ID

29014

Description

Effect of Ezetimibe or Simvastatin or Both on Low Densitiy Lipoprotein -Subfractions in Patients With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01384058

Link

https://clinicaltrials.gov/show/NCT01384058

Keywords

Versions (1)
  1. 2/20/18 2/20/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 20, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus Type 2 NCT01384058

English

Eligibility Diabetes Mellitus Type 2 NCT01384058

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
men > 18 and ≤ 75 years
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
post-menopausal women ≤ 75 years (follicle stimulating hormone (fsh) >30 miu/ml, women > 60 years fsh > 20 miu/ml )
Description

Gender | Age | Postmenopausal state | Follicle stimulating hormone measurement

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0202022
well controlled diabetes mellitus type ii (glycohaemoglobin ≤ 8,0 %)
Description

Non-Insulin-Dependent Diabetes Mellitus Well controlled | Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C3853142
UMLS CUI [2]
C0202054
ldl-cholesterol ≤ 160 mg/dl
Description

Serum LDL cholesterol measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428474
ldl-subfractions: concentration of apob-100 in dldl (ldl-5 und ldl-6) > 25 mg/dl
Description

Low density lipoprotein subfraction | Apolipoprotein B-100 | serum LDL cholesterol direct assay | LDL 5 | LDL 6

Data type

boolean

Alias
UMLS CUI [1]
C0578543
UMLS CUI [2]
C0205666
UMLS CUI [3]
C2210338
UMLS CUI [4]
C3167220
UMLS CUI [5]
C1954747
written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participation in a clinical trial within the last 30 d before screening- visit
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
patient is unable to give written informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
body mass index <15 kg/m² and > 35 kg/m²
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
Description

Atherosclerosis | Coronary heart disease | Peripheral Arterial Diseases | Carotid Artery Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0004153
UMLS CUI [2]
C0010068
UMLS CUI [3]
C1704436
UMLS CUI [4]
C0007273
malignoma
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
uncontrolled arterial hypertension (>160/>100 mmhg)
Description

Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C1868885
clinically relevant disease of liver and/or kidneys
Description

Liver diseases | Kidney Diseases

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
clinically relevant endocrinally or hematologic problems
Description

Endocrine System Diseases | Hematological Disease

Data type

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C0018939
allergy to study medication (ezetimibe and/or simvastatin)
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Ezetimibe | Simvastatin allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1142985
UMLS CUI [3]
C0571874
alcohol- or drug abuse
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
laboratory: alanine aminotransferase, aspartate aminotransferase, total bilirubin > 3 x uln, creatine kinase > 5 x uln
Description

Laboratory Results | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin | Serum creatinine raised

Data type

boolean

Alias
UMLS CUI [1]
C1254595
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0741494
UMLS CUI [5]
C0700225
concurrent treatment with potent cyp3a4-inhibitors (e.g. itraconazole, ketoconazole, hiv-protease-inhibitors, erythromycin, clarithromycin, telithromycin und nefazodone)
Description

CYP3A4 Inhibitors | Itraconazole | Ketoconazole | HIV Protease Inhibitors | Erythromycin | Clarithromycin | telithromycin | nefazodone

Data type

boolean

Alias
UMLS CUI [1]
C3850053
UMLS CUI [2]
C0064113
UMLS CUI [3]
C0022625
UMLS CUI [4]
C0162714
UMLS CUI [5]
C0014806
UMLS CUI [6]
C0055856
UMLS CUI [7]
C0907410
UMLS CUI [8]
C0068485
other relevant diseases
Description

Disease Relevant

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2347946
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Similar models

Eligibility Diabetes Mellitus Type 2 NCT01384058

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
men > 18 and ≤ 75 years
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Gender | Age | Postmenopausal state | Follicle stimulating hormone measurement
Item
post-menopausal women ≤ 75 years (follicle stimulating hormone (fsh) >30 miu/ml, women > 60 years fsh > 20 miu/ml )
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C0202022 (UMLS CUI [4])
Non-Insulin-Dependent Diabetes Mellitus Well controlled | Glucohemoglobin measurement
Item
well controlled diabetes mellitus type ii (glycohaemoglobin ≤ 8,0 %)
boolean
C0011860 (UMLS CUI [1,1])
C3853142 (UMLS CUI [1,2])
C0202054 (UMLS CUI [2])
Serum LDL cholesterol measurement
Item
ldl-cholesterol ≤ 160 mg/dl
boolean
C0428474 (UMLS CUI [1])
Low density lipoprotein subfraction | Apolipoprotein B-100 | serum LDL cholesterol direct assay | LDL 5 | LDL 6
Item
ldl-subfractions: concentration of apob-100 in dldl (ldl-5 und ldl-6) > 25 mg/dl
boolean
C0578543 (UMLS CUI [1])
C0205666 (UMLS CUI [2])
C2210338 (UMLS CUI [3])
C3167220 (UMLS CUI [4])
C1954747 (UMLS CUI [5])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
participation in a clinical trial within the last 30 d before screening- visit
boolean
C2348568 (UMLS CUI [1])
Informed Consent Unable
Item
patient is unable to give written informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Body mass index
Item
body mass index <15 kg/m² and > 35 kg/m²
boolean
C1305855 (UMLS CUI [1])
Atherosclerosis | Coronary heart disease | Peripheral Arterial Diseases | Carotid Artery Diseases
Item
clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease)
boolean
C0004153 (UMLS CUI [1])
C0010068 (UMLS CUI [2])
C1704436 (UMLS CUI [3])
C0007273 (UMLS CUI [4])
Malignant Neoplasms
Item
malignoma
boolean
C0006826 (UMLS CUI [1])
Uncontrolled hypertension
Item
uncontrolled arterial hypertension (>160/>100 mmhg)
boolean
C1868885 (UMLS CUI [1])
Liver diseases | Kidney Diseases
Item
clinically relevant disease of liver and/or kidneys
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
Endocrine System Diseases | Hematological Disease
Item
clinically relevant endocrinally or hematologic problems
boolean
C0014130 (UMLS CUI [1])
C0018939 (UMLS CUI [2])
Hypersensitivity Investigational New Drugs | Hypersensitivity Ezetimibe | Simvastatin allergy
Item
allergy to study medication (ezetimibe and/or simvastatin)
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1142985 (UMLS CUI [2,2])
C0571874 (UMLS CUI [3])
Substance Use Disorders
Item
alcohol- or drug abuse
boolean
C0038586 (UMLS CUI [1])
Laboratory Results | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin | Serum creatinine raised
Item
laboratory: alanine aminotransferase, aspartate aminotransferase, total bilirubin > 3 x uln, creatine kinase > 5 x uln
boolean
C1254595 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
CYP3A4 Inhibitors | Itraconazole | Ketoconazole | HIV Protease Inhibitors | Erythromycin | Clarithromycin | telithromycin | nefazodone
Item
concurrent treatment with potent cyp3a4-inhibitors (e.g. itraconazole, ketoconazole, hiv-protease-inhibitors, erythromycin, clarithromycin, telithromycin und nefazodone)
boolean
C3850053 (UMLS CUI [1])
C0064113 (UMLS CUI [2])
C0022625 (UMLS CUI [3])
C0162714 (UMLS CUI [4])
C0014806 (UMLS CUI [5])
C0055856 (UMLS CUI [6])
C0907410 (UMLS CUI [7])
C0068485 (UMLS CUI [8])
Disease Relevant
Item
other relevant diseases
boolean
C0012634 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
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