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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kastle Therapeutics, LLC
• Collaborator: Ionis Pharmaceuticals, Inc.
• Treatments: Mipomersen

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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