Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

Primary Objective: * To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo * To evaluate the safety and tolerability of alirocumab * To evaluate the development of anti-alirocumab antibodies * To evaluate the pharmacokinetics of alirocumab

Key facts

Study ID

NCT01288443

Run by

Sanofi

People needed

183

Starts

2011-01-01

Expected to finish

2011-12-01

Last updated by the study team

2015-09-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants with primary hypercholesterolemia receiving a lipid-lowering treatment other than atorvastatin or not at stable dose of atorvastatin 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to screening period or drug naive participants if they are likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the end of the 6-week run-in treatment period on atorvastatin therapy
• OR
• Participants with primary hypercholesterolemia treated with atorvastatin at stable dose of 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to screening period and likely to have LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) at the screening visit

You may not qualify if…

• LDL-C < 100 mg/dL (< 2.59 mmol/L):
• After the run-in period on atorvastatin (10 mg, 20 mg, or 40 mg) for participants receiving a lipid-lowering treatment other than atorvastatin or not at stable dose of atorvastatin 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to the screening, or drug naive participant
• OR
• At the first visit for participants who were being treated with stable dose of atorvastatin (10 mg, 20 mg, or 40 mg) for at least 6 weeks prior to screening
• Participants not previously instructed on a cholesterol-lowering diet
• Participants with type 1 diabetes
• Participants with type 2 diabetes treated with insulin
• Participants with type 2 diabetes and with an glycated hemoglobin (HbA1c) ≥ 8.5% at screening visit (considered poorly controlled)
• Laboratory findings measured before randomization:
• Triglycerides (TG) > 350 mg/dL (> 3.95 mmol/L) at screening visit
• Positive serum or urine pregnancy test in females of childbearing potential
• Pregnant or breast-feeding women
• Women of childbearing potential with no effective contraceptive method
• 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 840525 — Tempe, Arizona, United States
• Investigational Site Number 840516 — Los Angeles, California, United States
• Investigational Site Number 840528 — Mission Viejo, California, United States
• Investigational Site Number 840509 — Newport Beach, California, United States
• Investigational Site Number 840523 — Palm Springs, California, United States
• Investigational Site Number 840534 — Westlake Village, California, United States
• Investigational Site Number 840530 — Colorado Springs, Colorado, United States
• Investigational Site Number 840504 — Aventura, Florida, United States
• Investigational Site Number 840519 — Aventura, Florida, United States
• Investigational Site Number 840514 — Jacksonville, Florida, United States
• Investigational Site Number 840539 — Jupiter, Florida, United States
• Investigational Site Number 840502 — Miami, Florida, United States
• Investigational Site Number 840520 — Pembroke Pines, Florida, United States
• Investigational Site Number 840524 — Ponte Vedra, Florida, United States
• Investigational Site Number 840536 — Port Orange, Florida, United States
• Investigational Site Number 840507 — St. Petersburg, Florida, United States
• Investigational Site Number 840527 — Chicago, Illinois, United States
• Investigational Site Number 840506 — Evansville, Indiana, United States
• Investigational Site Number 840529 — Indianapolis, Indiana, United States
• Investigational Site Number 840515 — Wichita, Kansas, United States
• Investigational Site Number 840532 — Madisonville, Kentucky, United States
• Investigational Site Number 840535 — Auburn, Maine, United States
• Investigational Site Number 840503 — Brockton, Massachusetts, United States
• Investigational Site Number 840512 — Las Vegas, Nevada, United States
• Investigational Site Number 840505 — Edison, New Jersey, United States

Full record on ClinicalTrials.gov

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