Efficacy and Safety of Alirocumab SAR236553 (REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Combo II)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01644188
First received: July 16, 2012
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab SAR236553 (REGN727) as add-on therapy to stable maximally tolerated daily statin therapy in comparison with ezetimibe after 24 weeks of treatment in patients with hypercholesterolemia at high cardiovascular (CV) risk.

Secondary Objectives:

  • To evaluate the effect of alirocumab SAR236553 (REGN727) in comparison with ezetimibe 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)
Drug: matching placebo alirocumab SAR236553 (REGN727)
Drug: Ezetimibe
Drug: 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, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy

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 up to week 12 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 660
Study Start Date: August 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: August 2014 (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

Drug: 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.
Drug: 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 115 weeks per patient, including a 3 week screening period, 104 week randomized treatment period and 8 week follow-up 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 and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria:

  • Age < 18 or legal age of adulthood, whichever is greater.
  • Patients without established CHD or CHD risk equivalents.
  • LDL-C <70 mg/dL (<1.81 mmol/L) and patients with a history of documented cardiovascular disease.
  • LDL-C <100 mg/dL (<2.59 mmol/L) and patients without a history of documented CV disease.
  • Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L).

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: NCT01644188

  Show 126 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01644188     History of Changes
Other Study ID Numbers: EFC11569, U1111-1121-4315
Study First Received: July 16, 2012
Last Updated: August 25, 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 September 18, 2014