ID
41584
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 (3)
- 12-11-20 12-11-20 -
- 15-11-20 15-11-20 -
- 29-11-20 29-11-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
15 november 2020
DOI
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Licentie
Creative Commons BY 4.0
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Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692
Day 37 - 42, Follow-Up: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection, Central Laboratory
Beschrijving
Vital Signs (sitting) - Day 37 - 42, Follow up
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0277814
- UMLS CUI-3
- C1522577
Beschrijving
Vital Signs Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826644
Beschrijving
Vital Signs Time
Datatype
time
Alias
- UMLS CUI [1]
- C2826762
Beschrijving
Systolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
Beschrijving
Diastolic Blood Pressure
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Electrocardiogram (Day 37)
Alias
- UMLS CUI-1
- C1623258
Beschrijving
Date ECG Performed
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0011008
Beschrijving
Time ECG Performed
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTcB Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1882512
Beschrijving
QTcF Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1882513
Beschrijving
RR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489636
Beschrijving
Normal Sinus Rhythm?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0232202
Beschrijving
Overall interpretation of ECG
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Beschrijving
If abnormal, please specify:
Datatype
text
Alias
- UMLS CUI [1,1]
- C0243095
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [2]
- C2348235
Beschrijving
Central Laboratory - Haematology (Day 37)
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0018941
Beschrijving
Was the laboratory sample collected? (Haematology)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0018941
Beschrijving
Sample Date (Haematology)
Datatype
date
Alias
- UMLS CUI [1,1]
- C1302413
- UMLS CUI [1,2]
- C0018941
Beschrijving
Sample Time (Haematology)
Datatype
time
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0018941
- UMLS CUI [3]
- C0040223
Beschrijving
Comment (Haematology)
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2]
- C0018941
Beschrijving
Central Laboratory - Chemistry (Day 37)
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0008000
Beschrijving
Was the laboratory sample collected? (Chemistry)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0008000
Beschrijving
Sample Date (Chemistry)
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2]
- C0008000
Beschrijving
Sample Time (Chemistry)
Datatype
time
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0008000
- UMLS CUI [3]
- C0040223
Beschrijving
Comment (Chemistry)
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2]
- C0008000
Beschrijving
Central Laboratory - UA/UDS/Urine HCG/ Urine Chem (Day 37)
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0864414
- UMLS CUI-3
- C0430056
Beschrijving
Was the laboratory sample collected? (Urine)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0042036
Beschrijving
Sample Date (Urine)
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
- UMLS CUI [2]
- C0042036
Beschrijving
Sample Time (Urine)
Datatype
time
Alias
- UMLS CUI [1]
- C0005834
- UMLS CUI [2]
- C0042036
- UMLS CUI [3]
- C0040223
Beschrijving
Comment (Urine)
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2]
- C0042036
Beschrijving
Study Drug Administration (80 mg Simvastatin) - Day 38
Alias
- UMLS CUI-1
- C0013153
- UMLS CUI-2
- C0074554
Beschrijving
Was the dose administered?
Datatype
boolean
Alias
- UMLS CUI [1]
- C3174092
- UMLS CUI [2]
- C3469597
Beschrijving
Dose Date
Datatype
date
Alias
- UMLS CUI [1]
- C0178602
- UMLS CUI [2]
- C0011008
Beschrijving
Dose Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0040223
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Site of injection
Datatype
integer
Alias
- UMLS CUI [1]
- C2700396
Beschrijving
Pharmacokinetic Blood Collection (Simvastatin) - Day 38
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C0074554
Beschrijving
Timepoint
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschrijving
Not Done/ Not Collected
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Pharmacokinetic Blood Collection (Albiglutide) - Day 38
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C2607479
Beschrijving
Timepoint
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschrijving
Not Done/ Not Collected
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Pharmacokinetic Blood Collection (Simvastatin) - Day 39
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C0074554
Beschrijving
Timepoint
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschrijving
Not Done/ Not Collected
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Pharmacokinetic Blood Collection (Simvastatin) - Day 40
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C0074554
Beschrijving
Timepoint
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschrijving
Not Done/ Not Collected
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Pharmacokinetic Blood Collection (Simvastatin) - Day 41
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C0074554
Beschrijving
Timepoint
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschrijving
Not Done/ Not Collected
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Pharmacokinetic Blood Collection (Simvastatin) - Day 42
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005834
- UMLS CUI-3
- C0074554
Beschrijving
Timepoint
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
Beschrijving
Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Beschrijving
Sample Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0200345
Beschrijving
Not Done/ Not Collected
Datatype
integer
Alias
- UMLS CUI [1]
- C1272696
- UMLS CUI [2]
- C0445106
Beschrijving
Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Similar models
Day 37 - 42, Follow-Up: Vital Signs; Study Drug Administration; Pharmacokinetic Blood Collection, Central Laboratory
C0750479 (UMLS CUI [1,2])
C0277814 (UMLS CUI-2)
C1522577 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,2])
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C0008000 (UMLS CUI [2])
C0008000 (UMLS CUI [2])
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C0430056 (UMLS CUI-3)
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C0040223 (UMLS CUI [3])
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C0074554 (UMLS CUI-2)
C3469597 (UMLS CUI [2])
C0011008 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0445106 (UMLS CUI [2])
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C0074554 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
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C0074554 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0445106 (UMLS CUI [2])
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0445106 (UMLS CUI [2])
C0005834 (UMLS CUI-2)
C0074554 (UMLS CUI-3)
C0200345 (UMLS CUI [1,2])
C0445106 (UMLS CUI [2])