ID

21909

Beskrivning

The present pharmacokinetic study is designed to assess the pharmacokinetics of RSG XR as monotherapy in patients with mild Alzheimer's disease (AD) as such information will not be obtained from the current phase III trials . The study aims to enroll fourteen patients (seven of each APOE genotype). Each patient will receive a single oral dose of 4mg of RSG XR in the morning under fasted conditions and PK samples will be taken up to 36h. GSK Source & Descriptions: https://clinicaltrials.gov/ct2/show/NCT00688207?term=NCT00688207&rank=1

Länk

https://clinicaltrials.gov/ct2/show/NCT00688207?term=NCT00688207&rank=1

Nyckelord

  1. 2017-05-08 2017-05-08 -
  2. 2017-05-16 2017-05-16 -
Uppladdad den

8 maj 2017

DOI

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Licens

Creative Commons BY-NC 3.0

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Screening 12-lead ECG abnormalities Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941

Screening 12-lead ECG abnormalities Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941

12 lead ECG
Beskrivning

12 lead ECG

Alias
UMLS CUI-1
C0013798
Date of ECG
Beskrivning

Date of ECG

Datatyp

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Beskrivning

Time of ECG

Datatyp

time

Måttenheter
  • Hr : Min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0013798
Hr : Min
ECG finding
Beskrivning

ECG finding

Alias
UMLS CUI-1
C0438154
A. Rhythm (Check all that apply):
Beskrivning

ECG rhythm

Datatyp

integer

Alias
UMLS CUI [1]
C0232187
Comment:
Beskrivning

ECG other

Datatyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205394
B. P-Wave and QRS Morphology
Beskrivning

P-Wave and QRS Morphology

Datatyp

integer

Alias
UMLS CUI [1]
C2216025
UMLS CUI [2]
C0429098
Comment:
Beskrivning

ECG other

Datatyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205394
C. Conduction
Beskrivning

Conduction

Datatyp

integer

Alias
UMLS CUI [1]
C0264886
Comment:
Beskrivning

ECG other

Datatyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205394
D. Myocardial Infarction
Beskrivning

Myocardial Infarction

Datatyp

integer

Alias
UMLS CUI [1]
C0027051
Comment:
Beskrivning

ECG other

Datatyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205394
E. Depolarisation / Rebpolarisation (QRS-T)
Beskrivning

ECG findings

Datatyp

integer

Alias
UMLS CUI [1]
C0442977
Comment:
Beskrivning

ECG other

Datatyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205394
Other Abnormalities
Beskrivning

ECG Abnormalities

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
Comment:
Beskrivning

ECG other

Datatyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0205394

Similar models

Screening 12-lead ECG abnormalities Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone NCT00688207 / GSK-AVA109941

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
12 lead ECG
C0013798 (UMLS CUI-1)
Date of ECG
Item
Date of ECG
date
C2826640 (UMLS CUI [1])
Time of ECG
Item
Time of ECG
time
C0040223 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item Group
ECG finding
C0438154 (UMLS CUI-1)
Item
A. Rhythm (Check all that apply):
integer
C0232187 (UMLS CUI [1])
Code List
A. Rhythm (Check all that apply):
CL Item
Sinus bradycardia (1)
CL Item
Sinus bradycardia (heart rate 40-50 beats/min) (2)
CL Item
Sinus bradycardia (heart rate 30-39 beats/min) (3)
CL Item
Sinus bradycardia (heart rate <30 beats/min) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Ectopic supraventricular rhythm (8)
CL Item
Wandering atrial pacemaker (9)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker with heart rate >100 beats/min) (10)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (11)
CL Item
Atrial flutter (12)
CL Item
Atrial fibrillation (13)
CL Item
Junctional rhythm (heart rate >100 beats/min) (14)
CL Item
Junctional rhythm (15)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (16)
CL Item
Ectopic ventricular beats (17)
CL Item
Ventricular couplets (18)
CL Item
Bigeminy (19)
CL Item
Trigemini (20)
CL Item
Electrical alternans (21)
CL Item
R on T phenomenon (22)
CL Item
Ventricular fibrillation  (23)
CL Item
Idioventricular rhythm (heart rate <100 beats/min) (24)
CL Item
Sustained ventricular tachycardia (25)
CL Item
Non-sustained ventricular tachycardia (26)
CL Item
Wide QRS Tachycardia (diagnosis unknown) (27)
CL Item
Ventricular tachycardia (28)
CL Item
Monomorphic ventricular tachycardia (29)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (30)
CL Item
Polymorphic (sustained or non-sustained) ventricular tachycardia (31)
CL Item
Artificial pacemaker (32)
CL Item
Other abnormal rhythm (33)
ECG other
Item
Comment:
text
C0013798 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
B. P-Wave and QRS Morphology
integer
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
Code List
B. P-Wave and QRS Morphology
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraatrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology (6)
ECG other
Item
Comment:
text
C0013798 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
C. Conduction
integer
C0264886 (UMLS CUI [1])
Code List
C. Conduction
CL Item
First degree AV block (PR interval <200msec) (1)
CL Item
Short PR interval (2)
CL Item
Second degree AV block (Moritz type 1) (3)
CL Item
Second degree AV block (Moritz type 2) (4)
CL Item
2:1 AV block (5)
CL Item
Third degree AV block (6)
CL Item
Left axis deviation (QRS axis more negative than -30°) (7)
CL Item
Right axis deviation (QRS axis more positive than +110°) (8)
CL Item
Incomplete right bundle branch block (9)
CL Item
Incomplete left bundle branch block (10)
CL Item
right bundle branch block (11)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (12)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (13)
CL Item
Left bundle branch block (14)
CL Item
Bifascicular block (15)
CL Item
Non-süecific intraventricular conduction delay (QRS >120msec) (16)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Ganong-Levine) (17)
CL Item
Prolonged QT interval (18)
CL Item
QT/QTc Prolongation >500msec (19)
CL Item
AV dissociation (20)
CL Item
Other conduction (21)
ECG other
Item
Comment:
text
C0013798 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
D. Myocardial Infarction
integer
C0027051 (UMLS CUI [1])
Code List
D. Myocardial Infarction
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterios (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, Non-Q-wave (7)
CL Item
Other myocardial infarction (8)
ECG other
Item
Comment:
text
C0013798 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item
E. Depolarisation / Rebpolarisation (QRS-T)
integer
C0442977 (UMLS CUI [1])
Code List
E. Depolarisation / Rebpolarisation (QRS-T)
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST elevation-pericarditis (4)
CL Item
ST depression (5)
CL Item
ST segment abnormality, not specified (6)
CL Item
U waves abnormal (7)
CL Item
T wave inversion (8)
CL Item
T wave peaked (9)
CL Item
T wave flat (10)
CL Item
T waves biphasic (11)
CL Item
Notched T-waves (12)
CL Item
Low QRS voltage (13)
CL Item
T-wave flattering/inversion (14)
CL Item
T wave abnormality, not specified (15)
CL Item
Other depolarisation/repolarisation (16)
ECG other
Item
Comment:
text
C0013798 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
ECG Abnormalities
Item
Other Abnormalities
boolean
C0522055 (UMLS CUI [1])
ECG other
Item
Comment:
text
C0013798 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

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