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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 Sep 2, 2026, 3:01 AM 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
Sep 30, 2012
Primary completion
Jan 22, 2018
Completion
Jan 22, 2018
Last update posted
Mar 17, 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 17, 2019 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01663402 live on ClinicalTrials.gov.

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