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)
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 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.
Key facts
- Study ID
- NCT01507831
- Run by
- Sanofi
- People needed
- 2341
- Starts
- 2012-01-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2015-12-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Either A or B below and who were not adequately controlled with their lipid-modifying therapy:
- A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents
- OR
- B) Participants with hypercholesterolemia together with established CHD or CHD risk equivalents.
You may not qualify if…
- Age < 18 years
- LDL-C <70 mg/dL (< 1.81 mmol/L)
- 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 840028 — Gilbert, Arizona, United States
- Investigational Site Number 840035 — Sierra Vista, Arizona, United States
- Investigational Site Number 840052 — Tempe, Arizona, United States
- Investigational Site Number 840065 — Tempe, Arizona, United States
- Investigational Site Number 840079 — Tempe, Arizona, United States
- Investigational Site Number 840094 — Tempe, Arizona, United States
- Investigational Site Number 840103 — Tucson, Arizona, United States
- Investigational Site Number 840209 — Beverly Hills, California, United States
- Investigational Site Number 840194 — Beverly Hills, California, United States
- Investigational Site Number 840207 — Fresno, California, United States
- Investigational Site Number 840101 — Lincoln, California, United States
- Investigational Site Number 840076 — Long Beach, California, United States
- Investigational Site Number 840214 — Pasadena, California, United States
- Investigational Site Number 840045 — Sacramento, California, United States
- Investigational Site Number 840163 — Santa Rosa, California, United States
- Investigational Site Number 840086 — Colorado Springs, Colorado, United States
- Investigational Site Number 840077 — Golden, Colorado, United States
- Investigational Site Number 840224 — Bridgeport, Connecticut, United States
- Investigational Site Number 840134 — Guilford, Connecticut, United States
- Investigational Site Number 840246 — Hartford, Connecticut, United States
- Investigational Site Number 840055 — Stamford, Connecticut, United States
- Investigational Site Number 840091 — Stamford, Connecticut, United States
- Investigational Site Number 840150 — Atlantis, Florida, United States
- Investigational Site Number 840020 — Bradenton, Florida, United States
- Investigational Site Number 840159 — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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