Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)
Public ClinicalTrials.gov record NCT01644175. 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
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 (PCSK9). 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 with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk participants with hypercholesterolemia Secondary Objectives: * To evaluate the effect of alirocumab in comparison with placebo 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
Study identification
- NCT ID
- NCT01644175
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 316 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
- Jul 2012 (Type not available)
- Primary completion
- Apr 2014 (Actual)
- Completion
- Apr 2014 (Actual)
- Last update posted
- Nov 6, 2015
2012 – 2014
United States locations
- U.S. sites
- 76
- U.S. states
- 28
- U.S. cities
- 71
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840857 | Birmingham | Alabama | 35209 | — |
| Investigational Site Number 840891 | Mobile | Alabama | 36693 | — |
| Investigational Site Number 840876 | Montgomery | Alabama | 36109 | — |
| Investigational Site Number 840865 | Glendale | Arizona | 85306 | — |
| Investigational Site Number 840826 | Jonesboro | Arkansas | 72401 | — |
| Investigational Site Number 840870 | Burbank | California | 91505 | — |
| Investigational Site Number 840851 | Los Angeles | California | 90057 | — |
| Investigational Site Number 840845 | Los Gatos | California | 95032 | — |
| Investigational Site Number 840844 | Sacramento | California | 95823 | — |
| Investigational Site Number 840801 | San Jose | California | 95116 | — |
| Investigational Site Number 840886 | Tarzana | California | 91356 | — |
| Investigational Site Number 840862 | Torrance | California | 90505 | — |
| Investigational Site Number 840893 | Vista | California | 92083 | — |
| Investigational Site Number 840867 | Boca Raton | Florida | 33432 | — |
| Investigational Site Number 840884 | Boynton Beach | Florida | 33472 | — |
| Investigational Site Number 840836 | Clearwater | Florida | 33761 | — |
| Investigational Site Number 840866 | Coral Gables | Florida | 33134 | — |
| Investigational Site Number 840895 | Fort Lauderdale | Florida | 33308-4311 | — |
| Investigational Site Number 840820 | Hialeah | Florida | — | — |
| Investigational Site Number 840805 | Miami | Florida | 33143 | — |
| Investigational Site Number 840811 | Oviedo | Florida | 32765 | — |
| Investigational Site Number 840881 | Port Orange | Florida | 32127 | — |
| Investigational Site Number 840816 | West Palm Beach | Florida | — | — |
| Investigational Site Number 840850 | Columbus | Georgia | 31904 | — |
| Investigational Site Number 840840 | Eagle | Idaho | — | — |
| Investigational Site Number 840842 | Chicago | Illinois | 60611 | — |
| Investigational Site Number 840898 | Evanston | Illinois | 60201 | — |
| Investigational Site Number 840847 | Morton | Illinois | 61550 | — |
| Investigational Site Number 840896 | Indianapolis | Indiana | 46260 | — |
| Investigational Site Number 840894 | Michigan City | Indiana | 46360 | — |
| Investigational Site Number 840838 | Mishawaka | Indiana | 46545 | — |
| Investigational Site Number 840823 | Paducah | Kentucky | 42003 | — |
| Investigational Site Number 840858 | Eunice | Louisiana | 70535 | — |
| Investigational Site Number 840802 | New Orleans | Louisiana | 70119 | — |
| Investigational Site Number 840855 | Salisbury | Massachusetts | 01952 | — |
| Investigational Site Number 840890 | Battle Creek | Michigan | 49015 | — |
| Investigational Site Number 840832 | Southfield | Michigan | 48034 | — |
| Investigational Site Number 840839 | Edina | Minnesota | 55435 | — |
| Investigational Site Number 840888 | Minneapolis | Minnesota | 55455 | — |
| Investigational Site Number 840837 | Port Gibson | Mississippi | 39150 | — |
| Investigational Site Number 840814 | Jefferson City | Missouri | 65109 | — |
| Investigational Site Number 840833 | Sparks | Nevada | — | — |
| Investigational Site Number 840817 | Newington | New Hampshire | 3801 | — |
| Investigational Site Number 840853 | New Windsor | New York | 12553 | — |
| Investigational Site Number 840822 | Rochester | New York | 14609 | — |
| Investigational Site Number 840824 | Cary | North Carolina | — | — |
| Investigational Site Number 840880 | Smithfield | North Carolina | — | — |
| Investigational Site Number 840502 | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site Number 840852 | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site Number 840846 | Cincinnati | Ohio | 45219 | — |
| Investigational Site Number 840899 | Cincinnati | Ohio | 45245 | — |
| Investigational Site Number 840831 | Columbus | Ohio | 43231 | — |
| Investigational Site Number 840860 | Kettering | Ohio | 45429 | — |
| Investigational Site Number 840809 | Willoughby Hills | Ohio | 44094 | — |
| Investigational Site Number 840818 | Norman | Oklahoma | 73069 | — |
| Investigational Site Number 840812 | Eugene | Oregon | 97404 | — |
| Investigational Site Number 840803 | Downington | Pennsylvania | 19335 | — |
| Investigational Site Number 840869 | Philadelphia | Pennsylvania | 19146 | — |
| Investigational Site Number 840825 | Pittsburgh | Pennsylvania | 15206 | — |
| Investigational Site Number 840872 | Anderson | South Carolina | 29621 | — |
| Investigational Site Number 840885 | Charleston | South Carolina | 29407 | — |
| Investigational Site Number 840813 | Greer | South Carolina | 29651 | — |
| Investigational Site Number 840827 | Mt. Pleasant | South Carolina | 29464 | — |
| Investigational Site Number 840868 | Corpus Christi | Texas | 78404 | — |
| Investigational Site Number 840877 | Houston | Texas | 77070 | — |
| Investigational Site Number 840841 | Houston | Texas | 77072 | — |
| Investigational Site Number 840830 | San Antonio | Texas | 78224 | — |
| Investigational Site Number 840854 | San Antonio | Texas | 78229 | — |
| Investigational Site Number 840883 | San Antonio | Texas | 78258 | — |
| Investigational Site Number 840889 | Tomball | Texas | 77375 | — |
| Investigational Site Number 840878 | Bountiful | Utah | 84010 | — |
| Investigational Site Number 840819 | Orem | Utah | 84058 | — |
| Investigational Site Number 840863 | Salt Lake City | Utah | 84102 | — |
| Investigational Site Number 840804 | Manassas | Virginia | 20110 | — |
| Investigational Site Number 840882 | Norfolk | Virginia | 23507 | — |
| Investigational Site Number 840810 | Weber City | Virginia | 24290 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01644175, 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 Nov 6, 2015 · Synced Oct 22, 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 public registry record, listed eligibility criteria, and available contact information for NCT01644175 live on ClinicalTrials.gov.