ID
42295
Beschrijving
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
Trefwoorden
Versies (1)
- 10-05-21 10-05-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
10 mei 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY 4.0
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Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533)
Session 1-4: Vital Signs; Pharmacokinetics Blood; Investigational Product; Treatment Confirmation; 12-Lead ECG
Beschrijving
Date of Visit/ Assessment
Alias
- UMLS CUI-1
- C1320303
- UMLS CUI-2
- C2985720
Beschrijving
Randomisation (only Session 1)
Alias
- UMLS CUI-1
- C0034656
Beschrijving
Was the subject able to be randomised?
Datatype
boolean
Alias
- UMLS CUI [1]
- C0034656
Beschrijving
Randomisation Number
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschrijving
Date of randomisation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0011008
Beschrijving
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Beschrijving
Sitting Vital Signs - Predose
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0277814
- UMLS CUI-4
- C0439565
Beschrijving
Actual time (sitting Predose)
Datatype
time
Alias
- UMLS CUI [1]
- C0439565
- UMLS CUI [2]
- C0040223
- UMLS CUI [3]
- C0277814
Beschrijving
Systolic Blood Pressure (sitting Predose)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
- UMLS CUI [2]
- C0439565
Beschrijving
Diastolic Blood Pressure (sitting Predose)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
- UMLS CUI [2]
- C0439565
Beschrijving
Heart rate (sitting Predose)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C2029904
- UMLS CUI [2]
- C0439565
Beschrijving
Orthostatic Vital Signs - Predose (Reading 1) - Supine for 5 mins
Alias
- UMLS CUI-1
- C1827287
- UMLS CUI-2
- C0439565
- UMLS CUI-3
- C0038846
Beschrijving
Actual time (Orthostatic Vital signs Predose - 5 mins supine)
Datatype
time
Alias
- UMLS CUI [1,1]
- C1827287
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2]
- C0439565
- UMLS CUI [3]
- C0038846
Beschrijving
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 5 mins supine)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439565
- UMLS CUI [4]
- C0038846
Beschrijving
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 5 mins supine)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439565
- UMLS CUI [4]
- C0038846
Beschrijving
Heart Rate (Orthostatic Vital Signs Predose - 5 mins supine)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439565
- UMLS CUI [4]
- C0038846
Beschrijving
Orthostatic Vital Signs - Predose (Reading 2) - Sitting for 2 mins
Alias
- UMLS CUI-1
- C1827287
- UMLS CUI-2
- C0439565
- UMLS CUI-3
- C0277814
Beschrijving
Actual time (Orthostatic Vital signs Predose - 2 mins sitting)
Datatype
time
Alias
- UMLS CUI [1,1]
- C1827287
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2]
- C0439565
- UMLS CUI [3]
- C0277814
Beschrijving
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 2 mins sitting)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439565
- UMLS CUI [4]
- C0277814
Beschrijving
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 2 mins sitting)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439565
- UMLS CUI [4]
- C0277814
Beschrijving
Heart Rate (Orthostatic Vital Signs Predose - 2 mins sitting)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439565
- UMLS CUI [4]
- C0277814
Beschrijving
Orthostatic Vital Signs - Predose (Reading 3) - Standing for 3 mins
Alias
- UMLS CUI-1
- C1827287
- UMLS CUI-2
- C0439565
- UMLS CUI-3
- C0231472
Beschrijving
Actual time (Orthostatic Vital signs Predose - 3 mins standing)
Datatype
time
Alias
- UMLS CUI [1,1]
- C1827287
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2]
- C0439565
- UMLS CUI [3]
- C0231472
Beschrijving
Systolic Blood Pressure (Orthostatic Vital Signs Predose - 3 mins standing)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439565
- UMLS CUI [4]
- C0231472
Beschrijving
Diastolic Blood Pressure (Orthostatic Vital Signs Predose - 3 mins standing)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439565
- UMLS CUI [4]
- C0231472
Beschrijving
Heart Rate (Orthostatic Vital Signs Predose - 3 mins standing)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439565
- UMLS CUI [4]
- C0231472
Beschrijving
Orthostatic Vital Signs - Post Dose - Sitting
Alias
- UMLS CUI-1
- C1827287
- UMLS CUI-2
- C0439568
- UMLS CUI-3
- C0277814
Beschrijving
Timepoint (Orthostatic Vital Signs Post-Dose - Sitting)
Datatype
integer
Alias
- UMLS CUI [1]
- C2348792
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0277814
Beschrijving
Actual Time (Orthostatic Vital Signs Post Dose 1-10 Hours - Sitting)
Datatype
time
Alias
- UMLS CUI [1]
- C0040223
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0277814
Beschrijving
Actual date/time (Orthostatic Vital Signs Post Dose 12-96 Hours - Sitting)
Datatype
datetime
Alias
- UMLS CUI [1]
- C1264639
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0277814
Beschrijving
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose Sitting)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0277814
Beschrijving
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose Sitting)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0277814
Beschrijving
Heart Rate (Orthostatic Vital Signs Post-Dose Sitting)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0277814
Beschrijving
Orthostatic Vital Signs - 10 Hours (Reading 1) - Supine for 5 mins
Alias
- UMLS CUI-1
- C1827287
- UMLS CUI-2
- C0439568
- UMLS CUI-3
- C0038846
Beschrijving
Actual time (Orthostatic Vital signs Post-Dose- 5 mins supine)
Datatype
time
Alias
- UMLS CUI [1,1]
- C1827287
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2]
- C0439568
- UMLS CUI [3]
- C0038846
Beschrijving
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 5 mins supine)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0038846
Beschrijving
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 5 mins supine)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0038846
Beschrijving
Heart Rate (Orthostatic Vital Signs Post-Dose- 5 mins supine)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0038846
Beschrijving
Orthostatic Vital Signs - 10 Hours (Reading 2) - Sitting for 2 mins
Alias
- UMLS CUI-1
- C1827287
- UMLS CUI-2
- C0439568
- UMLS CUI-3
- C0277814
Beschrijving
Actual time (Orthostatic Vital signs Post-Dose- 2 mins sitting)
Datatype
time
Alias
- UMLS CUI [1,1]
- C1827287
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2]
- C0439568
- UMLS CUI [3]
- C0277814
Beschrijving
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 2 mins sitting)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0277814
Beschrijving
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 2 mins sitting)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0277814
Beschrijving
Heart Rate (Orthostatic Vital Signs Post-Dose- 2 mins sitting)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0277814
Beschrijving
Orthostatic Vital Signs - 10 Hours (Reading 3) - Standing for 3 mins
Alias
- UMLS CUI-1
- C1827287
- UMLS CUI-2
- C0439568
- UMLS CUI-3
- C0231472
Beschrijving
Actual time (Orthostatic Vital signs Post-Dose - 3 mins standing)
Datatype
time
Alias
- UMLS CUI [1,1]
- C1827287
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2]
- C0439568
- UMLS CUI [3]
- C0231472
Beschrijving
Systolic Blood Pressure (Orthostatic Vital Signs Post-Dose - 3 mins standing)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0871470
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0231472
Beschrijving
Diastolic Blood Pressure (Orthostatic Vital Signs Post-Dose- 3 mins standing)
Datatype
integer
Maateenheden
- mm[Hg]
Alias
- UMLS CUI [1]
- C0428883
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0231472
Beschrijving
Heart Rate (Orthostatic Vital Signs Post-Dose- 3 mins standing)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C0018810
- UMLS CUI [2]
- C1827287
- UMLS CUI [3]
- C0439568
- UMLS CUI [4]
- C0231472
Beschrijving
Pharmacokinetics Blood - Dosing Date and Time
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
- UMLS CUI-4
- C0178602
- UMLS CUI-5
- C1264639
Beschrijving
Pharmacokinetics Blood
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0005767
Beschrijving
Timepoint (Pharmacokinetics)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C2348792
Beschrijving
Actual time (Pharmacokinetics Pre-Dose-12 Hours)
Datatype
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [2]
- C0040223
- UMLS CUI [3]
- C0439565
Beschrijving
Actual date/time (Pharmacokinetics 18-96 Hours)
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0005767
- UMLS CUI [2]
- C0040223
Beschrijving
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Treatment Confirmation
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0750484
Beschrijving
If "No", record reason(s)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0087111
- UMLS CUI [1,2]
- C0750484
Beschrijving
Record reason for incorrect treatment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0566251
- UMLS CUI [1,2]
- C0087111
Beschrijving
12-Lead ECG (only Session 4)
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Dosing date/time (ECG - 48 Hours)
Datatype
datetime
Alias
- UMLS CUI [1]
- C0178602
- UMLS CUI [2]
- C0430456
- UMLS CUI [3]
- C1264639
Beschrijving
Date and Time of ECG (48 Hours)
Datatype
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschrijving
Heart Rate (ECG - 48 Hours)
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1,1]
- C0430456
- UMLS CUI [1,2]
- C0018810
Beschrijving
PR Interval (48 Hours)
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration (48 Hours)
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
Uncorrected QT Interval
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschrijving
QTc Interval (48 Hours)
Datatype
integer
Maateenheden
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschrijving
Result of ECG
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Similar models
Session 1-4: Vital Signs; Pharmacokinetics Blood; Investigational Product; Treatment Confirmation; 12-Lead ECG
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,3])
C0277814 (UMLS CUI-2)
C0439565 (UMLS CUI-4)
C0040223 (UMLS CUI [2])
C0277814 (UMLS CUI [3])
C0277814 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0277814 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0439565 (UMLS CUI [2])
C0439565 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0038846 (UMLS CUI [3])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
C0439565 (UMLS CUI-2)
C0277814 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0277814 (UMLS CUI [3])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C0439565 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C0439565 (UMLS CUI [2])
C0231472 (UMLS CUI [3])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
C0439568 (UMLS CUI-2)
C0277814 (UMLS CUI-3)
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C0439568 (UMLS CUI-2)
C0038846 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C0439568 (UMLS CUI [2])
C0038846 (UMLS CUI [3])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0038846 (UMLS CUI [4])
C0439568 (UMLS CUI-2)
C0277814 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C0439568 (UMLS CUI [2])
C0277814 (UMLS CUI [3])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0277814 (UMLS CUI [4])
C0439568 (UMLS CUI-2)
C0231472 (UMLS CUI-3)
C0040223 (UMLS CUI [1,2])
C0439568 (UMLS CUI [2])
C0231472 (UMLS CUI [3])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
C1827287 (UMLS CUI [2])
C0439568 (UMLS CUI [3])
C0231472 (UMLS CUI [4])
C0005767 (UMLS CUI-2)
C0178602 (UMLS CUI-4)
C1264639 (UMLS CUI-5)
C0005767 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C1264639 (UMLS CUI [2,2])
C0005767 (UMLS CUI-2)
C2348792 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
C0439565 (UMLS CUI [3])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
C0178602 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
C0750484 (UMLS CUI-2)
C0750484 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,2])
C0430456 (UMLS CUI [2])
C1264639 (UMLS CUI [3])
C0018810 (UMLS CUI [1,2])