ID

22105

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. 08-05-17 08-05-17 -
  2. 20-05-17 20-05-17 -
Geüploaded op

20 mei 2017

DOI

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Licentie

Creative Commons BY-NC 3.0
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Follow-up Vital Signs ECG Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) NCT00688207 / GSK-AVA109941

Engels

Follow-up Vital Signs ECG Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) NCT00688207 / GSK-AVA109941

1 Formulieren  
Vital Signs
Beschrijving

Vital Signs

Alias
UMLS CUI-1
C0518766
Date (e.g. 01 JAN 03)
Beschrijving

date of measurement

Datatype

date

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0011008
Planned Relative Time (e.g. 15min)
Beschrijving

planned time

Datatype

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C2348792
Actual time (e.g. 13:02)
Beschrijving

Actual time

Datatype

time

Maateenheden
  • Hr : Min
Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Hr : Min
Systolic Blood Pressure (e.g. 110)
Beschrijving

Systolic Blood Pressure

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure (e.g. 80)
Beschrijving

Diastolic blood pressure

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Beschrijving

Subject position

Datatype

integer

Alias
UMLS CUI [1,1]
C1262869
UMLS CUI [1,2]
C0005823
Heart rate (e.g. 75)
Beschrijving

Heart Rate

Datatype

float

Maateenheden
  • Beats/Min
Alias
UMLS CUI [1]
C0018810
Beats/Min
12-Lead ECG
Beschrijving

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beschrijving

ECG Number

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]
C0430456
UMLS CUI [1,2]
C0808070
Day Month Year
Planned Relative Time
Beschrijving

Planned Relative Time

Datatype

integer

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

Start Time of ECG

Datatype

time

Maateenheden
  • Hr : Min
Alias
UMLS CUI [1,1]
C0430456
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
Beschrijving

Enter Code for result from following list: 1=Normal 2=Abnormal - not clinically significant* 3=Abnormal - clinically significant 4=No result (not available) *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.

Datatype

float

Alias
UMLS CUI [1]
C0438154
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Similar models

Follow-up Vital Signs 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
Vital Signs
C0518766 (UMLS CUI-1)
date of measurement
Item
Date (e.g. 01 JAN 03)
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Planned Relative Time (e.g. 15min)
text
C0518766 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
planned time
Code List
Planned Relative Time (e.g. 15min)
CL Item
Follow-up (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
Actual time
Item
Actual time (e.g. 13:02)
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic Blood Pressure
Item
Systolic Blood Pressure (e.g. 110)
float
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure (e.g. 80)
float
C0428883 (UMLS CUI [1])
Item
Subject position
integer
C1262869 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
Subject position
Code List
Subject position
CL Item
Supine (1)
CL Item
Sitting (3)
Heart Rate
Item
Heart rate (e.g. 75)
float
C0018810 (UMLS CUI [1])
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)
Start date of ECG
Item
Start date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Follow-Up (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (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])
Result of the ECG
Item
Result of the ECG
float
C0438154 (UMLS CUI [1])
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