ID

19942

Description

Vytorin Treating Uncontrolled Lipids (VyTUL) Study (TERMINATED); ODM derived from: https://clinicaltrials.gov/show/NCT00395603

Link

https://clinicaltrials.gov/show/NCT00395603

Keywords

  1. 1/31/17 1/31/17 -
Uploaded on

January 31, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Cardiovascular Diseases NCT00395603

Eligibility Cardiovascular Diseases NCT00395603

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
greater than 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
Description

atorvastatin Dose U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C0286651
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0456683
existing coronary heart disease and cholesterol > 4.0 mmol/l
Description

Coronary heart disease | Cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0201950
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled diabetes
Description

Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1]
C0421258
elevated liver function tests
Description

Increased liver function tests

Data type

boolean

Alias
UMLS CUI [1]
C0877359
elevated creatine kinase (ck)
Description

Elevated creatine kinase

Data type

boolean

Alias
UMLS CUI [1]
C0151576
triglycerides (tg) > 4.5 mmol/l
Description

Triglycerides measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202236
drug or alcohol dependency within 6 months prior to visit 1
Description

Substance Dependence

Data type

boolean

Alias
UMLS CUI [1]
C0038580
woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
Description

Gender Hormone Therapy Unstable | Continuing therapy Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C0443343
UMLS CUI [2,1]
C1553904
UMLS CUI [2,2]
C0600109
woman of childbearing potential not using an acceptable method of birth control
Description

Childbearing Potential Contraceptive methods Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0332268
women who are pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147

Similar models

Eligibility Cardiovascular Diseases NCT00395603

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
greater than 18 years of age
boolean
C0001779 (UMLS CUI [1])
atorvastatin Dose U/day
Item
treated for at least the last 3 months with a daily dose of atorvastatin 40 mg
boolean
C0286651 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Coronary heart disease | Cholesterol measurement
Item
existing coronary heart disease and cholesterol > 4.0 mmol/l
boolean
C0010068 (UMLS CUI [1])
C0201950 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Diabetic - poor control
Item
uncontrolled diabetes
boolean
C0421258 (UMLS CUI [1])
Increased liver function tests
Item
elevated liver function tests
boolean
C0877359 (UMLS CUI [1])
Elevated creatine kinase
Item
elevated creatine kinase (ck)
boolean
C0151576 (UMLS CUI [1])
Triglycerides measurement
Item
triglycerides (tg) > 4.5 mmol/l
boolean
C0202236 (UMLS CUI [1])
Substance Dependence
Item
drug or alcohol dependency within 6 months prior to visit 1
boolean
C0038580 (UMLS CUI [1])
Gender Hormone Therapy Unstable | Continuing therapy Willing
Item
woman receiving hormonal therapy who have not been maintained on a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen for the duration of the study
boolean
C0079399 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0443343 (UMLS CUI [1,3])
C1553904 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods Lacking
Item
woman of childbearing potential not using an acceptable method of birth control
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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