ID
42297
Beskrivning
Study ID: 105533 Clinical Study ID: 105533 Study Title: A randomized, open-label, single-dose, four period cross-over study to evaluate the relative bioavailability of four formulations of GSK lisinopril compared to Zestril, and to compare over-incapsulated Zestril to Zestril Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Carvedilol Trade Name: Zestril Study Indication: Hypertension
Nyckelord
Versioner (1)
- 2021-05-10 2021-05-10 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
10 maj 2021
DOI
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Licens
Creative Commons BY 4.0
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Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533)
Logs and Repeats: Adverse Events; Concomitant Medications; ECG; Vital Signs; Pharmacokinetics
Beskrivning
Date of visit/assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Beskrivning
Adverse Event/ Concomitant Medication/Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-3
- C2347852
- UMLS CUI-5
- C0205341
- UMLS CUI-6
- C0220825
Beskrivning
Were any concomitant medications taken by the subject during the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beskrivning
Did the subject experience any adverse events during the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Were any repeat ECGs performed?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beskrivning
Did the subject have any abnormal ECGs during the study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0522055
Beskrivning
Were any repeat vital signs recorded?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beskrivning
Were any repeat Orthostatic Vital Signs recorded?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1827287
- UMLS CUI [1,2]
- C0205341
Beskrivning
Were any repeat PK taken?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0031327
- UMLS CUI [1,2]
- C0205341
Beskrivning
Adverse Events
Alias
- UMLS CUI-1
- C0877248
Beskrivning
Adverse Events Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C2348184
Beskrivning
Diagnosis (if known), otherwise sign/symptom.
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
Beskrivning
Adverse Event Modified Term
Datatyp
text
Alias
- UMLS CUI [1]
- C2826798
Beskrivning
Adverse Event MedDRA synonym
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C1140263
Beskrivning
Adverse Event MedDRA lower level term code
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C3898442
Beskrivning
Adverse Event Failed coding
Datatyp
text
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2,1]
- C0805701
- UMLS CUI [2,2]
- C0231175
Beskrivning
Adverse Event Start Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826806
Beskrivning
Adverse Event Outcome
Datatyp
integer
Alias
- UMLS CUI [1]
- C1705586
Beskrivning
Adverse Event End Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826793
Beskrivning
Adverse Event Frequency
Datatyp
integer
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C0439603
Beskrivning
Adverse Event Maximum Intensity
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0877248
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beskrivning
Action Taken with Investigational Product(s) as a Result of the AE
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C0877248
Beskrivning
Did the subject withdraw from study as a result of this AE?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1710677
- UMLS CUI [2]
- C0877248
Beskrivning
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0877248
- UMLS CUI [2]
- C0013230
- UMLS CUI [3]
- C0439849
Beskrivning
If "Yes", complete paper SAE form.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1710056
Beskrivning
If Adverse Event is serious, chack all that apply
Datatyp
integer
Alias
- UMLS CUI [1]
- C1519255
Beskrivning
Specify other reason for serious Adverse Event
Datatyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C3840932
- UMLS CUI [2]
- C2348235
Beskrivning
Was this SAE caused by an activity related to study participation (e.g., procedures)?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
- UMLS CUI [2]
- C0441655
- UMLS CUI [3]
- C2348568
Beskrivning
Serious Flag
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205404
- UMLS CUI [1,2]
- C1708067
Beskrivning
Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Beskrivning
Concomitant Medications Sequence Number
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beskrivning
Trade Name preferred
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
Beskrivning
Concomitant Medications Modified reported term
Datatyp
text
Alias
- UMLS CUI [1]
- C2826819
Beskrivning
Concomitant Medications GSK Drug synonym
Datatyp
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0013227
- UMLS CUI [2,2]
- C0871468
Beskrivning
Concomitant Medications GSK Drug Collection Date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [2]
- C0011008
Beskrivning
Concomitant Medications Failed coding
Datatyp
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2,1]
- C0805701
- UMLS CUI [2,2]
- C0231175
Beskrivning
Concomitant Medications Unit Dose
Datatyp
text
Alias
- UMLS CUI [1]
- C2826646
Beskrivning
Concomitant Medications Units
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C1519795
Beskrivning
Concomitant Medications Frequency
Datatyp
text
Alias
- UMLS CUI [1]
- C3476109
- UMLS CUI [2]
- C2347852
Beskrivning
Concomitant Medicaton Routes
Datatyp
text
Alias
- UMLS CUI [1]
- C2347852
- UMLS CUI [2]
- C0013153
Beskrivning
Concomitant Medications Reason for Medication
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C3146298
Beskrivning
Concomitant Medications Start Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826825
Beskrivning
Concomitant Medication Taken Prior to Study?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beskrivning
Concomitant Medications Ongoing?
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beskrivning
If Concomitant Medications not Ongoing, specify End Date and Time
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826815
Beskrivning
12-Lead/ Holter/ Telemetry ECG
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-3
- C0013801
- UMLS CUI-5
- C1623258
- UMLS CUI-6
- C0039451
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
Heart rate
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
PR Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429087
Beskrivning
QRS Duration
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0429025
Beskrivning
Uncorrected QT Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C1287082
Beskrivning
QTc Interval
Datatyp
integer
Måttenheter
- ms
Alias
- UMLS CUI [1]
- C0489625
Beskrivning
Result of the ECG
Datatyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beskrivning
12-Lead ECG Abnormalities
Alias
- UMLS CUI-1
- C0430456
- UMLS CUI-2
- C1704258
Beskrivning
Date and Time of ECG
Datatyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beskrivning
Record clinically significant abnormalities. Check all that apply.
Datatyp
text
Alias
- UMLS CUI [1]
- C0232187
Beskrivning
Other abnormal rhythm
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C0205161
- UMLS CUI [2]
- C0205394
Beskrivning
B. P-Wave Morphology
Datatyp
integer
Alias
- UMLS CUI [1]
- C2216025
Beskrivning
Other morphology
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C0332437
Beskrivning
C: Conduction
Datatyp
text
Alias
- UMLS CUI [1]
- C0232217
Beskrivning
Other conduction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
Beskrivning
D. Myocardial Infarction
Datatyp
integer
Alias
- UMLS CUI [1]
- C0027051
Beskrivning
Other myocardial infarction
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
Beskrivning
E. Depolarisation/Repolarisation (QRS-T)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1395184
- UMLS CUI [2]
- C0948857
Beskrivning
Other depolarisation/ repolarisation
Datatyp
text
Alias
- UMLS CUI [1,1]
- C2746082
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [2,1]
- C0948857
- UMLS CUI [2,2]
- C0205394
Beskrivning
Other abnormalities, enter comment
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [2]
- C0205394
- UMLS CUI [3]
- C0947611
Beskrivning
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beskrivning
Actual date/ time (Vital Signs)
Datatyp
datetime
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C1264639
Beskrivning
Subject position (Vital Signs)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1262869
- UMLS CUI [2]
- C0518766
Beskrivning
Systolic blood pressure (Vital Signs)
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0871470
Beskrivning
Diastolic blood pressure (Vital Signs)
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0428883
Beskrivning
Blood pressure not done (Vital Signs)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0005823
- UMLS CUI [3]
- C1272696
Beskrivning
Heart rate (Vital Signs)
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C0518766
- UMLS CUI [2]
- C0018810
Beskrivning
Heart rate not done (Vital Signs)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C0518766
- UMLS CUI [3]
- C1272696
Beskrivning
Pharmacokinetics
Alias
- UMLS CUI-1
- C0031328
Beskrivning
Orthostatic Vital Signs
Alias
- UMLS CUI-1
- C1827287
Beskrivning
Actual date/time (Orthostatic Vital Signs)
Datatyp
datetime
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C1264639
Beskrivning
Subject position (Orthostatic Vital Signs)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C1262869
Beskrivning
Systolic blood pressure (Orthostatic Vital Signs)
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C0871470
Beskrivning
Diastolic blood pressure (Orthostatic Vital Signs)
Datatyp
integer
Måttenheter
- mm[Hg]
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C0428883
Beskrivning
Blood pressure not done (Orthostatic Vital Signs)
Datatyp
integer
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C0005823
- UMLS CUI [3]
- C1272696
Beskrivning
Heart rate (Orthostatic Vital Signs)
Datatyp
integer
Måttenheter
- beats/min
Alias
- UMLS CUI [1]
- C1827287
- UMLS CUI [2]
- C0018810
Beskrivning
Heart rate not done (Orthostatic Vital Signs)
Datatyp
integer
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C1272696
Similar models
Logs and Repeats: Adverse Events; Concomitant Medications; ECG; Vital Signs; Pharmacokinetics
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C2347852 (UMLS CUI-3)
C0205341 (UMLS CUI-5)
C0220825 (UMLS CUI-6)
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C1140263 (UMLS CUI [2])
C3898442 (UMLS CUI [2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0439603 (UMLS CUI [2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [2])
C0013230 (UMLS CUI [2])
C0439849 (UMLS CUI [3])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C1708067 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
C0013227 (UMLS CUI [2,1])
C0871468 (UMLS CUI [2,2])
C1516698 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C1519795 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2])
C0013153 (UMLS CUI [2])
C3146298 (UMLS CUI [1,2])
C0013801 (UMLS CUI-3)
C1623258 (UMLS CUI-5)
C0039451 (UMLS CUI-6)
C1704258 (UMLS CUI-2)
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0332437 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
C1264639 (UMLS CUI [2])
C0518766 (UMLS CUI [2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [2])
C0005823 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
C0018810 (UMLS CUI [2])
C0518766 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
C1264639 (UMLS CUI [2])
C1264639 (UMLS CUI [2])
C1262869 (UMLS CUI [2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [2])
C0005823 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
C0018810 (UMLS CUI [2])
C1827287 (UMLS CUI [2])
C1272696 (UMLS CUI [3])