ID

29280

Description

The Efficacy and Tolerability of Two Formulations of Atorvastatin In Korean Adult With Hypercholesterolemia; ODM derived from: https://clinicaltrials.gov/show/NCT01285544

Link

https://clinicaltrials.gov/show/NCT01285544

Keywords

Versions (1)
  1. 3/15/18 3/15/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 15, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Dyslipidemia NCT01285544

English

Eligibility Dyslipidemia NCT01285544

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had ldl-c level over 100 mg/dl in high risk group.
Description

Age | Primary hypercholesterolemia | Lifestyle change therapy Unsatisfactory | Serum LDL cholesterol measurement High risk

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0342879
UMLS CUI [3,1]
C2960841
UMLS CUI [3,2]
C0439856
UMLS CUI [4,1]
C0428474
UMLS CUI [4,2]
C0332167
inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with ldl-c ≥100 mg/dl; patients with two or more risk factors and ldl-c≥130 mg/dl; patients with 0 or 1 risk factor and ldl-c >160 mg/dl after therapeutic lifestyle changes
Description

Coronary Artery Disease | Serum LDL cholesterol measurement | Risk factors Quantity | Lifestyle change therapy

Data type

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0428474
UMLS CUI [3,1]
C0035648
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C2960841
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
therapy with any other investigational drug within 30 days of randomization,
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
history of hypersensitivity to hmg-coa reductase inhibitors,
Description

HMG COA reductase inhibitor allergy

Data type

boolean

Alias
UMLS CUI [1]
C0571873
uncontrolled hypertension,
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
poorly controlled diabetes (glycosylated hemoglobin [hba1c] >9%),
Description

Poorly controlled diabetes mellitus | Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0554876
UMLS CUI [2]
C0202054
unstable angina or presented with new-onset myocardial infarction (within 6 months),
Description

Angina, Unstable | Myocardial Infarction New onset

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0027051
UMLS CUI [2,2]
C0746890
creatinine >2.5 mg/dl,
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
alanine aminotransferase (alt) >2 x upper limit of normal (uln), aspartate aminotransferase(ast) >2 x uln, or creatine kinase (ck) >2 x uln,
Description

Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated creatine kinase

Data type

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151576
history of malignancy or psychosis;
Description

Malignant Neoplasms | Psychotic Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0033975
chronic liver disease,
Description

Chronic liver disease

Data type

boolean

Alias
UMLS CUI [1]
C0341439
drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.
Description

Substance Use Disorders | Pregnancy | Breast Feeding | Contraceptive methods failed | Contraceptives, Oral, Hormonal | Hormone replacement therapy

Data type

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C0231175
UMLS CUI [5]
C0009907
UMLS CUI [6]
C0282402
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Similar models

Eligibility Dyslipidemia NCT01285544

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Primary hypercholesterolemia | Lifestyle change therapy Unsatisfactory | Serum LDL cholesterol measurement High risk
Item
the patients aged 20 to 79 years with primary hypercholesterolemia that was not sufficiently responsive to therapeutic lifestyle changes and had ldl-c level over 100 mg/dl in high risk group.
boolean
C0001779 (UMLS CUI [1])
C0342879 (UMLS CUI [2])
C2960841 (UMLS CUI [3,1])
C0439856 (UMLS CUI [3,2])
C0428474 (UMLS CUI [4,1])
C0332167 (UMLS CUI [4,2])
Coronary Artery Disease | Serum LDL cholesterol measurement | Risk factors Quantity | Lifestyle change therapy
Item
inclusion criteria was in accordance with drug treatment guidelines; coronary artery disease or equivalent group with ldl-c ≥100 mg/dl; patients with two or more risk factors and ldl-c≥130 mg/dl; patients with 0 or 1 risk factor and ldl-c >160 mg/dl after therapeutic lifestyle changes
boolean
C1956346 (UMLS CUI [1])
C0428474 (UMLS CUI [2])
C0035648 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C2960841 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
therapy with any other investigational drug within 30 days of randomization,
boolean
C0013230 (UMLS CUI [1])
HMG COA reductase inhibitor allergy
Item
history of hypersensitivity to hmg-coa reductase inhibitors,
boolean
C0571873 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled hypertension,
boolean
C1868885 (UMLS CUI [1])
Poorly controlled diabetes mellitus | Glucohemoglobin measurement
Item
poorly controlled diabetes (glycosylated hemoglobin [hba1c] >9%),
boolean
C0554876 (UMLS CUI [1])
C0202054 (UMLS CUI [2])
Angina, Unstable | Myocardial Infarction New onset
Item
unstable angina or presented with new-onset myocardial infarction (within 6 months),
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2,1])
C0746890 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
creatinine >2.5 mg/dl,
boolean
C0201976 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated creatine kinase
Item
alanine aminotransferase (alt) >2 x upper limit of normal (uln), aspartate aminotransferase(ast) >2 x uln, or creatine kinase (ck) >2 x uln,
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151576 (UMLS CUI [3])
Malignant Neoplasms | Psychotic Disorders
Item
history of malignancy or psychosis;
boolean
C0006826 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
Chronic liver disease
Item
chronic liver disease,
boolean
C0341439 (UMLS CUI [1])
Substance Use Disorders | Pregnancy | Breast Feeding | Contraceptive methods failed | Contraceptives, Oral, Hormonal | Hormone replacement therapy
Item
drug or alcohol abuse, pregnancy, breastfeeding, failure to practice adequate contraception, cyclical hormonal contraceptives or intermittent use of hormone replacement therapies.
boolean
C0038586 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0231175 (UMLS CUI [4,2])
C0009907 (UMLS CUI [5])
C0282402 (UMLS CUI [6])
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