Informazione:
Errore:
ID
42297
Descrizione
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
Keywords
versioni (1)
- 10/05/21 10/05/21 -
Titolare del copyright
GlaxoSmithKline
Caricato su
10 maggio 2021
DOI
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Licenza
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
Similar models
Logs and Repeats: Adverse Events; Concomitant Medications; ECG; Vital Signs; Pharmacokinetics
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient Number
Item
Patient Number
text
C2348585 (UMLS CUI [1])
Item Group
Date of visit/assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
C2985720 (UMLS CUI-2)
Date of visit/assessment
Item
Date of visit/assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Item Group
Adverse Event/ Concomitant Medication/Repeat Assessment Check Questions
C0877248 (UMLS CUI-1)
C2347852 (UMLS CUI-3)
C0205341 (UMLS CUI-5)
C0220825 (UMLS CUI-6)
C2347852 (UMLS CUI-3)
C0205341 (UMLS CUI-5)
C0220825 (UMLS CUI-6)
Were any concomitant medications taken by the subject during the study?
Item
Were any concomitant medications taken by the subject during the study?
boolean
C2347852 (UMLS CUI [1])
Did the subject experience any adverse events during the study?
Item
Did the subject experience any adverse events during the study?
boolean
C0877248 (UMLS CUI [1])
Were any repeat ECGs performed?
Item
Were any repeat ECGs performed?
boolean
C1623258 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
Did the subject have any abnormal ECGs during the study?
Item
Did the subject have any abnormal ECGs during the study?
boolean
C0522055 (UMLS CUI [1])
Were any repeat vital signs recorded?
Item
Were any repeat vital signs recorded?
boolean
C0518766 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
Were any repeat Orthostatic Vital Signs recorded?
Item
Were any repeat Orthostatic Vital Signs recorded?
boolean
C1827287 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
Were any repeat PK taken?
Item
Were any repeat PK taken?
boolean
C0031327 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
Adverse Events Sequence Number
Item
Adverse Events Sequence Number
integer
C0877248 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Adverse Event
Item
Adverse Event
text
C0877248 (UMLS CUI [1])
Adverse Event Modified Term
Item
Adverse Event Modified Term
text
C2826798 (UMLS CUI [1])
Adverse Event MedDRA synonym
Item
Adverse Event MedDRA synonym
text
C0877248 (UMLS CUI [1])
C1140263 (UMLS CUI [2])
C1140263 (UMLS CUI [2])
Adverse Event MedDRA lower level term code
Item
Adverse Event MedDRA lower level term code
text
C0877248 (UMLS CUI [1])
C3898442 (UMLS CUI [2])
C3898442 (UMLS CUI [2])
Adverse Event Failed coding
Item
Adverse Event Failed coding
text
C0877248 (UMLS CUI [1])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Adverse Event Start Date and Time
Item
Adverse Event Start Date and Time
datetime
C2826806 (UMLS CUI [1])
CL Item
Recovered/Resolved, provide End Date and Time (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/ Resolved with sequelae, provide End Date and Time (4)
CL Item
Fatal, record Date and Time of Death (5)
Adverse Event End Date and Time
Item
Adverse Event End Date and Time
datetime
C2826793 (UMLS CUI [1])
Item
Adverse Event Frequency
integer
C0877248 (UMLS CUI [1])
C0439603 (UMLS CUI [2])
C0439603 (UMLS CUI [2])
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Adverse Event Maximum Intensity
integer
C0877248 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (4)
Item
Action Taken with Investigational Product(s) as a Result of the AE
integer
C1704758 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (6)
Did the subject withdraw from study as a result of this AE?
Item
Did the subject withdraw from study as a result of this AE?
boolean
C1710677 (UMLS CUI [1])
C0877248 (UMLS CUI [2])
C0877248 (UMLS CUI [2])
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C0877248 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0439849 (UMLS CUI [3])
C0013230 (UMLS CUI [2])
C0439849 (UMLS CUI [3])
Does this Adverse Event meet the definition of serious?
Item
Does this Adverse Event meet the definition of serious?
boolean
C1710056 (UMLS CUI [1])
Item
If Adverse Event is serious, chack all that apply
integer
C1519255 (UMLS CUI [1])
Code List
If Adverse Event is serious, chack all that apply
CL Item
Results in death (1)
CL Item
Is life-threatening (2)
CL Item
Requires hospitalisation or prolongation of existing hospitalisation (3)
CL Item
Results in disability/ incapacity (4)
CL Item
Congenital anomaly/ birth defect (5)
CL Item
Other, specify (6)
Specify other reason for serious Adverse Event
Item
Specify other reason for serious Adverse Event
text
C1519255 (UMLS CUI [1,1])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
C3840932 (UMLS CUI [1,2])
C2348235 (UMLS CUI [2])
Was this SAE caused by an activity related to study participation (e.g., procedures)?
Item
Was this SAE caused by an activity related to study participation (e.g., procedures)?
boolean
C1519255 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
C0085978 (UMLS CUI [1,2])
C0441655 (UMLS CUI [2])
C2348568 (UMLS CUI [3])
Serious Flag
Item
Serious Flag
text
C0205404 (UMLS CUI [1,1])
C1708067 (UMLS CUI [1,2])
C1708067 (UMLS CUI [1,2])
Concomitant Medications Sequence Number
Item
Concomitant Medications Sequence Number
integer
C2347852 (UMLS CUI [1,1])
C2348184 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
Concomitant Medications Drug Name
Item
Concomitant Medications Drug Name
text
C2347852 (UMLS CUI [1,1])
C2360065 (UMLS CUI [1,2])
C2360065 (UMLS CUI [1,2])
Concomitant Medications Modified reported term
Item
Concomitant Medications Modified reported term
text
C2826819 (UMLS CUI [1])
Concomitant Medications GSK Drug synonym
Item
Concomitant Medications GSK Drug synonym
text
C2347852 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0871468 (UMLS CUI [2,2])
C0013227 (UMLS CUI [2,1])
C0871468 (UMLS CUI [2,2])
Concomitant Medications GSK Drug Collection Date
Item
Concomitant Medications GSK Drug Collection Date
date
C2347852 (UMLS CUI [1,1])
C1516698 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C1516698 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
Concomitant Medications Failed coding
Item
Concomitant Medications Failed coding
text
C2347852 (UMLS CUI [1])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0805701 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Concomitant Medications Unit Dose
Item
Concomitant Medications Unit Dose
text
C2826646 (UMLS CUI [1])
Concomitant Medications Units
Item
Concomitant Medications Units
text
C2347852 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
Concomitant Medications Frequency
Item
Concomitant Medications Frequency
text
C3476109 (UMLS CUI [1])
C2347852 (UMLS CUI [2])
C2347852 (UMLS CUI [2])
Concomitant Medicaton Routes
Item
Concomitant Medicaton Routes
text
C2347852 (UMLS CUI [1])
C0013153 (UMLS CUI [2])
C0013153 (UMLS CUI [2])
Concomitant Medications Reason for Medication
Item
Concomitant Medications Reason for Medication
text
C2347852 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C3146298 (UMLS CUI [1,2])
Concomitant Medications Start Date and Time
Item
Concomitant Medications Start Date and Time
datetime
C2826825 (UMLS CUI [1])
Concomitant Medication Taken Prior to Study?
Item
Concomitant Medications Taken Prior to Study?
boolean
C2826667 (UMLS CUI [1])
Concomitant Medications Ongoing?
Item
Concomitant Medications Ongoing?
boolean
C2826666 (UMLS CUI [1])
If Concomitant Medications not Ongoing, specify End Date and Time
Item
If Concomitant Medications not Ongoing, specify End Date and Time
datetime
C2826815 (UMLS CUI [1])
Item Group
12-Lead/ Holter/ Telemetry ECG
C0430456 (UMLS CUI-1)
C0013801 (UMLS CUI-3)
C1623258 (UMLS CUI-5)
C0039451 (UMLS CUI-6)
C0013801 (UMLS CUI-3)
C1623258 (UMLS CUI-5)
C0039451 (UMLS CUI-6)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
PR Interval
Item
PR Interval
integer
C0429087 (UMLS CUI [1])
QRS Duration
Item
QRS Duration
integer
C0429025 (UMLS CUI [1])
Uncorrected QT Interval
Item
Uncorrected QT Interval
integer
C1287082 (UMLS CUI [1])
QTc Interval
Item
QTc Interval
integer
C0489625 (UMLS CUI [1])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
CL Item
No result (4)
Item Group
12-Lead ECG Abnormalities
C0430456 (UMLS CUI-1)
C1704258 (UMLS CUI-2)
C1704258 (UMLS CUI-2)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C2826846 (UMLS CUI [1])
CL Item
Sinus bradycardia (1)
CL Item
Sinus bradycardia (heart rate 40 - 50 betas/min) (2)
CL Item
Sinus bradycarida (heart rate 30 - 39 beats/min) (3)
CL Item
Sinus bradycarida (heart rate <30 beats/min) (4)
CL Item
Sinus pause (5)
CL Item
Sinus tachycardia (heart rate >100 beats/min) (6)
CL Item
Ectopic supraventricular beats (7)
CL Item
Ectopic supraventricular rhythm (8)
CL Item
Wandering atrial pacemaker (9)
CL Item
Multifocal atrial tachycardia (wandering atrial pacemaker w/rate >100 beats/min) (10)
CL Item
Supraventricular tachycardia (heart rate >100 beats/min) (11)
CL Item
Atrial flutter (12)
CL Item
Atrial fibrillation (13)
CL Item
100 beats/min) (Junctional rhythm (heart rate <)
CL Item
Junctional rhythm (15)
CL Item
Junctional tachycardia (heart rate >100 beats/min) (16)
CL Item
Ectopic ventricular beats (17)
CL Item
Ventricular couplets (18)
CL Item
Bigeminy (19)
CL Item
Trigeminy (20)
CL Item
Electrical alternans (21)
CL Item
R on T phenomenon (22)
CL Item
Ventricular fibrillation (23)
CL Item
Idioventricular rhythm (24)
CL Item
Sustained ventriculat tachycardia (25)
CL Item
Non-sustained ventricular tachycardia (26)
CL Item
Ventricular tachycardia (27)
CL Item
Monomorphic ventricular tachycardia (28)
CL Item
Torsades de Pointes (Polymorphic ventricular tachycardia with prolonged QT) (29)
CL Item
Polymorphic (sustained and non-sustained) ventricular tachycardia (30)
CL Item
Artificial Pacemaker (31)
CL Item
Other abnormal rhythm, enter comment (32)
Other abnormal rhythm
Item
Other abnormal rhythm
text
C0199556 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0205161 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
CL Item
Left atrial abnormality (P mitrale) (1)
CL Item
Right atrial abnormality (P pulmonale) (2)
CL Item
Right ventricular hypertrophy (3)
CL Item
Intraartrial conduction delay (4)
CL Item
Increased voltage consistent with left ventricular hypertrophy (5)
CL Item
Other morphology, enter comment (6)
Other morphology
Item
Other morphology
text
C0205394 (UMLS CUI [1,1])
C0332437 (UMLS CUI [1,2])
C0332437 (UMLS CUI [1,2])
CL Item
First degree AV block (PR interval >200msec) (1)
CL Item
Second degree AV block (Mobitz type 1) (2)
CL Item
Second degree AV block (Mobitz type 2) (3)
CL Item
2:1 AV block (4)
CL Item
Third degree AV block (5)
CL Item
Left axis deviation (QRS axis more negative than -30 degrees) (6)
CL Item
Right axis deviation (QRS axis more positive than +110 degrees) (7)
CL Item
Incomplete right bundle branch block (8)
CL Item
Incomplete left bundle branch block (9)
CL Item
Right bundle branch block (10)
CL Item
Left anterior hemiblock (synonymous to left anterior fascicular block) (11)
CL Item
Left posterior hemiblock (synonymous to left posterior fascicular block) (12)
CL Item
Left bundle branch block (13)
CL Item
Bifascicular block (14)
CL Item
120msec) (Non-specific intraventricular conduction delay (QRS >)
CL Item
Accessory pathway (Wolff-Parkinson White, Lown-Gagnon-Levine) (16)
CL Item
500msec (QT/QTc prolongation >)
CL Item
AV dissociation (18)
CL Item
Other conduction, enter comment (19)
Other conduction
Item
Other conduction
text
C0232217 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
CL Item
Myocardial infarction, old (1)
CL Item
Myocardial infarction, anterior (2)
CL Item
Myocardial infarction, lateral (3)
CL Item
Myocardial infarction, posterior (4)
CL Item
Myocardial infarction, inferior (5)
CL Item
Myocardial infarction, septal (6)
CL Item
Myocardial infarction, Non Q-wave (7)
CL Item
Other Myocardial infarction, enter comment (8)
Other myocardial infarction
Item
Other myocardial infarction
text
C0027051 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
Item
E. Depolarisation/Repolarisation (QRS-T)
integer
C1395184 (UMLS CUI [1])
C0948857 (UMLS CUI [2])
C0948857 (UMLS CUI [2])
CL Item
Non-specific ST-T changes (1)
CL Item
J point elevation (2)
CL Item
ST elevation (3)
CL Item
ST-elevation-pericarditis (4)
CL Item
ST depression (5)
CL Item
U waves abnormal (6)
CL Item
T wave inversion (7)
CL Item
T wave peaked (8)
CL Item
T waves flat (9)
CL Item
T waves biphasic (10)
CL Item
Notched T-waves (11)
CL Item
Low QRS voltage (12)
CL Item
T-wave flattening/ inversion (13)
CL Item
Other depolarisation/ repolarisation, enter comment (14)
Other depolarisation/ repolarisation
Item
Other depolarisation/ repolarisation
text
C2746082 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0205394 (UMLS CUI [1,2])
C0948857 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Other abnormalities, enter comment
Item
Other abnormalities, enter comment
text
C0430456 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C0947611 (UMLS CUI [3])
Actual date/ time (Vital Signs)
Item
Actual date/ time (Vital Signs)
datetime
C0518766 (UMLS CUI [1])
C1264639 (UMLS CUI [2])
C1264639 (UMLS CUI [2])
Item
Subject position (Vital Signs)
integer
C1262869 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
C0518766 (UMLS CUI [2])
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
Systolic blood pressure (Vital Signs)
Item
Systolic blood pressure (Vital Signs)
integer
C0518766 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0871470 (UMLS CUI [2])
Diastolic blood pressure (Vital Signs)
Item
Diastolic blood pressure (Vital Signs)
integer
C0518766 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0428883 (UMLS CUI [2])
Item
Blood pressure not done (Vital Signs)
integer
C0518766 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
C0005823 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
CL Item
Not Done (1)
Heart rate (Vital Signs)
Item
Heart rate (Vital Signs)
integer
C0518766 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
C0018810 (UMLS CUI [2])
Item
Heart rate not done (Vital Signs)
integer
C0018810 (UMLS CUI [1])
C0518766 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
C0518766 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
CL Item
Not Done (1)
Actual date/time (Pharmacokinetics)
Item
Actual date/time (Pharmacokinetics)
datetime
C0031328 (UMLS CUI [1])
C1264639 (UMLS CUI [2])
C1264639 (UMLS CUI [2])
Actual date/time (Orthostatic Vital Signs)
Item
Actual date/time (Orthostatic Vital Signs)
datetime
C1827287 (UMLS CUI [1])
C1264639 (UMLS CUI [2])
C1264639 (UMLS CUI [2])
Item
Subject position (Orthostatic Vital Signs)
integer
C1827287 (UMLS CUI [1])
C1262869 (UMLS CUI [2])
C1262869 (UMLS CUI [2])
CL Item
Supine (1)
CL Item
Sitting (2)
CL Item
Standing (3)
Systolic blood pressure (Orthostatic Vital Signs)
Item
Systolic blood pressure (Orthostatic Vital Signs)
integer
C1827287 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0871470 (UMLS CUI [2])
Diastolic blood pressure (Orthostatic Vital Signs)
Item
Diastolic blood pressure (Orthostatic Vital Signs)
integer
C1827287 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0428883 (UMLS CUI [2])
Item
Blood pressure not done (Orthostatic Vital Signs)
integer
C1827287 (UMLS CUI [1])
C0005823 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
C0005823 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
Code List
Blood pressure not done (Orthostatic Vital Signs)
CL Item
Not Done (1)
Heart rate (Orthostatic Vital Signs)
Item
Heart rate (Orthostatic Vital Signs)
integer
C1827287 (UMLS CUI [1])
C0018810 (UMLS CUI [2])
C0018810 (UMLS CUI [2])
Item
Heart rate not done (Orthostatic Vital Signs)
integer
C0018810 (UMLS CUI [1])
C1827287 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
C1827287 (UMLS CUI [2])
C1272696 (UMLS CUI [3])
Code List
Heart rate not done (Orthostatic Vital Signs)
CL Item
Not Done (1)