Study of the Efficacy and Safety of REGN727 (SAR236553) in Combination With Other Lipid-modifying Treatments (LMT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01730040
First received: November 9, 2012
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).


Condition Intervention Phase
Hypercholesterolemia
Drug: REGN727 (SAR236553)
Drug: Atorvastatin
Drug: Ezetimibe
Drug: Rosuvastatin
Other: Placebo
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 Atorvastatin Versus Ezetimibe Added-on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin

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 week 24 ] [ Designated as safety issue: No ]
    Percent change in calculated LDL-C (low-density lipoprotein cholesterol) from baseline to week 24.


Secondary Outcome Measures:
  • Percent change in calculated LDL-C to wk 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    Percent change in calculated LDL-C from baseline to week 12

  • 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 ]
    Proportion of patients reaching LDL-C goal at 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 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 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 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 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


Enrollment: 347
Study Start Date: October 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
REGN727 (SAR236553) added on to atorvastatin and placebo
Drug: REGN727 (SAR236553) Drug: Atorvastatin
Active comparator
Other: Placebo
Experimental: Regimen 2
atorvastatin and placebo
Drug: Atorvastatin
Active comparator
Other: Placebo
Experimental: Regimen 3
atorvastatin added on to ezetimibe and placebo
Drug: Atorvastatin
Active comparator
Drug: Ezetimibe
Active comparator
Other: Placebo
Experimental: Regimen 4
REGN727 (SAR236553) added on to atorvastatin and placebo
Drug: REGN727 (SAR236553) Drug: Atorvastatin
Active comparator
Other: Placebo
Experimental: Regimen 5
atorvastatin and placebo
Drug: Atorvastatin
Active comparator
Other: Placebo
Experimental: Regimen 6
rosuvastatin and placebo
Drug: Rosuvastatin
Active comparator
Other: Placebo
Experimental: Regimen 7
atorvastatin added on to ezetimibe
Drug: Atorvastatin
Active comparator
Drug: Ezetimibe
Active comparator
Other: Placebo

  Eligibility

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

Inclusion Criteria:

  1. Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with documented CVD, not adequately controlled with a daily dose of atorvastatin. OR
  2. Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high risk for CVD who are not adequately controlled with a daily dose of atorvastatin.

Exclusion Criteria:

  1. LDL-C greater than 250 mg/dL
  2. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented CVD
  3. LDL-C less than 100 mg/dL at the screening visit in patients without history of documented CHD or non-CHD CVD, but with other risk factors
  4. TG greater than 400 mg/dL
  5. Homozygous FH (clinically or previous genotyping)
  6. Currently taking a statin that is not atorvastatin
  7. Currently taking Ezetimibe (EZE)
  8. Not on a stable dose of allowable lipid modifying treatments (LMT)

(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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730040

  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States
United States, Arizona
Chandler, Arizona, United States
Tucson, Arizona, United States
United States, California
Anaheim, California, United States
Beverly Hills, California, United States
Lakeland, California, United States
Newport Beach, California, United States
Northridge, California, United States
Sacramento, California, United States
Walnut Creek, California, United States
United States, Connecticut
Milford, Connecticut, United States
United States, Florida
Atlantis, Florida, United States
Boca Raton, Florida, United States
Clearwater, Florida, United States
Jacksonville, Florida, United States
Miami (2 locations), Florida, United States
Oviedo, Florida, United States
Pinellas Park, Florida, United States
Port Orange, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
United States, Idaho
Boise, Idaho, United States
Meridian, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
Morton, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Kansas
Newton, Kansas, United States
Overland Park, Kansas, United States
Wichita, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
Louisville, Kentucky, United States
United States, Maine
Auburn, Maine, United States
United States, Maryland
Bethesda, Maryland, United States
United States, Minnesota
Edina, Minnesota, United States
Rochester, Minnesota, United States
United States, Mississippi
Olive Branch, Mississippi, United States
Port Gibson, Mississippi, United States
United States, Missouri
St. Louis, Missouri, United States
United States, Montana
Butte, Montana, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Williamsville, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Rhode Island
Warwick, Rhode Island, United States
United States, South Carolina
Greer, South Carolina, United States
Summerville, South Carolina, United States
United States, Tennessee
Kingsport, Tennessee, United States
United States, Texas
Dallas (2 locations), Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
United States, Utah
Bountiful, Utah, United States
Marion, Utah, United States
Salt Lake City, Utah, United States
United States, Washington
Renton, Washington, United States
Australia
Herston QLD, Australia
New Lambton Heights, Australia
Perth, Australia
Sherwood, Australia
Woolloongabba, Australia
Canada, Ontario
Brampton, Ontario, Canada
Etobicoke, Ontario, Canada
London, Ontario, Canada
Newmarke, Ontario, Canada
Thornhill, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Chicoutimi, Quebec, Canada
France
Dijon, France
Lille, France
Venissieux, France
Germany
Bad Oeynhausen, Germany
Berlin, Germany
Koeln, Germany
Munich, Germany
Regensburg, Germany
Ulm, Germany
Italy
Chiete, Italy
Genova, Italy
Napoli, Italy
Palermo, Italy
Roma (2 locations), Italy
Mexico
Distrito Federal, Mexico
Guadalajara, Mexico
Guadalajara, Jalisco, Mexico
Monterrey Nuevo Leon, Mexico
Tijuana Baja California, Mexico
Zapopan Jalisco, Mexico
Spain
Barcelona (3 locations), Spain
Madrid, Spain
Sant Joan Despi, Spain
United Kingdom
Carmarthen, United Kingdom
Chester, United Kingdom
Peterborough, United Kingdom
Salford, United Kingdom
Stevenage, United Kingdom
West Bromwich, West Midlands, 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: NCT01730040     History of Changes
Other Study ID Numbers: R727-CL-1110
Study First Received: November 9, 2012
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
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 July 23, 2014