ID

42289

Description

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

Versions (1)
  1. 5/5/21 5/5/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

May 5, 2021

DOI

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License

Creative Commons BY 4.0
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Relative bioavailability of four formulations of GSK lisinopril compared to Zestril (105533)

English

Screen: Demography; Vital Signs; 12-Lead ECG; Eligibility Question; Subject Identification

1 forms  
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Site
Description

Site

Data type

text

Alias
UMLS CUI [1]
C2825164
Patient
Description

Patient

Data type

text

Alias
UMLS CUI [1]
C1299487
Patient No
Description

Patient No

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Alias
UMLS CUI-1
C1320303
UMLS CUI-2
C2985720
Date of Visit/ Assessment
Description

Date of Visit/ Assessment

Data type

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C2985720
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Date of birth
Description

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race
Description

Check all that apply

Data type

integer

Alias
UMLS CUI [1]
C0034510
Vital Signs
Description

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/time (Vital Signs)
Description

Actual date/time (Vital Signs)

Data type

datetime

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C1264639
Height
Description

Height

Data type

integer

Measurement units
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Description

Weight

Data type

float

Measurement units
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Description

Body mass index

Data type

float

Measurement units
  • kg/m^2
Alias
UMLS CUI [1]
C1305855
kg/m^2
Systolic blood pressure
Description

Systolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic blood pressure
Description

Diastolic blood pressure

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Description

Heart rate

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Orthostatic Vital Signs (3 Readings) - Supine
Description

Orthostatic Vital Signs (3 Readings) - Supine

Alias
UMLS CUI-1
C1827287
Reading
Description

Reading

Data type

integer

Alias
UMLS CUI [1]
C0456984
Actual time (Orthostatic Vital Signs)
Description

Actual time (Orthostatic Vital Signs)

Data type

time

Alias
UMLS CUI [1,1]
C1827287
UMLS CUI [1,2]
C0040223
Systolic blood pressure (supine)
Description

Systolic blood pressure (supine)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mm[Hg]
Diastolic Blood Pressure (supine)
Description

Diastolic Blood Pressure (supine)

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate (supine)
Description

Heart rate (supine)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
beats/min
12-Lead ECG (Screening Reading 1)
Description

12-Lead ECG (Screening Reading 1)

Alias
UMLS CUI-1
C0430456
Date and Time of ECG
Description

Date and Time of ECG

Data type

datetime

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1264639
Heart rate (ECG)
Description

Heart rate (ECG)

Data type

integer

Measurement units
  • beats/min
Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0018810
beats/min
PR Interval
Description

PR Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Description

QRS Duration

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Description

Uncorrected QT Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc Interval
Description

QTc Interval

Data type

integer

Measurement units
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Result of the ECG
Description

Result of the ECG

Data type

integer

Alias
UMLS CUI [1]
C0438154
Eligibility Question
Description

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Description

Did the subject meet all the entry criteria?

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Subject Number
Description

Subject Number

Alias
UMLS CUI-1
C2348585
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
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Similar models

Screen: Demography; Vital Signs; 12-Lead ECG; Eligibility Question; Subject Identification

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Site
Item
Site
text
C2825164 (UMLS CUI [1])
Patient
Item
Patient
text
C1299487 (UMLS CUI [1])
Patient No
Item
Patient No
text
C2348585 (UMLS CUI [1])
Item Group
Date of Visit/ Assessment
C1320303 (UMLS CUI-1)
C2985720 (UMLS CUI-2)
Date of Visit/ Assessment
Item
Date of Visit/ Assessment
date
C1320303 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
Item Group
Demography
C0011298 (UMLS CUI-1)
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Sex
Code List
Sex
CL Item
Male (M)
CL Item
Female: Record child-bearing potential (F)
CL Item
Pre-menarcheal (1)
CL Item
Post-menopausal (2)
CL Item
Sterile (of child-bearing age) (3)
CL Item
Potentially able to bear children (4)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Ethnicity
Code List
Ethnicity
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
Item
Race
integer
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
African American/ African Heritage (1)
CL Item
American Indian or Alaskan NAtive (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date/time (Vital Signs)
Item
Actual date/time (Vital Signs)
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Systolic blood pressure
Item
Systolic blood pressure
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Diastolic blood pressure
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Orthostatic Vital Signs (3 Readings) - Supine
C1827287 (UMLS CUI-1)
Item
Reading
integer
C0456984 (UMLS CUI [1])
Reading
Code List
Reading
CL Item
Reading 1 (1)
CL Item
Reading 2 (2)
CL Item
Reading 3 (3)
Actual time (Orthostatic Vital Signs)
Item
Actual time (Orthostatic Vital Signs)
time
C1827287 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic blood pressure (supine)
Item
Systolic blood pressure (supine)
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood Pressure (supine)
Item
Diastolic Blood Pressure (supine)
integer
C0428883 (UMLS CUI [1])
Heart rate (supine)
Item
Heart rate (supine)
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Item Group
12-Lead ECG (Screening Reading 1)
C0430456 (UMLS CUI-1)
Date and Time of ECG
Item
Date and Time of ECG
datetime
C0430456 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Heart rate (ECG)
Item
Heart rate (ECG)
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
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])
Item
Result of the ECG
integer
C0438154 (UMLS CUI [1])
Result of the ECG
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal, clinically significant (complete the AE form if clinically significant abnormalities meet the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Subject Number
C2348585 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
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