ID

22034

Beschreibung

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

Link

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

Stichworte

Versionen (2)
  1. 08.05.17 08.05.17 -
  2. 16.05.17 16.05.17 -
Hochgeladen am

16. Mai 2017

DOI

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Lizenz

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

Englisch

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

1 Formulare  
12 lead ECG
Beschreibung

12 lead ECG

Alias
UMLS CUI-1
C0013798
Date of ECG
Beschreibung

Date of ECG

Datentyp

date

Alias
UMLS CUI [1]
C2826640
Time of ECG
Beschreibung

Time of ECG

Datentyp

time

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

ECG finding

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

ECG rhythm

Datentyp

integer

Alias
UMLS CUI [1]
C0232187
Comment:
Beschreibung

ECG other

Datentyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C2348235
B. P-Wave and QRS Morphology
Beschreibung

P-Wave and QRS Morphology

Datentyp

integer

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

ECG other

Datentyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C2348235
C. Conduction
Beschreibung

Conduction

Datentyp

integer

Alias
UMLS CUI [1]
C0264886
Comment:
Beschreibung

ECG other

Datentyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C2348235
D. Myocardial Infarction
Beschreibung

Myocardial Infarction

Datentyp

integer

Alias
UMLS CUI [1]
C0027051
Comment:
Beschreibung

ECG other

Datentyp

text

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

ECG findings

Datentyp

integer

Alias
UMLS CUI [1]
C0442977
Comment:
Beschreibung

ECG other

Datentyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C2348235
Other Abnormalities
Beschreibung

ECG Abnormalities

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
Comment:
Beschreibung

ECG other

Datentyp

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C2348235
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item Group
ECG finding
C0438154 (UMLS CUI-1)
Item
A. Rhythm (Check all that apply):
integer
C0232187 (UMLS CUI [1])
ECG rhythm
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])
C2348235 (UMLS CUI [1,2])
Item
B. P-Wave and QRS Morphology
integer
C2216025 (UMLS CUI [1])
C0429098 (UMLS CUI [2])
P-Wave and QRS Morphology
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])
C2348235 (UMLS CUI [1,2])
Item
C. Conduction
integer
C0264886 (UMLS CUI [1])
Conduction
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])
C2348235 (UMLS CUI [1,2])
Item
D. Myocardial Infarction
integer
C0027051 (UMLS CUI [1])
Myocardial Infarction
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])
ECG findings
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])
C2348235 (UMLS CUI [1,2])
ECG Abnormalities
Item
Other Abnormalities
boolean
C0522055 (UMLS CUI [1])
ECG other
Item
Comment:
text
C0013798 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
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