Dan Gipe, MD -Study of 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 October 2012 by Regeneron Pharmaceuticals Sponsor:

Regeneron Pharmaceuticals
Collaborator:

Sanofi Study Director: Dan Gipe, MD

Information provided by (Responsible Party):

Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:

NCT01709513
First received: October 8, 2012 Last updated: October 16, 2012 Last verified: October 2012 History of Changes

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

Condition
Hypercholesterolemia

Intervention
Drug: REGN727 (SAR236553) Drug: Active Comparator 1 (ezetimibe) Drug: Active Comparator 2 (atorvastatin) Other: Placebo 1 (placebo for ezetimibe atorvastatin) Other: Placebo 2 [(placebo for REGN727 (SAR236553]

Phase
Phase 3

Study Type: Study Design:

Interventional 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 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: Study Start Date: Estimated Study Completion Date: Estimated Primary Completion Date:

250 September 2012 February 2014 February 2014 (Final data collection date for primary outcome measure)

Arms
Experimental: Regimen 1 REGN727 (SAR236553) and Placebo 1 (placebo for ezetimibe atorvastatin) Experimental: Regimen 2 Active Comparator 1 (ezetimibe) and Placebo 2 [(placebo for REGN727 (SAR236553)] Experimental: Regimen 3 Active Comparator 2 (atorvastatin) and Placebo 2 [(placebo for REGN727(SAR236553)]

Assigned Interventions
Drug: REGN727 (SAR236553) Other: Placebo 1 (placebo for ezetimibe atorvastatin)

Drug: Active Comparator 1 (ezetimibe) Other: Placebo 2 [(placebo for REGN727 (SAR236553]

Drug: Active Comparator 2 (atorvastatin) Other: Placebo 2 [(placebo for REGN727(SAR236553]

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

Criteria
Inclusion Criteria: 1. 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 2. Provide signed informed consent Exclusion Criteria: 1. Calculated serum LDL-C less than 70 mg/dL (1.81 mmol/L) and very high CV risk at the screening visit 2. Calculated serum LDL-C less than 100 mg/dL (2.59 mmol/L) and high or moderate CV risk at the screening visit 3. 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 28 Study Locations Sponsors and Collaborators

Regeneron Pharmaceuticals Sanofi

Investigators
Study Director: Dan Gipe, MD Regeneron Pharmaceuticals

More Information
No publications provided Responsible Party: ClinicalTrials.gov Identifier: Other Study ID Numbers: Study First Received: Last Updated: Health Authority: Regeneron Pharmaceuticals NCT01709513 R727-CL-1119 October 8, 2012 October 16, 2012 United States: Food and Drug Administration Italy: The Italian Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Norway: Norwegian Medicines Agency Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) France: Afssaps - Agence franaise de scurit sanitaire des produits de sant (SaintDenis) Canada: Health Canada Additional relevant MeSH terms: Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Ezetimibe Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents History of Changes

Hydroxymethylglutaryl-CoA Reductase Inhibitors ClinicalTrials.gov processed this record on October 29, 2012

Therapeutic Uses