ID
41629
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)
- 16-11-20 16-11-20 -
- 29-11-20 29-11-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
29 november 2020
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Pharmacokinetics of Simvastatin When Coadministered With Albiglutide NCT01147692
Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction
Beschrijving
Study Completion
Alias
- UMLS CUI-1
- C0008976
- UMLS CUI-2
- C0444930
Beschrijving
Date of final contact
Datatype
date
Alias
- UMLS CUI [1]
- C0805839
Beschrijving
Date of last dose
Datatype
date
Alias
- UMLS CUI [1]
- C1762893
Beschrijving
Did subject complete the study?
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348577
Beschrijving
Date of discontinuation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0011008
Beschrijving
If subject did not complete the study, mark ONE reason
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3827242
- UMLS CUI [1,2]
- C0566251
Beschrijving
Specify AE No (Liver chemistry stopping criteria)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C0023884
- UMLS CUI [2,2]
- C0008000
- UMLS CUI [3,1]
- C2746065
- UMLS CUI [3,2]
- C0243161
Beschrijving
Specify AE No (Adverse event)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0237753
Beschrijving
Specify AE No (Severe or repeated occurences of hypoglycaemia)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C0342316
Beschrijving
Specify AE No (Occurence of Pancreatitis)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2]
- C0030305
Beschrijving
Comments
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
Beschrijving
Vital Signs (Unscheduled)
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C3854240
Beschrijving
Vital Signs - Repeat or Unscheduled?
Datatype
integer
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0205341
- UMLS CUI [3]
- C3854240
Beschrijving
Vital Signs - If Repeat, please specify original period/day
Datatype
text
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0205341
- UMLS CUI [3]
- C2347804
- UMLS CUI [4]
- C0439228
Beschrijving
Vital Signs - Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826644
Beschrijving
Vital Signs - Time
Datatype
time
Alias
- UMLS CUI [1]
- C2826762
Beschrijving
Heart Rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0018810
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
Respirations
Datatype
integer
Maateenheden
- breaths/min
Alias
- UMLS CUI [1]
- C0035203
Beschrijving
Temperature
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0005903
Beschrijving
Vital Signs - Body Position
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C1262869
Beschrijving
Vital Signs - Comment
Datatype
text
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0947611
Beschrijving
Physical Examination (Unscheduled Visit)
Alias
- UMLS CUI-1
- C0031809
- UMLS CUI-2
- C3854240
Beschrijving
Date of Physical Exam
Datatype
date
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
Assessment
Datatype
integer
Alias
- UMLS CUI [1]
- C2911685
Beschrijving
Electrocardiogram (Unscheduled)
Alias
- UMLS CUI-1
- C0013798
- UMLS CUI-2
- C3854240
Beschrijving
Electrocardiogram - Repeat or Unscheduled?
Datatype
integer
Alias
- UMLS CUI [1]
- C0013798
- UMLS CUI [2]
- C0205341
- UMLS CUI [3]
- C3854240
Beschrijving
Electrocardiogram - If Repeat, please specify original Period/Day
Datatype
text
Alias
- UMLS CUI [1]
- C0013798
- UMLS CUI [2]
- C0205341
- UMLS CUI [3]
- C2347804
- UMLS CUI [4]
- C0439228
Beschrijving
Electrocardiogram - Date
Datatype
date
Alias
- UMLS CUI [1]
- C2826640
Beschrijving
Electrocardiogram - Time
Datatype
time
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0040223
Beschrijving
Electrocardiogram - Heart Rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0013798
- UMLS CUI [2]
- C0018810
Beschrijving
Electrocardiogram - PR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
Electrocardiogram - QRS Duration
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0013798
- UMLS CUI [2]
- C0429025
Beschrijving
Electrocardiogram - QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C1287082
Beschrijving
Electrocardiogram - Q-TcB Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0429087
- UMLS CUI [1,2]
- C1882512
Beschrijving
Electrocardiogram - Q-TcF Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0429087
- UMLS CUI [1,2]
- C1882513
Beschrijving
Electrocardiogram - RR Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C0489636
Beschrijving
Electrocardiogram - Normal Sinus Rhythm?
Datatype
boolean
Alias
- UMLS CUI [1]
- C1960147
Beschrijving
Overall Interpretation of ECG
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0459471
Beschrijving
Electrocardiogram - If abnormal, please specify
Datatype
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C2348235
Beschrijving
Central Laboratory Blood (Unscheduled)
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C3854240
- UMLS CUI-3
- C0005767
Beschrijving
Central Laboratory Blood
Datatype
integer
Alias
- UMLS CUI [1]
- C1880016
- UMLS CUI [2]
- C0005767
Beschrijving
Central Laboratory Blood - Repeat or Unscheduled?
Datatype
integer
Alias
- UMLS CUI [1]
- C0205341
- UMLS CUI [2]
- C0005767
- UMLS CUI [3]
- C3854240
Beschrijving
Central Laboratory Blood - If Repeat, please specify original period/day:
Datatype
text
Alias
- UMLS CUI [1]
- C1880016
- UMLS CUI [2]
- C0005767
- UMLS CUI [3]
- C0205341
- UMLS CUI [4]
- C2347804
- UMLS CUI [5]
- C0439228
- UMLS CUI [6]
- C2348235
Beschrijving
Central Laboratory Blood - Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1880016
- UMLS CUI [2]
- C0005767
- UMLS CUI [3]
- C1302413
Beschrijving
Central Laboratory Blood - Sample Time
Datatype
time
Alias
- UMLS CUI [1]
- C1880016
- UMLS CUI [2]
- C0005767
- UMLS CUI [3,1]
- C0040223
- UMLS CUI [3,2]
- C0200345
Beschrijving
Central Laboratory Blood - Comment
Datatype
text
Alias
- UMLS CUI [1]
- C1880016
- UMLS CUI [2]
- C0005767
- UMLS CUI [3]
- C0947611
Beschrijving
Central Laboratory Urine (Unscheduled)
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C3854240
- UMLS CUI-3
- C0042036
Beschrijving
Central Laboratory Urine
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1880016
- UMLS CUI [1,2]
- C0042036
Beschrijving
Central Laboratory Urine - Repeat or Unscheduled?
Datatype
text
Alias
- UMLS CUI [1]
- C0205341
- UMLS CUI [2]
- C0042036
- UMLS CUI [3]
- C3854240
Beschrijving
Central Laboratory Urine - If Repeat, please specify original period/day:
Datatype
text
Alias
- UMLS CUI [1]
- C1880016
- UMLS CUI [2]
- C0042036
- UMLS CUI [3]
- C0205341
- UMLS CUI [4]
- C2347804
- UMLS CUI [5]
- C0439228
- UMLS CUI [6]
- C2348235
Beschrijving
Central Laboratory Urine - Sample Date
Datatype
date
Alias
- UMLS CUI [1]
- C1880016
- UMLS CUI [2]
- C0042036
- UMLS CUI [3]
- C1302413
Beschrijving
Central Laboratory Urine - Sample Time
Datatype
time
Alias
- UMLS CUI [1]
- C1880016
- UMLS CUI [2]
- C0042036
- UMLS CUI [3,1]
- C0040223
- UMLS CUI [3,2]
- C0200345
Beschrijving
Central Laboratory Urine - Comment
Datatype
text
Alias
- UMLS CUI [1]
- C1880016
- UMLS CUI [2]
- C0042036
- UMLS CUI [3]
- C0947611
Beschrijving
Hypoglycaemia
Alias
- UMLS CUI-1
- C0020615
Beschrijving
Has the subject experienced any protocol defined hypoglycaemic events?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0745153
- UMLS CUI [2]
- C2348563
Beschrijving
AE/SAE Reference Event Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0237753
Beschrijving
Start date of Event
Datatype
date
Alias
- UMLS CUI [1]
- C2697888
Beschrijving
Start time of Event
Datatype
time
Alias
- UMLS CUI [1]
- C2697889
Beschrijving
End date of Event
Datatype
date
Alias
- UMLS CUI [1]
- C2697886
Beschrijving
End time of Event
Datatype
time
Alias
- UMLS CUI [1]
- C2826658
Beschrijving
Blood Glucose Test Result at Time of Event (mg/dL)
Datatype
integer
Maateenheden
- mg/dL
Alias
- UMLS CUI [1]
- C0457578
- UMLS CUI [2]
- C0040223
- UMLS CUI [3]
- C2697889
Beschrijving
Blood Glucose Test Result at Time of Event (mmol/L)
Datatype
integer
Maateenheden
- mmol/L
Alias
- UMLS CUI [1]
- C0457578
- UMLS CUI [2]
- C0040223
- UMLS CUI [3]
- C2697889
Beschrijving
Frequency
Datatype
integer
Alias
- UMLS CUI [1]
- C0439603
Beschrijving
Severity of hypoglycaemic event: (per ADA working group guidelines)
Datatype
integer
Alias
- UMLS CUI [1]
- C1710066
- UMLS CUI [2]
- C0745153
Beschrijving
If Severe (at least one must be checked to fit the ADA criterion of severe), check all that apply:
Datatype
integer
Alias
- UMLS CUI [1]
- C0205082
Beschrijving
Please follow serious adverse event instructions.
Datatype
integer
Alias
- UMLS CUI [1]
- C0019993
- UMLS CUI [2]
- C0439228
Beschrijving
Intervention (enter the most severe, enter details on concomitant medication page if applicable)
Datatype
integer
Alias
- UMLS CUI [1]
- C0184661
Beschrijving
Action Taken with Background or Anti-Hyperglycemic Medication?
Datatype
integer
Alias
- UMLS CUI [1]
- C2826626
Beschrijving
Injection Site Reaction
Alias
- UMLS CUI-1
- C0151735
Beschrijving
AE/SAE Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0237753
Beschrijving
Date of injection
Datatype
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0021485
Beschrijving
Date of Reaction
Datatype
date
Alias
- UMLS CUI [1,1]
- C0443286
- UMLS CUI [1,2]
- C0011008
Beschrijving
(maximum)
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0221743
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2]
- C1301886
Beschrijving
(maximum)
Datatype
integer
Maateenheden
- mm
Alias
- UMLS CUI [1,1]
- C0221743
- UMLS CUI [1,2]
- C0456389
- UMLS CUI [2]
- C1301886
Beschrijving
Location of injection
Datatype
integer
Alias
- UMLS CUI [1]
- C2700396
Beschrijving
Specify other location of injection
Datatype
text
Alias
- UMLS CUI [1]
- C2700396
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
Was this local reaction within 24 hrs of dose?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0853813
- UMLS CUI [2]
- C0178602
Beschrijving
Check all that apply regarding local reaction symptoms:
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0853813
Beschrijving
Specify other symptoms
Datatype
text
Alias
- UMLS CUI [1]
- C1457887
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C2348235
Beschrijving
If Yes, please record all treatments on the Concomitant Medications/Non-drug Therapies eCRF
Datatype
boolean
Alias
- UMLS CUI [1]
- C0853813
- UMLS CUI [2]
- C0087111
Beschrijving
Subjects with a severe injection site reaction or a severe systemic allergic reaction must have three 1-mL serum samples obtained for immunogenicity testing.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0229671
- UMLS CUI [2]
- C0200345
Beschrijving
Provide date sample obtained
Datatype
date
Alias
- UMLS CUI [1]
- C1302413
Similar models
Study Completion; Unscheduled Visit; Hypoglycaemia; Injection Site Reaction
C0750479 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0566251 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0023884 (UMLS CUI [2,1])
C0008000 (UMLS CUI [2,2])
C2746065 (UMLS CUI [3,1])
C0243161 (UMLS CUI [3,2])
C0237753 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0342316 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C0030305 (UMLS CUI [2])
C3854240 (UMLS CUI-2)
C0205341 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
C0205341 (UMLS CUI [2])
C2347804 (UMLS CUI [3])
C0439228 (UMLS CUI [4])
C1262869 (UMLS CUI [1,2])
C0947611 (UMLS CUI [2])
C3854240 (UMLS CUI-2)
C3854240 (UMLS CUI-2)
C0205341 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
C0205341 (UMLS CUI [2])
C2347804 (UMLS CUI [3])
C0439228 (UMLS CUI [4])
C0040223 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2])
C0429025 (UMLS CUI [2])
C1287082 (UMLS CUI [1,2])
C1882512 (UMLS CUI [1,2])
C1882513 (UMLS CUI [1,2])
C0489636 (UMLS CUI [1,2])
C0459471 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C3854240 (UMLS CUI-2)
C0005767 (UMLS CUI-3)
C0005767 (UMLS CUI [2])
C0005767 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
C0005767 (UMLS CUI [2])
C0205341 (UMLS CUI [3])
C2347804 (UMLS CUI [4])
C0439228 (UMLS CUI [5])
C2348235 (UMLS CUI [6])
C0005767 (UMLS CUI [2])
C1302413 (UMLS CUI [3])
C0005767 (UMLS CUI [2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
C0005767 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
C3854240 (UMLS CUI-2)
C0042036 (UMLS CUI-3)
C0042036 (UMLS CUI [1,2])
C0042036 (UMLS CUI [2])
C3854240 (UMLS CUI [3])
C0042036 (UMLS CUI [2])
C0205341 (UMLS CUI [3])
C2347804 (UMLS CUI [4])
C0439228 (UMLS CUI [5])
C2348235 (UMLS CUI [6])
C0042036 (UMLS CUI [2])
C1302413 (UMLS CUI [3])
C0042036 (UMLS CUI [2])
C0040223 (UMLS CUI [3,1])
C0200345 (UMLS CUI [3,2])
C0042036 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
C2348563 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2])
C2697889 (UMLS CUI [3])
C0040223 (UMLS CUI [2])
C2697889 (UMLS CUI [3])
C0745153 (UMLS CUI [2])
C0439228 (UMLS CUI [2])
C0237753 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
C0021485 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2])
C0456389 (UMLS CUI [1,2])
C1301886 (UMLS CUI [2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0178602 (UMLS CUI [2])
C0853813 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
C0087111 (UMLS CUI [2])
C0200345 (UMLS CUI [2])
Geen commentaren