Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia, Coronary Heart Disease

In brief

The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (CHD).

Key facts

Study ID

NCT00770146

Run by

Kastle Therapeutics, LLC

People needed

158

Starts

2008-11-01

Expected to finish

2010-10-01

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 hypercholesterolemia (LDL-C ≥ 100 mg/dL)
• At high risk of CHD
• On stable, maximally tolerated statin therapy for 8 weeks
• On stable, low fat diet for 12 weeks
• Stable weight for 6 weeks

You may not qualify if…

• Significant health problems in the recent past including heart attack, stroke, coronary syndrome, unstable angina, heart failure, significant arrhythmia, hypertension, liver disease, cancer, type I diabetes.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Huntsville, Alabama, United States
• Study site — Muscle Shoals, Alabama, United States
• Study site — Litchfield Park, Arizona, United States
• Study site — Beverly Hills, California, United States
• Study site — Escondido, 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 — San Diego, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Thousand Oaks, California, United States
• Study site — Westlake Village, California, United States
• Study site — Aventura, Florida, United States
• Study site — Inverness, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Longwood, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Ponte Verda, Florida, United States
• Study site — Port Orange, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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