Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia, Coronary Heart Disease

In brief

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-lowering regimen and who are not on apheresis.

Key facts

Study ID

NCT00794664

Run by

Kastle Therapeutics, LLC

People needed

58

Starts

2009-01-01

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…

• 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

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, 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

Where it is running

• Study site — Jupiter, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Kansas City, Kansas, United States
• Study site — Boston, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Concord, New Hampshire, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Aiken, South Carolina, United States
• Study site — Winnipeg, Manitoba, Canada
• Study site — Chicoutimi, Quebec, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Hardec Kralove, Czechia
• Study site — Pilsen, Czechia
• Study site — Prague, Czechia
• Study site — Uherské Hradiště, Czechia
• Study site — Berlin, Germany
• Study site — Freiburg im Breisgau, Germany
• Study site — Heidelberg, Germany
• Study site — Koln (Lindenthal), Germany
• Study site — Cape Town, South Africa
• Study site — Cape Town, South Africa
• Study site — Gauteng, South Africa
• Study site — Pretoria, South Africa
• Study site — Guildford, Surrey, United Kingdom

Full record on ClinicalTrials.gov

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