Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin lipid modifying background therapy or as monotherapy in comparison with placebo in participants with primary hypercholesterolemia not treated with a statin. Secondary Objective: * To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus placebo. * To evaluate the safety and tolerability of Alirocumab 150 mg Q4W. Alirocumab 75 mg Q2W was added as a calibrator arm.

Key facts

Study ID

NCT02023879

Run by

Sanofi

People needed

233

Starts

2013-12-16

Expected to finish

2017-06-30

Last updated by the study team

2018-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with primary hypercholesterolemia (heterozygous familial hypercholesterolemia [heFH] or non-FH) not adequately controlled with their non-statin LMT (either ezetimibe or fenofibrate) or diet alone.

You may not qualify if…

• LDL-C <70 mg/dL (1.81 mmol/L) at screening for statin intolerant participants at very high cardiovascular (CV) risk;
• LDL-C <100 mg/dL (<2.59 mmol/L) at screening for statin intolerant participants at high or moderate CV risk or, participants not fulfilling the statin intolerant definition at moderate CV risk;
• LDL-C ≥160 mg/dL (≥4.1 mmol/L) at screening for participants receiving diet only or, participants not fulfilling the statin intolerant definition at moderate CV risk and receiving a non-statin LMT.
• 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 840703 — Beverly Hills, California, United States
• Investigational Site Number 840704 — Atlantis, Florida, United States
• Investigational Site Number 840708 — Jacksonville, Florida, United States
• Investigational Site Number 840701 — Sarasota, Florida, United States
• Investigational Site Number 840706 — Fall River, Massachusetts, United States
• Investigational Site Number 840705 — St Louis, Missouri, United States
• Investigational Site Number 840707 — Durham, North Carolina, United States
• Investigational Site Number 840702 — Summerville, South Carolina, United States
• Investigational Site Number 036703 — Ashford, Australia
• Investigational Site Number 036702 — Perth, Australia
• Investigational Site Number 036701 — Woolloongabba, Australia
• Investigational Site Number 056702 — Antwerp, Belgium
• Investigational Site Number 056703 — Haine-Saint-Paul, Belgium
• Investigational Site Number 056701 — Leuven, Belgium
• Investigational Site Number 124703 — Chicoutimi, Canada
• Investigational Site Number 124701 — Québec, Canada
• Investigational Site Number 124704 — Sherbrooke, Canada
• Investigational Site Number 124706 — Toronto, Canada
• Investigational Site Number 124702 — Vancouver, Canada
• Investigational Site Number 124705 — Victoria, Canada
• Investigational Site Number 208703 — Aarhus, Denmark
• Investigational Site Number 208702 — Esbjerg, Denmark
• Investigational Site Number 208701 — Glostrup Municipality, Denmark
• Investigational Site Number 208704 — Hvidovre, Denmark
• Investigational Site Number 208705 — Køge, Denmark

Full record on ClinicalTrials.gov

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