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:
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 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
Drug: REGN727 (SAR236553) Other: Placebo 1 (placebo
REGN727 (SAR236553) and Placebo 1 (placebo for
for ezetimibe atorvastatin)
ezetimibe atorvastatin) Experimental: Regimen 2
Drug: Active Comparator 1 (ezetimibe) Other: Placebo 2
Active Comparator 1 (ezetimibe) and Placebo 2
[(placebo for REGN727 (SAR236553]
[(placebo for REGN727 (SAR236553)] Experimental: Regimen 3
Drug: Active Comparator 2 (atorvastatin) Other: Placebo 2
Active Comparator 2 (atorvastatin) and Placebo 2
[(placebo for REGN727(SAR236553]
[(placebo for REGN727(SAR236553)]
Eligibility Ages Eligible for Study:
18 Years and older
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
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:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01709513
Other Study ID Numbers:
R727-CL-1119
Study First Received:
October 8, 2012
Last Updated:
October 16, 2012
Health Authority:
United States: Food and Drug Administration
History of Changes
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 française de sécurité sanitaire des produits de santé (SaintDenis) Canada: Health Canada Additional relevant MeSH terms: Hypercholesterolemia
Anticholesteremic Agents
Hyperlipidemias
Hypolipidemic Agents
Dyslipidemias
Antimetabolites
Lipid Metabolism Disorders
Molecular Mechanisms of Pharmacological Action
Metabolic Diseases
Pharmacologic Actions
Atorvastatin
Enzyme Inhibitors
Ezetimibe
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors ClinicalTrials.gov processed this record on October 29, 2012
Therapeutic Uses