ID

21929

Descripción

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

Palabras clave

Versiones (2)
  1. 9/5/17 9/5/17 -
  2. 22/5/17 22/5/17 -
Subido en

9 de mayo de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Study Day 12-Lead ECG Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) NCT00688207 / GSK-AVA109941

Inglés

Study Day 12-Lead ECG Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) NCT00688207 / GSK-AVA109941

1 formularios  
12-Lead ECG
Descripción

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Descripción

id

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0180600
Start date of ECG
Descripción

Start date of ECG

Tipo de datos

date

Unidades de medida
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Day Month Year
Planned Relative Time
Descripción

Planned Relative Time

Tipo de datos

text

Alias
UMLS CUI [1]
C0439564
Start Time of ECG
Descripción

Start Time of ECG

Tipo de datos

time

Unidades de medida
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0013798
Hr : Min
Heart Rate
Descripción

Heart Rate

Tipo de datos

float

Unidades de medida
  • Beats/min
Alias
UMLS CUI [1]
C0018810
Beats/min
PR Interval
Descripción

PR Interval

Tipo de datos

time

Unidades de medida
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Descripción

QRS Duration

Tipo de datos

time

Unidades de medida
  • Hr : Min
Alias
UMLS CUI [1]
C0429025
Hr : Min
Uncorrected QT Interval
Descripción

Uncorrected QT Interval

Tipo de datos

time

Unidades de medida
  • Hr : Min
Alias
UMLS CUI [1]
C1287082
Hr : Min
QTc interval
Descripción

QTc interval

Tipo de datos

time

Unidades de medida
  • Hr : Min
Alias
UMLS CUI [1]
C0489625
Hr : Min
Result of the ECG (enter Code for result from following list) *Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
Descripción

Result of the ECG

Tipo de datos

integer

Alias
UMLS CUI [1]
C0438154
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Similar models

Study Day 12-Lead ECG Mild Alzheimer's Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) NCT00688207 / GSK-AVA109941

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG Number
text
C1300638 (UMLS CUI [1,1])
C0180600 (UMLS CUI [1,2])
id
Code List
ECG Number
CL Item
ECG 1 (1)
CL Item
ECG 2 (2)
CL Item
ECG 3 (3)
CL Item
ECG 4 (ECG 4)
CL Item
ECG 5 (ECG 5)
CL Item
ECG 6 (ECG 6)
CL Item
ECG 7 (ECG 7)
CL Item
ECG 8 (ECG 8)
Start date of ECG
Item
Start date of ECG
date
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Pre-Dose (1)
CL Item
12 hrs (12 hrs)
CL Item
24 hrs (24 hrs)
CL Item
36 hrs (36 hrs)
CL Item
Unscheduled (Unscheduled)
CL Item
Unscheduled (Unscheduled)
CL Item
Unscheduled (Unscheduled)
CL Item
Unscheduled (Unscheduled)
Start Time of ECG
Item
Start Time of ECG
time
C1301880 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
float
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
time
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
time
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
time
C1287082 (UMLS CUI [1])
QTc interval
Item
QTc interval
time
C0489625 (UMLS CUI [1])
Item
Result of the ECG (enter Code for result from following list) *Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG (enter Code for result from following list) *Complete the Non-Serious Adverse Events (AE) or Serious Adverse Event (SAE) page(s) if clinically significant abnormalities meet the protocol definition for an AE or SAE. Complete the additional ECG Abnormalities page if clinically significant abnormalities are present.
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant* (3)
CL Item
No result (not available) (4)
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