Overview

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

Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
0
Participant gender:
All
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-lowering regimen and who are not on apheresis.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kastle Therapeutics, LLC
Collaborator:
Ionis Pharmaceuticals, Inc.
Treatments:
Mipomersen
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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