Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Heterozygous Familial Hypercholesterolemia, Coronary Artery Disease

In brief

The purpose of this study is to determine whether mipomersen safely and effectively lowers low-density lipoprotein cholesterol (LDL-C) in patients with Heterozygous Familial Hypercholesterolemia (HeFH) and coronary artery disease (CAD) who are already on a stable dose of other lipid-lowering agents (including maximally tolerated statin therapy).

Key facts

Study ID

NCT00706849

Run by

Kastle Therapeutics, LLC

People needed

124

Starts

2008-07-01

Expected to finish

2010-05-01

Last updated by the study team

2016-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Heterozygous Familial Hypercholesterolemia (HeFH)
• Diagnosis of Coronary Artery Disease (CAD)
• Stable lipid-lowering therapy for 12 weeks
• On maximally tolerated statin therapy with at least 1 statin at a dose greater than zero, per Investigator judgment
• Stable low-fat diet for 8 weeks
• Stable weight for 6 weeks

You may not qualify if…

• Significant health problems in recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, orthostatic hypotension, uncontrolled hypertension, blood disorders, liver disease, cancer, or digestive problems
• Receiving apheresis treatment or last apheresis treatment within 8 weeks

Where it is running

• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Mission Viejo, California, United States
• Study site — Newport Beach, California, United States
• Study site — Santa Ana, California, United States
• Study site — Thousand Oaks, California, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Melbourne, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Naperville, Illinois, United States
• Study site — Kansas City, Kansas, United States
• Study site — Biddeford, Maine, United States
• Study site — Scarborough, Maine, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Concord, New Hampshire, United States
• Study site — New York, New York, United States
• The Rogosin Institute Comprehensive Lipid Control Center — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Durham, North Carolina, United States
• Study site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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