Phase 3
Completed N=124
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
Heterozygous Familial Hypercholesterolemia · Coronary Artery Disease
Source: ClinicalTrials.gov NCT00706849 ↗
Enrolled (actual)
124
Serious AEs
6.5%
Results posted
Mar 2013
Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point — 5.17; -28.02 percentage of Baseline — p=<0.001
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point |
5.17; -28.02 | <0.001 sig |
| PRIMARY LDL Cholesterol at Baseline and at the Primary Efficacy Time Point |
142.9; 152.9; 146.4; 103.9 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point |
7.02; -26.31 | <0.001 sig |
| SECONDARY Apolipoprotein B at Baseline and at the Primary Efficacy Time Point |
126.8; 132.8; 133.8; 95.0 | — |
| SECONDARY Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point |
3.85; -19.43 | <0.001 sig |
| SECONDARY Total Cholesterol at Baseline and at the Primary Efficacy Time Point |
213.4; 225.3; 219.0; 176.0 | — |
| SECONDARY Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point |
3.74; -25.05 | <0.001 sig |
| SECONDARY Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point |
165.3; 175.5; 168.2; 125.2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00706849). 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.