ID

41635

Beschrijving

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

Trefwoorden

Versies (2)
  1. 05-11-20 05-11-20 -
  2. 29-11-20 29-11-20 -
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GlaxoSmithKline

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29 november 2020

DOI

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

Engels

Screening - Informed Consent; Admission Criteria; Demographics; Electocardiogram; Central Laboratory

1 Formulieren  
Administrative
Beschrijving

Administrative

Alias
UMLS CUI-1
C1320722
Site
Beschrijving

Site

Datatype

text

Alias
UMLS CUI [1]
C2825164
Subject
Beschrijving

Subject

Datatype

text

Alias
UMLS CUI [1]
C2348585
Status
Beschrijving

Status

Datatype

text

Alias
UMLS CUI [1]
C0449438
Doc #
Beschrijving

Doc #

Datatype

text

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

Is Page Blank?

Datatype

boolean

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

Visit Date

Datatype

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Beschrijving

Informed Consent

Alias
UMLS CUI-1
C0021430
Date of Informed Consent
Beschrijving

Date of Informed Consent

Datatype

date

Alias
UMLS CUI [1]
C2985782
Admission Criteria
Beschrijving

Admission Criteria

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

Protocol Date

Datatype

date

Alias
UMLS CUI [1,1]
C2985700
UMLS CUI [1,2]
C0011008
Did the subject meet all eligibility criteria?
Beschrijving

If No, please complete below

Datatype

boolean

Alias
UMLS CUI [1]
C1516637
Admission Criteria
Beschrijving

Admission Criteria

Alias
UMLS CUI-1
C0030673
UMLS CUI-2
C0243161
Check one criteria type
Beschrijving

Check one criteria type

Datatype

text

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0332307
Criteria Number
Beschrijving

Criteria Number

Datatype

integer

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C0237753
Waiver Granted?
Beschrijving

Waiver Granted?

Datatype

boolean

Alias
UMLS CUI [1]
C3827528
Date of Sponsor Approval
Beschrijving

Date of Sponsor Approval

Datatype

date

Alias
UMLS CUI [1]
C2346844
Comment
Beschrijving

Comment

Datatype

text

Alias
UMLS CUI [1]
C0947611
Demographics
Beschrijving

Demographics

Alias
UMLS CUI-1
C1704791
Date of Birth
Beschrijving

Date of Birth

Datatype

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschrijving

Sex

Datatype

text

Alias
UMLS CUI [1]
C0079399
Race
Beschrijving

Check all that apply.

Datatype

integer

Alias
UMLS CUI [1]
C0034510
Specify Other Race
Beschrijving

Specify Other Race

Datatype

text

Alias
UMLS CUI [1]
C0034510
UMLS CUI [2,1]
C0205394
UMLS CUI [2,2]
C3845569
Ethnicity
Beschrijving

Mark one.

Datatype

integer

Alias
UMLS CUI [1]
C0015031
Is the subject of childbearing potential?
Beschrijving

Is the subject of childbearing potential?

Datatype

text

Alias
UMLS CUI [1]
C3831118
Electrocardiogram
Beschrijving

Electrocardiogram

Alias
UMLS CUI-1
C0013798
Date ECG Performed
Beschrijving

Date ECG Performed

Datatype

date

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

Time ECG Performed

Datatype

time

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

Heart Rate

Datatype

integer

Maateenheden
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR Interval
Beschrijving

PR Interval

Datatype

float

Maateenheden
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschrijving

QRS Duration

Datatype

float

Maateenheden
  • ms
Alias
UMLS CUI [1]
C0429025
ms
QT Interval
Beschrijving

QT Interval

Datatype

float

Maateenheden
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTcB Interval
Beschrijving

QTcB Interval

Datatype

float

Maateenheden
  • ms
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
ms
QTcF Interval
Beschrijving

QTcF Interval

Datatype

float

Maateenheden
  • ms
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C1882513
ms
RR Interval
Beschrijving

RR Interval

Datatype

float

Maateenheden
  • ms
Alias
UMLS CUI [1]
C0489636
ms
Normal Sinus Rhythmus?
Beschrijving

Normal Sinus Rhythmus?

Datatype

boolean

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

Overall interpretation of ECG:

Datatype

integer

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

If abnormal, please specify

Datatype

text

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

Central Laboratory - Haematology

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

Was the laboratory sample collected? (Haematology)

Datatype

boolean

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

Sample Date (Haematology)

Datatype

date

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

Sample Time (Haematology)

Datatype

time

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

Comment (Haematology)

Datatype

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2]
C0018941
Central Laboratory - Chemistry/ Serum HCG/ SP Chem
Beschrijving

Central Laboratory - Chemistry/ Serum HCG/ SP Chem

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C0008000
UMLS CUI-3
C0430060
Was the laboratory sample collected? (Chemistry)
Beschrijving

Was the laboratory sample collected? (Chemistry)

Datatype

boolean

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

Sample Date (Chemistry)

Datatype

date

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

Sample Time (Chemistry)

Datatype

time

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

Comment (Chemistry)

Datatype

text

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

Central Laboratory - UA/ UDS/ Urine Chem

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

Was the laboratory sample collected? (Urine)

Datatype

boolean

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

Sample Date (Urine)

Datatype

date

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

Sample Time (Urine)

Datatype

time

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

Comment (Urine)

Datatype

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2]
C0864414
Central Laboratory - Serology
Beschrijving

Central Laboratory - Serology

Alias
UMLS CUI-1
C1880016
UMLS CUI-2
C0036743
Was the laboratory sample collected? (Serology)
Beschrijving

Was the laboratory sample collected? (Serology)

Datatype

boolean

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0036743
Sample Date (Serology)
Beschrijving

Sample Date (Serology)

Datatype

date

Alias
UMLS CUI [1]
C1302413
UMLS CUI [2]
C0036743
Sample Time (Serology)
Beschrijving

Sample Time (Serology)

Datatype

time

Alias
UMLS CUI [1]
C0005834
UMLS CUI [2]
C0040223
UMLS CUI [3]
C0036743
Comment (Serology)
Beschrijving

Comment (Serology)

Datatype

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2]
C0036743
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Similar models

Screening - Informed Consent; Admission Criteria; Demographics; Electocardiogram; Central Laboratory

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 #
text
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
Informed Consent
C0021430 (UMLS CUI-1)
Date of Informed Consent
Item
Date of Informed Consent
date
C2985782 (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])
Did the subject meet all eligibility criteria?
Item
Did the subject meet all eligibility criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Admission Criteria
C0030673 (UMLS CUI-1)
C0243161 (UMLS CUI-2)
Item
Check one criteria type
text
C0243161 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Check one criteria type
Code List
Check one criteria type
CL Item
Inclusion (I)
CL Item
Exclusion (E)
Criteria Number
Item
Criteria Number
integer
C0243161 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Waiver Granted?
Item
Waiver Granted?
boolean
C3827528 (UMLS CUI [1])
Date of Sponsor Approval
Item
Date of Sponsor Approval
date
C2346844 (UMLS CUI [1])
Comment
Item
Comment
text
C0947611 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female (F)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
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)
CL Item
Other, Specify (10)
Specify Other Race
Item
Specify Other Race
text
C0034510 (UMLS CUI [1])
C0205394 (UMLS CUI [2,1])
C3845569 (UMLS CUI [2,2])
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Is the subject of childbearing potential?
text
C3831118 (UMLS CUI [1])
Is the subject of childbearing potential?
Code List
Is the subject of childbearing potential?
CL Item
Yes (Y)
CL Item
No (N)
CL Item
Not Applicable (NA)
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
float
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT Interval
Item
QT Interval
float
C1287082 (UMLS CUI [1])
QTcB Interval
Item
QTcB Interval
float
C1882512 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
QTcF Interval
Item
QTcF Interval
float
C0855331 (UMLS CUI [1,1])
C1882513 (UMLS CUI [1,2])
RR Interval
Item
RR Interval
float
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/ Serum HCG/ SP Chem
C1880016 (UMLS CUI-1)
C0008000 (UMLS CUI-2)
C0430060 (UMLS CUI-3)
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 Chem
C1880016 (UMLS CUI-1)
C0864414 (UMLS CUI-2)
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])
Item Group
Central Laboratory - Serology
C1880016 (UMLS CUI-1)
C0036743 (UMLS CUI-2)
Was the laboratory sample collected? (Serology)
Item
Was the laboratory sample collected? (Serology)
boolean
C0005834 (UMLS CUI [1])
C0036743 (UMLS CUI [2])
Sample Date (Serology)
Item
Sample Date (Serology)
date
C1302413 (UMLS CUI [1])
C0036743 (UMLS CUI [2])
Sample Time (Serology)
Item
Sample Time (Serology)
time
C0005834 (UMLS CUI [1])
C0040223 (UMLS CUI [2])
C0036743 (UMLS CUI [3])
Comment (Serology)
Item
Comment (Serology)
text
C0947611 (UMLS CUI [1])
C0036743 (UMLS CUI [2])
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