ID

38878

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

Stichworte

Versionen (1)
  1. 11.11.19 11.11.19 -
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GlaxoSmithKline

Hochgeladen am

11. November 2019

DOI

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Creative Commons BY-NC 3.0
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Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597

Englisch

Screening - Medical Conditions; Alcohol Intake; Drug and Alcohol Screen; Serology (HIV Screen); Electronically Transferred Lab Data

1 Formulare  
Medical Conditions
Beschreibung

Medical Conditions

Alias
UMLS CUI-1
C0012634
Diagnosis
Beschreibung

Only in the absence of a diagnosis, record the signs and symptoms on separate lines

Datentyp

text

Alias
UMLS CUI [1]
C0011900
Status
Beschreibung

Status

Datentyp

integer

Alias
UMLS CUI [1]
C0449438
Alcohol Intake
Beschreibung

Alcohol Intake

Alias
UMLS CUI-1
C0001948
Does the subject consume alcohol?
Beschreibung

Does the subject consume alcohol?

Datentyp

boolean

Alias
UMLS CUI [1]
C0001948
If subject consumes alcohol, record the average number of units of alcohol consumed per week
Beschreibung

If subject consumes alcohol, record the average number of units of alcohol consumed per week

Datentyp

float

Maßeinheiten
  • units per week
Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
units per week
Drug and Alcohol Sreen
Beschreibung

Drug and Alcohol Sreen

Alias
UMLS CUI-1
C0373483
UMLS CUI-2
C0001948
Drug and Alcohol Sreen - Date and time of sample taken
Beschreibung

Drug and Alcohol Sreen - Date and time of sample taken

Datentyp

datetime

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C0001948
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0040223
UMLS CUI [2,3]
C0200345
Cocaine
Beschreibung

Cocaine

Datentyp

integer

Alias
UMLS CUI [1]
C0009170
Amphetamines
Beschreibung

Amphetamines

Datentyp

integer

Alias
UMLS CUI [1]
C0002667
Benzodiazepines
Beschreibung

Benzodiazepines

Datentyp

integer

Alias
UMLS CUI [1]
C0005064
Cannabinoids
Beschreibung

Cannabinoids

Datentyp

integer

Alias
UMLS CUI [1]
C0006864
Opiates
Beschreibung

Opiates

Datentyp

integer

Alias
UMLS CUI [1]
C0376196
Barbiturates
Beschreibung

Barbiturates

Datentyp

integer

Alias
UMLS CUI [1]
C0004745
Methadone
Beschreibung

Methadone

Datentyp

integer

Alias
UMLS CUI [1]
C0025605
Alcohol
Beschreibung

Alcohol

Datentyp

integer

Alias
UMLS CUI [1]
C0001948
Serology - HIV Screen
Beschreibung

Serology - HIV Screen

Alias
UMLS CUI-1
C0036743
UMLS CUI-2
C0459958
HIV Screen - Date sample taken
Beschreibung

HIV Screen - Date sample taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0459958
UMLS CUI [1,2]
C1302413
HIV antibody
Beschreibung

HIV antibody

Datentyp

integer

Alias
UMLS CUI [1]
C0019683
Hepatitis B surface antigen
Beschreibung

Hepatitis B surface antigen

Datentyp

integer

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Beschreibung

Hepatitis C antibody

Datentyp

integer

Alias
UMLS CUI [1]
C0201487
Electronically Transferred Laboratory Data
Beschreibung

Electronically Transferred Laboratory Data

Alias
UMLS CUI-1
C0745590
UMLS CUI-2
C1705822
Clinical Chemistry - Date Sample Taken
Beschreibung

Clinical Chemistry - Date Sample Taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C1302413
Clinical Chemistry - Actual Time
Beschreibung

Clinical Chemistry - Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0040223
Haematology - Date Sample Take
Beschreibung

Haematology - Date Sample Take

Datentyp

date

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C1302413
Haematology - Actual Time
Beschreibung

Haematology - Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0018941
UMLS CUI [1,2]
C0040223
Urinalysis - Date Sample Taken
Beschreibung

Urinalysis - Date Sample Taken

Datentyp

date

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C1302413
Urinalysis - Actual Time
Beschreibung

Urinalysis - Actual Time

Datentyp

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
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Ähnliche Modelle

Screening - Medical Conditions; Alcohol Intake; Drug and Alcohol Screen; Serology (HIV Screen); Electronically Transferred Lab Data

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Medical Conditions
C0012634 (UMLS CUI-1)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Status
integer
C0449438 (UMLS CUI [1])
Status
Code List
Status
CL Item
Current (1)
CL Item
Past (2)
Item Group
Alcohol Intake
C0001948 (UMLS CUI-1)
Does the subject consume alcohol?
Item
Does the subject consume alcohol?
boolean
C0001948 (UMLS CUI [1])
If subject consumes alcohol, record the average number of units of alcohol consumed per week
Item
If subject consumes alcohol, record the average number of units of alcohol consumed per week
float
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Item Group
Drug and Alcohol Sreen
C0373483 (UMLS CUI-1)
C0001948 (UMLS CUI-2)
Drug and Alcohol Sreen - Date and time of sample taken
Item
Drug and Alcohol Sreen - Date and time of sample taken
datetime
C0373483 (UMLS CUI [1,1])
C0001948 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
Item
Cocaine
integer
C0009170 (UMLS CUI [1])
Cocaine
Code List
Cocaine
CL Item
Positive (1)
CL Item
Negative (2)
Item
Amphetamines
integer
C0002667 (UMLS CUI [1])
Amphetamines
Code List
Amphetamines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Benzodiazepines
integer
C0005064 (UMLS CUI [1])
Benzodiazepines
Code List
Benzodiazepines
CL Item
Positive (1)
CL Item
Negative (2)
Item
Cannabinoids
integer
C0006864 (UMLS CUI [1])
Cannabinoids
Code List
Cannabinoids
CL Item
Positive (1)
CL Item
Negative (2)
Item
Opiates
integer
C0376196 (UMLS CUI [1])
Opiates
Code List
Opiates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Barbiturates
integer
C0004745 (UMLS CUI [1])
Barbiturates
Code List
Barbiturates
CL Item
Positive (1)
CL Item
Negative (2)
Item
Methadone
integer
C0025605 (UMLS CUI [1])
Methadone
Code List
Methadone
CL Item
Positive (1)
CL Item
Negative (2)
Item
Alcohol
integer
C0001948 (UMLS CUI [1])
Alcohol
Code List
Alcohol
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Serology - HIV Screen
C0036743 (UMLS CUI-1)
C0459958 (UMLS CUI-2)
HIV Screen - Date sample taken
Item
HIV Screen - Date sample taken
date
C0459958 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Item
HIV antibody
integer
C0019683 (UMLS CUI [1])
HIV antibody
Code List
HIV antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis B surface antigen
integer
C0019168 (UMLS CUI [1])
Hepatitis B surface antigen
Code List
Hepatitis B surface antigen
CL Item
Positive (1)
CL Item
Negative (2)
Item
Hepatitis C antibody
integer
C0201487 (UMLS CUI [1])
Hepatitis C antibody
Code List
Hepatitis C antibody
CL Item
Positive (1)
CL Item
Negative (2)
Item Group
Electronically Transferred Laboratory Data
C0745590 (UMLS CUI-1)
C1705822 (UMLS CUI-2)
Clinical Chemistry - Date Sample Taken
Item
Clinical Chemistry - Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Clinical Chemistry - Actual Time
Item
Clinical Chemistry - Actual Time
time
C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Haematology - Date Sample Take
Item
Haematology - Date Sample Take
date
C0018941 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Haematology - Actual Time
Item
Haematology - Actual Time
time
C0018941 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Urinalysis - Date Sample Taken
Item
Urinalysis - Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C1302413 (UMLS CUI [1,2])
Urinalysis - Actual Time
Item
Urinalysis - Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
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