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
  Purpose

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)

Condition Intervention Phase
Hypercholesterolemia
Drug: alirocumab SAR236553 (REGN727)
Other: matching placebo alirocumab SAR236553 (REGN727)
Drug: Ezetimibe
Other: matching placebo for Ezetimibe
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percent change in LDL-C [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 103
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alirocumab SAR236553 (REGN727)/Ezetimibe placebo
Injection through subcutaneous (SC) administration. Ezetimibe placebo is administered orally.
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 for Ezetimibe
Pharmaceutical form: capsules Route of administration: oral
Active Comparator: alirocumab SAR236553 (REGN727) Placebo/ Ezetimibe
Injection through subcutaneous (SC) administration. Ezetimibe is administered orally.
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644474

Locations
United States, Kansas
Investigational Site Number 840603
Overland Park, Kansas, United States, 66212
United States, Ohio
Investigational Site Number 840601
Cincinnati, Ohio, United States, 45219
United States, Virginia
Investigational Site Number 840602
Richmond, Virginia, United States, 23227
Belgium
Investigational Site Number 056601
Antwerpen, Belgium, 2060
Finland
Investigational Site Number 246601
Helsinki, Finland, 00290
Netherlands
Investigational Site Number 528602
Groningen, Netherlands, 9711 SG
Investigational Site Number 528601
Rotterdam, Netherlands, 3021 HC
Investigational Site Number 528603
Velp, Netherlands, 6883 ES
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01644474     History of Changes
Other Study ID Numbers: EFC11716, U1111-1124-1167
Study First Received: July 17, 2012
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014