ID

39125

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01462877

Keywords

versioni (1)
  1. 03/12/19 03/12/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

3 dicembre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Eligibility Dyslipidemias NCT01462877

Inglese

Eligibility Dyslipidemias NCT01462877

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

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

Age

Tipo di dati

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,
Descrizione

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

Tipo di dati

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)
Descrizione

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

Tipo di dati

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
Descrizione

Diabetes Mellitus, Non-Insulin-Dependent

Tipo di dati

boolean

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

Risk factors multiple | Risk Percentage Coronary heart disease

Tipo di dati

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
Descrizione

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

Tipo di dati

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)
Descrizione

Triglycerides measurement

Tipo di dati

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.
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

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

Fenofibrate allergy | Hypersensitivity Fenofibrate Excipient

Tipo di dati

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)]
Descrizione

Hepatic Insufficiency | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo di dati

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)]
Descrizione

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

Tipo di dati

boolean

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

Elevated creatine kinase

Tipo di dati

boolean

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

Galactosemia Congenital | Glucose-galactose malabsorption | Lactase deficiency

Tipo di dati

boolean

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

Hypothyroidism

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Combined Modality Therapy | Pharmaceutical Preparations Fenofibrate Similar | Ketoprofen

Tipo di dati

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
Descrizione

Combined Modality Therapy | Oral anticoagulants

Tipo di dati

boolean

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

Pregnancy | Breast Feeding

Tipo di dati

boolean

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

Condition Other

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0205394
Ritorna all'inizio della pagina

Similar models

Eligibility Dyslipidemias NCT01462877

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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])
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial