Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
NCT ID: NCT01730040
Last Updated: 2015-08-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
355 participants
INTERVENTIONAL
2012-10-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Atorvastatin 40 mg
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
Atorvastatin
Atorvastatin over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Ezetimibe 10 mg + Atorvastatin 20 mg
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
Atorvastatin
Atorvastatin over-encapsulated tablets orally.
Ezetimibe
Ezetimibe over-encapsulated tablet orally.
Placebo
Placebo for alirocumab and ezetimibe.
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. 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 baseline disease characteristic and medical history.
Alirocumab
Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
Atorvastatin
Atorvastatin over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Atorvastatin 80 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
Atorvastatin
Atorvastatin over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Rosuvastatin 40 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
Rosuvastatin
Rosuvastatin over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Ezetimibe 10 mg + Atorvastatin 40 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
Atorvastatin
Atorvastatin over-encapsulated tablets orally.
Ezetimibe
Ezetimibe over-encapsulated tablet orally.
Placebo
Placebo for alirocumab and ezetimibe.
Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. 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 baseline disease characteristic and medical history.
Alirocumab
Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
Atorvastatin
Atorvastatin over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Interventions
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Alirocumab
Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
Atorvastatin
Atorvastatin over-encapsulated tablets orally.
Ezetimibe
Ezetimibe over-encapsulated tablet orally.
Rosuvastatin
Rosuvastatin over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high risk for CVD who are not adequately controlled with a daily dose of atorvastatin.
Exclusion Criteria
2. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented CVD
3. LDL-C less than 100 mg/dL at the screening visit in patients without history of documented CHD or non-CHD CVD, but with other risk factors
4. TG greater than 400 mg/dL
5. Homozygous FH (clinically or previous genotyping)
6. Currently taking a statin that is not atorvastatin
7. Currently taking Ezetimibe (EZE)
8. Not on a stable dose of allowable lipid modifying treatments (LMT)
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Mobile, Alabama, United States
Chandler, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Beverly Hills, California, United States
Lakeland Village, California, United States
Newport Beach, California, United States
Northridge, California, United States
Sacramento, California, United States
Walnut Creek, California, United States
Milford, Connecticut, United States
Atlantis, Florida, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Miami (2 Locations), Florida, United States
Oviedo, Florida, United States
Pinellas Park, Florida, United States
Port Orange, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Boise, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Morton, Illinois, United States
Indianapolis, Indiana, United States
Newton, Kansas, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Auburn, Maine, United States
Bethesda, Maryland, United States
Edina, Minnesota, United States
Rochester, Minnesota, United States
Olive Branch, Mississippi, United States
Port Gibson, Mississippi, United States
St Louis, Missouri, United States
Butte, Montana, United States
Las Vegas, Nevada, United States
Williamsville, New York, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Warwick, Rhode Island, United States
Greer, South Carolina, United States
Summerville, South Carolina, United States
Kingsport, Tennessee, United States
Dallas (2 Locations), Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Bountiful, Utah, United States
Marion, Utah, United States
Salt Lake City, Utah, United States
Renton, Washington, United States
Herston QLD, , Australia
New Lambton Heights, , Australia
Perth, , Australia
Sherwood, , Australia
Woolloongabba, , Australia
Brampton, Ontario, Canada
Etobicoke, Ontario, Canada
London, Ontario, Canada
Newmarke, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Dijon, , France
Lille, , France
Vénissieux, , France
Bad Oeynhausen, , Germany
Berlin, , Germany
Cologne, , Germany
Munich, , Germany
Regensburg, , Germany
Ulm, , Germany
Chiete, , Italy
Genova, , Italy
Napoli, , Italy
Palermo, , Italy
Roma (2 Locations), , Italy
Distrito Federal, , Mexico
Guadalajara, , Mexico
Guadalajara, Jalisco, , Mexico
Monterrey Nuevo Leon, , Mexico
Tijuana Baja California, , Mexico
Zapopan Jalisco, , Mexico
Barcelona (3 Locations), , Spain
Madrid, , Spain
Sant Joan Despí, , Spain
Carmarthen, , United Kingdom
Chester, , United Kingdom
Peterborough, , United Kingdom
Salford, , United Kingdom
Stevenage, , United Kingdom
West Bromwich, West Midlands, , United Kingdom
Countries
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References
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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.
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.
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.
Bays H, Gaudet D, Weiss R, Ruiz JL, Watts GF, Gouni-Berthold I, Robinson J, Zhao J, Hanotin C, Donahue S. Alirocumab as Add-On to Atorvastatin Versus Other Lipid Treatment Strategies: ODYSSEY OPTIONS I Randomized Trial. J Clin Endocrinol Metab. 2015 Aug;100(8):3140-8. doi: 10.1210/jc.2015-1520. Epub 2015 Jun 1.
Robinson JG, Colhoun HM, Bays HE, Jones PH, Du Y, Hanotin C, Donahue S. Efficacy and safety of alirocumab as add-on therapy in high-cardiovascular-risk patients with hypercholesterolemia not adequately controlled with atorvastatin (20 or 40 mg) or rosuvastatin (10 or 20 mg): design and rationale of the ODYSSEY OPTIONS Studies. Clin Cardiol. 2014 Oct;37(10):597-604. doi: 10.1002/clc.22327. Epub 2014 Sep 30.
Other Identifiers
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R727-CL-1110
Identifier Type: -
Identifier Source: org_study_id