ID

39900

Beskrivning

Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis; ODM derived from: https://clinicaltrials.gov/show/NCT00794664

Länk

https://clinicaltrials.gov/show/NCT00794664

Nyckelord

Versioner (1)
  1. 2020-03-02 2020-03-02 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

2 mars 2020

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hypercholesterolemia NCT00794664

Engelsk

Eligibility Hypercholesterolemia NCT00794664

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
fasting ldl-c ≥200 mg/dl (5.1 mmol/l) at screening and the presence of at least 1 of the following criteria:
Beskrivning

Serum fasting LDL cholesterol measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0582830
myocardial infarction (mi)
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg)
Beskrivning

Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0010055
coronary artery disease documented by angiography or any other accepted imaging technique
Beskrivning

Coronary Artery Disease Angiography | Coronary Artery Disease Imaging Technique

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0002978
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0079595
positive exercise test (≥1 mm st-depression at maximal exercise or test terminated because of angina) or a perfusion defect (e.g., thallium or single photon emission computed tomography)
Beskrivning

Exercise test Positive | ST segment depression Exercise Maximal | Myocardial perfusion defect Localized study using thallium with tomography | Myocardial perfusion defect Single-Photon Emission-Computed Tomography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015260
UMLS CUI [1,2]
C1514241
UMLS CUI [2,1]
C0520887
UMLS CUI [2,2]
C0015259
UMLS CUI [2,3]
C0205289
UMLS CUI [3,1]
C0428858
UMLS CUI [3,2]
C0846135
UMLS CUI [4,1]
C0428858
UMLS CUI [4,2]
C0040399
other clinical atherosclerotic diseases: peripheral artery disease, symptomatic carotid artery disease, abdominal aortic aneurysm
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0004153
UMLS CUI [2]
C1704436
UMLS CUI [3,1]
C0007273
UMLS CUI [3,2]
C0231220
UMLS CUI [4]
C0162871
or, if alternative above were not met, fasting ldl-c ≥300 mg/dl (7.8 mmol/l)
Beskrivning

Serum fasting LDL cholesterol measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0582830
on stable, maximally tolerated statin therapy for 8 weeks
Beskrivning

Statin therapy Maximum Tolerated Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1278454
UMLS CUI [1,2]
C0752079
UMLS CUI [1,3]
C0205360
on stable, medication from an additional class of hypolipidemic agents for 8 weeks.
Beskrivning

Hypolipidemic Agents Additional Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0086440
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0205360
on stable, low fat diet for 12 weeks
Beskrivning

Fat-Restricted Diet Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242970
UMLS CUI [1,2]
C0205360
stable weight for 6 weeks
Beskrivning

Stable body weight

Datatyp

boolean

Alias
UMLS CUI [1]
C0517386
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
significant health problems in the recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, hypertension, blood disorders, liver disease, cancer, digestive disorders, type i diabetes, or uncontrolled type ii diabetes
Beskrivning

Medical Problem | Myocardial Infarction | Cerebrovascular accident | Acute Coronary Syndrome | Angina, Unstable | Heart failure | Cardiac Arrhythmia | Hypertensive disease | Hematological Disease | Liver disease | Malignant Neoplasms | Digestive System Disorders | Diabetes Mellitus, Insulin-Dependent | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED

Datatyp

boolean

Alias
UMLS CUI [1]
C1254481
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0948089
UMLS CUI [5]
C0002965
UMLS CUI [6]
C0018801
UMLS CUI [7]
C0003811
UMLS CUI [8]
C0020538
UMLS CUI [9]
C0018939
UMLS CUI [10]
C0023895
UMLS CUI [11]
C0006826
UMLS CUI [12]
C0012242
UMLS CUI [13]
C0011854
UMLS CUI [14]
C0743118
apheresis within 3 months prior to screening or expected to start apheresis during the treatment phase
Beskrivning

Apheresis | Apheresis Expected

Datatyp

boolean

Alias
UMLS CUI [1]
C0005791
UMLS CUI [2,1]
C0005791
UMLS CUI [2,2]
C1517001
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Similar models

Eligibility Hypercholesterolemia NCT00794664

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Serum fasting LDL cholesterol measurement
Item
fasting ldl-c ≥200 mg/dl (5.1 mmol/l) at screening and the presence of at least 1 of the following criteria:
boolean
C0582830 (UMLS CUI [1])
Myocardial Infarction
Item
myocardial infarction (mi)
boolean
C0027051 (UMLS CUI [1])
Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
percutaneous coronary intervention (pci) or coronary artery bypass graft (cabg)
boolean
C1532338 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Coronary Artery Disease Angiography | Coronary Artery Disease Imaging Technique
Item
coronary artery disease documented by angiography or any other accepted imaging technique
boolean
C1956346 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2,1])
C0079595 (UMLS CUI [2,2])
Exercise test Positive | ST segment depression Exercise Maximal | Myocardial perfusion defect Localized study using thallium with tomography | Myocardial perfusion defect Single-Photon Emission-Computed Tomography
Item
positive exercise test (≥1 mm st-depression at maximal exercise or test terminated because of angina) or a perfusion defect (e.g., thallium or single photon emission computed tomography)
boolean
C0015260 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0520887 (UMLS CUI [2,1])
C0015259 (UMLS CUI [2,2])
C0205289 (UMLS CUI [2,3])
C0428858 (UMLS CUI [3,1])
C0846135 (UMLS CUI [3,2])
C0428858 (UMLS CUI [4,1])
C0040399 (UMLS CUI [4,2])
Atherosclerosis | Peripheral Arterial Disease | Symptomatic Carotid Artery Disease | Aortic Aneurysm, Abdominal
Item
other clinical atherosclerotic diseases: peripheral artery disease, symptomatic carotid artery disease, abdominal aortic aneurysm
boolean
C0004153 (UMLS CUI [1])
C1704436 (UMLS CUI [2])
C0007273 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C0162871 (UMLS CUI [4])
Serum fasting LDL cholesterol measurement
Item
or, if alternative above were not met, fasting ldl-c ≥300 mg/dl (7.8 mmol/l)
boolean
C0582830 (UMLS CUI [1])
Statin therapy Maximum Tolerated Dose Stable
Item
on stable, maximally tolerated statin therapy for 8 weeks
boolean
C1278454 (UMLS CUI [1,1])
C0752079 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Hypolipidemic Agents Additional Stable
Item
on stable, medication from an additional class of hypolipidemic agents for 8 weeks.
boolean
C0086440 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Fat-Restricted Diet Stable
Item
on stable, low fat diet for 12 weeks
boolean
C0242970 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Stable body weight
Item
stable weight for 6 weeks
boolean
C0517386 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Medical Problem | Myocardial Infarction | Cerebrovascular accident | Acute Coronary Syndrome | Angina, Unstable | Heart failure | Cardiac Arrhythmia | Hypertensive disease | Hematological Disease | Liver disease | Malignant Neoplasms | Digestive System Disorders | Diabetes Mellitus, Insulin-Dependent | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED
Item
significant health problems in the recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, hypertension, blood disorders, liver disease, cancer, digestive disorders, type i diabetes, or uncontrolled type ii diabetes
boolean
C1254481 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0948089 (UMLS CUI [4])
C0002965 (UMLS CUI [5])
C0018801 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0020538 (UMLS CUI [8])
C0018939 (UMLS CUI [9])
C0023895 (UMLS CUI [10])
C0006826 (UMLS CUI [11])
C0012242 (UMLS CUI [12])
C0011854 (UMLS CUI [13])
C0743118 (UMLS CUI [14])
Apheresis | Apheresis Expected
Item
apheresis within 3 months prior to screening or expected to start apheresis during the treatment phase
boolean
C0005791 (UMLS CUI [1])
C0005791 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
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