Efficacy and Safety of Alirocumab SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY Combo I)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01644175
First received: July 16, 2012
Last updated: May 28, 2014
Last verified: May 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 with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk patients with hypercholesterolemia.

Secondary Objectives:

  • To evaluate the effect of alirocumab SAR236553 (REGN727) in comparison with placebo 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: Placebo
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, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REG727 in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying 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 to weeks 12 and 52 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters [ Time Frame: From baseline to weeks 12, 24 and 52 ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: July 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alirocumab SAR236553 (REGN727)
Injection through subcutaneous (SC) administration
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

Placebo Comparator: Placebo
Injection through subcutaneous (SC) administration
Other: Placebo
Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Detailed Description:

The maximum study duration will be 63 weeks per patient, including a 3 week screening period, 52 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 with or without other LMT, both at stable dose for at least 4 weeks to 6 weeks prior to screening (Week -2).

Exclusion criteria:

  • Age < 18 or legal age of adulthood, whichever is greater.
  • Patients without established CHD or CHD risk equivalent.
  • 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 cardiovascular disease.
  • Not on a stable dose of LMT (including statin) for at least 4 Weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (Week -2) and from screening to randomization.
  • 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: NCT01644175

  Show 83 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: NCT01644175     History of Changes
Other Study ID Numbers: EFC11568, U1111-1121-4356
Study First Received: July 16, 2012
Last Updated: May 28, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 13, 2014