Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia

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 compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg. Secondary Objectives: * To evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment. * To evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg. * To evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetics of alirocumab.

Key facts

Study ID

NCT01288469

Run by

Sanofi

People needed

92

Starts

2011-01-01

Expected to finish

2011-09-01

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 receiving a lipid-lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive participants with primary hypercholesterolemia 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 stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening and likely to have low-density lipoprotein cholesterol (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) at Week -1 (V1):
• After the run-in period on atorvastatin 10 mg for participants receiving a lipid lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to the screening period, or drug naive participants.
• OR
• At the first visit for participants who are being treated with atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening visit.
• 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 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 840616 — Mesa, Arizona, United States
• Investigational Site Number 840601 — Tucson, Arizona, United States
• Investigational Site Number 840610 — Los Angeles, California, United States
• Investigational Site Number 840608 — Newport Beach, California, United States
• Investigational Site Number 840603 — Doral, Florida, United States
• Investigational Site Number 840611 — Jacksonville, Florida, United States
• Investigational Site Number 840618 — Jupiter, Florida, United States
• Investigational Site Number 840612 — Miami, Florida, United States
• Investigational Site Number 840614 — Miami, Florida, United States
• Investigational Site Number 840607 — St. Petersburg, Florida, United States
• Investigational Site Number 840605 — Chicago, Illinois, United States
• Investigational Site Number 840619 — Chicago, Illinois, United States
• Investigational Site Number 840604 — Edison, New Jersey, United States
• Investigational Site Number 840606 — Rochester, New York, United States
• Investigational Site Number 840615 — Cincinnati, Ohio, United States
• Investigational Site Number 840617 — Cincinnati, Ohio, United States
• Investigational Site Number 840602 — Eugene, Oregon, United States
• Investigational Site Number 840621 — Richmond, Virginia, United States
• Investigational Site Number 840609 — Olympia, Washington, United States
• Investigational Site Number 840613 — Oregon, Wisconsin, United States

Full record on ClinicalTrials.gov

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