ID

41635

Beschreibung

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

Stichworte

Versionen (2)
  1. 05.11.20 05.11.20 -
  2. 29.11.20 29.11.20 -
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GlaxoSmithKline

Hochgeladen am

29. November 2020

DOI

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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692

Englisch

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

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Site
Beschreibung

Site

Datentyp

text

Alias
UMLS CUI [1]
C2825164
Subject
Beschreibung

Subject

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Status
Beschreibung

Status

Datentyp

text

Alias
UMLS CUI [1]
C0449438
Doc #
Beschreibung

Doc #

Datentyp

text

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

Is Page Blank?

Datentyp

boolean

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

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Informed Consent
Beschreibung

Informed Consent

Alias
UMLS CUI-1
C0021430
Date of Informed Consent
Beschreibung

Date of Informed Consent

Datentyp

date

Alias
UMLS CUI [1]
C2985782
Admission Criteria
Beschreibung

Admission Criteria

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

Protocol Date

Datentyp

date

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

If No, please complete below

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Admission Criteria
Beschreibung

Admission Criteria

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

Check one criteria type

Datentyp

text

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

Criteria Number

Datentyp

integer

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

Waiver Granted?

Datentyp

boolean

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

Date of Sponsor Approval

Datentyp

date

Alias
UMLS CUI [1]
C2346844
Comment
Beschreibung

Comment

Datentyp

text

Alias
UMLS CUI [1]
C0947611
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Check all that apply.

Datentyp

integer

Alias
UMLS CUI [1]
C0034510
Specify Other Race
Beschreibung

Specify Other Race

Datentyp

text

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

Mark one.

Datentyp

integer

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

Is the subject of childbearing potential?

Datentyp

text

Alias
UMLS CUI [1]
C3831118
Electrocardiogram
Beschreibung

Electrocardiogram

Alias
UMLS CUI-1
C0013798
Date ECG Performed
Beschreibung

Date ECG Performed

Datentyp

date

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

Time ECG Performed

Datentyp

time

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

Heart Rate

Datentyp

integer

Maßeinheiten
  • bpm
Alias
UMLS CUI [1]
C0018810
bpm
PR Interval
Beschreibung

PR Interval

Datentyp

float

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschreibung

QRS Duration

Datentyp

float

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429025
ms
QT Interval
Beschreibung

QT Interval

Datentyp

float

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTcB Interval
Beschreibung

QTcB Interval

Datentyp

float

Maßeinheiten
  • ms
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0855331
ms
QTcF Interval
Beschreibung

QTcF Interval

Datentyp

float

Maßeinheiten
  • ms
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C1882513
ms
RR Interval
Beschreibung

RR Interval

Datentyp

float

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0489636
ms
Normal Sinus Rhythmus?
Beschreibung

Normal Sinus Rhythmus?

Datentyp

boolean

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

Overall interpretation of ECG:

Datentyp

integer

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

If abnormal, please specify

Datentyp

text

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

Central Laboratory - Haematology

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

Was the laboratory sample collected? (Haematology)

Datentyp

boolean

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

Sample Date (Haematology)

Datentyp

date

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

Sample Time (Haematology)

Datentyp

time

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

Comment (Haematology)

Datentyp

text

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

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)
Beschreibung

Was the laboratory sample collected? (Chemistry)

Datentyp

boolean

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

Sample Date (Chemistry)

Datentyp

date

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

Sample Time (Chemistry)

Datentyp

time

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

Comment (Chemistry)

Datentyp

text

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

Central Laboratory - UA/ UDS/ Urine Chem

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

Was the laboratory sample collected? (Urine)

Datentyp

boolean

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

Sample Date (Urine)

Datentyp

date

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

Sample Time (Urine)

Datentyp

time

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

Comment (Urine)

Datentyp

text

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

Central Laboratory - Serology

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

Was the laboratory sample collected? (Serology)

Datentyp

boolean

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

Sample Date (Serology)

Datentyp

date

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

Sample Time (Serology)

Datentyp

time

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

Comment (Serology)

Datentyp

text

Alias
UMLS CUI [1]
C0947611
UMLS CUI [2]
C0036743
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Ähnliche Modelle

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

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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