ID

39900

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00794664

Trefwoorden

Versies (1)
  1. 02-03-20 02-03-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 maart 2020

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Hypercholesterolemia NCT00794664

Engels

Eligibility Hypercholesterolemia NCT00794664

1 Formulieren  
Inclusion Criteria
Beschrijving

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:
Beschrijving

Serum fasting LDL cholesterol measurement

Datatype

boolean

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

Myocardial Infarction

Datatype

boolean

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

Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Datatype

boolean

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

Coronary Artery Disease Angiography | Coronary Artery Disease Imaging Technique

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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)
Beschrijving

Serum fasting LDL cholesterol measurement

Datatype

boolean

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

Statin therapy Maximum Tolerated Dose Stable

Datatype

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.
Beschrijving

Hypolipidemic Agents Additional Stable

Datatype

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
Beschrijving

Fat-Restricted Diet Stable

Datatype

boolean

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

Stable body weight

Datatype

boolean

Alias
UMLS CUI [1]
C0517386
Exclusion Criteria
Beschrijving

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
Beschrijving

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

Datatype

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
Beschrijving

Apheresis | Apheresis Expected

Datatype

boolean

Alias
UMLS CUI [1]
C0005791
UMLS CUI [2,1]
C0005791
UMLS CUI [2,2]
C1517001
Terug naar het begin van de pagina

Similar models

Eligibility Hypercholesterolemia NCT00794664

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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