Status:
COMPLETED
Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborating Sponsors:
Ionis Pharmaceuticals, Inc.
Conditions:
Hypercholesterolemia
Coronary Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in treating severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowerin...
Detailed Description
Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL). Elevated LDL is a major risk factor for coronary heart disease (CHD). Mipomersen is an antisense drug that r...
Eligibility Criteria
Inclusion
- Fasting LDL-C ≥200 mg/dL (5.1 mmol/L) at screening and the presence of at least 1 of the following criteria:
- Myocardial infarction (MI)
- Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
- Coronary artery disease documented by angiography or any other accepted imaging technique
- 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)
- Other clinical atherosclerotic diseases: peripheral artery disease, symptomatic carotid artery disease, abdominal aortic aneurysm
- Or, if alternative above were not met, fasting LDL-C ≥300 mg/dL (7.8 mmol/L)
- On stable, maximally tolerated statin therapy for 8 weeks
- On stable, medication from an additional class of hypolipidemic agents for 8 weeks.
- On stable, low fat diet for 12 weeks
- Stable weight for 6 weeks
Exclusion
- 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
- Apheresis within 3 months prior to Screening or expected to start apheresis during the treatment phase
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00794664
Start Date
January 1 2009
End Date
October 1 2010
Last Update
September 9 2016
Active Locations (27)
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1
Jupiter, Florida, United States, 33458
2
Winter Park, Florida, United States, 32792
3
Atlanta, Georgia, United States, 30338
4
Kansas City, Kansas, United States, 66160