung
Start Date of ECG
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0808070
Beschreibung
Planned Relative Time
Datentyp
integer
Alias
- UMLS CUI [1]
- C0439564
Beschreibung
Start Time of ECG
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1301880
Beschreibung
Ventricular Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C2189285
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1880451
Beschreibung
Uncorrected QT Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschreibung
QTc Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
Result of the ECG
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Ähnliche Modelle
24 Hrs Holter ECG; 12-Lead ECG
- StudyEvent: ODM
C0220908 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C2347804 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0439568 (UMLS CUI-2)
C2347804 (UMLS CUI-3)
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C0220908 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0444504 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
C0220908 (UMLS CUI [1,2])
C0456984 (UMLS CUI [2,1])
C1879533 (UMLS CUI [2,2])
C0220908 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2])
C0444504 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0444504 (UMLS CUI [1,2])
C0489625 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C2347804 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])