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Status:

COMPLETED

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Lead Sponsor:

Sanofi

Collaborating Sponsors:

Regeneron Pharmaceuticals

Conditions:

Hypercholesterolemia

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the long-term safety...

Detailed Description

The maximum study duration was to be 89 weeks per participant, including a 3-week screening period, a 78-week randomized treatment period and 8-week follow-up period.

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Either A or B below and who were not adequately controlled with their lipid-modifying therapy:
  • A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents
  • OR
  • B) Participants with hypercholesterolemia together with established CHD or CHD risk equivalents.
  • Exclusion criteria:
  • Age \< 18 years
  • LDL-C \<70 mg/dL (\< 1.81 mmol/L)
  • Fasting serum triglycerides \> 400 mg/dL (\>4.52 mmol/L)
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 1 2014

    Estimated Enrollment :

    2341 Patients enrolled

    Trial Details

    Trial ID

    NCT01507831

    Start Date

    January 1 2012

    End Date

    November 1 2014

    Last Update

    December 22 2015

    Active Locations (320)

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    Page 1 of 80 (320 locations)

    1

    Investigational Site Number 840159

    Huntsville, Alabama, United States, 35801

    2

    Investigational Site Number 840028

    Gilbert, Arizona, United States, 85295

    3

    Investigational Site Number 840035

    Sierra Vista, Arizona, United States, 85635

    4

    Investigational Site Number 840052

    Tempe, Arizona, United States, 85282