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)
Completed · Phase 3 · Has a placebo group
Conditions studied: Hypercholesterolemia
In brief
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
Key facts
- Study ID
- NCT01644175
- Run by
- Sanofi
- People needed
- 316
- Starts
- 2012-07-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2015-11-06
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 with or without other LMT, both at stable dose for at least 4 weeks to 6 weeks prior to screening (Week -2)
You may not qualify if…
- Age <18 or legal age of adulthood, whichever was greater
- Participants without established CHD or CHD risk equivalent
- 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 cardiovascular disease
- Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (Week -2) and from screening to randomization
- Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L)
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Where it is running
- Investigational Site Number 840891 — Mobile, Alabama, United States
- Investigational Site Number 840876 — Montgomery, Alabama, United States
- Investigational Site Number 840865 — Glendale, Arizona, United States
- Investigational Site Number 840826 — Jonesboro, Arkansas, United States
- Investigational Site Number 840870 — Burbank, California, United States
- Investigational Site Number 840851 — Los Angeles, California, United States
- Investigational Site Number 840845 — Los Gatos, California, United States
- Investigational Site Number 840844 — Sacramento, California, United States
- Investigational Site Number 840801 — San Jose, California, United States
- Investigational Site Number 840886 — Tarzana, California, United States
- Investigational Site Number 840862 — Torrance, California, United States
- Investigational Site Number 840893 — Vista, California, United States
- Investigational Site Number 840867 — Boca Raton, Florida, United States
- Investigational Site Number 840884 — Boynton Beach, Florida, United States
- Investigational Site Number 840836 — Clearwater, Florida, United States
- Investigational Site Number 840866 — Coral Gables, Florida, United States
- Investigational Site Number 840895 — Fort Lauderdale, Florida, United States
- Investigational Site Number 840820 — Hialeah, Florida, United States
- Investigational Site Number 840805 — Miami, Florida, United States
- Investigational Site Number 840811 — Oviedo, Florida, United States
- Investigational Site Number 840881 — Port Orange, Florida, United States
- Investigational Site Number 840816 — West Palm Beach, Florida, United States
- Investigational Site Number 840850 — Columbus, Georgia, United States
- Investigational Site Number 840840 — Eagle, Idaho, United States
- Investigational Site Number 840857 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.