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Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT)

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:
NCT01730053
First received: November 9, 2012
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/ SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.


Condition Intervention Phase
Hypercholesterolemia
 Drug: alirocumab (REGN727/ SAR236553)
Other: placebo
Drug: Rosuvastatin
Drug: Ezetimibe
 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 Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Percent change in calculated LDL-C to week 24 [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change in calculated LDL-C to week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Percent change in ApoB [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in ApoB (Apolipoprotein B) at time points up to week 24

  • Proportion of patients reaching LDL-C goal [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
  • Percent change in non-HDL-C [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in non HDL-C (non-high-density lipoprotein cholesterol) at time points up to week 24

  • Percent change in total-C [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in total-C at time points up to week 24

  • Percent change in Lp(a) [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in LP(a) [(Lipoprotein(a)] at time points up to week 24

  • Percent change in HDL-C [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in HDL-C at time points up to week 24

  • Percent change in TG [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in TG (Triglycerides) at time points up to week 24

  • Percent change in ApoA-1 [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in ApoA-1 at time points up to week 24


Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen 1
alirocumab (REGN727/ SAR236553) added-on to Rosuvastatin and placebo
 Drug: alirocumab (REGN727/ SAR236553) Other: placebo Drug: Rosuvastatin
Active Comparator: Regimen 2
Rosuvastatin and placebo
 Other: placebo Drug: Rosuvastatin
Active Comparator: Regimen 3
Ezetimibe added-on to Rosuvastatin and placebo
 Other: placebo Drug: Rosuvastatin Drug: Ezetimibe
Experimental: Regimen 4
alirocumab (REGN727/ SAR236553) added-on to Rosuvastatin and placebo
 Drug: alirocumab (REGN727/ SAR236553) Other: placebo Drug: Rosuvastatin
Active Comparator: Regimen 5
Rosuvastatin and placebo
 Other: placebo Drug: Rosuvastatin
Active Comparator: Regimen 6
Ezetimibe added-on to Rosuvastatin and placebo
 Other: placebo Drug: Rosuvastatin Drug: Ezetimibe

  Eligibility

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

Inclusion Criteria:

  1. Patients with LDL-C greater than or equal to 70 mg/dL at the screening visit and who are not adequately controlled with a stable daily dose of rosuvastatin, with or without other LMT.

    OR

  2. Patients with screening LDL-C greater than or equal to 100 mg/dL who are not adequately controlled with a stable daily dose of rosuvastatin before the screening visit, with or without other LMT.

Exclusion Criteria:

  1. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented cardiovascular disease (CVD)
  2. LDL-C less than 100 mg/dL at the screening visit in patients without history of documented coronary heart disease (CHD) or non-CHD CVD, but with other risk factors
  3. Homozygous familial hypercholesterolemia (FH) (clinically or previous genotyping)
  4. Recent (within 3 months prior to the screening visit) myocardial infarction (MI), unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
  5. Newly diagnosed (within 3 months prior to randomization visit) or poorly controlled diabetes
  6. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins

(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: NCT01730053

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Alabama
Recruiting
Mobile, Alabama, United States
United States, Kansas
Recruiting
Newton, Kansas, United States
United States, Kentucky
Recruiting
Louisville, Kentucky, United States
United States, Maine
Recruiting
Auburn, Maine, United States
United States, Texas
Recruiting
Dallas, Texas, United States
Australia
Recruiting
Melbourne, Australia
Canada
Recruiting
Montreal, Canada
France
Recruiting
TBD, France
Germany
Recruiting
TBD, Germany
Italy
Recruiting
TBD, Italy
Mexico
Recruiting
TBD, Mexico
Spain
Recruiting
TBD, Spain
United Kingdom
Recruiting
TBD, United Kingdom
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01730053     History of Changes
Other Study ID Numbers: R727-CL-1118
Study First Received: November 9, 2012
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin
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 May 22, 2013