Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
Completed · Phase 3 · Has a placebo group
Conditions studied: Hypercholesterolemia
In brief
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
Key facts
- Study ID
- NCT01644188
- Run by
- Sanofi
- People needed
- 720
- Starts
- 2012-08-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2016-08-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).
You may not qualify if…
- Age < 18 or legal age of adulthood, whichever was greater
- Participants without established CHD or CHD risk equivalents
- LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented cardiovascular disease
- LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented CV disease
- Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L)
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Where it is running
- Investigational Site Number 840918 — Phoenix, Arizona, United States
- Investigational Site Number 840925 — Tucson, Arizona, United States
- Investigational Site Number 840959 — Anaheim, California, United States
- Investigational Site Number 840301 — Beverly Hills, California, United States
- Investigational Site Number 840933 — Chino, California, United States
- Investigational Site Number 840991 — Lincoln, California, United States
- Investigational Site Number 840979 — Los Angeles, California, United States
- Investigational Site Number 840952 — Palm Springs, California, United States
- Investigational Site Number 840930 — Thousand Oaks, California, United States
- Investigational Site Number 840921 — Vista, California, United States
- Investigational Site Number 840962 — Boynton Beach, Florida, United States
- Investigational Site Number 840987 — Bradenton, Florida, United States
- Investigational Site Number 840302 — Clearwater, Florida, United States
- Investigational Site Number 840935 — Jacksonville, Florida, United States
- Investigational Site Number 840903 — Miami, Florida, United States
- Investigational Site Number 840920 — Miami, Florida, United States
- Investigational Site Number 840943 — Ocala, Florida, United States
- Investigational Site Number 840981 — Oveido, Florida, United States
- Investigational Site Number 840961 — Port Orange, Florida, United States
- Investigational Site Number 840303 — Sarasota, Florida, United States
- Investigational Site Number 840986 — St. Petersburg, Florida, United States
- Investigational Site Number 840988 — St. Petersburg, Florida, United States
- Investigational Site Number 840995 — Meridian, Idaho, United States
- Investigational Site Number 840902 — Evansville, Indiana, United States
- Investigational Site Number 840980 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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