Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

Sponsor
Sanofi
Study ID
NCT02476006
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ALIROCUMAB SAR236553 (REGN727) — DRUG
    Pharmaceutical form:solution Route of administration: subcutaneous
  • placebo (for injection training only) — DRUG
    Pharmaceutical form:solution Route of administration: subcutaneous
  • 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 provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this participant population. Secondary Objectives: To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of treatment. To document participant's acceptability of self-injection (Self Injection Assessment Questionnaire, SIAQ).

Key Dates

Start date
Jun 23, 2015
Status verified
Mar 2022
Primary completion
Apr 12, 2019
Completion
Apr 12, 2019

Study Design

Enrollment
998 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Alirocumab
    Participants received Alirocumab 150 milligram (mg) subcutaneously (SC) once every two weeks (Q2W) or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.

Primary Outcome Measure

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120) ]

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