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41682
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
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Versies (1)
- 13-12-20 13-12-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
13 december 2020
DOI
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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
Similar models
Logs and Repeats - Pharmacokinetics Blood; Local Laboratory; Summary Holter; Holter Abnormalities
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Pharmacokinetics Blood
C0031328 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0005767 (UMLS CUI-2)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Date/time of test
Item
Date/time of test
datetime
C0024119 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
FEV1 (3 readings) - 1
Item
FEV1 (3 readings) - 1
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 2
Item
FEV1 (3 readings) - 2
integer
C0748133 (UMLS CUI [1])
FEV1 (3 readings) - 3
Item
FEV1 (3 readings) - 3
integer
C0748133 (UMLS CUI [1])
FVC (3 readings) - 1
Item
FVC (3 readings) - 1
integer
C1287681 (UMLS CUI [1])
FVC (3 readings) - 2
Item
FVC (3 readings) - 2
integer
C1287681 (UMLS CUI [1])
FVC (3 readings) - 3
Item
FVC (3 readings) - 3
integer
C1287681 (UMLS CUI [1])
Date and time sample taken
Item
Date and time sample taken
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
Has the subject fasted?
Item
Has the subject fasted?
boolean
C0015663 (UMLS CUI [1])
Item
Laboratory Test - Clinical Chemistry
integer
C0022885 (UMLS CUI [1,1])
C0008000 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,2])
CL Item
Albumin (1)
CL Item
Alkaline Phosphatse (2)
CL Item
ALT (3)
CL Item
AST (4)
CL Item
Calcium (5)
CL Item
Creatinine (6)
CL Item
Direct Bilirubin (7)
CL Item
GGT (8)
CL Item
Glucose (9)
CL Item
Potassium (10)
CL Item
Sodium (11)
CL Item
Total Bilirubin (12)
CL Item
Total Protein (13)
CL Item
Urea (14)
CL Item
Uric Acid (15)
Item
Laboratory Test - Haematology
integer
C0022885 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,2])
CL Item
Basophils (1)
CL Item
Eosinophils (2)
CL Item
Haemoglobin (3)
CL Item
Haematocrit (4)
CL Item
Lymphocytes (5)
CL Item
MCH (6)
CL Item
MCHC (7)
CL Item
MCV (8)
CL Item
Monocytes (9)
CL Item
Neutrophils (10)
CL Item
RBC (11)
CL Item
WBC (12)
Laboratory Test Result - Numeric
Item
Laboratory Test Result - Numeric
integer
C0587081 (UMLS CUI [1,1])
C2347373 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,2])
Laboratory result - Character result
Item
Laboratory result - Character result
text
C0587081 (UMLS CUI [1,1])
C2350015 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
CL Item
No result (1)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
MInimum heart rate
Item
MInimum heart rate
integer
C0018810 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C1524031 (UMLS CUI [1,2])
Maximum heart rate
Item
Maximum heart rate
integer
C0018810 (UMLS CUI [1,1])
C0806909 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,2])
Mean heart rate
Item
Mean heart rate
integer
C1881634 (UMLS CUI [1])
Number of ventricular runs
Item
Number of ventricular runs
integer
C2189285 (UMLS CUI [1])
Number of ventricular runs - Not done, specify reason
Item
Number of ventricular runs - Not done, specify reason
text
C2189285 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,2])
Item
Number of ventricular runs - Not applicable
integer
C2189285 (UMLS CUI [1])
CL Item
Not applicable (1)
Number of supraventricular runs
Item
Number of supraventricular runs
integer
C0039240 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
Supraventricular runs - Not done, specify reason
Item
Supraventricular runs - Not done, specify reason
text
C0039240 (UMLS CUI [1,1])
C2826287 (UMLS CUI [1,2])
C2826287 (UMLS CUI [1,2])
Item
Supraventricular runs - Not applicable
integer
C0039240 (UMLS CUI [1])
CL Item
Not applicable (1)
Item
Interpretation of Holter
integer
C0013801 (UMLS CUI [1,1])
C4086187 (UMLS CUI [1,2])
C4086187 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (4)
CL Item
Unable to evaluate (8)
Start Date and Time of Holter
Item
Start Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C0808070 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
Stop Date and Time of Holter
Item
Stop Date and Time of Holter
datetime
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0806020 (UMLS CUI [1,2])
C0013801 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
CL Item
Electrical alternans (A21)
CL Item
R on T phenomenon (A22)
CL Item
Ventricular fibrillation (A23)
CL Item
Trigeminy (A20)
CL Item
Ventricular premature depolarisation (A17)
CL Item
Sustained ventricular tachycardia (>100 beats/min, >30 beats) (A26)
CL Item
Non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A25)
CL Item
Idioventricular rhythm (<= beats/min, defined by wide QRS complex) (A24)
CL Item
Sustained supraventricular tachycardia (>100 beats/min, >30 beats) (A12)
CL Item
Atrial flutter (A13)
CL Item
Monomorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A28)
CL Item
Atrial fibrillation (A14)
CL Item
Monomorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A29)
CL Item
Ventricular couplets (A18)
CL Item
Bigeminy (A19)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (A10)
CL Item
Non-sustained supraventricular tachycardia (>100 beats/min, 3-30 beats) (A11)
CL Item
Torsade de Pointes (TdP) (A32)
CL Item
Pacemaker (A33)
CL Item
Wide QRS tachycardia (diagnosis unknown) (A27)
CL Item
Polymorphic non-sustained ventricular tachycardia (>100 beats/min, 3-30 beats) (A30)
CL Item
Junctional rhythm (<=100 beats/min, defined by narrow QRS complex) (A15)
CL Item
Polymorphic sustained ventricular tachycardia (>100 beats/min, >30 beats) (A31)
CL Item
Junctional tachycardia (>100 beats/min) (A16)
CL Item
Short PR Interval (A35)
CL Item
No abnormalities (A00)
CL Item
Sinus bradycardia (50-59 beats/min) (A01)
CL Item
Sinus bradycardia (40-49 beats/min) (A02)
CL Item
Sinus bradycardia (30-39 beats/min) (A03)
CL Item
Sinus bradycardia (<30 beats/min) (A04)
CL Item
Sinus pause (A05)
CL Item
Sinus tachycardia (>100 beats/min) (A06)
CL Item
Ectopic supraventricular beats (A07)
CL Item
Ectopic supraventricular rhythm (A08)
CL Item
Wandering atrial pacemaker (A09)
CL Item
First degree AV block (PR Interval >200msec) (A34)
CL Item
Second degree AV block (Mobitz type 1) (A36)
CL Item
Second degree AV block (Mobitz type 2) (A37)
CL Item
2:1 AV block (A38)
CL Item
Third degree AV block (A39)
CL Item
Left axis deviation (QRS axis more negative thant -30 degrees) (A40)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (A41)
CL Item
Incomplete right bundle branch block (A42)
CL Item
Incomplete left bundle branch block (A43)
CL Item
Right bundle branch block (A44)
CL Item
Left anterior hemiblock (A45)
CL Item
Left posterior hemiblock (A46)
CL Item
Left bundle branch block (A47)
CL Item
Bifascicular block (A48)
CL Item
Non-specific intraventricular conduction delay (QRS >=120 msec) (A49)
CL Item
Accessory pathway (Wolff-Parkinson-White, Lown-Ganong-levine) (A50)
CL Item
QTc prolongation >=500 msec (A51)
CL Item
AV dissociation (A52)
CL Item
Myocardial Infarction, old (A53)
CL Item
Myocardial Infarction, non Q-wave (A54)
CL Item
Non-specific ST-T changes (A55)
CL Item
J point elevation (A56)
CL Item
ST elevation (A57)
CL Item
ST depression (A58)
CL Item
St segment abnormality (A59)
CL Item
U waves (A60)
CL Item
T wave Inversion (A61)
CL Item
T wave peaked (A62)
CL Item
T waves biphasic (A63)
CL Item
T waves flat (A64)
CL Item
Notched T-waves (A65)
CL Item
Low QRS voltage (A66)
CL Item
T wave abnormality (A67)
CL Item
Other abnormal rhythm (A94)
CL Item
Other morphology (A95)
CL Item
Other conduction (A96)
CL Item
Other myocardial infarction (A97)
CL Item
Other depolarisation/repolarisation (A98)
CL Item
Other abnormality/Cardiologist comments (A99)
Other abnormal rhythm, specify
Item
Other abnormal rhythm, specify
text
C0199556 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [2])
Other morphology, specify
Item
Other morphology, specify
text
C0332437 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other conduction, specify
Item
Other conduction, specify
text
C0340494 (UMLS CUI [1])
C2348235 (UMLS CUI [2])
C2348235 (UMLS CUI [2])
Other myocardial infarction, specify
Item
Other myocardial infarction, specify
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other depolarisation/repolrisation, specify
Item
Other depolarisation/repolrisation, specify
text
C0948857 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Other abnormality/ Cardiologist comments
Item
Other abnormality/ Cardiologist comments
text
C1704258 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C0175906 (UMLS CUI [2,1])
C0947611 (UMLS CUI [2,2])
Item
Holter monitoring method
integer
C0013801 (UMLS CUI [1,1])
C0871511 (UMLS CUI [1,2])
C0871511 (UMLS CUI [1,2])
CL Item
12 Lead 1000Hz (1)
CL Item
12 Lead 180Hz (2)
CL Item
3 Lead 180Hz (3)
CL Item
3 Lead 512Hz (4)
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