Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia

Sponsor
Sanofi
Study ID
NCT02715726
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Alirocumab — DRUG
    Pharmaceutical form:solution Route of administration: subcutaneous
  • Placebo for alirocumab — DRUG
    Pharmaceutical form:solution Route of administration: subcutaneous
  • ezetimibe — DRUG
    Pharmaceutical form:capsule Route of administration: oral
  • placebo for ezetimibe — DRUG
    Pharmaceutical form:capsule Route of administration: oral
  • atorvastatin — DRUG
    Pharmaceutical form:tablet Route of administration: oral
  • rosuvastatin — DRUG
    Pharmaceutical form:tablet Route of administration: oral
  • simvastatin — DRUG
    Pharmaceutical form:tablet Route of administration: oral

Study Details

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy in comparison to ezetimibe 10 mg daily after 24 weeks of treatment in Asia in participants with hypercholesterolemia at high cardiovascular (CV) risk. Secondary Objectives: * To evaluate the effect of alirocumab 75 mg in comparison with ezetimibe 10 mg on LDL-C after 12 weeks of treatment. * To evaluate the effect of alirocumab on other lipid parameters: e.g., apolipoprotein B (Apo B), non-high density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein a (Lp\[a\]), HDL-C, triglycerides (TG), apolipoprotein A-1 (Apo A-1). * To evaluate the safety and tolerability of alirocumab. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetics (PK) of alirocumab.

Key Dates

Start date
Jul 27, 2016
Status verified
Sep 2019
Primary completion
Aug 6, 2018
Completion
Aug 6, 2018

Study Design

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

Arms

  • Active Comparator: Ezetimibe 10 mg
    Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab every 2 weeks (Q2W) for 22 weeks added to lipid modifying therapy (LMT).
  • Experimental: Alirocumab 75 mg Q2W/up to 150 mg Q2W
    Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was \>=70 milligrams per deciliter (mg/dL) (1.81 millimoles per liter \[mmol/L\]) at Week 8.

Primary Outcome Measure

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis [ Time Frame: From Baseline to Week 24 ]

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