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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)

NCT01576484

CompletedPhase 2

Sponsor: Regeneron Pharmaceuticals

Conditions: Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia

Interventions: Alirocumab, Placebo Matched to Alirocumab

Countries: United States, Canada

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Key Inclusion Criteria:

1. Prior participation in and the successful completion of the R727-CL-1003 study (NCT01266876).
2. Patients must be on a stable daily statin regimen for at least 3 weeks before prior to entry into the study
3. A negative urine pregnancy at the screening/baseline visit for women of childbearing potential

Key Exclusion Criteria:

1. Reported a drug-related serious adverse event (SAE) or drug-related clinical or laboratory adverse event (AE) in the R727-CL-1003 study that resulted in early termination or withdrawal
2. Significant protocol deviation in R727-CL-1003, such as non-compliance by the investigator or patient
3. Low-density lipoprotein (LDL) apheresis within 12 months before the screening/baseline visit

Note: Other exclusion criteria applied

Locations (14)

Mission Viejo, California, United States
Newport Beach, California, United States
Thousand Oaks, California, United States
Miami, Florida, United States
Port Orange, Florida, United States
Kansas City, Kansas, United States
Auburn, Maine, United States
St Louis, Missouri, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Houston, Texas, United States
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada