Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT01266876
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Alirocumab — DRUG
    Alirocumab two SC injections in the abdomen only.
  • Placebo — DRUG
    Placebo two SC injections in the abdomen only.

Study Details

The purpose of this study is to assess the efficacy and safety of REGN727/SAR236553 in participants diagnosed with heterozygous familial hypercholesterolemia (heFH)

Key Dates

Start date
Jan 31, 2011
Status verified
Aug 2015
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
77 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
  • Experimental: Alirocumab 150 mg Q4W
    Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
  • Experimental: Alirocumab 200 mg Q4W
    Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
  • Experimental: Alirocumab 300 mg Q4W
    Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
  • Experimental: Alirocumab 150 mg Q2W
    Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.

Primary Outcome Measure

Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis [ Time Frame: From Baseline to Week 12 (LOCF) ]

Locations (17)

FacilityCityStateZIPSite coordinators
-HuntsvilleAlabama--
-Mission ViejoCalifornia--
-Newport BeachCalifornia--
-BridgeportConnecticut--
-JacksonvilleFlorida--
-MiamiFlorida--
-Port OrangeFlorida--
-ChicagoIllinois--
-Kansas CityKansas--
-AuburnMaine--
-BiddefordMaine--
-St LouisMissouri--
-ConcordNew Hampshire--
-DurhamNorth Carolina--
-CincinnatiOhio--
-NashvilleTennessee--
-HoustonTexas--

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