ID

38878

Beschrijving

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

Trefwoorden

Versies (1)
  1. 11-11-19 11-11-19 -
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GlaxoSmithKline

Geüploaded op

11 november 2019

DOI

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Licentie

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

Engels

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

1 Formulieren  
Medical Conditions
Beschrijving

Medical Conditions

Alias
UMLS CUI-1
C0012634
Diagnosis
Beschrijving

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

Datatype

text

Alias
UMLS CUI [1]
C0011900
Status
Beschrijving

Status

Datatype

integer

Alias
UMLS CUI [1]
C0449438
Alcohol Intake
Beschrijving

Alcohol Intake

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

Does the subject consume alcohol?

Datatype

boolean

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

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

Datatype

float

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

Drug and Alcohol Sreen

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

Drug and Alcohol Sreen - Date and time of sample taken

Datatype

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
Beschrijving

Cocaine

Datatype

integer

Alias
UMLS CUI [1]
C0009170
Amphetamines
Beschrijving

Amphetamines

Datatype

integer

Alias
UMLS CUI [1]
C0002667
Benzodiazepines
Beschrijving

Benzodiazepines

Datatype

integer

Alias
UMLS CUI [1]
C0005064
Cannabinoids
Beschrijving

Cannabinoids

Datatype

integer

Alias
UMLS CUI [1]
C0006864
Opiates
Beschrijving

Opiates

Datatype

integer

Alias
UMLS CUI [1]
C0376196
Barbiturates
Beschrijving

Barbiturates

Datatype

integer

Alias
UMLS CUI [1]
C0004745
Methadone
Beschrijving

Methadone

Datatype

integer

Alias
UMLS CUI [1]
C0025605
Alcohol
Beschrijving

Alcohol

Datatype

integer

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

Serology - HIV Screen

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

HIV Screen - Date sample taken

Datatype

date

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

HIV antibody

Datatype

integer

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

Hepatitis B surface antigen

Datatype

integer

Alias
UMLS CUI [1]
C0019168
Hepatitis C antibody
Beschrijving

Hepatitis C antibody

Datatype

integer

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

Electronically Transferred Laboratory Data

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

Clinical Chemistry - Date Sample Taken

Datatype

date

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

Clinical Chemistry - Actual Time

Datatype

time

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

Haematology - Date Sample Take

Datatype

date

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

Haematology - Actual Time

Datatype

time

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

Urinalysis - Date Sample Taken

Datatype

date

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

Urinalysis - Actual Time

Datatype

time

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0040223
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Similar models

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

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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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