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