ID

37660

Beschreibung

Study ID: 109385 Clinical Study ID: 109385 Study Title: A Randomized, Open Label, 4 Period Crossover Study in Healthy Subjects to Determine the Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00517543 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW856553 Trade Name: N/A Study Indication: Chronic Obstructive Pulmonary Disease (COPD), Rheumatoid Arthritis, Atherosclerosis

Stichworte

Versionen (5)
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  3. 23.04.19 23.04.19 -
  4. 14.08.19 14.08.19 -
  5. 14.08.19 14.08.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

14. August 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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The Effect of Particle Size on the Pharmacokinetics of a Single mg Dose of GW856553 NCT00517543

Englisch

Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Subject Identification; Electronically Transferred Lab Data

1 Formulare  
Inform Screening
Beschreibung

Inform Screening

Alias
UMLS CUI-1
C1710477
Subject initials
Beschreibung

Subject initials

Datentyp

integer

Alias
UMLS CUI [1,1]
C1997894
UMLS CUI [1,2]
C2986440
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Subject number
Beschreibung

Subject number

Alias
UMLS CUI-1
C2348585
Subject number
Beschreibung

Subject number

Datentyp

integer

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

Date of Visit/ Assessment

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

Date of Visit/ Assessment

Datentyp

date

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

Demography

Alias
UMLS CUI-1
C0011298
Date of Birth
Beschreibung

Date of Birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Sex
Beschreibung

Sex

Datentyp

text

Alias
UMLS CUI [1]
C0079399
If subject is female, record childbearing potential
Beschreibung

If subject is female, record childbearing potential

Datentyp

integer

Alias
UMLS CUI [1]
C3831118
Ethnicity
Beschreibung

Ethnicity

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Geographic ancestry
Beschreibung

Geographic ancestry

Datentyp

integer

Alias
UMLS CUI [1]
C3841890
12-Lead ECG
Beschreibung

12-Lead ECG

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

Date and Time of ECG

Datentyp

datetime

Alias
UMLS CUI [1]
C2826846
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
RR Interval
Beschreibung

RR Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0489636
ms
PR Interval
Beschreibung

PR Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429087
ms
QRS Duration
Beschreibung

QRS Duration

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0429025
ms
Uncorrected QT Interval
Beschreibung

Uncorrected QT Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C1287082
ms
QTc (b) Interval
Beschreibung

QTc (b) Interval

Datentyp

integer

Maßeinheiten
  • ms
Alias
UMLS CUI [1]
C0489625
ms
Method of QTc Calculation
Beschreibung

Method of QTc Calculation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Actual date/time
Beschreibung

Actual date/time

Datentyp

datetime

Alias
UMLS CUI [1]
C1264639
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschreibung

Body mass index

Datentyp

integer

Alias
UMLS CUI [1]
C1305855
Systolic Blood pressure
Beschreibung

Systolic Blood pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0871470
mm[Hg]
Diastolic Blood Pressure
Beschreibung

Diastolic Blood Pressure

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1]
C0428883
mm[Hg]
Heart rate
Beschreibung

Heart rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Respiration rate
Beschreibung

Respiration rate

Datentyp

integer

Maßeinheiten
  • breaths/min
Alias
UMLS CUI [1]
C0231832
breaths/min
Temperature
Beschreibung

Temperature

Datentyp

float

Maßeinheiten
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Subject identification
Beschreibung

Subject identification

Alias
UMLS CUI-1
C2348585
Subject identification
Beschreibung

Subject identification

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Electronically Transferred Lab Data
Beschreibung

Electronically Transferred Lab Data

Alias
UMLS CUI-1
C0200345
UMLS CUI-2
C0022885
UMLS CUI-3
C1320722
Haematology Date and time sample taken
Beschreibung

Haematology Date and time sample taken

Datentyp

date

Alias
UMLS CUI [1]
C0018941
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Haematology sample not done
Beschreibung

Haematology sample not done

Datentyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0018941
UMLS CUI [1,3]
C1272696
Clinical Chemistry Date and time sample taken
Beschreibung

Clinical Chemistry Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1]
C0008000
UMLS CUI [2,1]
C0200345
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C0040223
Clinical Chemistry sample not done
Beschreibung

Clinical Chemistry sample not done

Datentyp

integer

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
Urinalysis Date and time sample taken
Beschreibung

Urinalysis Date and time sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinanalysis sample not done
Beschreibung

Urinanalysis sample not done

Datentyp

integer

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1272696
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Ähnliche Modelle

Screen - Date of Visit; Demography, 12-Lead ECG; Vital Signs; Subject Identification; Electronically Transferred Lab Data

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inform Screening
C1710477 (UMLS CUI-1)
Subject initials
Item
Subject initials
integer
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date of Birth
Item
Date of Birth
date
C0421451 (UMLS CUI [1])
Item Group
Subject number
C2348585 (UMLS CUI-1)
Subject number
Item
Subject number
integer
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 (F)
Item
If subject is female, record childbearing potential
integer
C3831118 (UMLS CUI [1])
If subject is female, record childbearing potential
Code List
If subject is female, record childbearing potential
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
Geographic ancestry
integer
C3841890 (UMLS CUI [1])
Geographic ancestry
Code List
Geographic ancestry
CL Item
African American/African Heritage (11)
CL Item
American Indian or Alaskan Native (12)
CL Item
Asian - Central/South Asian Heritage (13)
CL Item
Asian - East Asian Heritage (14)
CL Item
Asian - Japanese Heritage (15)
CL Item
Asian - South East Asian Heritage (16)
CL Item
Native Hawaiian or Other Pacific Islander (17)
CL Item
White - Arabic/North African Heritage (18)
CL Item
White - White/Caucasian/European Heritage (19)
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
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])
RR Interval
Item
RR Interval
integer
C0489636 (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 (b) Interval
Item
QTc (b) Interval
integer
C0489625 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Method of QTc Calculation
Code List
Method of QTc Calculation
CL Item
Machine (1)
CL Item
Manual (2)
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 (complete the ECG abnormality form for all abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all clinically significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Actual date/time
Item
Actual date/time
datetime
C1264639 (UMLS CUI [1])
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
integer
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])
Respiration rate
Item
Respiration rate
integer
C0231832 (UMLS CUI [1])
Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Item Group
Subject identification
C2348585 (UMLS CUI-1)
Subject identification
Item
Subject identification
integer
C2348585 (UMLS CUI [1])
Item Group
Electronically Transferred Lab Data
C0200345 (UMLS CUI-1)
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
Haematology Date and time sample taken
Item
Haematology Date and time sample taken
date
C0018941 (UMLS CUI [1])
C0005834 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item
Haematology sample not done
integer
C0005834 (UMLS CUI [1,1])
C0018941 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Haematology sample not taken
Code List
Haematology sample not done
CL Item
Haematology sample not done (1)
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1])
C0200345 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Item
Clinical Chemistry sample not done
integer
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Clinical Chemistry sample not done
Code List
Clinical Chemistry sample not done
CL Item
Clinical Chemistry sample not done (1)
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item
Urinanalysis sample not done
integer
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Urinanalysis sample not done
Code List
Urinanalysis sample not done
CL Item
Urinanalysis sample not done (1)
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