ID
41682
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 (1)
- 13.12.20 13.12.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
13. Dezember 2020
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 and Repeats - Pharmacokinetics Blood; Local Laboratory; Summary Holter; Holter Abnormalities
Beschreibung
Pulmonary Function Tests
Alias
- UMLS CUI-1
- C0024119
Beschreibung
Date/time of test
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beschreibung
FEV1 (3 readings) - 1
Datentyp
integer
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C0748133
Beschreibung
FEV1 (3 readings) - 2
Datentyp
integer
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C0748133
Beschreibung
FEV1 (3 readings) - 3
Datentyp
integer
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C0748133
Beschreibung
FVC (3 readings) - 1
Datentyp
integer
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C1287681
Beschreibung
FVC (3 readings) - 2
Datentyp
integer
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C1287681
Beschreibung
FVC (3 readings) - 3
Datentyp
integer
Maßeinheiten
- L
Alias
- UMLS CUI [1]
- C1287681
Beschreibung
Local Laboratory
Alias
- UMLS CUI-1
- C0022885
Beschreibung
Date and time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschreibung
Has the subject fasted?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0015663
Beschreibung
Laboratory Test - Clinical Chemistry
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0008000
Beschreibung
Laboratory Test - Haematology
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0018941
Beschreibung
Laboratory Test Result - Numeric
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C2347373
Beschreibung
Laboratory result - Character result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C2350015
Beschreibung
Laboratory - No result
Datentyp
integer
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Summary Holter
Alias
- UMLS CUI-1
- C0013801
- UMLS CUI-2
- C0242482
Beschreibung
Start Date and Time of Holter
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0013801
- UMLS CUI [2,2]
- C1301880
Beschreibung
Stop Date and Time of Holter
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0013801
- UMLS CUI [2,2]
- C1522314
Beschreibung
MInimum heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C1524031
Beschreibung
Maximum heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0018810
- UMLS CUI [1,2]
- C0806909
Beschreibung
Mean heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C1881634
Beschreibung
Number of ventricular runs
Datentyp
integer
Alias
- UMLS CUI [1]
- C2189285
Beschreibung
Number of ventricular runs - Not done, specify reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2189285
- UMLS CUI [1,2]
- C2826287
Beschreibung
Number of ventricular runs - Not applicable
Datentyp
integer
Alias
- UMLS CUI [1]
- C2189285
Beschreibung
Number of supraventricular runs
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C0237753
Beschreibung
Supraventricular runs - Not done, specify reason
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0039240
- UMLS CUI [1,2]
- C2826287
Beschreibung
Supraventricular runs - Not applicable
Datentyp
integer
Alias
- UMLS CUI [1]
- C0039240
Beschreibung
Interpretation of Holter
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C4086187
Beschreibung
Holter Abnormalities
Alias
- UMLS CUI-1
- C0013801
- UMLS CUI-2
- C1704258
Beschreibung
Start Date and Time of Holter
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C0013801
- UMLS CUI [2,2]
- C1301880
Beschreibung
Stop Date and Time of Holter
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C0013801
- UMLS CUI [2,2]
- C1522314
Beschreibung
Holter Abnormalities
Alias
- UMLS CUI-1
- C0013801
- UMLS CUI-2
- C1704258
Beschreibung
Holter abnormality
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C1704258
Beschreibung
Other abnormal rhythm, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C2348235
Beschreibung
Other morphology, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0332437
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Beschreibung
Other conduction, specify
Datentyp
text
Alias
- UMLS CUI [1]
- C0340494
- UMLS CUI [2]
- C2348235
Beschreibung
Other myocardial infarction, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Beschreibung
Other depolarisation/repolrisation, specify
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0948857
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2]
- C2348235
Beschreibung
Other abnormality/ Cardiologist comments
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C0175906
- UMLS CUI [2,2]
- C0947611
Beschreibung
integer
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0871511
Ähnliche Modelle
Logs and Repeats - Pharmacokinetics Blood; Local Laboratory; Summary Holter; Holter Abnormalities
C0005767 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C1524031 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,2])
C4086187 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C0871511 (UMLS CUI [1,2])
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