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Completed Phase 3 Interventional Results available

ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

ClinicalTrials.gov ID: NCT01663402

Public ClinicalTrials.gov record NCT01663402. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 11:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia. Secondary Objectives: * To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, CHD deaths, CV deaths, all cause mortality). * To evaluate the safety and tolerability of alirocumab. * To evaluate the effect of alirocumab on lipid parameters.

Study identification

NCT ID
NCT01663402
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sanofi
Industry
Enrollment
18,924 participants

Conditions and interventions

Eligibility (public fields only)

Age range
40 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2012 (Actual)
Primary completion
Jan 23, 2018 (Actual)
Completion
Jan 23, 2018 (Actual)
Last update posted
Mar 18, 2019

2012 – 2018

United States locations

U.S. sites
273
U.S. states
42
U.S. cities
221
Facility City State ZIP Site status
Investigational Site Number 840163 Birmingham Alabama 35235 —
Investigational Site Number 840060 Birmingham Alabama 35294 —
Investigational Site Number 840117 Huntsville Alabama 35801 —
Investigational Site Number 840192 Huntsville Alabama 35801 —
Investigational Site Number 840121 Mobile Alabama 36604 —
Investigational Site Number 840319 Mobile Alabama 36695 —
Investigational Site Number 840332 Atlantis Arizona 33462 —
Investigational Site Number 840320 Newport Beach Arizona 92663 —
Investigational Site Number 840103 Tucson Arizona 85724 —
Investigational Site Number 840084 Tucson Arizona — —
Investigational Site Number 840139 Banning California — —
Investigational Site Number 840286 Beverly Hills California 90210 —
Investigational Site Number 840246 Beverly Hills California 90211 —
Investigational Site Number 840353 Beverly Hills California 90211 —
Investigational Site Number 840341 Carmichael California 95608 —
Investigational Site Number 840299 Chula Vista California 91910 —
Investigational Site Number 840164 Fresno California 93721 —
Investigational Site Number 840076 Fullerton California 92835 —
Investigational Site Number 840073 Huntington Beach California 92648 —
Investigational Site Number 840092 La Jolla California 92093 —
Investigational Site Number 840208 Long Beach California 90801 —
Investigational Site Number 840068 Long Beach California 90822 —
Investigational Site Number 840269 Los Alamitos California 90720 —
Investigational Site Number 840009 Los Angeles California 90073 —
Investigational Site Number 840282 Los Angeles California 90095 —
Investigational Site Number 840019 Mission Viejo California 92691 —
Investigational Site Number 840336 Moreno Valley California 92553 —
Investigational Site Number 840124 Northridge California 91325 —
Investigational Site Number 840251 Pasadena California 91105 —
Investigational Site Number 840289 Pasadena California 91105 —
Investigational Site Number 840312 Port Hueneme California 93041 —
Investigational Site Number 840261 San Diego California 92120 —
Investigational Site Number 840310 San Diego California 92120 —
Investigational Site Number 840024 San Diego California — —
Investigational Site Number 840071 Santa Ana California 92704 —
Investigational Site Number 840236 Santa Rosa California 95405 —
Investigational Site Number 840012 Torrance California — —
Investigational Site Number 840096 Aurora Colorado 80012 —
Investigational Site Number 840037 Colorado Springs Colorado 80909 —
Investigational Site Number 840189 Denver Colorado 80220 —
Investigational Site Number 840122 Bridgeport Connecticut 06606 —
Investigational Site Number 840219 Guilford Connecticut 06437 —
Investigational Site Number 840347 Altamonte Springs Florida 32714 —
Investigational Site Number 840066 Clearwater Florida 33756 —
Investigational Site Number 840079 Daytona Beach Florida 32114 —
Investigational Site Number 840051 Daytona Beach Florida 32117 —
Investigational Site Number 840368 Delray Beach Florida 33484 —
Investigational Site Number 840242 Fort Lauderdale Florida 33308 —
Investigational Site Number 840134 Gainesville Florida 32608 —
Investigational Site Number 840327 Hollywood Florida 33021 —
Investigational Site Number 840153 Hudson Florida 34667 —
Investigational Site Number 840105 Hudson Florida — —
Investigational Site Number 840253 Jacksonville Florida 32204 —
Investigational Site Number 840141 Jacksonville Florida 32209 —
Investigational Site Number 840042 Jacksonville Florida 32216 —
Investigational Site Number 840206 Jacksonville Florida 32216 —
Investigational Site Number 840063 Jacksonville Florida 32258 —
Investigational Site Number 840002 Jupiter Florida 33458 —
Investigational Site Number 840119 Largo Florida — —
Investigational Site Number 840241 Miami Beach Florida 33140 —
Investigational Site Number 840210 Mount Clemens Florida — —
Investigational Site Number 840366 New Port Richey Florida 34653 —
Investigational Site Number 840311 Palm Beach Gardens Florida 33410 —
Investigational Site Number 840280 Palm Harbor Florida 34684 —
Investigational Site Number 840054 Panama City Florida 32401 —
Investigational Site Number 840239 Pembroke Pines Florida 33024 —
Investigational Site Number 840044 Pensacola Florida 32501 —
Investigational Site Number 840367 Plantation Florida 33317 —
Investigational Site Number 840132 Safety Harbor Florida 34695 —
Investigational Site Number 840061 Safety Harbor Florida — —
Investigational Site Number 840247 Sarasota Florida 34239 —
Investigational Site Number 840264 Tampa Florida 33606 —
Investigational Site Number 840082 Tampa Florida 33613 —
Investigational Site Number 840213 Trinity Florida 34655 —
Investigational Site Number 840165 Wellington Florida 33449 —
Investigational Site Number 840323 West Palm Beach Florida 33401 —
Investigational Site Number 840075 Atlanta Georgia — —
Investigational Site Number 840176 Augusta Georgia 30901 —
Investigational Site Number 840048 Covington Georgia 30014 —
Investigational Site Number 840065 Cumming Georgia 30041 —
Investigational Site Number 840356 Thomasville Georgia 31792 —
Investigational Site Number 840114 Tucker Georgia 30084 —
Investigational Site Number 840211 Idaho Falls Idaho 83404 —
Investigational Site Number 840237 Arlington Heights Illinois 60005 —
Investigational Site Number 840292 Chicago Illinois 60612 —
Investigational Site Number 840146 Harvey Illinois 60426 —
Investigational Site Number 840340 Joliet Illinois 60435 —
Investigational Site Number 840196 Peoria Illinois 61614 —
Investigational Site Number 840081 Rock Island Illinois 61201 —
Investigational Site Number 840090 Rock Island Illinois 61201 —
Investigational Site Number 840358 Elkhart Indiana 46514 —
Investigational Site Number 840036 Hammond Indiana 46320 —
Investigational Site Number 840026 Indianapolis Indiana — —
Investigational Site Number 840102 Muncie Indiana 47303-3400 —
Investigational Site Number 840145 South Bend Indiana 46601-1075 —
Investigational Site Number 840154 Ames Iowa 50010 —
Investigational Site Number 840345 Iowa City Iowa — —
Investigational Site Number 840283 West Des Moines Iowa 50266 —
Investigational Site Number 840335 Kansas City Kansas 64116 —
Investigational Site Number 840089 Kansas City Kansas 66160-7321 —
Investigational Site Number 840218 Kansas City Kansas — —
Investigational Site Number 840140 Overland Park Kansas 66209 —
Investigational Site Number 840030 Lexington Kentucky — —
Investigational Site Number 840023 Louisville Kentucky 40205 —
Investigational Site Number 840007 Louisville Kentucky 40207 —
Investigational Site Number 840279 Owensboro Kentucky 42303 —
Investigational Site Number 840308 Pikeville Kentucky 41501 —
Investigational Site Number 840181 Saint Paul Kentucky 55102 —
Investigational Site Number 840254 Alexandria Louisiana 71301 —
Investigational Site Number 840344 Lafayette Louisiana 70503 —
Investigational Site Number 840187 Lake Charles Louisiana 70601 —
Investigational Site Number 840291 Minden Louisiana 71055 —
Investigational Site Number 840278 New Orleans Louisiana 70112 —
Investigational Site Number 840290 Shreveport Louisiana 71103 —
Investigational Site Number 840142 Auburn Maine 04210 —
Investigational Site Number 840148 Auburn Maine — —
Investigational Site Number 840097 Bangor Maine 04401 —
Investigational Site Number 840234 Framingham Maine 01702 —
Investigational Site Number 840276 Scarborough Maine 04074 —
Investigational Site Number 840351 Annapolis Maryland 21401 —
Investigational Site Number 840072 Beltsville Maryland — —
Investigational Site Number 840193 Bethesda Maryland 20817 —
Investigational Site Number 840200 Columbia Maryland 21044 —
Investigational Site Number 840349 Rockville Maryland 20850 —
Investigational Site Number 840111 Winfield Maryland — —
Investigational Site Number 840056 Boston Massachusetts 02111 —
Investigational Site Number 840144 Flint Michigan 48532 —
Investigational Site Number 840365 Grandville Michigan 49418 —
Investigational Site Number 840093 Kalamazoo Michigan — —
Investigational Site Number 840198 Lansing Michigan 48910 —
Investigational Site Number 840087 Rochester Hills Michigan 48085 —
Investigational Site Number 840004 Springfield Michigan 65807 —
Investigational Site Number 840267 Springfield Michigan — —
Investigational Site Number 840035 Ypsilanti Michigan 48197 —
Investigational Site Number 840199 Duluth Minnesota 55805 —
Investigational Site Number 840116 Edina Minnesota 55435 —
Investigational Site Number 840281 Minneapolis Minnesota 55407 —
Investigational Site Number 840094 Saint Cloud Minnesota 56303 —
Investigational Site Number 840324 Saint Paul Minnesota 55101 —
Investigational Site Number 840046 Columbia Missouri 65201 —
Investigational Site Number 840180 Independence Missouri 64057 —
Investigational Site Number 840013 Marquette Missouri — —
Investigational Site Number 840179 Overland Missouri — —
Investigational Site Number 840228 St Louis Missouri 63128 —
Investigational Site Number 840233 St Louis Missouri 63128 —
Investigational Site Number 840235 St Louis Missouri 63128 —
Investigational Site Number 840175 St Louis Missouri 63136 —
Investigational Site Number 840125 St Louis Missouri 63141 —
Investigational Site Number 840168 St Louis Missouri — —
Investigational Site Number 840274 Thomure Missouri — —
Investigational Site Number 840032 Kalispell Montana 59901 —
Investigational Site Number 840033 Grand Island Nebraska 68803 —
Investigational Site Number 840015 Omaha Nebraska 68122 —
Investigational Site Number 840021 Omaha Nebraska 68122 —
Investigational Site Number 840001 Omaha Nebraska — —
Investigational Site Number 840221 Las Vegas Nevada 89146 —
Investigational Site Number 840062 Nashua New Hampshire 03060 —
Investigational Site Number 840077 Bridgewater New Jersey 08807 —
Investigational Site Number 840173 Bridgewater New Jersey — —
Investigational Site Number 840127 Flemington New Jersey 08822 —
Investigational Site Number 840359 Hackensack New Jersey 07601 —
Investigational Site Number 840348 Moorestown New Jersey 08057 —
Investigational Site Number 840128 New Brunswick New Jersey 08903-0019 —
Investigational Site Number 840167 Pomona New Jersey 08240 —
Investigational Site Number 840067 Ridgewood New Jersey 07506 —
Investigational Site Number 840250 Somerset New Jersey 08873 —
Investigational Site Number 840277 Voorhees Township New Jersey 08043 —
Investigational Site Number 840083 Westwood New Jersey — —
Investigational Site Number 840322 Buffalo New York 14215 —
Investigational Site Number 840248 New York New York 10016 —
Investigational Site Number 840371 New York New York — —
Investigational Site Number 840333 Newburgh New York 47630 —
Investigational Site Number 840017 Poughkeepsie New York 12601 —
Investigational Site Number 840222 The Bronx New York 10467 —
Investigational Site Number 840166 Valhalla New York 10595 —
Investigational Site Number 840354 Williamsville New York 14221 —
Investigational Site Number 840070 Elizabeth City North Carolina 27909 —
Investigational Site Number 840303 Greenville North Carolina 27834 —
Investigational Site Number 840182 Greenville North Carolina — —
Investigational Site Number 840243 Raleigh North Carolina 27610 —
Investigational Site Number 840342 Raleigh North Carolina 27610 —
Investigational Site Number 840293 Rocky Mount North Carolina 27804 —
Investigational Site Number 840088 Statesville North Carolina 28627 —
Investigational Site Number 840052 Wilmington North Carolina 28401 —
Investigational Site Number 840214 Fargo North Dakota — —
Investigational Site Number 840306 Glasston North Dakota 21229 —
Investigational Site Number 840095 Minot North Dakota 58701 —
Investigational Site Number 840257 Mountain Lakes North Dakota — —
Investigational Site Number 840364 Akron Ohio 44304 —
Investigational Site Number 840131 Cincinnati Ohio — —
Investigational Site Number 840045 Columbus Ohio 43210 —
Investigational Site Number 840265 Columbus Ohio 43210 —
Investigational Site Number 840113 Lorain Ohio 44053 —
Investigational Site Number 840115 Lorain Ohio 44053 —
Investigational Site Number 840309 Maumee Ohio 43537 —
Investigational Site Number 840297 Springfield Ohio 45505 —
Investigational Site Number 840172 Toledo Ohio 43623 —
Investigational Site Number 840263 Youngstown Ohio 44501 —
Investigational Site Number 840334 Oklahoma City Oklahoma 73104 —
Investigational Site Number 840337 Oklahoma City Oklahoma 73120 —
Investigational Site Number 840018 Tulsa Oklahoma 74104 —
Investigational Site Number 840184 Portland Oregon 97239 —
Investigational Site Number 840133 Allentown Pennsylvania 18102 —
Investigational Site Number 840104 Beaver Pennsylvania 15009 —
Investigational Site Number 840170 Camp Hill Pennsylvania 17011 —
Investigational Site Number 840020 Doylestown Pennsylvania 18901 —
Investigational Site Number 840016 Erie Pennsylvania 16502-4604 —
Investigational Site Number 840329 Goodyear Pennsylvania 85395 —
Investigational Site Number 840126 Knoxville Pennsylvania — —
Investigational Site Number 840249 Lancaster Pennsylvania 17603 —
Investigational Site Number 840150 Lancaster Pennsylvania — —
Investigational Site Number 840231 Philadelphia Pennsylvania 19085 —
Investigational Site Number 840339 Philadelphia Pennsylvania 19104 —
Investigational Site Number 840230 Pittsburgh Pennsylvania 15240 —
Investigational Site Number 840028 Sayre Pennsylvania 18840 —
Investigational Site Number 840069 Scranton Pennsylvania 18503 —
Investigational Site Number 840316 Scranton Pennsylvania 18510 —
Investigational Site Number 840273 Seven Fields Pennsylvania 16046 —
Investigational Site Number 840227 Washington Pennsylvania — —
Investigational Site Number 840129 Pawtucket Rhode Island 02860 —
Investigational Site Number 840118 Anderson South Carolina 29621 —
Investigational Site Number 840190 Greenwood South Carolina — —
Investigational Site Number 840360 Lancaster South Carolina 29720 —
Investigational Site Number 840314 Myrtle Beach South Carolina 29572 —
Investigational Site Number 840008 Rapid City South Dakota 57701 —
Investigational Site Number 840285 Chattanooga Tennessee 37421 —
Investigational Site Number 840287 Jackson Tennessee 38301 —
Investigational Site Number 840040 Johnson City Tennessee 37604 —
Investigational Site Number 840238 Knoxville Tennessee 37917-4524 —
Investigational Site Number 840195 Oak Ridge Tennessee 37830 —
Investigational Site Number 840205 Amarillo Texas 79106 —
Investigational Site Number 840352 Amarillo Texas 79106 —
Investigational Site Number 840135 Austin Texas 78756 —
Investigational Site Number 840301 Dallas Texas 75226 —
Investigational Site Number 840152 Dallas Texas 75231 —
Investigational Site Number 840157 Dallas Texas 75390 —
Investigational Site Number 840229 Fort Worth Texas 76104 —
Investigational Site Number 840120 Fort Worth Texas 76107 —
Investigational Site Number 840258 Fort Worth Texas — —
Investigational Site Number 840136 Kingwood Texas 77339 —
Investigational Site Number 840027 Lubbock Texas 79410 —
Investigational Site Number 840202 Lufkin Texas 75904 —
Investigational Site Number 840270 Odessa Texas 79761 —
Investigational Site Number 840162 San Antonio Texas 78229 —
Investigational Site Number 840232 San Antonio Texas 78229 —
Investigational Site Number 840328 Schertz Texas 78154 —
Investigational Site Number 840158 Tyler Texas 75701 —
Investigational Site Number 840318 Victoria Texas 77901 —
Investigational Site Number 840245 Wichita Falls Texas — —
Investigational Site Number 840256 Orem Utah 84058 —
Investigational Site Number 840296 Salt Lake City Utah 84124 —
Investigational Site Number 840053 Burlington Vermont 05401 —
Investigational Site Number 840049 Charlottesville Virginia 22908-0679 —
Investigational Site Number 840260 Charlottesville Virginia — —
Investigational Site Number 840350 Harrisonburg Virginia 22801 —
Investigational Site Number 840215 Leesburg Virginia — —
Investigational Site Number 840010 Lynchburg Virginia 24501 —
Investigational Site Number 840225 Manassas Virginia 20109 —
Investigational Site Number 840022 Richmond Virginia 23225 —
Investigational Site Number 840078 Richmond Virginia 23249 —
Investigational Site Number 840110 Richmond Virginia 23298 —
Investigational Site Number 840149 Roanoke Virginia 24014 —
Investigational Site Number 840223 Winchester Virginia 22601 —
Investigational Site Number 840025 Bellevue Washington 98004 —
Investigational Site Number 840321 Everett Washington 98201 —
Investigational Site Number 840326 Spokane Washington 99204 —
Investigational Site Number 840086 Tacoma Washington 98415-0299 —
Investigational Site Number 840295 Walla Walla Washington 99362 —
Investigational Site Number 840262 Burlington Wisconsin 53105 —
Investigational Site Number 840298 Green Bay Wisconsin 54303 —
Investigational Site Number 840059 Green Bay Wisconsin — —
Investigational Site Number 840177 La Crosse Wisconsin 54601 —
Investigational Site Number 840300 Manitowoc Wisconsin 54220 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1115 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01663402, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 18, 2019 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01663402 live on ClinicalTrials.gov.

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