Phase 2
N=34
Safety and Efficacy Study of ISIS 301012 (Mipomersen) Administration in High Risk Statin Intolerant Subjects
Metabolic Diseases · Hyperlipidemias · Metabolic Disorder · Hypercholesterolemia · Dyslipidemias
Bottom Line
View on ClinicalTrials.gov: NCT00707746 ↗Enrolled (actual)
34
Serious AEs
3.0%
Results posted
Apr 2013
Primary outcome: Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point — -2.0; -47.3 percentage of baseline — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- mipomersen (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kastle Therapeutics, LLC
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point |
-2.0; -47.3 | <0.001 sig |
| PRIMARY Low-density Lipoprotein Cholesterol at Baseline and the Primary Efficacy Time Point |
243.7; 241.9; 236.3; 128.3 | — |
| PRIMARY Summary of Participants With Adverse Events |
3; 7; 9; 20; 12; 21 | — |
| SECONDARY Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point |
-4.0; -45.8 | <0.001 sig |
| SECONDARY Apolipoprotein B at Baseline and at the Primary Efficacy Time Point |
180; 177; 173; 96 | — |
| SECONDARY Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point |
-1.7; -36.9 | <0.001 sig |
| SECONDARY Total Cholesterol at Baseline and at the Primary Efficacy Time Point |
322.3; 318.9; 314.5; 200.1 | — |
| SECONDARY Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point |
-1.9; -45.6 | <0.001 sig |
| SECONDARY Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point |
273.5; 270.1; 266.0; 147.7 | — |
Summary
The purpose of this study is to determine safety and efficacy of mipomersen (ISIS 301012) in the reduction of total cholesterol, low density lipoprotein cholesterol (LDL-C), and apolipoprotein B (apoB) in high risk subjects intolerant to statins.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of statin intolerance
- Diagnosis of Coronary Artery Disease (CAD)
- Diagnosis of hypercholesterolemia
- Stable weight for > 6 weeks
Exclusion Criteria
- Significant health problems in the recent past (≤24 weeks) including heart attack, heart surgery, heart failure, uncontrolled hypothyroidism, blood disorders, digestive problems, disease of central nervous system, cancer, liver or renal disease
Data sourced from ClinicalTrials.gov (NCT00707746). 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.