Hypercholesterolemia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) as Add-on Therapy in High Risk Hypercholesterolemic Patients
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).
Hypercholesterolemia is characterized by markedly elevated low density lipoproteins (LDL).
Elevated LDL is a major risk factor for CHD.
Mipomersen 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 (LDL-C) (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 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. The purpose of this study is to
determine whether mipomersen safely and effectively lowers LDL-C in patients with high
cholesterol who are at high risk for CHD and who are already on the maximally tolerated dose
of statin.
This study consisted of a 26-week treatment period and a 24-week post-treatment follow-up
period. Participants who finished treatment or who discontinued prematurely from the study
for any reason were assessed for safety for 24 weeks after the last study drug dose.
;
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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