ID

22027

Description

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

Keywords

Versions (2)
  1. 4/4/17 4/4/17 -
  2. 5/15/17 5/15/17 -
Uploaded on

May 15, 2017

DOI

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License

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

English

Screening Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) NCT00688207 / GSK-AVA109941

1 forms  
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Gender

Data type

integer

Alias
UMLS CUI [1]
C0079399
Ethnicity (Check one):
Description

Ethnic Group

Data type

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry (Check all that apply):
Description

Racial Group

Data type

integer

Alias
UMLS CUI [1]
C0034510
Vital signs
Description

Vital signs

Alias
UMLS CUI-1
C0518766
Height
Description

Body Height

Data type

float

Measurement units
  • cm
Alias
UMLS CUI [1,1]
C0005890
UMLS CUI [1,2]
C0518766
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1,1]
C0005910
UMLS CUI [1,2]
C0518766
kg
Body mass index
Description

BMI

Data type

float

Measurement units
  • kg/m2
Alias
UMLS CUI [1,1]
C1305855
UMLS CUI [1,2]
C0518766
kg/m2
Blood Pressure and Heart Rate Measurements
Description

Blood Pressure and Heart Rate Measurements

Alias
UMLS CUI-1
C0005823
UMLS CUI-3
C0018810
Date (e.g. 01 JAN 03)
Description

date of measurement

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0005823
Planned Relative Time (e.g. 15min)
Description

planned time

Data type

text

Alias
UMLS CUI [1,1]
C2348792
UMLS CUI [1,2]
C0005823
Actual time (e.g. 13:02)
Description

Actual time

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0005823
Hr : Min
Systolic Blood Pressure (e.g. 110)
Description

Systolic Blood Pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Diastolic blood pressure (e.g. 80)
Description

Diastolic blood pressure

Data type

float

Measurement units
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Description

Subject position

Data type

integer

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

Heart Rate

Data type

float

Measurement units
  • Beats/Min
Alias
UMLS CUI [1]
C0018810
Beats/Min
12-Lead ECG
Description

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Description

id

Data type

text

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

Start date of ECG

Data type

date

Measurement units
  • Day Month Year
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013798
Day Month Year
Planned Relative Time
Description

Planned Relative Time

Data type

integer

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

Start Time of ECG

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1,1]
C1301880
UMLS CUI [1,2]
C0013798
Hr : Min
Heart Rate
Description

Heart Rate

Data type

float

Measurement units
  • Beats/min
Alias
UMLS CUI [1]
C0018810
Beats/min
PR Interval
Description

PR Interval

Data type

time

Measurement units
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Description

QRS Duration

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1]
C0429025
Hr : Min
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1]
C1287082
Hr : Min
QTc interval
Description

QTc interval

Data type

time

Measurement units
  • Hr : Min
Alias
UMLS CUI [1]
C0489625
Hr : Min
Result of the ECG
Description

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

Data type

float

Alias
UMLS CUI [1]
C0438154
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Similar models

Screening Mild Alzheimer''s Disease to Assess the of Extended Release Formulation of Rosiglitazone (RSG XR) NCT00688207 / GSK-AVA109941

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
integer
C0079399 (UMLS CUI [1])
Gender
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
Ethnicity (Check one):
integer
C0015031 (UMLS CUI [1])
Ethnic Group
Code List
Ethnicity (Check one):
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Geographic Ancestry (Check all that apply):
integer
C0034510 (UMLS CUI [1])
Racial Group
Code List
Geographic Ancestry (Check all that apply):
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage  (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Body Height
Item
Height
float
C0005890 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
BMI
Item
Body mass index
float
C1305855 (UMLS CUI [1,1])
C0518766 (UMLS CUI [1,2])
Item Group
Blood Pressure and Heart Rate Measurements
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-3)
date of measurement
Item
Date (e.g. 01 JAN 03)
date
C0011008 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
Item
Planned Relative Time (e.g. 15min)
text
C2348792 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
planned time
Code List
Planned Relative Time (e.g. 15min)
CL Item
Screening (1)
CL Item
Unscheduled (2)
CL Item
Unscheduled (3)
Actual time
Item
Actual time (e.g. 13:02)
time
C0040223 (UMLS CUI [1,1])
C0005823 (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
C0808070 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Item
Planned Relative Time
integer
C0439564 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Planned Relative Time
Code List
Planned Relative Time
CL Item
Screening (1)
CL Item
Unscheduled (2)
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])
Result of the ECG
Item
Result of the ECG
float
C0438154 (UMLS CUI [1])
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