ID

38828

Beschreibung

Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

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Versionen (1)
  1. 07.11.19 07.11.19 -
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GlaxoSmithKline

Hochgeladen am

7. November 2019

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Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597

Englisch

Screening - Administrative; Demography; Vital Signs; 12-Lead ECG; Summary Holter

1 Formulare  
Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Volunteer Identifier
Beschreibung

Volunteer Identifier

Datentyp

text

Alias
UMLS CUI [1,1]
C1300638
UMLS CUI [1,2]
C0020155
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Centre Number
Beschreibung

Centre Number

Datentyp

text

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
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
Ethnicity
Beschreibung

Check one

Datentyp

integer

Alias
UMLS CUI [1]
C0015031
Geographic Ancestry
Beschreibung

Check all that apply

Datentyp

integer

Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
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

float

Maßeinheiten
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Date
Beschreibung

Date

Datentyp

date

Alias
UMLS CUI [1]
C0011008
Planned Relative Time - Vital Signs
Beschreibung

Planned Relative Time - Vital Signs

Datentyp

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0518766
Actual Time
Beschreibung

Actual Time

Datentyp

time

Alias
UMLS CUI [1]
C0040223
Systolic Blood Pressure Semi-recumbent
Beschreibung

Systolic Blood Pressure Semi-recumbent

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0522019
mm[Hg]
Diastolic Blood Pressure Semi-recumbent
Beschreibung

Diastolic Blood Pressure Semi-recumbent

Datentyp

integer

Maßeinheiten
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0522019
mm[Hg]
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
12-Lead ECG
Beschreibung

12-Lead ECG

Alias
UMLS CUI-1
C0430456
ECG Number
Beschreibung

ECG Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0237753
Start Date of ECG
Beschreibung

Start Date of ECG

Datentyp

date

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0808070
Planned Relative Time - ECG
Beschreibung

Planned Relative Time - ECG

Datentyp

text

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0439564
Start Time of ECG
Beschreibung

Start Time of ECG

Datentyp

time

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C1301880
Heart Rate
Beschreibung

Heart Rate

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
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
Result of the ECG
Beschreibung

Result of the ECG

Datentyp

integer

Alias
UMLS CUI [1]
C0438154
Summary Holter
Beschreibung

Summary Holter

Alias
UMLS CUI-1
C0013801
UMLS CUI-2
C0242482
Start date of Holter
Beschreibung

Start date of Holter

Datentyp

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0808070
Start time of Holter
Beschreibung

Start time of Holter

Datentyp

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1301880
Stop date of Holter
Beschreibung

Stop date of Holter

Datentyp

date

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0806020
Stop time of Holter
Beschreibung

Stop time of Holter

Datentyp

time

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1522314
Interpretation of Holter
Beschreibung

Check one

Datentyp

text

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C0438154
Holter monitoring method
Beschreibung

Check one

Datentyp

integer

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Ähnliche Modelle

Screening - Administrative; Demography; Vital Signs; 12-Lead ECG; Summary Holter

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Volunteer Identifier
Item
Volunteer Identifier
text
C1300638 (UMLS CUI [1,1])
C0020155 (UMLS CUI [1,2])
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Centre Number
Item
Centre Number
text
C0600091 (UMLS CUI [1,1])
C0019994 (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
Female (F)
CL Item
Male (M)
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
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
Vital Signs
C0518766 (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
float
C1305855 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Planned Relative Time - Vital Signs
Item
Planned Relative Time - Vital Signs
text
C0439564 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,3])
Actual Time
Item
Actual Time
time
C0040223 (UMLS CUI [1])
Systolic Blood Pressure Semi-recumbent
Item
Systolic Blood Pressure Semi-recumbent
integer
C0871470 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Diastolic Blood Pressure Semi-recumbent
Item
Diastolic Blood Pressure Semi-recumbent
integer
C0428883 (UMLS CUI [1,1])
C0522019 (UMLS CUI [1,2])
Heart Rate
Item
Heart Rate
integer
C0018810 (UMLS CUI [1])
Item Group
12-Lead ECG
C0430456 (UMLS CUI-1)
Item
ECG Number
integer
C0430456 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
ECG Number
Code List
ECG Number
CL Item
ECG 1 (1)
CL Item
ECG 2 (2)
CL Item
ECG 3 (3)
Start Date of ECG
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Planned Relative Time - ECG
Item
Planned Relative Time - ECG
text
C0430456 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Start Time of ECG
Item
Start Time of ECG
time
C0430456 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
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])
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  (3)
CL Item
No result (not available) (4)
Item Group
Summary Holter
C0013801 (UMLS CUI-1)
C0242482 (UMLS CUI-2)
Start date of Holter
Item
Start date of Holter
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Start time of Holter
Item
Start time of Holter
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
Stop date of Holter
Item
Stop date of Holter
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Stop time of Holter
Item
Stop time of Holter
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Interpretation of Holter
text
C0013801 (UMLS CUI [1,1])
C0438154 (UMLS CUI [1,2])
Interpretation of Holter
Code List
Interpretation of Holter
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant 1 (3)
CL Item
No result (4)
CL Item
Unable to evaluate (5)
Item
Holter monitoring method
integer
Holter monitoring method
Code List
Holter monitoring method
CL Item
12 Lead 1000Hz (1)
CL Item
12 lead 180Hz (2)
CL Item
3 Lead 180 Hz (3)
CL Item
Telemetry (4)
CL Item
5 Lead 512Hz (5)
CL Item
4 Lead 0.05-40 Hz (6)
CL Item
6 Lead 0.05-40 Hz (7)
CL Item
7 Lead 0.05-100 Hz-3dB (8)
CL Item
7 Lead 3 channel 133 Hz (9)
CL Item
2 Lead 200 Hz (10)
CL Item
Other (11)
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