ID
41656
Beschrijving
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
Trefwoorden
Versies (1)
- 05-12-20 05-12-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
5 december 2020
DOI
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Licentie
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
Beschrijving
ECG
Alias
- UMLS CUI-1
- C1623258
Beschrijving
Date and Time of ECG
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C1264639
Beschrijving
Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
QTc(b) Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1882512
Beschrijving
Method of QTc Calculation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschrijving
Result of the ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
Vital Signs - Follow-up 1
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1522577
Beschrijving
Vital Signs - Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
Beschrijving
Systolic Blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Vital Signs - Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschrijving
Vital Signs - Follow-up 2
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1522577
Beschrijving
Vital Signs - Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
Beschrijving
Systolic Blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Vital Signs - Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschrijving
Vital Signs - Follow-up 3
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C1522577
Beschrijving
Vital Signs - Actual date/time
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1264639
Beschrijving
Systolic Blood pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Vital Signs - Heart rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
Beschrijving
Pulmonary Function Tests
Alias
- UMLS CUI-1
- C0024119
Beschrijving
Date/time of test
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0024119
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Beschrijving
FEV1 (3 readings) - 1
Datatype
integer
Maateenheden
- L
Alias
- UMLS CUI [1]
- C0748133
Beschrijving
FEV1 (3 readings) - 2
Datatype
integer
Maateenheden
- L
Alias
- UMLS CUI [1]
- C0748133
Beschrijving
FEV1 (3 readings) - 3
Datatype
integer
Maateenheden
- L
Alias
- UMLS CUI [1]
- C0748133
Beschrijving
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Beschrijving
If Yes, complete the paper Pregnancy Notofocation form
Datatype
boolean
Alias
- UMLS CUI [1]
- C3828490
Beschrijving
If Yes, complete the paper Pregnancy Notification form.
Datatype
text
Alias
- UMLS CUI [1]
- C0919624
Beschrijving
Status of Treatment Blind
Alias
- UMLS CUI-1
- C0749659
- UMLS CUI-2
- C2347038
Beschrijving
If Yes, complete the Adverse Event form and/or Investigational Product forms as appropriate.
Datatype
boolean
Alias
- UMLS CUI [1]
- C3897431
Beschrijving
Date/time blind broken
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C1264639
Beschrijving
Reason blind broken
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Beschrijving
Specify other reason for blind broken
Datatype
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Beschrijving
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008972
Beschrijving
Date of subject completion or withdrawal
Datatype
date
Alias
- UMLS CUI [1]
- C2983670
Beschrijving
Was the subject withdrawn from the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0422727
Beschrijving
Primary reason for withdrawal
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Beschrijving
Case book ready for signature
Datatype
text
Alias
- UMLS CUI [1]
- C1519316
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Follow-Up - ECG; Vital Signs; Pulmonary Function Test; Pregnancy Information; Status of treatment blind; Study conclusion
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