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

This study is currently recruiting participants.

Verified June 2013 by Sanofi

Sponsor:

Collaborator:

Regeneron Pharmaceuticals

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT01644188

First received: July 16, 2012

Last updated: June 17, 2013

Last verified: June 2013

History of Changes

Purpose

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by 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 SAR236553 (REGN727) in comparison with ezetimibe on LDL-C at other time points.
To evaluate the effect of SAR236553 (REGN727) on other lipid parameters.
To evaluate the safety and tolerability of SAR236553 (REGN727).

Condition	Intervention	Phase
Hypercholesterolemia	Drug: SAR236553 (REGN727) Drug: matching placebo 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:

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Ezetimibe

U.S. FDA Resources

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:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: SAR236553 (REGN727) / Ezetimibe placebo Injection through subcutaneous (SC) administration. Ezetimibe placebo is administered orally.	Drug: SAR236553 (REGN727) 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: SAR236553 (REGN727) Placebo / Ezetimibe Injection through subcutaneous (SC) administration. Ezetimibe is administered orally.	Drug: matching placebo 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 114 weeks per patient, including a 2 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644188

Contacts

Contact: For site information, send an email with site number to

Contact-Us@sanofi.com

Show 139 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:	June 17, 2013
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 June 18, 2013

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