Phase 3 Completed N=158 Randomized Quadruple-blind Treatment

Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients

Hypercholesterolemia · Heart Failure

Source: ClinicalTrials.gov NCT00770146 ↗

Enrolled (actual)

158

Serious AEs

7.0%

Results posted

Mar 2013

Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point — -3.4; -40.2 percentage of baseline — p=<0.001

Summary

The purpose of this study is to evaluate the safety and efficacy of dosing with mipomersen for 26 weeks in patients with high cholesterol who are on a maximally tolerated dose of statin and who have a diagnosis that puts them at least at high risk of coronary heart disease (CHD).

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at the Primary Efficacy Time Point	-3.4; -40.2	<0.001 sig
PRIMARY Low-density Lipoprotein Cholesterol (LDL-C) at Baseline and at the Primary Efficacy Time Point	112; 116; 109; 69	—
SECONDARY Percent Change From Baseline in Apolipoprotein B at the Primary Efficacy Time Point	-1.7; -40.6	<0.001 sig
SECONDARY Apolipoprotein B at Baseline and at the Primary Efficacy Time Point	106; 114; 108; 64	—
SECONDARY Percent Change From Baseline in Total Cholesterol at the Primary Efficacy Time Point	-2.7; -26.4	<0.001 sig
SECONDARY Total Cholesterol at Baseline and at the Primary Efficacy Time Point	200.0; 202.6; 192.2; 147.4	—
SECONDARY Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol at the Primary Efficacy Time Point	-1.2; -38.7	<0.001 sig
SECONDARY Non-High-Density Lipoprotein Cholesterol at Baseline and at the Primary Efficacy Time Point	144; 144; 140; 90	—

Eligibility Criteria

Inclusion Criteria

Diagnosis of hypercholesterolemia (LDL-C ≥ 100 mg/dL)
At high risk of CHD
On stable, maximally tolerated statin therapy 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, liver disease, cancer, type I diabetes.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00770146). 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.