Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Sanofi
Study ID
NCT01644474
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab — DRUG
    1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
  • Ezetimibe — DRUG
    One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.
  • Placebo (for Alirocumab) — DRUG
    1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self--injection or by another designated person using the autoinjector.
  • Placebo (for Ezetimibe) — DRUG
    One capsule orally once daily at approximately the same time of the day with or without food..

Study Details

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab in comparison with ezetimibe after 24 weeks of treatment in participants with hypercholesterolemia. Secondary Objectives: * To evaluate the effect of alirocumab in comparison with ezetimibe on LDL-C at other time points * To evaluate the effect of alirocumab on other lipid parameters * To evaluate the safety and tolerability of alirocumab

Key Dates

Start date
Jul 31, 2012
Status verified
Oct 2015
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

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

Arms

  • Active Comparator: Ezetimibe 10 mg
    Oral ezetimibe 10 mg capsule daily and subcutaneous (SC) placebo injection for alirocumab every 2 weeks (Q2W) for 24 weeks.
  • Experimental: Alirocumab 75/Up to 150 mg Q2W
    SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.

Primary Outcome Measure

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis [ Time Frame: From Baseline to Week 24 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Investigational Site Number 840603Overland ParkKansas66212-
Investigational Site Number 840601CincinnatiOhio45219-
Investigational Site Number 840602RichmondVirginia23227-

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