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

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01644474
First received: July 17, 2012
Last updated: July 7, 2014
Last verified: July 2014

July 17, 2012
July 7, 2014
July 2012
July 2013   (final data collection date for primary outcome measure)
Percent change in LDL-C [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01644474 on ClinicalTrials.gov Archive Site
  • Percent change in LDL-C [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters [ Time Frame: From baseline up to week 24 ] [ Designated as safety issue: No ]
  • Percent change in LDL-C [ Time Frame: From baseline up to week 12 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters [ Time Frame: From baseline up to week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Alirocumab SAR236553 (REGN727) Versus Ezetimibe in Patients With Hypercholesterolemia
A Randomized, Double-Blind, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy And Safety of SAR236553/REGN727 Over 24 Weeks in Patients With Hypercholesterolemia

Primary Objective:

The purpose of this study is to demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab SAR236553 (REGN727) in comparison with ezetimibe (EZE) after 24 weeks of treatment in patients with hypercholesterolemia

Secondary Objectives:

  • To evaluate the effect of alirocumab SAR236553 (REGN727) in comparison with EZE on LDL-C at other time points
  • To evaluate the effect of alirocumab SAR236553 (REGN727) on other lipid parameters
  • To evaluate the safety and tolerability of alirocumab SAR236553 (REGN727)

The maximum study duration will be 34 weeks per participant, including a 24-week randomized treatment period.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: alirocumab SAR236553 (REGN727)

    alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

    Pharmaceutical form: Solution for injection Route of administration: subcutaneous

  • Other: matching placebo alirocumab SAR236553 (REGN727)
    Pharmaceutical form:Solution for injection Route of administration: subcutaneous
  • Drug: Ezetimibe
    Pharmaceutical form: encapsulated tablets Route of administration: oral
  • Other: matching placebo for Ezetimibe
    Pharmaceutical form: capsules Route of administration: oral
  • Experimental: alirocumab SAR236553 (REGN727)/Ezetimibe placebo
    Injection through subcutaneous (SC) administration. Ezetimibe placebo is administered orally.
    Interventions:
    • Drug: alirocumab SAR236553 (REGN727)
    • Other: matching placebo for Ezetimibe
  • Active Comparator: alirocumab SAR236553 (REGN727) Placebo/ Ezetimibe
    Injection through subcutaneous (SC) administration. Ezetimibe is administered orally.
    Interventions:
    • Other: matching placebo alirocumab SAR236553 (REGN727)
    • Drug: Ezetimibe
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
July 2013
July 2013   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients with hypercholesterolemia

Exclusion criteria:

  • Age < 18 or legal age of adulthood, whichever is greater
  • LDL-C < 100 mg/dL (< 2.59 mmol/L) or > 190 mg/dL (> 4.9 mmol/L)
  • Fasting serum TG > 400 mg/dL (> 4.52 mmol/L)
  • Known history of homozygous or heterozygous familial hypercholesterolemia

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Finland,   Netherlands
 
NCT01644474
EFC11716, U1111-1124-1167
Yes
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP