Safety and Efficacy of Mipomersen (ISIS 301012) As Add-on Therapy in High Risk Hypercholesterolemic Patients
NCT ID: NCT00770146
Last Updated: 2016-09-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
158 participants
INTERVENTIONAL
2008-11-30
2010-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety Study of ISIS 301012 (Mipomersen) as Add-on in Familial Hypercholesterolemic Patients With Coronary Artery Disease
NCT00706849
Study to Assess the Safety and Efficacy of ISIS 301012 (Mipomersen) in Homozygous Familial Hypercholesterolemia
NCT00607373
A Study to Evaluate 3 Different Dosing Regimens of Mipomersen Administered Via Subcutaneous Injections to Healthy Volunteers
NCT01061814
Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels
NCT00216463
Dose-escalating Safety Study of ISIS 301012 in Homozygous Familial Hypercholesterolemia Subjects on Lipid Lowering Therapy
NCT00280995
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Participants received placebo subcutaneous injection once a week for 26 weeks.
Placebo
1 mL matching placebo (i.e., vehicle consisting of 9 mg of sodium chloride, 0.004 mg of riboflavin, filled to 1 mL with water).
Mipomersen
Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
Mipomersen sodium
200 mg/mL
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mipomersen sodium
200 mg/mL
Placebo
1 mL matching placebo (i.e., vehicle consisting of 9 mg of sodium chloride, 0.004 mg of riboflavin, filled to 1 mL with water).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ionis Pharmaceuticals, Inc.
INDUSTRY
Kastle Therapeutics, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Muscle Shoals, Alabama, United States
Litchfield Park, Arizona, United States
Beverly Hills, California, United States
Escondido, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Newport Beach, California, United States
San Diego, California, United States
Santa Rosa, California, United States
Thousand Oaks, California, United States
Westlake Village, California, United States
Aventura, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Longwood, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Pembroke Pines, Florida, United States
Pensacola, Florida, United States
Ponte Verda, Florida, United States
Port Orange, Florida, United States
Sandy Springs, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Bloomingtom, Indiana, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Brockton, Massachusetts, United States
New Bedford, Massachusetts, United States
Edina, Minnesota, United States
Kansas City, Missouri, United States
Berlin, New Jersey, United States
Johnson City, New York, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Wilson, North Carolina, United States
Cincinnati, Ohio, United States
Mentor, Ohio, United States
Norman, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Lansdale, Pennsylvania, United States
Murrells Inlet, South Carolina, United States
Simpsonville, South Carolina, United States
Spartanburg, South Carolina, United States
Rapid City, South Dakota, United States
Dallas, Texas, United States
Dallas, Texas, United States
Grapevine, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Olympia, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Thomas GS, Cromwell WC, Ali S, Chin W, Flaim JD, Davidson M. Mipomersen, an apolipoprotein B synthesis inhibitor, reduces atherogenic lipoproteins in patients with severe hypercholesterolemia at high cardiovascular risk: a randomized, double-blind, placebo-controlled trial. J Am Coll Cardiol. 2013 Dec 10;62(23):2178-84. doi: 10.1016/j.jacc.2013.07.081. Epub 2013 Sep 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
301012-CS12
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.