Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)
NCT ID: NCT01730053
Last Updated: 2020-04-07
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
305 participants
INTERVENTIONAL
2012-11-30
2014-05-31
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.
Effect of Alirocumab(Proprotein Convertase Subtilisin/Kexin type9 Inhibitor) and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaques in Coronary Artery Disease Evaluated by Near-infrared Spectroscopy Intravascular Ultrasound
NCT03529253
Drug Interaction Statin
NCT02089061
A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
NCT00783263
Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With High Cholesterol (P03317)
NCT00651144
Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)
NCT00653744
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.
Rosuvastatin 20 mg
Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
Rosuvastatin
Rosuvastatin over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Ezetimibe 10 mg + Rosuvastatin 10 mg
Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
Rosuvastatin
Rosuvastatin over-encapsulated tablets orally.
Ezetimibe
Ezetimibe over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg
Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet 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.
Rosuvastatin
Rosuvastatin over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Rosuvastatin 40 mg
Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
Rosuvastatin
Rosuvastatin over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Ezetimibe 10 mg + Rosuvastatin 20 mg
Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
Rosuvastatin
Rosuvastatin over-encapsulated tablets orally.
Ezetimibe
Ezetimibe over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg
Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet 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.
Rosuvastatin
Rosuvastatin over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Alirocumab
Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
Rosuvastatin
Rosuvastatin over-encapsulated tablets orally.
Ezetimibe
Ezetimibe over-encapsulated tablets orally.
Placebo
Placebo for alirocumab and ezetimibe.
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
OR
2. Patients with screening LDL-C greater than or equal to 100 mg/dL who are not adequately controlled with a stable daily dose of rosuvastatin before the screening visit, with or without other LMT.
Exclusion Criteria
2. LDL-C less than 100 mg/dL at the screening visit in patients without history of documented coronary heart disease (CHD) or non-CHD CVD, but with other risk factors
3. Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping)
4. Recent (within 3 months prior to the screening visit) myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
5. Newly diagnosed (within 3 months prior to randomization visit) or poorly controlled diabetes
6. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
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.
Chandler, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Beverly Hills, California, United States
Fair Oaks, 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
Bradenton, Florida, United States
Clearwater, Florida, United States
Fort Lauderdale, Florida, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
(2 Locations)
Miami, 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
Winter Park, Florida, United States
Boise, Idaho, United States
Morton, Illinois, United States
Evansville, Indiana, 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
Williamsville, New York, United States
Cincinnati, Ohio, United States
Marion, Ohio, United States
Portland, Oregon, United States
Warwick, Rhode Island, United States
Greer, South Carolina, United States
Summerville, South Carolina, United States
Kingsport, Tennessee, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Bountiful, Utah, United States
Salt Lake City, Utah, United States
Herston, , Australia
New Lambton Heights, , Australia
Perth, , Australia
Sherwood, , Australia
Woolloongabba, , Australia
Brampton, Ontario, Canada
Burlington, Ontario, Canada
Etobicoke, Ontario, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Dijon, , France
Lille, , France
Bad Oeynhausen, , Germany
Berlin, , Germany
Cologne, , Germany
Regensburg, , Germany
Ulm, , Germany
Chieti, , Italy
Genova, , Italy
Napoli, , Italy
Palermo, , Italy
(2 Locations)
Roma, , Italy
Baja California, , Mexico
Distrito Federal, , Mexico
(3 Locations)
Guadalajara, , Mexico
Monterrey, , Mexico
Zapopan Jalisco, , Mexico
(2 Locations)
Barcelona, , Spain
Madrid, , Spain
Santiago, , Spain
Seville, , Spain
West Bromwich, West Midlands, United Kingdom
Chester, , 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.
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.
Farnier M, Jones P, Severance R, Averna M, Steinhagen-Thiessen E, Colhoun HM, Du Y, Hanotin C, Donahue S. Efficacy and safety of adding alirocumab to rosuvastatin versus adding ezetimibe or doubling the rosuvastatin dose in high cardiovascular-risk patients: The ODYSSEY OPTIONS II randomized trial. Atherosclerosis. 2016 Jan;244:138-46. doi: 10.1016/j.atherosclerosis.2015.11.010. Epub 2015 Nov 14.
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
Review additional registry numbers or institutional identifiers associated with this trial.
R727-CL-1118
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.