Informazione:
Errore:
ID
42289
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)
- 05/05/21 05/05/21 -
Titolare del copyright
GlaxoSmithKline
Caricato su
5 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)
Screen: Demography; Vital Signs; 12-Lead ECG; Eligibility Question; Subject Identification
Similar models
Screen: Demography; Vital Signs; 12-Lead ECG; Eligibility Question; Subject Identification
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 No
Item
Patient No
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])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
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)
CL Item
Hispanic or Latino (1)
CL Item
Not Hispanic or Latino (2)
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)
Actual date/time (Vital Signs)
Item
Actual date/time (Vital Signs)
datetime
C0518766 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
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)
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])
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])
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])
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])
C1264639 (UMLS CUI [1,2])
Heart rate (ECG)
Item
Heart rate (ECG)
integer
C0430456 (UMLS CUI [1,1])
C0018810 (UMLS CUI [1,2])
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])
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)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])