Phase 3
Completed N=58
Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis
Source: ClinicalTrials.gov NCT00794664 ↗Enrolled (actual)
58
Serious AEs
10.3%
Results posted
Mar 2013
Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point — 12.5; -35.9 percentage of baseline — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Primary Efficacy Time Point |
12.5; -35.9 | <0.001 sig |
| PRIMARY LDL-C at Baseline and the Primary Efficacy Time Point (PET) |
249.4; 276.1; 263.9; 174.9 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein B (Apo-B) at Primary Efficacy Time Point |
11.41; -35.88 | <0.001 sig |
| SECONDARY Apo-B at Baseline and the Primary Efficacy Time Point (PET) |
182.8; 202.1; 193.7; 126.8 | — |
| SECONDARY Percentage Change From Baseline in Total Cholesterol at Primary Efficacy Time Point (PET) |
11.13; -28.31 | <0.001 sig |
| SECONDARY Total Cholesterol at Baseline and the Primary Efficacy Time Point (PET) |
320.6; 356.8; 341.5; 251.5 | — |
| SECONDARY Percentage Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at Primary Efficacy Time Point (PET) |
14.17; -33.95 | <0.001 sig |
| SECONDARY Non-HDL-C at Baseline and the Primary Efficacy Time Point (PET) |
277.5; 305.6; 296.7; 198.1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00794664). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.