Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
NCT ID: NCT01709513
Last Updated: 2020-06-23
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
314 participants
INTERVENTIONAL
2012-09-30
2017-05-31
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.
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
NCT02476006
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
NCT01730040
Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
NCT01507831
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
NCT01644188
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
NCT01644175
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Atorvastatin (statin rechallenge arm)
Atorvastatin 20 mg over-encapsulated tablets orally once daily (QD) for 24 weeks and placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) for 24 weeks added to stable lipid-modifying therapy (LMT).
Atorvastatin
Atorvastatin over-encapsulated tablets.
Placebo
Placebo for alirocumab, ezitimibe and atorvastatin.
Ezetimibe
Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
Ezetimibe
Ezetimibe over-encapsulated tablet.
Placebo
Placebo for alirocumab, ezitimibe and atorvastatin.
Alirocumab 75 mg/ up to 150 mg
Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
Alirocumab
Alirocumab SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
Placebo
Placebo for alirocumab, ezitimibe and atorvastatin.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atorvastatin
Atorvastatin over-encapsulated tablets.
Ezetimibe
Ezetimibe over-encapsulated tablet.
Alirocumab
Alirocumab SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
Placebo
Placebo for alirocumab, ezitimibe and atorvastatin.
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
2. Provide signed informed consent
Exclusion:
1. Calculated serum LDL-C \<70 mg/dL (1.81 mmol/L) and very high CV risk at the screening visit
2. Calculated serum LDL-C \<100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the screening visit
3. A 10-year fatal cardiovascular disease risk score \<1% at the screening visit
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sanofi
INDUSTRY
Regeneron Pharmaceuticals
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.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Anaheim, California, United States
Beverly Hills, California, United States
Mission Viejo, California, United States
Newport Beach, California, United States
Northridge, California, United States
Thousand Oaks, California, United States
Hartford, Connecticut, United States
Boynton Beach, Florida, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Trinity, Florida, United States
Addison, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Auburn, Maine, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Clifton, New Jersey, United States
New York, New York, United States
Poughkeepsie, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Marion, Ohio, United States
Danville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Port Matilda, Pennsylvania, United States
Scranton, Pennsylvania, United States
Wilkes-Barre, Pennsylvania, United States
Summerville, South Carolina, United States
Kingsport, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Salt Lake City, Utah, United States
Richmond, Virginia, United States
Feldkirch, , Austria
Graz, , Austria
Innsbruck, , Austria
Chicoutimi, Quebec, Canada
Montreal (2 Locations), Quebec, Canada
Sainte-Foy, Quebec, Canada
Bron, , France
Dijon, , France
Lille, , France
Paris, , France
Saint-Herblain, , France
Vénissieux, , France
Holon, , Israel
Jerusalem, , Israel
Ofakim, , Israel
Safed, , Israel
Tel Litwinsky, , Israel
Cinisello Balsamo, , Italy
Napoli, , Italy
Palermo, , Italy
Roma, , Italy
Oslo (2 Locations), , Norway
Burton-on-Trent, , United Kingdom
Chesterfield, , United Kingdom
Isle of White, , United Kingdom
Londonderry/N. Ireland, , United Kingdom
Peterborough, , United Kingdom
Salford, , United Kingdom
Stevenage, , United Kingdom
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.
Moriarty PM, Jacobson TA, Bruckert E, Thompson PD, Guyton JR, Baccara-Dinet MT, Gipe D. Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial. J Clin Lipidol. 2014 Nov-Dec;8(6):554-561. doi: 10.1016/j.jacl.2014.09.007. Epub 2014 Sep 19.
Moriarty PM, Thompson PD, Cannon CP, Guyton JR, Bergeron J, Zieve FJ, Bruckert E, Jacobson TA, Kopecky SL, Baccara-Dinet MT, Du Y, Pordy R, Gipe DA; ODYSSEY ALTERNATIVE Investigators. Efficacy and safety of alirocumab vs ezetimibe in statin-intolerant patients, with a statin rechallenge arm: The ODYSSEY ALTERNATIVE randomized trial. J Clin Lipidol. 2015 Nov-Dec;9(6):758-769. doi: 10.1016/j.jacl.2015.08.006. Epub 2015 Aug 29.
Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.
Moriarty PM, Thompson PD, Cannon CP, Guyton JR, Bergeron J, Zieve FJ, Bruckert E, Jacobson TA, Baccara-Dinet MT, Zhao J, Donahue S, Ali S, Manvelian G, Pordy R. Efficacy and safety of alirocumab in statin-intolerant patients over 3 years: open-label treatment period of the ODYSSEY ALTERNATIVE trial. J Clin Lipidol. 2020 Jan-Feb;14(1):88-97.e2. doi: 10.1016/j.jacl.2020.01.001. Epub 2020 Jan 13.
Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.
Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4.
Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R727-CL-1119
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.