Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Regeneron Pharmaceuticals

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective of the study was to assess the long-term safety and tolerability of alirocumab in patients with heFH who were receiving concomitant treatment with hydroxymethyl glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins), with or without other lipid-modifying therapies (LMTs).

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

Prior participation in and the successful completion of the R727-CL-1003 study (NCT01266876).

Patients must be on a stable daily statin regimen for at least 3 weeks before prior to entry into the study

A negative urine pregnancy at the screening/baseline visit for women of childbearing potential

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Treatment Details

Interventions

Alirocumab (Monoclonal Antibodies)
Placebo Matched to Alirocumab (Drug)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Alirocumab 150 mgExperimental Treatment1 Intervention

Participants who received alirocumab in parent study (NCT01576484), has received a subcutaneous injection of alirocumab 150 milligram (mg) every 2 weeks for 4 years in this study.

Group II: Placebo Matched to AlirocumabPlacebo Group1 Intervention

Participants who received placebo in parent study (NCT01576484), has received a subcutaneous injection of placebo matched to alirocumab every 2 weeks for 4 years in this study.