ID

21035

Beskrivning

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

Länk

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

Nyckelord

Versioner (2)
  1. 2017-04-04 2017-04-04 -
  2. 2017-05-15 2017-05-15 -
Uppladdad den

4 april 2017

DOI

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Licens

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

Engelsk

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

1 Formulär  
Demography
Beskrivning

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Beskrivning

Date of birth

Datatyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beskrivning

Gender

Datatyp

integer

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

Ethnic Group

Datatyp

integer

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

Racial Group

Datatyp

integer

Alias
UMLS CUI [1]
C0034510
Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Height
Beskrivning

Body Height

Datatyp

float

Måttenheter
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beskrivning

BMI

Datatyp

float

Måttenheter
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Blood Pressure and Heart Rate Measurements
Beskrivning

Blood Pressure and Heart Rate Measurements

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

date of measurement

Datatyp

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time (e.g. 15min)
Beskrivning

planned time

Datatyp

text

Alias
UMLS CUI [1]
C2348792
Actual time (e.g. 13:02)
Beskrivning

Actual time

Datatyp

time

Måttenheter
  • Hr : Min
Alias
UMLS CUI [1]
C0040223
Hr : Min
Systolic Blood Pressure (e.g. 110)
Beskrivning

Systolic Blood Pressure

Datatyp

float

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

Diastolic blood pressure

Datatyp

float

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Subject position
Beskrivning

Subject position

Datatyp

integer

Alias
UMLS CUI [1]
C1262869
Heart rate (e.g. 75)
Beskrivning

Heart Rate

Datatyp

float

Måttenheter
  • Beats/Min
Alias
UMLS CUI [1]
C0018810
Beats/Min
12-Lead ECG
Beskrivning

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beskrivning

id

Datatyp

text

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

Start date of ECG

Datatyp

date

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

Planned Relative Time

Datatyp

integer

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

Start Time of ECG

Datatyp

time

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

Heart Rate

Datatyp

float

Måttenheter
  • Beats/min
Alias
UMLS CUI [1]
C0018810
Beats/min
PR Interval
Beskrivning

PR Interval

Datatyp

time

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

time

Måttenheter
  • Hr : Min
Alias
UMLS CUI [1]
C0429025
Hr : Min
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

time

Måttenheter
  • Hr : Min
Alias
UMLS CUI [1]
C1287082
Hr : Min
QTc interval
Beskrivning

QTc interval

Datatyp

time

Måttenheter
  • Hr : Min
Alias
UMLS CUI [1]
C0489625
Hr : Min
Result of the ECG
Beskrivning

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

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
BMI
Item
Body mass index
float
C1305855 (UMLS CUI [1])
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])
Item
Planned Relative Time (e.g. 15min)
text
C2348792 (UMLS CUI [1])
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])
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])
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])
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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