Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)
NCT ID: NCT01926782
Last Updated: 2017-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
803 participants
INTERVENTIONAL
2013-09-30
2015-04-30
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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Placebo Q2W
Two subcutaneous (SC) injections of placebo (for alirocumab) Q2W with or without stable statin therapy for 48 weeks.
Placebo (for alirocumab)
Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Statin
Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy
Alirocumab 75 mg/ Up 150 mg Q2W
One SC injection of each Alirocumab 75 mg and placebo Q2W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk participants) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk participants) at Week 8.
Placebo (for alirocumab)
Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Alirocumab
Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Statin
Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy
Alirocumab 300 mg/ Up 150 mg Q4W
Two SC injections of Alirocumab 150 mg Q4W alternating with two SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk participants) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk participants) at Week 8.
Placebo (for alirocumab)
Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Alirocumab
Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Statin
Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy
Interventions
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Placebo (for alirocumab)
Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Alirocumab
Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
Statin
Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk
3. Willing and able to comply with clinic visits and study-related procedures
4. Provided signed informed consent
Exclusion Criteria
2. Known history of positive test for human immunodeficiency virus (HIV)
3. Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or participants with short life expectancy.
4. Participants considered by the investigator or any sub-investigator to be inappropriate for this study (e.g, geographic or social), actual or anticipated, that the investigator felt would restrict or limit the participant's participation for the duration of the study.
5. Certain laboratory findings obtained during the screening period
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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Chandler, Arizona, United States
Goodyear, Arizona, United States
Carmichael, California, United States
Fresno, California, United States
West Hills, California, United States
Wildomar, California, United States
Colorado Springs, Colorado, United States
Golden, Colorado, United States
Boynton Beach, Florida, United States
Jacksonville, Florida, United States
Safety Harbor, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Monroe, Louisiana, United States
Auburn, Maine, United States
Methuen, Massachusetts, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Rochester, New York, United States
Farmville, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
Raleigh, North Carolina, United States
Wilson, North Carolina, United States
Cincinnati, Ohio, United States
Marion, Ohio, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
South Jordan, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Kenosha, Wisconsin, United States
Varna, Varna, Bulgaria
Sofia, , Bulgaria
Victoria, British Columbia, Canada
Oshawa, Ontario, Canada
Toronto, Ontario, Canada
Woodstock, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Trois-Rivières, Quebec, Canada
Budapest, Becsi Ut, Hungary
Debrecen, HBM, Hungary
Nyíregyháza, Sz-sz-b_m, Hungary
Ajka, Veszprém, Hungary
Nagykanizsa, Zala County, Hungary
Zalaegerszeg, Zala County, Hungary
Tel Litwinsky, IL, Israel
Safed, ISR, Israel
Ofakim, South, Israel
Holon, , Israel
Tel Litwinsky, , Israel
Skedsmokorset, Akershus, Norway
Oslo, , Norway
Svidník, Presov, Slovakia
Bratislava, SK, Slovakia
Bratislava, SR, Slovakia
Lučenec, , Slovakia
Považská Bystrica, , Slovakia
Worton Grange, Reading, Berkshire, United Kingdom
Edgbaston, Birmingham, United Kingdom
Llanishen, Cardiff, United Kingdom
Choley, Lancashire, United Kingdom
Waterloo, Liverpool, United Kingdom
Lloyd Street North, Manchester, United Kingdom
Glasgow, Scotland, United Kingdom
Countries
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References
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Roth EM, Kastelein JJP, Cannon CP, Farnier M, McKenney JM, DiCioccio AT, Brunet A, Manvelian G, Sasiela WJ, Baccara-Dinet MT, Zhao J, Robinson JG. Pharmacodynamic relationship between PCSK9, alirocumab, and LDL-C lowering in the ODYSSEY CHOICE I trial. J Clin Lipidol. 2020 Sep-Oct;14(5):707-719. doi: 10.1016/j.jacl.2020.07.009. Epub 2020 Jul 25.
Muller-Wieland D, Rader DJ, Moriarty PM, Bergeron J, Langslet G, Ray KK, Manvelian G, Thompson D, Bujas-Bobanovic M, Roth EM. Efficacy and Safety of Alirocumab 300 mg Every 4 Weeks in Individuals With Type 2 Diabetes on Maximally Tolerated Statin. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5253-5262. doi: 10.1210/jc.2018-02703.
Roth EM, Moriarty PM, Bergeron J, Langslet G, Manvelian G, Zhao J, Baccara-Dinet MT, Rader DJ; ODYSSEY CHOICE I investigators. A phase III randomized trial evaluating alirocumab 300 mg every 4 weeks as monotherapy or add-on to statin: ODYSSEY CHOICE I. Atherosclerosis. 2016 Nov;254:254-262. doi: 10.1016/j.atherosclerosis.2016.08.043. Epub 2016 Aug 31.
Other Identifiers
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R727-CL-1308
Identifier Type: -
Identifier Source: org_study_id
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