Informatie:
Fout:
ID
41150
Beschrijving
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)
Trefwoorden
Versies (1)
- 01-07-20 01-07-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
1 juli 2020
DOI
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Licentie
Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)
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Vital Signs
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs (BMI Calculation) (Screening)
C0518766 (UMLS CUI-1)
C1305855 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
C1305855 (UMLS CUI-2)
C0220908 (UMLS CUI-3)
Does the subject have a body mass index within the range 18.0 to 34.9 kg/m2?
Item
Does the subject have a body mass index within the range 18.0 to 34.9 kg/m2?
boolean
C1305855 (UMLS CUI [1])
Item Group
Vital Signs (Mean Calculation) (Screening)
C0518766 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
C0220908 (UMLS CUI-2)
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
CL Item
Screening (1)
CL Item
Mean (2)
Systolic Blood Pressure Supine
Item
Systolic Blood Pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure Supine
Item
Diastolic Blood Pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs (Screening)
C0518766 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
C0220908 (UMLS CUI-2)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Item Group
Vital Signs (Screening)
C0518766 (UMLS CUI-1)
C0220908 (UMLS CUI-2)
C0220908 (UMLS CUI-2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
CL Item
Screening (1)
CL Item
Unscheduled (2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure Supine
Item
Systolic Blood Pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure Supine
Item
Diastolic Blood Pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs (Treatment Period 1 - 4)
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
CL Item
Pre-dose (1)
CL Item
15 mins (2)
CL Item
45 mins (3)
CL Item
1.5 hrs (4)
CL Item
4 hrs (5)
CL Item
8 hrs (6)
CL Item
24 hrs (7)
CL Item
Unscheduled (8)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure Supine
Item
Systolic Blood Pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure Supine
Item
Diastolic Blood Pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
CL Item
Pre-dose (1)
CL Item
15 mins (2)
CL Item
45 mins (3)
CL Item
1.5 hrs (4)
CL Item
4 hrs (5)
CL Item
8 hrs (6)
CL Item
24 hrs (7)
CL Item
48 hrs (8)
CL Item
Unscheduled (9)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure Supine
Item
Systolic Blood Pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure Supine
Item
Diastolic Blood Pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
Vital Signs (Follow-Up)
C0518766 (UMLS CUI-1)
C1522577 (UMLS CUI-2)
C1522577 (UMLS CUI-2)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
CL Item
Follow-up (1)
CL Item
Unscheduled (2)
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure Supine
Item
Systolic Blood Pressure Supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure Supine
Item
Diastolic Blood Pressure Supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0038846 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])