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)

Part of paid clinical trials in Mission Viejo, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT01576484
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    Alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
  • Placebo Matched to Alirocumab — DRUG
    Placebo matched to alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody

Study Details

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).

Key Dates

Start date
Feb 28, 2012
Status verified
Jul 2020
Primary completion
Dec 22, 2016
Completion
Dec 22, 2016

Study Design

Enrollment
58 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo Matched to Alirocumab
    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.
  • Experimental: Alirocumab 150 mg
    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.

Primary Outcome Measure

Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death [ Time Frame: Baseline (Day 1 of current study) to end of study (Week 218) ]

Locations (11)

FacilityCityStateZIPSite coordinators
-Mission ViejoCalifornia--
-Newport BeachCalifornia--
-Thousand OaksCalifornia--
-MiamiFlorida--
-Port OrangeFlorida--
-Kansas CityKansas--
-AuburnMaine--
-St LouisMissouri--
-DurhamNorth Carolina--
-CincinnatiOhio--
-HoustonTexas--

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