ID
41656
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)
- 05.12.20 05.12.20 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
5. 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
Follow-Up - ECG; Vital Signs; Pulmonary Function Test; Pregnancy Information; Status of treatment blind; Study conclusion
Beschreibung
ECG
Alias
- UMLS CUI-1
- C1623258
Beschreibung
Date and Time of ECG
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C1264639
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Duration
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429025
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
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 - Follow-up 1
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1522577
Beschreibung
Vital Signs - Actual date/time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
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
Vital Signs - Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschreibung
Vital Signs - Follow-up 2
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1522577
Beschreibung
Vital Signs - Actual date/time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
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
Vital Signs - Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschreibung
Vital Signs - Follow-up 3
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1522577
Beschreibung
Vital Signs - Actual date/time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
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
Vital Signs - Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
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
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschreibung
If Yes, complete the paper Pregnancy Notofocation form
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3828490
Beschreibung
If Yes, complete the paper Pregnancy Notification form.
Datentyp
text
Alias
- UMLS CUI [1]
- C0919624
Beschreibung
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beschreibung
If Yes, complete the Adverse Event form and/or Investigational Product forms as appropriate.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C3897431
Beschreibung
Date/time blind broken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C1264639
Beschreibung
Reason blind broken
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Beschreibung
Specify other reason for blind broken
Datentyp
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Beschreibung
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschreibung
Date of subject completion or withdrawal
Datentyp
date
Alias
- UMLS CUI [1]
- C2983670
Beschreibung
Was the subject withdrawn from the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschreibung
Primary reason for withdrawal
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Beschreibung
Case book ready for signature
Datentyp
text
Alias
- UMLS CUI [1]
- C1519316
Ähnliche Modelle
Follow-Up - ECG; Vital Signs; Pulmonary Function Test; Pregnancy Information; Status of treatment blind; Study conclusion
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C2911685 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C1264639 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C1264639 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C1522577 (UMLS CUI-2)
C1264639 (UMLS CUI [1,2])
C0018810 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C2347038 (UMLS CUI-2)
C1264639 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])