ID

22162

Beschrijving

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

Trefwoorden

Versies (2)
  1. 09-05-17 09-05-17 -
  2. 22-05-17 22-05-17 -
Geüploaded op

22 mei 2017

DOI

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Licentie

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

Engels

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

1 Formulieren  
12-Lead ECG
Beschrijving

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beschrijving

id

Datatype

text

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

Start date of ECG

Datatype

date

Maateenheden
  • Day Month Year
Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0808070
Day Month Year
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

text

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0439564
Start Time of ECG
Beschrijving

Start Time of ECG

Datatype

time

Maateenheden
  • Hr : Min
Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C1301880
Hr : Min
Heart Rate
Beschrijving

Heart Rate

Datatype

float

Maateenheden
  • Beats/min
Alias
UMLS CUI [1]
C0018810
Beats/min
PR Interval
Beschrijving

PR Interval

Datatype

time

Maateenheden
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beschrijving

QRS Duration

Datatype

time

Maateenheden
  • Hr : Min
Alias
UMLS CUI [1]
C0429025
Hr : Min
Uncorrected QT Interval
Beschrijving

Uncorrected QT Interval

Datatype

time

Maateenheden
  • Hr : Min
Alias
UMLS CUI [1]
C1287082
Hr : Min
QTc interval
Beschrijving

QTc interval

Datatype

time

Maateenheden
  • 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.
Beschrijving

Result of the ECG

Datatype

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 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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
C0013798 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
text
C0013798 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
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
C0013798 (UMLS CUI [1,1])
C1301880 (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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