Study of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (Odyssey Alternative)

This study is currently recruiting participants.

Verified May 2013 by Regeneron Pharmaceuticals

Sponsor:

Collaborator:

Sanofi

Information provided by (Responsible Party):

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01709513

First received: October 8, 2012

Last updated: May 20, 2013

Last verified: May 2013

History of Changes

Purpose

This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study of alirocumab (REGN727/ SAR236553) in patients with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: alirocumab (REGN727/ SAR236553) Drug: Active Comparator 1 (ezetimibe) Drug: Active Comparator 2 (atorvastatin) Other: Placebo 1 (placebo for ezetimibe atorvastatin) Other: Placebo 2 [alirocumab (REGN727/ SAR236553)]	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Primary Hypercholesterolemia Who Are Intolerant to Statins

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Atorvastatin calcium Ezetimibe

U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Percent change in calculated LDL-C to wk 24 [ Time Frame: Baseline to Wk 24 ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the percent change in calculated low-density lipoprotein-cholesterol (LDL-C) from baseline to week 24

Secondary Outcome Measures:

Percent change in calculated LDL-C to wk 12 [ Time Frame: Baseline to WK 12 ] [ Designated as safety issue: No ]
The effect of alirocumab (REGN727/ SAR236553) on LDL-C in comparison with placebo from baseline to other time points
Percent change in ApoB, non-HDL-C, total-C, HDL-C, Lp(a), TG, and Apo A-1 to time points up to wk 24 [ Time Frame: Baseline to Wk 24 ] [ Designated as safety issue: No ]
The change in ApoB, non-HDL-C, total-C, HDL-C, Lp(a), TG, and Apo A-1 from baseline to time points up to wk 24.
Proportion of patients reaching LDL-C less than 70 mg/dL [ Time Frame: At Wk 24 ] [ Designated as safety issue: No ]
The proportion of patients reaching LDL-C less than 70 mg/dL at week 24

Estimated Enrollment:	250
Study Start Date:	September 2012
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Regimen 1 alirocumab (REGN727/ SAR236553) and Placebo 1 (placebo for ezetimibe atorvastatin)	Drug: alirocumab (REGN727/ SAR236553) Other: Placebo 1 (placebo for ezetimibe atorvastatin)
Experimental: Regimen 2 Active Comparator 1 (ezetimibe) and Placebo 2 [(placebo for alirocumab (REGN727/ SAR236553)]	Drug: Active Comparator 1 (ezetimibe) Other: Placebo 2 [alirocumab (REGN727/ SAR236553)]
Experimental: Regimen 3 Active Comparator 2 (atorvastatin) and Placebo 2 [(placebo for alirocumab (REGN727/ SAR236553)]	Drug: Active Comparator 2 (atorvastatin) Other: Placebo 2 [alirocumab (REGN727/ SAR236553)]

Eligibility

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

Criteria

Inclusion Criteria:

Patients with primary hypercholesterolemia [Heterozygous Familial Hypercholesterolemia (heFH) or non-FH] with moderate, high or very high CV risk and a history of statin intolerance
Provide signed informed consent

Exclusion Criteria:

Calculated serum LDL-C less than 70 mg/dL (1.81 mmol/L) and very high CV risk at the screening visit
Calculated serum LDL-C less than 100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the screening visit
A 10-year fatal cardiovascular disease risk score less than 1% at the screening visit

(The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709513

Contacts

Contact: Clinical Trials Administrator

clinicaltrials@regeneron.com

Show 24 Study Locations

Sponsors and Collaborators

Regeneron Pharmaceuticals

Sanofi

Investigators

Study Director:

Dan Gipe, MD

Regeneron Pharmaceuticals

More Information

No publications provided

Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01709513 History of Changes
Other Study ID Numbers:	R727-CL-1119
Study First Received:	October 8, 2012
Last Updated:	May 20, 2013
Health Authority:	United States: Food and Drug Administration Italy: The Italian Medicines Agency Norway: Norwegian Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Canada: Health Canada

Additional relevant MeSH terms:

Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013

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