Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
NCT ID: NCT00706849
Last Updated: 2016-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
124 participants
INTERVENTIONAL
2008-07-31
2010-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Mipomersen
Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
mipomersen sodium
200 mg /mL
Placebo
Participants received a placebo subcutaneous injection once a week for 26 weeks.
placebo
1 mL matching placebo
Interventions
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mipomersen sodium
200 mg /mL
placebo
1 mL matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Receiving apheresis treatment or last apheresis treatment within 8 weeks
18 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Kastle Therapeutics, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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La Jolla, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Newport Beach, California, United States
Santa Ana, California, United States
Thousand Oaks, California, United States
Bridgeport, Connecticut, United States
Melbourne, Florida, United States
Pensacola, Florida, United States
Chicago, Illinois, United States
Naperville, Illinois, United States
Kansas City, Kansas, United States
Biddeford, Maine, United States
Scarborough, Maine, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Concord, New Hampshire, United States
New York, New York, United States
The Rogosin Institute Comprehensive Lipid Control Center
New York, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
ResEvo, LLC
Cuyahoga Falls, Ohio, United States
Franklin, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Grapevine, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Saint Foy, Quebec, Canada
Sherbrooke, Quebec, Canada
Countries
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References
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Stein EA, Dufour R, Gagne C, Gaudet D, East C, Donovan JM, Chin W, Tribble DL, McGowan M. Apolipoprotein B synthesis inhibition with mipomersen in heterozygous familial hypercholesterolemia: results of a randomized, double-blind, placebo-controlled trial to assess efficacy and safety as add-on therapy in patients with coronary artery disease. Circulation. 2012 Nov 6;126(19):2283-92. doi: 10.1161/CIRCULATIONAHA.112.104125. Epub 2012 Oct 11.
Duell PB, Santos RD, Kirwan BA, Witztum JL, Tsimikas S, Kastelein JJP. Long-term mipomersen treatment is associated with a reduction in cardiovascular events in patients with familial hypercholesterolemia. J Clin Lipidol. 2016 Jul-Aug;10(4):1011-1021. doi: 10.1016/j.jacl.2016.04.013. Epub 2016 May 9.
Santos RD, Raal FJ, Catapano AL, Witztum JL, Steinhagen-Thiessen E, Tsimikas S. Mipomersen, an antisense oligonucleotide to apolipoprotein B-100, reduces lipoprotein(a) in various populations with hypercholesterolemia: results of 4 phase III trials. Arterioscler Thromb Vasc Biol. 2015 Mar;35(3):689-99. doi: 10.1161/ATVBAHA.114.304549. Epub 2015 Jan 22.
Other Identifiers
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301012-CS7
Identifier Type: -
Identifier Source: org_study_id
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