ID

39125

Beskrivning

A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic; ODM derived from: https://clinicaltrials.gov/show/NCT01462877

Länk

https://clinicaltrials.gov/show/NCT01462877

Nyckelord

Versioner (1)
  1. 2019-12-03 2019-12-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 december 2019

DOI

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Creative Commons BY 4.0
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Eligibility Dyslipidemias NCT01462877

Engelsk

Eligibility Dyslipidemias NCT01462877

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. ≥18 years and < 80 years, male or female
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
2. with at least one risk of coronary heart disease (chd) [medical history of myocardial infarction (mi) or coronary angiography shows coronary stenosis ≥ 50% or post percutaneous coronary intervention (pci) or post coronary artery bypass grafting (cabg)] or chd risk equivalents, which comprise,
Beskrivning

Risk Quantity Coronary heart disease | Myocardial Infarction | Coronary Stenosis Percentage Coronary angiography | Status post Percutaneous Coronary Intervention | Status post Coronary Artery Bypass Surgery | Coronary heart disease Risk Equivalent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035647
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0010068
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C0242231
UMLS CUI [3,2]
C0439165
UMLS CUI [3,3]
C0085532
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C1532338
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0010055
UMLS CUI [6,1]
C0010068
UMLS CUI [6,2]
C0035647
UMLS CUI [6,3]
C0205163
other clinical forms of atherosclerotic disease (ischemic stroke, peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease)
Beskrivning

Atherosclerosis | Ischemic stroke | Peripheral Arterial Disease | Aortic Aneurysm, Abdominal | Carotid Artery Disease Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0004153
UMLS CUI [2]
C0948008
UMLS CUI [3]
C1704436
UMLS CUI [4]
C0162871
UMLS CUI [5,1]
C0007273
UMLS CUI [5,2]
C0231220
type 2 diabetes
Beskrivning

Diabetes Mellitus, Non-Insulin-Dependent

Datatyp

boolean

Alias
UMLS CUI [1]
C0011860
multiple risk factors that confer a 10-year risk for chd >20%.
Beskrivning

Risk factors multiple | Risk Percentage Coronary heart disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0439064
UMLS CUI [2,1]
C0035647
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0010068
3. ≥ 2 months statin monotherapy with standard dose (atorvastatin ≤20mg q.d. or rosuvastatin ≤10mg q.d. or simvastatin ≤40mg q.d. or pravastatin ≤40mg q.d. or pitavastatin ≤4mg q.d or fluvastatin ≤80mg q.d. or lovastatin ≤40mg q.d.) and plan to continue the previous type and dose of statin
Beskrivning

Statins Standard dose | atorvastatin U/day | rosuvastatin U/day | Simvastatin U/day | Pravastatin U/day | pitavastatin U/day | fluvastatin U/day | Lovastatin U/day | Statins Dose Continue Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0360714
UMLS CUI [1,2]
C1442989
UMLS CUI [1,3]
C0178602
UMLS CUI [2,1]
C0286651
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0965129
UMLS CUI [3,2]
C0456683
UMLS CUI [4,1]
C0074554
UMLS CUI [4,2]
C0456683
UMLS CUI [5,1]
C0085542
UMLS CUI [5,2]
C0456683
UMLS CUI [6,1]
C1101838
UMLS CUI [6,2]
C0456683
UMLS CUI [7,1]
C0082608
UMLS CUI [7,2]
C0456683
UMLS CUI [8,1]
C0024027
UMLS CUI [8,2]
C0456683
UMLS CUI [9,1]
C0360714
UMLS CUI [9,2]
C0178602
UMLS CUI [9,3]
C0549178
UMLS CUI [9,4]
C1301732
4. triglycerides (tg)≥1.70 mmol/l (150mg/dl) and tg<5.65 mmol/l (500mg/dl)
Beskrivning

Triglycerides measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0202236
5. subject must be able to provide informed consent, approved by an independent ethics committee (iec)/institutional review board (irb), on his or her own behalf, prior to any study-specific procedures.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. hypersensitive to fenofibrate or to any of its excipients
Beskrivning

Fenofibrate allergy | Hypersensitivity Fenofibrate Excipient

Datatyp

boolean

Alias
UMLS CUI [1]
C0571869
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0033228
UMLS CUI [2,3]
C0015237
2. hepatic insufficiency [alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 2uln (upper limit of normal)]
Beskrivning

Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased

Datatyp

boolean

Alias
UMLS CUI [1]
C1306571
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
3. renal insufficiency [creatinine clearance rate (ccr)<60ml/min estimated from cockcroft-gault equation ccr=(140-age)*weight(kg)*0.85(if female)/[0.818*cr (µmol/l)]
Beskrivning

Renal Insufficiency | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2711451
4. creatine kinase (ck) > 2 uln
Beskrivning

Elevated creatine kinase

Datatyp

boolean

Alias
UMLS CUI [1]
C0151576
5. congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency
Beskrivning

Galactosemia Congenital | Glucose-galactose malabsorption | Lactase deficiency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0016952
UMLS CUI [1,2]
C1744681
UMLS CUI [2]
C0268186
UMLS CUI [3]
C0302813
6. hypothyroidism
Beskrivning

Hypothyroidism

Datatyp

boolean

Alias
UMLS CUI [1]
C0020676
7. combination use of other non-statin lipid-regulating drugs such as fibrates, niacin and fish oil in previous 2 months
Beskrivning

Combined Modality Therapy | Hypolipidemic Agents | Exception Statins | Fibrates | Niacin | Fish Oil

Datatyp

boolean

Alias
UMLS CUI [1]
C0009429
UMLS CUI [2]
C0086440
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0360714
UMLS CUI [4]
C1449704
UMLS CUI [5]
C0027996
UMLS CUI [6]
C0016157
8. combination use of drug with similar structure as fenofibrate, especially ketoprofen
Beskrivning

Combined Modality Therapy | Pharmaceutical Preparations Fenofibrate Similar | Ketoprofen

Datatyp

boolean

Alias
UMLS CUI [1]
C0009429
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0033228
UMLS CUI [2,3]
C2348205
UMLS CUI [3]
C0022635
9. combination use of oral anticoagulants
Beskrivning

Combined Modality Therapy | Oral anticoagulants

Datatyp

boolean

Alias
UMLS CUI [1]
C0009429
UMLS CUI [2]
C0354604
10. pregnant or lactating woman
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
11. other conditions at investigator's discretion
Beskrivning

Condition Other

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205394
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Similar models

Eligibility Dyslipidemias NCT01462877

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. ≥18 years and < 80 years, male or female
boolean
C0001779 (UMLS CUI [1])
Risk Quantity Coronary heart disease | Myocardial Infarction | Coronary Stenosis Percentage Coronary angiography | Status post Percutaneous Coronary Intervention | Status post Coronary Artery Bypass Surgery | Coronary heart disease Risk Equivalent
Item
2. with at least one risk of coronary heart disease (chd) [medical history of myocardial infarction (mi) or coronary angiography shows coronary stenosis ≥ 50% or post percutaneous coronary intervention (pci) or post coronary artery bypass grafting (cabg)] or chd risk equivalents, which comprise,
boolean
C0035647 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0010068 (UMLS CUI [1,3])
C0027051 (UMLS CUI [2])
C0242231 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0085532 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C1532338 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C0010055 (UMLS CUI [5,2])
C0010068 (UMLS CUI [6,1])
C0035647 (UMLS CUI [6,2])
C0205163 (UMLS CUI [6,3])
Atherosclerosis | Ischemic stroke | Peripheral Arterial Disease | Aortic Aneurysm, Abdominal | Carotid Artery Disease Symptomatic
Item
other clinical forms of atherosclerotic disease (ischemic stroke, peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease)
boolean
C0004153 (UMLS CUI [1])
C0948008 (UMLS CUI [2])
C1704436 (UMLS CUI [3])
C0162871 (UMLS CUI [4])
C0007273 (UMLS CUI [5,1])
C0231220 (UMLS CUI [5,2])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes
boolean
C0011860 (UMLS CUI [1])
Risk factors multiple | Risk Percentage Coronary heart disease
Item
multiple risk factors that confer a 10-year risk for chd >20%.
boolean
C0035648 (UMLS CUI [1,1])
C0439064 (UMLS CUI [1,2])
C0035647 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0010068 (UMLS CUI [2,3])
Statins Standard dose | atorvastatin U/day | rosuvastatin U/day | Simvastatin U/day | Pravastatin U/day | pitavastatin U/day | fluvastatin U/day | Lovastatin U/day | Statins Dose Continue Planned
Item
3. ≥ 2 months statin monotherapy with standard dose (atorvastatin ≤20mg q.d. or rosuvastatin ≤10mg q.d. or simvastatin ≤40mg q.d. or pravastatin ≤40mg q.d. or pitavastatin ≤4mg q.d or fluvastatin ≤80mg q.d. or lovastatin ≤40mg q.d.) and plan to continue the previous type and dose of statin
boolean
C0360714 (UMLS CUI [1,1])
C1442989 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0286651 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0965129 (UMLS CUI [3,1])
C0456683 (UMLS CUI [3,2])
C0074554 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0085542 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
C1101838 (UMLS CUI [6,1])
C0456683 (UMLS CUI [6,2])
C0082608 (UMLS CUI [7,1])
C0456683 (UMLS CUI [7,2])
C0024027 (UMLS CUI [8,1])
C0456683 (UMLS CUI [8,2])
C0360714 (UMLS CUI [9,1])
C0178602 (UMLS CUI [9,2])
C0549178 (UMLS CUI [9,3])
C1301732 (UMLS CUI [9,4])
Triglycerides measurement
Item
4. triglycerides (tg)≥1.70 mmol/l (150mg/dl) and tg<5.65 mmol/l (500mg/dl)
boolean
C0202236 (UMLS CUI [1])
Informed Consent
Item
5. subject must be able to provide informed consent, approved by an independent ethics committee (iec)/institutional review board (irb), on his or her own behalf, prior to any study-specific procedures.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Fenofibrate allergy | Hypersensitivity Fenofibrate Excipient
Item
1. hypersensitive to fenofibrate or to any of its excipients
boolean
C0571869 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0033228 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
2. hepatic insufficiency [alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 2uln (upper limit of normal)]
boolean
C1306571 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
Renal Insufficiency | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
3. renal insufficiency [creatinine clearance rate (ccr)<60ml/min estimated from cockcroft-gault equation ccr=(140-age)*weight(kg)*0.85(if female)/[0.818*cr (µmol/l)]
boolean
C1565489 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Elevated creatine kinase
Item
4. creatine kinase (ck) > 2 uln
boolean
C0151576 (UMLS CUI [1])
Galactosemia Congenital | Glucose-galactose malabsorption | Lactase deficiency
Item
5. congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency
boolean
C0016952 (UMLS CUI [1,1])
C1744681 (UMLS CUI [1,2])
C0268186 (UMLS CUI [2])
C0302813 (UMLS CUI [3])
Hypothyroidism
Item
6. hypothyroidism
boolean
C0020676 (UMLS CUI [1])
Combined Modality Therapy | Hypolipidemic Agents | Exception Statins | Fibrates | Niacin | Fish Oil
Item
7. combination use of other non-statin lipid-regulating drugs such as fibrates, niacin and fish oil in previous 2 months
boolean
C0009429 (UMLS CUI [1])
C0086440 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0360714 (UMLS CUI [3,2])
C1449704 (UMLS CUI [4])
C0027996 (UMLS CUI [5])
C0016157 (UMLS CUI [6])
Combined Modality Therapy | Pharmaceutical Preparations Fenofibrate Similar | Ketoprofen
Item
8. combination use of drug with similar structure as fenofibrate, especially ketoprofen
boolean
C0009429 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0033228 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C0022635 (UMLS CUI [3])
Combined Modality Therapy | Oral anticoagulants
Item
9. combination use of oral anticoagulants
boolean
C0009429 (UMLS CUI [1])
C0354604 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
10. pregnant or lactating woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Condition Other
Item
11. other conditions at investigator's discretion
boolean
C0348080 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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