Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Combo II)
This study is ongoing, but not recruiting participants.
Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01644188
First received: July 16, 2012
Last updated: February 9, 2015
Last verified: February 2015
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Purpose
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).
Primary Objective of the study:
To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in patients with hypercholesterolemia at high cardiovascular (CV) risk.
Secondary Objectives:
- To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points.
- To evaluate the effect of alirocumab on other lipid parameters.
- To evaluate the safety and tolerability of alirocumab.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: Alirocumab Drug: Placebo (for alirocumab) Drug: Ezetimibe Drug: Placebo (for ezetimibe) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Percent change in calculated LDL-C at Week 24 [ Time Frame: From baseline to Week 52 ] [ Designated as safety issue: No ]From a mixed-effect model including all LDL-C values collected up to Week 52
Secondary Outcome Measures:
- Percent change in calculated LDL-C at Week 12 and 52 [ Time Frame: From baseline up to Week 52 ] [ Designated as safety issue: No ]
- Percent change in other lipid parameters at Week 12, Week 24 and 52 [ Time Frame: From baseline up to Week 52 ] [ Designated as safety issue: No ]
- Percent change in calculated LDL-C at Week 104 [ Time Frame: From baseline up to Week 104 ] [ Designated as safety issue: No ]From a mixed-effect model including all LDL-C values collected up to Week 104
- Percent change in other lipid parameters at Week 104 [ Time Frame: From baseline up to Week 104 ] [ Designated as safety issue: No ]
| Enrollment: | 720 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | July 2015 |
| Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Alirocumab
Alirocumab injection through subcutaneous (SC) administration + placebo (for ezetimibe) orally.
|
Drug: Alirocumab
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous Other Names:
Drug: Placebo (for ezetimibe)
Pharmaceutical form: Capsules Route of administration: Oral |
|
Active Comparator: Ezetimibe
Placebo (for alirocumab) injection through subcutaneous (SC) administration + ezetimibe orally.
|
Drug: Placebo (for alirocumab)
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous Pharmaceutical form: Encapsulated tablets Route of administration: Oral |
Detailed Description:
The maximum study duration will be 115 weeks per patient, including a 3 week screening period, 104 week randomized treatment period and 8 week follow-up period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
Patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).
Exclusion criteria:
- Age < 18 or legal age of adulthood, whichever is greater.
- Patients without established CHD or CHD risk equivalents.
- LDL-C <70 mg/dL (<1.81 mmol/L) and patients with a history of documented cardiovascular disease.
- LDL-C <100 mg/dL (<2.59 mmol/L) and patients without a history of documented CV disease.
- Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644188
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01644188
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Locations
| United States, Alabama | |
| Investigational Site Number 840980 | |
| Birmingham, Alabama, United States, 35209 | |
| United States, Arizona | |
| Investigational Site Number 840918 | |
| Phoenix, Arizona, United States, 85032 | |
| Investigational Site Number 840925 | |
| Tucson, Arizona, United States | |
| United States, California | |
| Investigational Site Number 840959 | |
| Anaheim, California, United States, 92801 | |
| Investigational Site Number 840301 | |
| Beverly Hills, California, United States, 90211 | |
| Investigational Site Number 840933 | |
| Chino, California, United States, 91710 | |
| Investigational Site Number 840991 | |
| Lincoln, California, United States, 95648 | |
| Investigational Site Number 840979 | |
| Los Angeles, California, United States, 90057 | |
| Investigational Site Number 840952 | |
| Palm Springs, California, United States, 92262 | |
| Investigational Site Number 840930 | |
| Thousand Oaks, California, United States, 91360 | |
| Investigational Site Number 840921 | |
| Vista, California, United States, 92083 | |
| United States, Florida | |
| Investigational Site Number 840962 | |
| Boynton Beach, Florida, United States, 33472 | |
| Investigational Site Number 840987 | |
| Bradenton, Florida, United States, 34203 | |
| Investigational Site Number 840302 | |
| Clearwater, Florida, United States, 33756 | |
| Investigational Site Number 840935 | |
| Jacksonville, Florida, United States, 32223 | |
| Investigational Site Number 840903 | |
| Miami, Florida, United States, 33126 | |
| Investigational Site Number 840920 | |
| Miami, Florida, United States | |
| Investigational Site Number 840943 | |
| Ocala, Florida, United States, 34471 | |
| Investigational Site Number 840981 | |
| Oveido, Florida, United States, 32765 | |
| Investigational Site Number 840961 | |
| Port Orange, Florida, United States, 32127 | |
| Investigational Site Number 840303 | |
| Sarasota, Florida, United States, 34239 | |
| Investigational Site Number 840986 | |
| St. Petersburg, Florida, United States | |
| Investigational Site Number 840988 | |
| St. Petersburg, Florida, United States | |
| United States, Idaho | |
| Investigational Site Number 840995 | |
| Meridian, Idaho, United States, 83646 | |
| United States, Indiana | |
| Investigational Site Number 840902 | |
| Evansville, Indiana, United States, 47714 | |
| United States, Kansas | |
| Investigational Site Number 840960 | |
| Topeka, Kansas, United States, 66606 | |
| United States, Maryland | |
| Investigational Site Number 840940 | |
| Oxon Hill, Maryland, United States, 20745 | |
| United States, Massachusetts | |
| Investigational Site Number 840966 | |
| Fall River, Massachusetts, United States, 02720 | |
| United States, Missouri | |
| Investigational Site Number 840917 | |
| Kansas City, Missouri, United States, 64114 | |
| Investigational Site Number 840998 | |
| St. Louis, Missouri, United States, 63131 | |
| United States, Montana | |
| Investigational Site Number 840946 | |
| Butte, Montana, United States, 59701 | |
| United States, Nebraska | |
| Investigational Site Number 840914 | |
| Lincoln, Nebraska, United States, 68510 | |
| United States, New Mexico | |
| Investigational Site Number 840949 | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Investigational Site Number 840974 | |
| New Windsor, New York, United States, 12553 | |
| United States, North Carolina | |
| Investigational Site Number 840955 | |
| Greenville, North Carolina, United States, 27834 | |
| Investigational Site Number 840938 | |
| Lexington, North Carolina, United States, 27292 | |
| Investigational Site Number 840976 | |
| Smithfield, North Carolina, United States, 27577 | |
| Investigational Site Number 840985 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Investigational Site Number 840963 | |
| Cincinnati, Ohio, United States, 45219 | |
| Investigational Site Number 840970 | |
| Lyndhust, Ohio, United States, 44124 | |
| Investigational Site Number 840997 | |
| Marion, Ohio, United States, 43302 | |
| Investigational Site Number 840906 | |
| Marion, Ohio, United States, 43302 | |
| Investigational Site Number 840964 | |
| Perrysburg, Ohio, United States, 43551 | |
| United States, South Carolina | |
| Investigational Site Number 840913 | |
| Charleston, South Carolina, United States, 29412 | |
| Investigational Site Number 840912 | |
| Greer, South Carolina, United States, 29651 | |
| Investigational Site Number 840992 | |
| Summerville, South Carolina, United States, 29485 | |
| United States, Tennessee | |
| Investigational Site Number 840932 | |
| Bristol, Tennessee, United States, 37620 | |
| Investigational Site Number 840944 | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| Investigational Site Number 840994 | |
| Fort Worth, Texas, United States, 76104 | |
| Investigational Site Number 840973 | |
| Houston, Texas, United States | |
| Investigational Site Number 840939 | |
| Houston, Texas, United States, 77074 | |
| Investigational Site Number 840945 | |
| Sugarland, Texas, United States | |
| Investigational Site Number 840971 | |
| Tomball, Texas, United States, 77375 | |
| United States, Utah | |
| Investigational Site Number 840982 | |
| Orem, Utah, United States, 84058 | |
| United States, Virginia | |
| Investigational Site Number 840931 | |
| Norfolk, Virginia, United States, 23502 | |
| Investigational Site Number 840984 | |
| Richmond, Virginia, United States, 23227 | |
| United States, Washington | |
| Investigational Site Number 840928 | |
| Renton, Washington, United States, 98055 | |
| Investigational Site Number 840990 | |
| Spokane, Washington, United States, 99204 | |
| Canada | |
| Investigational Site Number 124902 | |
| Brampton, Canada, L6T 3J1 | |
| Investigational Site Number 124914 | |
| Mirabel, Canada, J7J 2K8 | |
| Investigational Site Number 124903 | |
| Montreal, Canada, H1T 3Y7 | |
| Investigational Site Number 124918 | |
| Toronto, Canada, M9V 4B4 | |
| Denmark | |
| Investigational Site Number 208913 | |
| Esbjerg, Denmark, 6700 | |
| Investigational Site Number 208914 | |
| Glostrup, Denmark, 2600 | |
| Investigational Site Number 208905 | |
| Hellerup, Denmark, 2900 | |
| Investigational Site Number 208911 | |
| Herlev, Denmark, 2730 | |
| Investigational Site Number 208907 | |
| Hvidovre, Denmark, 2650 | |
| Investigational Site Number 208901 | |
| København S, Denmark, 2300 | |
| Investigational Site Number 208906 | |
| Køge, Denmark, 4600 | |
| Investigational Site Number 208908 | |
| Roskilde, Denmark, 4000 | |
| Investigational Site Number 208903 | |
| Silkeborg, Denmark, 8600 | |
| France | |
| Investigational Site Number 250906 | |
| Dijon, France, 21079 | |
| Investigational Site Number 250907 | |
| Montpellier Cedex 5, France, 34295 | |
| Investigational Site Number 250903 | |
| Nantes, France, 44093 | |
| Investigational Site Number 250905 | |
| Nimes, France, 30900 | |
| Hungary | |
| Investigational Site Number 348901 | |
| Budapest, Hungary, 1134 | |
| Investigational Site Number 348903 | |
| Budapest, Hungary, 1134 | |
| Investigational Site Number 348908 | |
| Budapest, Hungary, 1036 | |
| Investigational Site Number 348905 | |
| Debrecen, Hungary, 4032 | |
| Investigational Site Number 348906 | |
| Szekesfehervar, Hungary, 8000 | |
| Israel | |
| Investigational Site Number 376908 | |
| Holon, Israel, 58100 | |
| Investigational Site Number 376903 | |
| Kfar Saba, Israel, 44281 | |
| Investigational Site Number 376906 | |
| Ofakim, Israel, 80300 | |
| Investigational Site Number 376902 | |
| Petach Tikva, Israel | |
| Investigational Site Number 376904 | |
| Rehovot, Israel, 76100 | |
| Investigational Site Number 376907 | |
| Safed, Israel, 13100 | |
| Investigational Site Number 376901 | |
| Tel Aviv, Israel, 64239 | |
| Korea, Republic of | |
| Investigational Site Number 410908 | |
| Anyang, Korea, Republic of, 431-070 | |
| Investigational Site Number 410920 | |
| Busan, Korea, Republic of, 602-715 | |
| Investigational Site Number 410926 | |
| Daegu, Korea, Republic of, 700-712 | |
| Investigational Site Number 410923 | |
| Gwangju, Korea, Republic of, 501-757 | |
| Investigational Site Number 410905 | |
| Seoul, Korea, Republic of, 135-720 | |
| Investigational Site Number 410914 | |
| Seoul, Korea, Republic of, 138-736 | |
| Investigational Site Number 410909 | |
| Seoul, Korea, Republic of, 110-744 | |
| Investigational Site Number 410924 | |
| Seoul, Korea, Republic of, 156-707 | |
| Investigational Site Number 410921 | |
| Seoul, Korea, Republic of, 135-710 | |
| Investigational Site Number 410901 | |
| Seoul, Korea, Republic of, 137-701 | |
| Investigational Site Number 410922 | |
| Seoul, Korea, Republic of, 120-752 | |
| Investigational Site Number 410915 | |
| Suwon, Korea, Republic of, 443-721 | |
| Investigational Site Number 410913 | |
| Uijeongbu, Korea, Republic of, 480-717 | |
| Investigational Site Number 410927 | |
| Wonju, Korea, Republic of, 220-701 | |
| Russian Federation | |
| Investigational Site Number 643906 | |
| Barnaul, Russian Federation, 656055 | |
| Investigational Site Number 643903 | |
| Kemerovo, Russian Federation, 650002 | |
| Investigational Site Number 643904 | |
| Moscow, Russian Federation, 129090 | |
| Investigational Site Number 643908 | |
| Moscow, Russian Federation, 121552 | |
| Investigational Site Number 643924 | |
| Moscow, Russian Federation, 119048 | |
| Investigational Site Number 643927 | |
| Moscow, Russian Federation, 111539 | |
| Investigational Site Number 643928 | |
| Moscow, Russian Federation, 111539 | |
| Investigational Site Number 643931 | |
| Moscow, Russian Federation, 115404 | |
| Investigational Site Number 643932 | |
| Moscow, Russian Federation, 121374 | |
| Investigational Site Number 643911 | |
| Orenburg, Russian Federation, 450000 | |
| Investigational Site Number 643921 | |
| Ryazan, Russian Federation, 390026 | |
| Investigational Site Number 643922 | |
| Saint-Petersburg, Russian Federation, 198205 | |
| Investigational Site Number 643925 | |
| Saint-Petersburg, Russian Federation, 197110 | |
| Investigational Site Number 643929 | |
| Saratov, Russian Federation, 410028 | |
| Investigational Site Number 643914 | |
| St-Petersburg, Russian Federation, 199106 | |
| South Africa | |
| Investigational Site Number 710917 | |
| Alberton, South Africa, 1450 | |
| Investigational Site Number 710909 | |
| Bloemfontein, South Africa, 9301 | |
| Investigational Site Number 710914 | |
| Bloemfontein, South Africa, 9301 | |
| Investigational Site Number 710904 | |
| Cape Town, South Africa, 7925 | |
| Investigational Site Number 710905 | |
| Cape Town, South Africa, 7500 | |
| Investigational Site Number 710918 | |
| Middelburg, South Africa, 1055 | |
| Investigational Site Number 710913 | |
| Pretoria, South Africa, 0002 | |
| Investigational Site Number 710915 | |
| Somerset West, South Africa, 7130 | |
| Ukraine | |
| Investigational Site Number 804905 | |
| Kiev, Ukraine, 02091 | |
| Investigational Site Number 804902 | |
| Uzhhorod, Ukraine, 88009 | |
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01644188 History of Changes |
| Other Study ID Numbers: | EFC11569, U1111-1121-4315, 2011-004130-34 |
| Study First Received: | July 16, 2012 |
| Last Updated: | February 9, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Ezetimibe Anticholesteremic Agents |
Antimetabolites Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 02, 2015