ClinicalTrials.gov record
Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
ClinicalTrials.gov ID: NCT01507831
Public ClinicalTrials.gov record NCT01507831. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: * To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. * To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points. * To evaluate the effects of alirocumab on other lipid parameters.
Study identification
- NCT ID
- NCT01507831
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,341 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 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
- Dec 31, 2011
- Primary completion
- Oct 31, 2014
- Completion
- Oct 31, 2014
- Last update posted
- Dec 21, 2015
2012 – 2014
United States locations
- U.S. sites
- 115
- U.S. states
- 28
- U.S. cities
- 93
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840159 | Huntsville | Alabama | 35801 | — |
| Investigational Site Number 840028 | Gilbert | Arizona | 85295 | — |
| Investigational Site Number 840035 | Sierra Vista | Arizona | 85635 | — |
| Investigational Site Number 840052 | Tempe | Arizona | 85282 | — |
| Investigational Site Number 840065 | Tempe | Arizona | 85282 | — |
| Investigational Site Number 840079 | Tempe | Arizona | 85282 | — |
| Investigational Site Number 840094 | Tempe | Arizona | 85282 | — |
| Investigational Site Number 840103 | Tucson | Arizona | 85741-3565 | — |
| Investigational Site Number 840209 | Beverly Hills | California | 90210 | — |
| Investigational Site Number 840194 | Beverly Hills | California | 90211 | — |
| Investigational Site Number 840207 | Fresno | California | 93720 | — |
| Investigational Site Number 840101 | Lincoln | California | 95648 | — |
| Investigational Site Number 840076 | Long Beach | California | 90807 | — |
| Investigational Site Number 840214 | Pasadena | California | 91105 | — |
| Investigational Site Number 840045 | Sacramento | California | 95842 | — |
| Investigational Site Number 840163 | Santa Rosa | California | 95405 | — |
| Investigational Site Number 840086 | Colorado Springs | Colorado | 80906 | — |
| Investigational Site Number 840077 | Golden | Colorado | 80401 | — |
| Investigational Site Number 840224 | Bridgeport | Connecticut | 06610 | — |
| Investigational Site Number 840134 | Guilford | Connecticut | 06437 | — |
| Investigational Site Number 840246 | Hartford | Connecticut | 06102 | — |
| Investigational Site Number 840055 | Stamford | Connecticut | 06905 | — |
| Investigational Site Number 840091 | Stamford | Connecticut | 06905 | — |
| Investigational Site Number 840150 | Atlantis | Florida | 33462 | — |
| Investigational Site Number 840020 | Bradenton | Florida | 34208 | — |
| Investigational Site Number 840041 | Brandon | Florida | 33511 | — |
| Investigational Site Number 840184 | Clearwater | Florida | 33756 | — |
| Investigational Site Number 840242 | Clearwater | Florida | 33756 | — |
| Investigational Site Number 840039 | Clearwater | Florida | 33765 | — |
| Investigational Site Number 840182 | Crystal River | Florida | 34429 | — |
| Investigational Site Number 840002 | Daytona Beach | Florida | 32117 | — |
| Investigational Site Number 840166 | Daytona Beach | Florida | 32117 | — |
| Investigational Site Number 840167 | Fleming Island | Florida | 32003 | — |
| Investigational Site Number 840090 | Fort Lauderdale | Florida | 33308 | — |
| Investigational Site Number 840018 | Fort Lauderdale | Florida | 33309 | — |
| Investigational Site Number 840153 | Jacksonville | Florida | 32204 | — |
| Investigational Site Number 840181 | Jacksonville | Florida | 32205 | — |
| Investigational Site Number 840152 | Jacksonville | Florida | 32216 | — |
| Investigational Site Number 840154 | Lake Mary | Florida | 32746 | — |
| Investigational Site Number 840059 | Largo | Florida | 33773 | — |
| Investigational Site Number 840221 | Miami | Florida | 33176 | — |
| Investigational Site Number 840021 | New Port Richey | Florida | 34652 | — |
| Investigational Site Number 840122 | New Smyrna Beach | Florida | 32169 | — |
| Investigational Site Number 840151 | Ocala | Florida | 34471 | — |
| Investigational Site Number 840108 | Ormond Beach | Florida | 32174 | — |
| Investigational Site Number 840067 | Palm Harbor | Florida | 34684 | — |
| Investigational Site Number 840006 | Pembroke Pines | Florida | 33026 | — |
| Investigational Site Number 840168 | Ponte Vedra | Florida | 32081 | — |
| Investigational Site Number 840164 | Sarasota | Florida | 34239 | — |
| Investigational Site Number 840175 | Sarasota | Florida | 34239 | — |
| Investigational Site Number 840001 | St. Petersburg | Florida | — | — |
| Investigational Site Number 840003 | St. Petersburg | Florida | — | — |
| Investigational Site Number 840036 | West Palm Beach | Florida | 33401 | — |
| Investigational Site Number 840117 | Cumming | Georgia | 30041 | — |
| Investigational Site Number 840110 | Roswell | Georgia | 30076 | — |
| Investigational Site Number 840026 | Savannah | Georgia | 31405 | — |
| Investigational Site Number 840075 | Meridian | Idaho | 83646 | — |
| Investigational Site Number 840027 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 840093 | Indianapolis | Indiana | 46260 | — |
| Investigational Site Number 840222 | Iowa City | Iowa | 52242 | — |
| Investigational Site Number 840165 | West Des Moines | Iowa | 50266 | — |
| Investigational Site Number 840200 | Kansas City | Kansas | 66160-7321 | — |
| Investigational Site Number 840040 | Wichita | Kansas | 67203 | — |
| Investigational Site Number 840061 | Wichita | Kansas | 67205 | — |
| Investigational Site Number 840032 | Wichita | Kansas | 67207 | — |
| Investigational Site Number 840084 | Wichita | Kansas | 67207 | — |
| Investigational Site Number 840244 | Biddeford | Maine | 04005 | — |
| Investigational Site Number 840158 | Framingham | Maine | 01702 | — |
| Investigational Site Number 840193 | Novi | Michigan | 48374 | — |
| Investigational Site Number 840162 | Saginaw | Michigan | 48604 | — |
| Investigational Site Number 840033 | St Louis | Missouri | 63117 | — |
| Investigational Site Number 840113 | St Louis | Missouri | 63131 | — |
| Investigational Site Number 840095 | Henderson | Nevada | 89052 | — |
| Investigational Site Number 840096 | Henderson | Nevada | 89052 | — |
| Investigational Site Number 840022 | Edison | New Jersey | 08817 | — |
| Investigational Site Number 840011 | Hillsborough | New Jersey | 08844 | — |
| Investigational Site Number 840049 | Trenton | New Jersey | 08611 | — |
| Investigational Site Number 840097 | Bronxville | New York | 10708 | — |
| Investigational Site Number 840129 | Brooklyn | New York | 11215 | — |
| Investigational Site Number 840160 | Poughkeepsie | New York | 12601 | — |
| Investigational Site Number 840217 | Asheville | North Carolina | 28803 | — |
| Investigational Site Number 840023 | Charlotte | North Carolina | 28211 | — |
| Investigational Site Number 840083 | Greensboro | North Carolina | 27408 | — |
| Investigational Site Number 840104 | Raleigh | North Carolina | 27609 | — |
| Investigational Site Number 840068 | Cincinnati | Ohio | 45236 | — |
| Investigational Site Number 840007 | Dayton | Ohio | 45406 | — |
| Investigational Site Number 840013 | Marion | Ohio | 43302 | — |
| Investigational Site Number 840161 | Mentor | Ohio | 44060 | — |
| Investigational Site Number 840005 | Tulsa | Oklahoma | 74136 | — |
| Investigational Site Number 840170 | Beaver | Pennsylvania | 15009 | — |
| Investigational Site Number 840180 | Camp Hill | Pennsylvania | 17011 | — |
| Investigational Site Number 840004 | Duncansville | Pennsylvania | 16635 | — |
| Investigational Site Number 840046 | Jersey Shore | Pennsylvania | 17740 | — |
| Investigational Site Number 840155 | Phoenixville | Pennsylvania | 19460 | — |
| Investigational Site Number 840177 | Scranton | Pennsylvania | 18508 | — |
| Investigational Site Number 840202 | Wyomissing | Pennsylvania | 19610 | — |
| Investigational Site Number 840073 | Charleston | South Carolina | 29485 | — |
| Investigational Site Number 840087 | Greenville | South Carolina | 29615 | — |
| Investigational Site Number 840074 | Simpsonville | South Carolina | 29681 | — |
| Investigational Site Number 840105 | Varnville | South Carolina | 29944 | — |
| Investigational Site Number 840190 | Knoxville | Tennessee | 37917 | — |
| Investigational Site Number 840092 | Dallas | Texas | 75216 | — |
| Investigational Site Number 840212 | Dallas | Texas | 75226 | — |
| Investigational Site Number 840058 | Fort Worth | Texas | 76104 | — |
| Investigational Site Number 840149 | Fort Worth | Texas | 76104 | — |
| Investigational Site Number 840070 | Fort Worth | Texas | 76117 | — |
| Investigational Site Number 840038 | Houston | Texas | 77024 | — |
| Investigational Site Number 840047 | Houston | Texas | 77074 | — |
| Investigational Site Number 840053 | Plano | Texas | 75023 | — |
| Investigational Site Number 840072 | Sugar Land | Texas | 77479 | — |
| Investigational Site Number 840241 | Tyler | Texas | 75701 | — |
| Investigational Site Number 840031 | Salt Lake City | Utah | 84107 | — |
| Investigational Site Number 840204 | Chesapeake | Virginia | 23320 | — |
| Investigational Site Number 840120 | Spokane | Washington | 99204 | — |
| Investigational Site Number 840111 | Milwaukee | Wisconsin | 53209-0996 | — |
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 205 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01507831, 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 Dec 21, 2015 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01507831 live on ClinicalTrials.gov.