Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
Public ClinicalTrials.gov record NCT01644188. 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, 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
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 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 participants 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
Study identification
- NCT ID
- NCT01644188
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 720 participants
Conditions and interventions
Conditions
Interventions
- Alirocumab Drug
- Placebo (for alirocumab) Drug
- Ezetimibe Drug
- Placebo (for ezetimibe) Drug
- Lipid Modifying Therapy (LMT) Drug
Drug
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
- Aug 2012 (Type not available)
- Primary completion
- May 2014 (Actual)
- Completion
- Jul 2015 (Actual)
- Last update posted
- Aug 4, 2016
2012 – 2015
United States locations
- U.S. sites
- 58
- U.S. states
- 22
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Investigational Site Number 840980 | Birmingham | Alabama | 35209 | — |
| Investigational Site Number 840918 | Phoenix | Arizona | 85032 | — |
| Investigational Site Number 840925 | Tucson | Arizona | — | — |
| Investigational Site Number 840959 | Anaheim | California | 92801 | — |
| Investigational Site Number 840301 | Beverly Hills | California | 90211 | — |
| Investigational Site Number 840933 | Chino | California | 91710 | — |
| Investigational Site Number 840991 | Lincoln | California | 95648 | — |
| Investigational Site Number 840979 | Los Angeles | California | 90057 | — |
| Investigational Site Number 840952 | Palm Springs | California | 92262 | — |
| Investigational Site Number 840930 | Thousand Oaks | California | 91360 | — |
| Investigational Site Number 840921 | Vista | California | 92083 | — |
| Investigational Site Number 840962 | Boynton Beach | Florida | 33472 | — |
| Investigational Site Number 840987 | Bradenton | Florida | 34203 | — |
| Investigational Site Number 840302 | Clearwater | Florida | 33756 | — |
| Investigational Site Number 840935 | Jacksonville | Florida | 32223 | — |
| Investigational Site Number 840903 | Miami | Florida | 33126 | — |
| Investigational Site Number 840920 | Miami | Florida | — | — |
| Investigational Site Number 840943 | Ocala | Florida | 34471 | — |
| Investigational Site Number 840981 | Oveido | Florida | 32765 | — |
| Investigational Site Number 840961 | Port Orange | Florida | 32127 | — |
| Investigational Site Number 840303 | Sarasota | Florida | 34239 | — |
| Investigational Site Number 840986 | St. Petersburg | Florida | — | — |
| Investigational Site Number 840988 | St. Petersburg | Florida | — | — |
| Investigational Site Number 840995 | Meridian | Idaho | 83646 | — |
| Investigational Site Number 840902 | Evansville | Indiana | 47714 | — |
| Investigational Site Number 840960 | Topeka | Kansas | 66606 | — |
| Investigational Site Number 840940 | Oxon Hill | Maryland | 20745 | — |
| Investigational Site Number 840966 | Fall River | Massachusetts | 02720 | — |
| Investigational Site Number 840917 | Kansas City | Missouri | 64114 | — |
| Investigational Site Number 840998 | St Louis | Missouri | 63131 | — |
| Investigational Site Number 840946 | Butte | Montana | 59701 | — |
| Investigational Site Number 840914 | Lincoln | Nebraska | 68510 | — |
| Investigational Site Number 840949 | Albuquerque | New Mexico | 87106 | — |
| Investigational Site Number 840974 | New Windsor | New York | 12553 | — |
| Investigational Site Number 840955 | Greenville | North Carolina | 27834 | — |
| Investigational Site Number 840938 | Lexington | North Carolina | 27292 | — |
| Investigational Site Number 840976 | Smithfield | North Carolina | 27577 | — |
| Investigational Site Number 840985 | Winston-Salem | North Carolina | 27103 | — |
| Investigational Site Number 840963 | Cincinnati | Ohio | 45219 | — |
| Investigational Site Number 840970 | Lyndhust | Ohio | 44124 | — |
| Investigational Site Number 840906 | Marion | Ohio | 43302 | — |
| Investigational Site Number 840997 | Marion | Ohio | 43302 | — |
| Investigational Site Number 840964 | Perrysburg | Ohio | 43551 | — |
| Investigational Site Number 840913 | Charleston | South Carolina | 29412 | — |
| Investigational Site Number 840912 | Greer | South Carolina | 29651 | — |
| Investigational Site Number 840992 | Summerville | South Carolina | 29485 | — |
| Investigational Site Number 840932 | Bristol | Tennessee | 37620 | — |
| Investigational Site Number 840944 | Nashville | Tennessee | 37205 | — |
| Investigational Site Number 840994 | Fort Worth | Texas | 76104 | — |
| Investigational Site Number 840973 | Houston | Texas | 77070 | — |
| Investigational Site Number 840939 | Houston | Texas | 77074 | — |
| Investigational Site Number 840945 | Sugar Land | Texas | 77479 | — |
| Investigational Site Number 840971 | Tomball | Texas | 77375 | — |
| Investigational Site Number 840982 | Orem | Utah | 84058 | — |
| Investigational Site Number 840931 | Norfolk | Virginia | 23502 | — |
| Investigational Site Number 840984 | Richmond | Virginia | 23227 | — |
| Investigational Site Number 840928 | Renton | Washington | 98055 | — |
| Investigational Site Number 840990 | Spokane | Washington | 99204 | — |
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 68 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01644188, 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 Aug 4, 2016 · Synced Oct 17, 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 NCT01644188 live on ClinicalTrials.gov.