Overview
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Status:
Completed
Completed
Trial end date:
2017-06-30
2017-06-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
SanofiCollaborator:
Regeneron PharmaceuticalsTreatments:
Antibodies, Monoclonal
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.