ID

41633

Description

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

Keywords

Versions (2)
  1. 11/9/20 11/9/20 -
  2. 11/29/20 11/29/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

November 29, 2020

DOI

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License

Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

English

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

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Subject
Description

Subject

Data type

text

Alias
UMLS CUI [1]
C2348585
Status
Description

Status

Data type

text

Alias
UMLS CUI [1]
C0449438
Doc#
Description

Doc#

Data type

integer

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

Is Page Blank?

Data type

boolean

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

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Admission Criteria
Description

Admission Criteria

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

Protocol Date

Data type

date

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

Does the subject continue to meet all eligibility criteria?

Data type

boolean

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

Vital Signs (sitting)

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

Vital Signs Date

Data type

date

Alias
UMLS CUI [1]
C2826644
Vital Signs Time
Description

Vital Signs Time

Data type

time

Alias
UMLS CUI [1]
C2826762
Systolic Blood Pressure
Description

Systolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Description

Diastolic Blood Pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Temperature
Description

Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Heart Rate
Description

Heart Rate

Data type

integer

Measurement units
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
Comment
Description

Comment

Data type

text

Alias
UMLS CUI [1]
C0947611
Electrocardiogram
Description

Electrocardiogram

Alias
UMLS CUI-1
C0013798
Date ECG Performed
Description

Date ECG Performed

Data type

date

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

Time ECG Performed

Data type

time

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

Heart Rate

Data type

integer

Measurement units
  • bmp
Alias
UMLS CUI [1]
C0018810
bmp
PR Interval
Description

PR Interval

Data type

integer

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

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
QT Interval
Description

QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTcB Interval
Description

QTcB Interval

Data type

integer

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

QTcF Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C1882513
ms
RR Interval
Description

RR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489636
ms
Normal Sinus Rhythmus?
Description

Normal Sinus Rhythmus?

Data type

boolean

Alias
UMLS CUI [1]
C0232202
Overall interpretation of ECG:
Description

Overall interpretation of ECG:

Data type

integer

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

If abnormal, please specify

Data type

text

Alias
UMLS CUI [1,1]
C0243095
UMLS CUI [1,2]
C0205161
UMLS CUI [1,3]
C2348235
Central Laboratory - Haematology
Description

Central Laboratory - Haematology

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

Was the laboratory sample collected? (Haematology)

Data type

boolean

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

Sample Date (Haematology)

Data type

date

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

Sample Time (Haematology)

Data type

time

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

Comment (Haematology)

Data type

text

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

Central Laboratory - Chemistry

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

Was the laboratory sample collected? (Chemistry)

Data type

boolean

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

Sample Date (Chemistry)

Data type

date

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

Sample Time (Chemistry)

Data type

time

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

Comment (Chemistry)

Data type

text

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

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)
Description

Was the laboratory sample collected? (Urine)

Data type

boolean

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

Sample Date (Urine)

Data type

date

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

Sample Time (Urine)

Data type

time

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

Comment (Urine)

Data type

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2]
C0864414
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Similar models

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

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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])
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