ID

41633

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 (2)
  1. 2020-11-09 2020-11-09 -
  2. 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 -1 - Admission Criteria; Vital Signs; Electrocardiogram; Central Laboratory

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
Admission Criteria
Beskrivning

Admission Criteria

Alias
UMLS CUI-1
C0030673
UMLS CUI-2
C0243161
Protocol Date
Beskrivning

Protocol Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2985700
UMLS CUI [1,2]
C0011008
Does the subject continue to meet all eligibility criteria?
Beskrivning

Does the subject continue to meet all eligibility criteria?

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1516637
Vital Signs (sitting)
Beskrivning

Vital Signs (sitting)

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
Electrocardiogram
Beskrivning

Electrocardiogram

Alias
UMLS CUI-1
C0013798
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
  • bmp
Alias
UMLS CUI [1]
C0018810
bmp
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

Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
QTcF Interval
Beskrivning

QTcF Interval

Datatyp

integer

Måttenheter
  • ms
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C1882513
ms
RR Interval
Beskrivning

RR Interval

Datatyp

integer

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

Normal Sinus Rhythmus?

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 [1,3]
C2348235
Central Laboratory - Haematology
Beskrivning

Central Laboratory - Haematology

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C0018941
Was the laboratory sample collected? (Haematology)
Beskrivning

Was the laboratory sample collected? (Haematology)

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0018941
Sample Date (Haematology)
Beskrivning

Sample Date (Haematology)

Datatyp

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2]
C0018941
Sample Time (Haematology)
Beskrivning

Sample Time (Haematology)

Datatyp

time

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0040223
UMLS CUI [3]
C0018941
Comment (Haematology)
Beskrivning

Comment (Haematology)

Datatyp

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2]
C0018941
Central Laboratory - Chemistry
Beskrivning

Central Laboratory - Chemistry

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C0008000
Was the laboratory sample collected? (Chemistry)
Beskrivning

Was the laboratory sample collected? (Chemistry)

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0008000
Sample Date (Chemistry)
Beskrivning

Sample Date (Chemistry)

Datatyp

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2]
C0008000
Sample Time (Chemistry)
Beskrivning

Sample Time (Chemistry)

Datatyp

time

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0040223
UMLS CUI [3]
C0008000
Comment (Chemistry)
Beskrivning

Comment (Chemistry)

Datatyp

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2]
C0008000
Central Laboratory - UA/ UDS/ Urine HCG/ Urine Chem
Beskrivning

Central Laboratory - UA/ UDS/ Urine HCG/ Urine Chem

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C0430056
UMLS CUI-3
C0864414
Was the laboratory sample collected? (Urine)
Beskrivning

Was the laboratory sample collected? (Urine)

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0864414
Sample Date (Urine)
Beskrivning

Sample Date (Urine)

Datatyp

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2]
C0864414
Sample Time (Urine)
Beskrivning

Sample Time (Urine)

Datatyp

time

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0040223
UMLS CUI [3]
C0864414
Comment (Urine)
Beskrivning

Comment (Urine)

Datatyp

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2]
C0864414
Tillbaka till toppen

Similar models

Day -1 - Admission Criteria; Vital Signs; Electrocardiogram; Central Laboratory

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
Admission Criteria
C0030673 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
Protocol Date
Item
Protocol Date
date
C2985700 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Does the subject continue to meet all eligibility criteria?
Item
Does the subject continue to meet all eligibility criteria?
boolean
C2348568 (UMLS CUI [1,1])
C1516637 (UMLS CUI [1,2])
Item Group
Vital Signs (sitting)
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
Electrocardiogram
C0013798 (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 [1,1])
C0855331 (UMLS CUI [1,2])
QTcF Interval
Item
QTcF Interval
integer
C0855331 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
RR Interval
Item
RR Interval
integer
C0489636 (UMLS CUI [1])
Normal Sinus Rhythmus?
Item
Normal Sinus Rhythmus?
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; Not Clinically Significant  (2)
CL Item
Abnormal; 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 [1,3])
Item Group
Central Laboratory - Haematology
C1880016 (UMLS CUI-1)
C0018941 (UMLS CUI-2)
Was the laboratory sample collected? (Haematology)
Item
Was the laboratory sample collected? (Haematology)
boolean
C0005834 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Sample Date (Haematology)
Item
Sample Date (Haematology)
date
C1302413 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Sample Time (Haematology)
Item
Sample Time (Haematology)
time
C0005834 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0018941 (UMLS CUI [3])
Comment (Haematology)
Item
Comment (Haematology)
text
C0947611 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
Item Group
Central Laboratory - Chemistry
C1880016 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
Was the laboratory sample collected? (Chemistry)
Item
Was the laboratory sample collected? (Chemistry)
boolean
C0005834 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Sample Date (Chemistry)
Item
Sample Date (Chemistry)
date
C1302413 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Sample Time (Chemistry)
Item
Sample Time (Chemistry)
time
C0005834 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0008000 (UMLS CUI [3])
Comment (Chemistry)
Item
Comment (Chemistry)
text
C0947611 (UMLS CUI [1])
C0008000 (UMLS CUI [2])
Item Group
Central Laboratory - UA/ UDS/ Urine HCG/ Urine Chem
C1880016 (UMLS CUI-1)
C0430056 (UMLS CUI-2)
C0864414 (UMLS CUI-3)
Was the laboratory sample collected? (Urine)
Item
Was the laboratory sample collected? (Urine)
boolean
C0005834 (UMLS CUI [1])
C0864414 (UMLS CUI [2])
Sample Date (Urine)
Item
Sample Date (Urine)
date
C1302413 (UMLS CUI [1])
C0864414 (UMLS CUI [2])
Sample Time (Urine)
Item
Sample Time (Urine)
time
C0005834 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0864414 (UMLS CUI [3])
Comment (Urine)
Item
Comment (Urine)
text
C0947611 (UMLS CUI [1])
C0864414 (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