Safety and Efficacy of Mipomersen in Patients With Severe Hypercholesterolemia on a Maximally Tolerated Lipid-Lowering Regimen and Who Are Not on Apheresis
NCT ID: NCT00794664
Last Updated: 2016-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
58 participants
INTERVENTIONAL
2009-01-31
2010-10-31
Brief Summary
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Detailed Description
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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 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. The purpose of this study is to determine whether mipomersen safely and effectively lowers LDL-C in severely hypercholesterolemic patients who are on a maximally tolerated lipid-lowering regimen and who are not on apheresis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Weekly subcutaneous injections for 26 weeks
Placebo
1 mL weekly subcutaneous injections for 26 weeks
Mipomersen
200 mg weekly subcutaneous injections for 26 weeks
Mipomersen
200 mg (1 mL), weekly subcutaneous injections for 26 weeks
Interventions
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Mipomersen
200 mg (1 mL), weekly subcutaneous injections for 26 weeks
Placebo
1 mL weekly subcutaneous injections for 26 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Myocardial infarction (MI)
* Percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
* Coronary artery disease documented by angiography or any other accepted imaging technique
* Positive exercise test (≥1 mm ST-depression at maximal exercise or test terminated because of angina) or a perfusion defect (e.g., thallium or single photon emission computed tomography)
* Other clinical atherosclerotic diseases: peripheral artery disease, symptomatic carotid artery disease, abdominal aortic aneurysm
* Or, if alternative above were not met, fasting LDL-C ≥300 mg/dL (7.8 mmol/L)
* On stable, maximally tolerated statin therapy for 8 weeks
* On stable, medication from an additional class of hypolipidemic agents for 8 weeks.
* On stable, low fat diet for 12 weeks
* Stable weight for 6 weeks
Exclusion Criteria
* Apheresis within 3 months prior to Screening or expected to start apheresis during the treatment phase
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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Jupiter, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
St Louis, Missouri, United States
Concord, New Hampshire, United States
Cincinnati, Ohio, United States
Aiken, South Carolina, United States
Winnipeg, Manitoba, Canada
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Hardec Kralove, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Uherské Hradiště, , Czechia
Berlin, , Germany
Freiburg im Breisgau, , Germany
Heidelberg, , Germany
Koln (Lindenthal), , Germany
Cape Town, , South Africa
Cape Town, , South Africa
Gauteng, , South Africa
Pretoria, , South Africa
Guildford, Surrey, United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Countries
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References
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McGowan MP, Tardif JC, Ceska R, Burgess LJ, Soran H, Gouni-Berthold I, Wagener G, Chasan-Taber S. Randomized, placebo-controlled trial of mipomersen in patients with severe hypercholesterolemia receiving maximally tolerated lipid-lowering therapy. PLoS One. 2012;7(11):e49006. doi: 10.1371/journal.pone.0049006. Epub 2012 Nov 13.
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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2008-006020-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MIPO3500108
Identifier Type: -
Identifier Source: org_study_id
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