Coronary Artery Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess Efficacy and Safety of ISIS 301012 as Add-on Therapy in Heterozygous Familial Hypercholesterolemia Subjects With Coronary Artery Disease
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).
Familial hypercholesterolemia (FH) is an autosomal dominant genetic disorder of lipoprotein
metabolism characterized by markedly elevated LDL-C, premature onset of atherosclerosis and
development of xanthomata. Patients with heterozygous familial hypercholesterolemia
typically have total plasma cholesterol between 350 to 550 mg/dL and disease onset in their
third and fourth decade.
Mipomersen (ISIS 301012) is an antisense drug that reduces a protein in the liver cells
called apolipoprotein B (apo-B). Apo-B plays a role in producing low density lipoprotein
cholesterol (the "bad" cholesterol) and moving it from the liver to one's bloodstream. High
LDL-C is an independent risk factor for the development of coronary heart disease (CHD) or
other diseases of blood vessels. It has been shown that lowering LDL-C reduces the risk of
heart attacks and other major adverse cardiovascular events.
This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up
period (with the exception of patients who enrolled in the open-label extension study [Study
301012-CS6; NCT00694109]). The treatment period spanned the time during which the study
treatment was administered until the later of the primary efficacy time point (PET) or 14
days beyond the last day of study drug administration. The post-treatment follow-up period
began the day after completion of the treatment period and ended on the day of the patient's
last contact date within the study.
Following treatment and Week 28 evaluations, eligible patients who tolerated study drug
could elect to enroll in an open-label extension study (301012-CS6). Patients who were not
eligible for or who elected not to enroll in the open-label extension study and patients who
discontinued during the 26-week treatment period were followed in this study for an
additional 24 weeks from administration of the last dose of study drug.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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