ID

41631

Beskrivning

Study ID: 108366 Clinical Study ID: 108366 Study Title: An Open-label, Sequential Study to Evaluate the Pharmacokinetics of Simvastatin When Coadministered With Albiglutide in Healthy Adult Subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01147692 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: simvastatin plus albiglutide Trade Name: simvastatin plus albiglutide Study Indication: Diabetes Mellitus, Type 2

Nyckelord

Versioner (3)
  1. 2020-11-12 2020-11-12 -
  2. 2020-11-12 2020-11-12 -
  3. 2020-11-29 2020-11-29 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

29 november 2020

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

Engelsk

Day 7 - 35: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Albiglutide), Electrocardiogram

1 Formulär  
Administrative
Beskrivning

Administrative

Alias
UMLS CUI-1
C1320722
Site
Beskrivning

Site

Datatyp

text

Alias
UMLS CUI [1]
C2825164
Subject
Beskrivning

Subject

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Status
Beskrivning

Status

Datatyp

text

Alias
UMLS CUI [1]
C0449438
Doc#
Beskrivning

Doc#

Datatyp

integer

Alias
UMLS CUI [1]
C1301746
Is Page Blank?
Beskrivning

Is Page Blank?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1704732
UMLS CUI [1,2]
C0750479
Visit Date
Beskrivning

Visit Date

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Vital Signs (sitting) - Day 7 - 35
Beskrivning

Vital Signs (sitting) - Day 7 - 35

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C0277814
Vital Signs Date
Beskrivning

Vital Signs Date

Datatyp

date

Alias
UMLS CUI [1]
C2826644
Vital Signs Time
Beskrivning

Vital Signs Time

Datatyp

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure
Beskrivning

Systolic Blood Pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beskrivning

Diastolic Blood Pressure

Datatyp

integer

Måttenheter
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Temperature
Beskrivning

Temperature

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Study Drug Administration (50 mg Albiglutide) - Day 7 - 35
Beskrivning

Study Drug Administration (50 mg Albiglutide) - Day 7 - 35

Alias
UMLS CUI-1
C0013153
UMLS CUI-2
C2607479
Was the dose administered?
Beskrivning

Was the dose administered?

Datatyp

boolean

Alias
UMLS CUI [1]
C3174092
UMLS CUI [2]
C3469597
Dose Date
Beskrivning

Dose Date

Datatyp

date

Alias
UMLS CUI [1]
C0178602
UMLS CUI [2]
C0011008
Dose Time
Beskrivning

Dose Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Site of injection
Beskrivning

Site of injection

Datatyp

integer

Alias
UMLS CUI [1]
C2700396
Pharmacokinetic Blood Collection (Albiglutide) - Day 35
Beskrivning

Pharmacokinetic Blood Collection (Albiglutide) - Day 35

Alias
UMLS CUI-1
C0031328
UMLS CUI-2
C0005834
UMLS CUI-3
C2607479
Timepoint
Beskrivning

Timepoint

Datatyp

integer

Alias
UMLS CUI [1]
C2348792
Sample Date
Beskrivning

Sample Date

Datatyp

date

Alias
UMLS CUI [1]
C1302413
Sample Time
Beskrivning

Sample Time

Datatyp

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0200345
Not Done/ Not Collected
Beskrivning

Not Done/ Not Collected

Datatyp

integer

Alias
UMLS CUI [1]
C1272696
UMLS CUI [2]
C0445106
Comment
Beskrivning

Comment

Datatyp

text

Alias
UMLS CUI [1]
C0947611
Electrocardiogram (Day 14)
Beskrivning

Electrocardiogram (Day 14)

Alias
UMLS CUI-1
C1623258
Date ECG Performed
Beskrivning

Date ECG Performed

Datatyp

date

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0011008
Time ECG Performed
Beskrivning

Time ECG Performed

Datatyp

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR Interval
Beskrivning

PR Interval

Datatyp

integer

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

QRS Duration

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0429025
ms
QT Interval
Beskrivning

QT Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTcB Interval
Beskrivning

QTcB Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C1882512
ms
QTcF Interval
Beskrivning

QTcF Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C1882513
ms
RR Interval
Beskrivning

RR Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1]
C0489636
ms
Normal Sinus Rhythm?
Beskrivning

Normal Sinus Rhythm?

Datatyp

boolean

Alias
UMLS CUI [1]
C0232202
Overall interpretation of ECG
Beskrivning

Overall interpretation of ECG

Datatyp

integer

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0459471
If abnormal, please specify:
Beskrivning

If abnormal, please specify:

Datatyp

text

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0205161
UMLS CUI [2]
C2348235
Tillbaka till toppen

Similar models

Day 7 - 35: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection (Albiglutide), Electrocardiogram

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Subject
Item
Subject
text
C2348585 (UMLS CUI [1])
Status
Item
Status
text
C0449438 (UMLS CUI [1])
Doc#
Item
Doc#
integer
C1301746 (UMLS CUI [1])
Is Page Blank?
Item
Is Page Blank?
boolean
C1704732 (UMLS CUI [1,1])
C0750479 (UMLS CUI [1,2])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Vital Signs (sitting) - Day 7 - 35
C0518766 (UMLS CUI-1)
C0277814 (UMLS CUI-2)
Vital Signs Date
Item
Vital Signs Date
date
C2826644 (UMLS CUI [1])
Vital Signs Time
Item
Vital Signs Time
time
C2826762 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic Blood Pressure
integer
C0871470 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic Blood Pressure
integer
C0428883 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Study Drug Administration (50 mg Albiglutide) - Day 7 - 35
C0013153 (UMLS CUI-1)
C2607479 (UMLS CUI-2)
Was the dose administered?
Item
Was the dose administered?
boolean
C3174092 (UMLS CUI [1])
C3469597 (UMLS CUI [2])
Dose Date
Item
Dose Date
date
C0178602 (UMLS CUI [1])
C0011008 (UMLS CUI [2])
Dose Time
Item
Dose Time
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item
Site of injection
integer
C2700396 (UMLS CUI [1])
Site of injection
Code List
Site of injection
CL Item
Right Abdomen (1)
CL Item
Left Abdomen (2)
Item Group
Pharmacokinetic Blood Collection (Albiglutide) - Day 35
C0031328 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
C2607479 (UMLS CUI-3)
Item
Timepoint
integer
C2348792 (UMLS CUI [1])
Timepoint
Code List
Timepoint
CL Item
Predose (1)
Sample Date
Item
Sample Date
date
C1302413 (UMLS CUI [1])
Sample Time
Item
Sample Time
time
C0040223 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
Item
Not Done/ Not Collected
integer
C1272696 (UMLS CUI [1])
C0445106 (UMLS CUI [2])
Not Done/ Not Collected
Code List
Not Done/ Not Collected
CL Item
Not Done/ Not Collected (1)
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Electrocardiogram (Day 14)
C1623258 (UMLS CUI-1)
Date ECG Performed
Item
Date ECG Performed
date
C0013798 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time ECG Performed
Item
Time ECG Performed
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
QT Interval
Item
QT Interval
integer
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
integer
C1882512 (UMLS CUI [1])
QTcF Interval
Item
QTcF Interval
integer
C1882513 (UMLS CUI [1])
RR Interval
Item
RR Interval
integer
C0489636 (UMLS CUI [1])
Normal Sinus Rhythm?
Item
Normal Sinus Rhythm?
boolean
C0232202 (UMLS CUI [1])
Item
Overall interpretation of ECG
integer
C1623258 (UMLS CUI [1,1])
C0459471 (UMLS CUI [1,2])
Overall interpretation of ECG
Code List
Overall interpretation of ECG
CL Item
Normal (1)
CL Item
Abnormal; Clinically Significant (2)
CL Item
Abnormal; Not Clinically Significant (3)
If abnormal, please specify:
Item
If abnormal, please specify:
text
C0243095 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial