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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01709513
First received: October 8, 2012
Last updated: October 7, 2013
Last verified: October 2013
  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:


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


Enrollment: 314
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 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:

  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

  Show 70 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: October 7, 2013
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency
Norway: Norwegian Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Israel: Ethics Commission

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 April 17, 2014