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

NCT02023879

CompletedPhase 3

Sponsor: Sanofi

Conditions: Hypercholesterolemia

Interventions: Alirocumab, Placebo (for Alirocumab), Non-statin LMT, Diet Alone

Countries: United States, Australia, Belgium, Canada, Denmark, Netherlands, New Zealand, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

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.

Exclusion criteria:

* 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.
Locations (43)
  • Beverly Hills, California, United States
  • Atlantis, Florida, United States
  • Jacksonville, Florida, United States
  • Sarasota, Florida, United States
  • Fall River, Massachusetts, United States
  • St Louis, Missouri, United States
  • Durham, North Carolina, United States
  • Summerville, South Carolina, United States
  • Ashford, Australia
  • Perth, Australia
  • Woolloongabba, Australia
  • Antwerp, Belgium
  • Haine-Saint-Paul, Belgium
  • Leuven, Belgium
  • Chicoutimi, Canada
  • Québec, Canada
  • Sherbrooke, Canada
  • Toronto, Canada
  • Vancouver, Canada
  • Victoria, Canada
  • Aarhus, Denmark
  • Esbjerg, Denmark
  • Glostrup Municipality, Denmark
  • Hvidovre, Denmark
  • Køge, Denmark
  • Amsterdam, Netherlands
  • Den Helder, Netherlands
  • Hoogeveen, Netherlands
  • Hoorn, Netherlands
  • Rotterdam, Netherlands
  • + 13 more on CT.gov