Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01507831
First received: January 6, 2012
Last updated: November 18, 2015
Last verified: November 2015
  Purpose

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).

Secondary Objectives:

  • To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
  • To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
  • To evaluate the effects of alirocumab on other lipid parameters.

Condition Intervention Phase
Hypercholesterolemia
Drug: Placebo (for alirocumab)
Drug: Alirocumab
Drug: Lipid-Modifying Therapy (LMT)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants Who Experienced Adverse Events (AEs) [ Time Frame: Up to 10 weeks after last study drug administration (maximum of 86 weeks) ] [ Designated as safety issue: Yes ]
    Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).


Secondary Outcome Measures:
  • Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).

  • Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).

  • Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

  • Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

  • Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

  • Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Apo B at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Total-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percentage of Very High Cardiovascular (CV) Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]
    Very high CV risk: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents or non- Familial Hypercholesterolemia (FH). High CV risk: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in imputation model.

  • Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]
    Adjusted percentages at Week 24 were from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

  • Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]
    Adjusted percentages at Week 24 were obtained from multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.

  • Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis [ Time Frame: Up to Week 52 ] [ Designated as safety issue: No ]
    Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

  • Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment were included in the imputation model.

  • Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

  • Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

  • Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

  • Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.


Other Outcome Measures:
  • Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis [ Time Frame: From Baseline to Week 52 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

  • Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis [ Time Frame: From Baseline to Week 78 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 78 from MMRM model including all available post-baseline data from Week 4 to Week 78 regardless of status on- or off-treatment.

  • Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis [ Time Frame: From Baseline to Week 78 ] [ Designated as safety issue: No ]
    Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).

  • Percentage of Participants Who Experienced Cardiovascular (CV) Events [ Time Frame: Up to 10 weeks after last study drug administration (maximum of 86 weeks) ] [ Designated as safety issue: Yes ]
    CV events included coronary heart disease (CHD) death; non-fatal myocardial infarction (MI); fatal and non-fatal ischemic stroke; unstable angina requiring hospitalization; congestive heart failure (CHF) requiring hospitalization; ischemia-driven coronary revascularization procedure. Reported events are CV events as confirmed by an independent Clinical Events Committee (CEC) that occurred during the treatment emergent period ( i.e. from first dose up to the last dose of study drug + 70 days).


Enrollment: 2341
Study Start Date: January 2012
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 78 weeks.
Drug: Placebo (for alirocumab)
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
Drug: Lipid-Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Experimental: Alirocumab
Alirocumab 150 mg Q2W added to stable LMT for 78 weeks.
Drug: Alirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
Other Names:
  • SAR236553
  • REGN727
  • Praluent
Drug: Lipid-Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Detailed Description:
The maximum study duration was to be 89 weeks per participant, including a 3-week screening period, a 78-week randomized treatment period and 8-week follow-up period.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Either A or B below and who were not adequately controlled with their lipid-modifying therapy:

A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents

OR

B) Participants with hypercholesterolemia together with established CHD or CHD risk equivalents.

Exclusion criteria:

  • Age < 18 years
  • LDL-C <70 mg/dL (< 1.81 mmol/L)
  • Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L)

The above information was not intended to contain all considerations relevant to a participant's potential participation in a 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: NCT01507831

  Hide Study Locations
Locations
United States, Alabama
Investigational Site Number 840159
Huntsville, Alabama, United States, 35801
United States, Arizona
Investigational Site Number 840028
Gilbert, Arizona, United States, 85295
Investigational Site Number 840035
Sierra Vista, Arizona, United States, 85635
Investigational Site Number 840052
Tempe, Arizona, United States, 85282
Investigational Site Number 840065
Tempe, Arizona, United States, 85282
Investigational Site Number 840079
Tempe, Arizona, United States, 85282
Investigational Site Number 840094
Tempe, Arizona, United States, 85282
Investigational Site Number 840103
Tucson, Arizona, United States, 85741-3565
United States, California
Investigational Site Number 840209
Beverly Hills, California, United States, 90210
Investigational Site Number 840194
Beverly Hills, California, United States, 90211
Investigational Site Number 840207
Fresno, California, United States, 93720
Investigational Site Number 840101
Lincoln, California, United States, 95648
Investigational Site Number 840076
Long Beach, California, United States, 90807
Investigational Site Number 840214
Pasadena, California, United States, 91105
Investigational Site Number 840045
Sacramento, California, United States, 95842
Investigational Site Number 840163
Santa Rosa, California, United States, 95405
United States, Colorado
Investigational Site Number 840086
Colorado Springs, Colorado, United States, 80906
Investigational Site Number 840077
Golden, Colorado, United States, 80401
United States, Connecticut
Investigational Site Number 840224
Bridgeport, Connecticut, United States, 06610
Investigational Site Number 840134
Guilford, Connecticut, United States, 06437
Investigational Site Number 840246
Hartford, Connecticut, United States, 06102
Investigational Site Number 840055
Stamford, Connecticut, United States, 06905
Investigational Site Number 840091
Stamford, Connecticut, United States, 06905
United States, Florida
Investigational Site Number 840150
Atlantis, Florida, United States, 33462
Investigational Site Number 840020
Bradenton, Florida, United States, 34208
Investigational Site Number 840041
Brandon, Florida, United States, 33511
Investigational Site Number 840184
Clearwater, Florida, United States, 33756
Investigational Site Number 840242
Clearwater, Florida, United States, 33756
Investigational Site Number 840039
Clearwater, Florida, United States, 33765
Investigational Site Number 840182
Crystal River, Florida, United States, 34429
Investigational Site Number 840002
Daytona Beach, Florida, United States, 32117
Investigational Site Number 840166
Daytona Beach, Florida, United States, 32117
Investigational Site Number 840167
Fleming Island, Florida, United States, 32003
Investigational Site Number 840018
Fort Lauderdale, Florida, United States, 33309
Investigational Site Number 840090
Ft. Lauderdale, Florida, United States, 33308
Investigational Site Number 840153
Jacksonville, Florida, United States, 32204
Investigational Site Number 840181
Jacksonville, Florida, United States, 32205
Investigational Site Number 840152
Jacksonville, Florida, United States, 32216
Investigational Site Number 840154
Lake Mary, Florida, United States, 32746
Investigational Site Number 840059
Largo, Florida, United States, 33773
Investigational Site Number 840221
Miami, Florida, United States, 33176
Investigational Site Number 840021
New Port Richey, Florida, United States, 34652
Investigational Site Number 840122
New Smyrna Beach, Florida, United States, 32169
Investigational Site Number 840151
Ocala, Florida, United States, 34471
Investigational Site Number 840108
Ormond Beach, Florida, United States, 32174
Investigational Site Number 840067
Palm Harbor, Florida, United States, 34684
Investigational Site Number 840006
Pembroke Pines, Florida, United States, 33026
Investigational Site Number 840168
Ponte Vedra, Florida, United States, 32081
Investigational Site Number 840164
Sarasota, Florida, United States, 34239
Investigational Site Number 840175
Sarasota, Florida, United States, 34239
Investigational Site Number 840001
St. Petersburg, Florida, United States
Investigational Site Number 840003
St. Petersburg, Florida, United States
Investigational Site Number 840036
West Palm Beach, Florida, United States, 33401
United States, Georgia
Investigational Site Number 840117
Cumming, Georgia, United States, 30041
Investigational Site Number 840110
Roswell, Georgia, United States, 30076
Investigational Site Number 840026
Savannah, Georgia, United States, 31405
United States, Idaho
Investigational Site Number 840075
Meridian, Idaho, United States, 83646
United States, Indiana
Investigational Site Number 840027
Evansville, Indiana, United States, 47714
Investigational Site Number 840093
Indianapolis, Indiana, United States, 46260
United States, Iowa
Investigational Site Number 840222
Iowa City, Iowa, United States, 52242
Investigational Site Number 840165
West Des Moines, Iowa, United States, 50266
United States, Kansas
Investigational Site Number 840200
Kansas City, Kansas, United States, 66160-7321
Investigational Site Number 840040
Wichita, Kansas, United States, 67203
Investigational Site Number 840061
Wichita, Kansas, United States, 67205
Investigational Site Number 840032
Wichita, Kansas, United States, 67207
Investigational Site Number 840084
Wichita, Kansas, United States, 67207
United States, Maine
Investigational Site Number 840244
Biddeford, Maine, United States, 04005
Investigational Site Number 840158
Framingham, Maine, United States, 01702
United States, Michigan
Investigational Site Number 840193
Novi, Michigan, United States, 48374
Investigational Site Number 840162
Saginaw, Michigan, United States, 48604
United States, Missouri
Investigational Site Number 840033
Saint Louis, Missouri, United States, 63117
Investigational Site Number 840113
St. Louis, Missouri, United States, 63131
United States, Nevada
Investigational Site Number 840095
Henderson, Nevada, United States, 89052
Investigational Site Number 840096
Henderson, Nevada, United States, 89052
United States, New Jersey
Investigational Site Number 840022
Edison, New Jersey, United States, 08817
Investigational Site Number 840011
Hillsborough, New Jersey, United States, 08844
Investigational Site Number 840049
Trenton, New Jersey, United States, 08611
United States, New York
Investigational Site Number 840097
Bronxville, New York, United States, 10708
Investigational Site Number 840129
Brooklyn, New York, United States, 11215
Investigational Site Number 840160
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Investigational Site Number 840217
Asheville, North Carolina, United States, 28803
Investigational Site Number 840023
Charlotte, North Carolina, United States, 28211
Investigational Site Number 840083
Greensboro, North Carolina, United States, 27408
Investigational Site Number 840104
Raleigh, North Carolina, United States, 27609
United States, Ohio
Investigational Site Number 840068
Cincinnati, Ohio, United States, 45236
Investigational Site Number 840007
Dayton, Ohio, United States, 45406
Investigational Site Number 840013
Marion, Ohio, United States, 43302
Investigational Site Number 840161
Mentor, Ohio, United States, 44060
United States, Oklahoma
Investigational Site Number 840005
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Investigational Site Number 840170
Beaver, Pennsylvania, United States, 15009
Investigational Site Number 840180
Camp Hill, Pennsylvania, United States, 17011
Investigational Site Number 840004
Duncansville, Pennsylvania, United States, 16635
Investigational Site Number 840046
Jersey Shore, Pennsylvania, United States, 17740
Investigational Site Number 840155
Phoenixville, Pennsylvania, United States, 19460
Investigational Site Number 840177
Scranton, Pennsylvania, United States, 18508
Investigational Site Number 840202
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Investigational Site Number 840073
Charleston, South Carolina, United States, 29485
Investigational Site Number 840087
Greenville, South Carolina, United States, 29615
Investigational Site Number 840074
Simpsonville, South Carolina, United States, 29681
Investigational Site Number 840105
Varnville, South Carolina, United States, 29944
United States, Tennessee
Investigational Site Number 840190
Knoxville, Tennessee, United States, 37917
United States, Texas
Investigational Site Number 840092
Dallas, Texas, United States, 75216
Investigational Site Number 840212
Dallas, Texas, United States, 75226
Investigational Site Number 840058
Fort Worth, Texas, United States, 76104
Investigational Site Number 840149
Fort Worth, Texas, United States, 76104
Investigational Site Number 840070
Fort Worth, Texas, United States, 76117
Investigational Site Number 840038
Houston, Texas, United States, 77024
Investigational Site Number 840047
Houston, Texas, United States, 77074
Investigational Site Number 840053
Plano, Texas, United States, 75023
Investigational Site Number 840072
Sugar Land, Texas, United States, 77479
Investigational Site Number 840241
Tyler, Texas, United States, 75701
United States, Utah
Investigational Site Number 840031
Salt Lake City, Utah, United States, 84107
United States, Virginia
Investigational Site Number 840204
Chesapeake, Virginia, United States, 23320
United States, Washington
Investigational Site Number 840120
Spokane, Washington, United States, 99204
United States, Wisconsin
Investigational Site Number 840111
Milwaukee, Wisconsin, United States, 53209-0996
Argentina
Investigational Site Number 032006
Buenos Aires, Argentina, C1425DES
Investigational Site Number 032010
Caba, Argentina, C1440AAD
Investigational Site Number 032008
Capital Federal, Argentina, 1119
Investigational Site Number 032001
Coronel Suarez, Argentina, B7540GHD
Investigational Site Number 032004
Resistencia, Argentina, H3500CDM
Investigational Site Number 032007
Zarate, Argentina, B2800DGH
Belgium
Investigational Site Number 056005
Antwerpen, Belgium, 2020
Investigational Site Number 056004
Genk, Belgium, 3600
Investigational Site Number 056001
Natoye, Belgium, 5360
Investigational Site Number 056002
Wetteren, Belgium, 9230
Bulgaria
Investigational Site Number 100008
Pleven, Bulgaria, 5800
Investigational Site Number 100014
Plovdiv, Bulgaria, 4000
Investigational Site Number 100005
Sofia, Bulgaria, 1203
Investigational Site Number 100012
Sofia, Bulgaria, 1233
Investigational Site Number 100015
Sofia, Bulgaria, 1233
Investigational Site Number 100009
Sofia, Bulgaria, 1527
Investigational Site Number 100001
Sofia, Bulgaria, 1606
Investigational Site Number 100013
Stara Zagora, Bulgaria, 6000
Investigational Site Number 100007
Varna, Bulgaria, 9010
Canada
Investigational Site Number 124013
Cambridge, Canada, N1R 6V6
Investigational Site Number 124027
Coquitlam, Canada, V3K 3P4
Investigational Site Number 124001
Hawkesbury, Canada, K6A 1A1
Investigational Site Number 124002
London, Canada, N5W 6A2
Investigational Site Number 124009
Mirabel, Canada, J7J 2K8
Investigational Site Number 124018
Montreal, Canada, H1T 3Y7
Investigational Site Number 124007
Ottawa, Canada, K1K 4L2
Investigational Site Number 124011
Quebec, Canada, G1V 4M6
Investigational Site Number 124005
Saint John'S, Canada, A1A 3R5
Investigational Site Number 124008
Sarnia, Canada, N7T 4X3
Investigational Site Number 124022
Terrebonne, Canada, J6V 1S8
Investigational Site Number 124003
Vancouver, Canada, V5Z 1M9
Investigational Site Number 124006
Victoria, Canada, V8T 5G4
Investigational Site Number 124015
Woodstock, Canada, N4S 5P5
Chile
Investigational Site Number 152007
Osorno, Chile, 5311092
Investigational Site Number 152008
Santiago, Chile, 7980378
Investigational Site Number 152006
Santiago, Chile, 8053095
Investigational Site Number 152004
Temuco, Chile, 4790869
Colombia
Investigational Site Number 170004
Barranquilla, Colombia
Investigational Site Number 170005
Barranquilla, Colombia
Investigational Site Number 170008
Barranquilla, Colombia
Investigational Site Number 170001
Manizales, Colombia
Investigational Site Number 170003
Medellin, Colombia
Czech Republic
Investigational Site Number 203004
Praha 2, Czech Republic, 128 08
Investigational Site Number 203007
Praha 5, Czech Republic, 15006
Investigational Site Number 203006
Praha 5, Czech Republic, 15800
Denmark
Investigational Site Number 208005
Aarhus, Denmark, 8200
Investigational Site Number 208004
Hellerup, Denmark, 2900
Investigational Site Number 208003
Slagelse, Denmark, 4200
Investigational Site Number 208001
Svendborg, Denmark, 5700
Investigational Site Number 208002
Viborg, Denmark, 8800
Finland
Investigational Site Number 246002
Joensuu, Finland, 80100
Investigational Site Number 246001
Kokkola, Finland, 67100
Investigational Site Number 246003
Kuopio, Finland, 70210
Investigational Site Number 246004
Vantaa, Finland, 01600
France
Investigational Site Number 250007
Bandol, France, 83150
Investigational Site Number 250003
Broglie, France, 27270
Investigational Site Number 250014
Bron Cedex, France, 69677
Investigational Site Number 250004
Dijon, France, 21000
Investigational Site Number 250006
Lille Cedex, France, 59037
Investigational Site Number 250009
Nantes, France, 44093
Investigational Site Number 250001
Nantes, France, 44300
Investigational Site Number 250002
Paris Cedex 13, France, 75651
Investigational Site Number 250010
Pessac, France, 33604
Investigational Site Number 250012
Rennes, France, 35033
Investigational Site Number 250005
Vieux Conde, France, 59690
Investigational Site Number 250008
Vihiers, France, 49310
Germany
Investigational Site Number 276001
Bad Wörishofen, Germany, 86825
Investigational Site Number 276007
Berlin, Germany, 12627
Investigational Site Number 276005
Berlin, Germany, 13125
Investigational Site Number 276014
Berlin, Germany, 13158
Investigational Site Number 276008
Bochum, Germany, 44787
Investigational Site Number 276009
Dresden, Germany, 01067
Investigational Site Number 276004
Essen, Germany, 45355
Investigational Site Number 276010
Frankfurt A.M., Germany, 60596
Investigational Site Number 276011
Görlitz, Germany, 02826
Investigational Site Number 276019
Hannover, Germany, 30159
Investigational Site Number 276013
Leipzig, Germany, 04103
Investigational Site Number 276012
Magdeburg, Germany, 39104
Investigational Site Number 276003
Magdeburg, Germany, 39120
Investigational Site Number 276006
Schwerin, Germany, 19055
Investigational Site Number 276015
Witten, Germany, 58455
Hungary
Investigational Site Number 348003
Baja, Hungary, 6500
Investigational Site Number 348007
Budapest, Hungary, 1036
Investigational Site Number 348009
Budapest, Hungary, 1036
Investigational Site Number 348008
Budapest, Hungary, 1135
Investigational Site Number 348013
Budapest, Hungary, 1136
Investigational Site Number 348004
Debrecen, Hungary, 4032
Investigational Site Number 348002
Nagykanizsa, Hungary, 8800
Investigational Site Number 348006
Nyiregyhaza, Hungary, 4400
Investigational Site Number 348001
Sopron, Hungary, 9400
Investigational Site Number 348011
Urhida, Hungary, 8142
Israel
Investigational Site Number 376002
Afula, Israel, 18101
Investigational Site Number 376003
Holon, Israel, 58100
Investigational Site Number 376005
Holon, Israel, 58100
Investigational Site Number 376004
Nazareth, Israel, 16100
Italy
Investigational Site Number 380006
Chieti, Italy, 66013
Investigational Site Number 380002
Cinisello Balsamo, Italy, 20092
Investigational Site Number 380009
Milano, Italy, 20138
Investigational Site Number 380007
Napoli, Italy, 80131
Investigational Site Number 380001
Palermo, Italy, 90127
Investigational Site Number 380005
Pozzilli, Italy, 86077
Investigational Site Number 380008
Vittorio Veneto, Italy, 31029
Investigational Site Number 380010
Zingonia-Osio Sotto, Italy
Mexico
Investigational Site Number 484010
Df, Mexico, 03300
Investigational Site Number 484004
Mexico, Mexico, 06090
Investigational Site Number 484008
Not Provided, Mexico
Investigational Site Number 484001
San Luis Potosi, Mexico, 78200
Investigational Site Number 484002
Tijuana, Mexico, 22500
Investigational Site Number 484009
Torreon, Mexico, 27000
Investigational Site Number 484003
Xalapa, Mexico, 91020
Netherlands
Investigational Site Number 528013
Amsterdam, Netherlands, 1091 AC
Investigational Site Number 528001
Amsterdam, Netherlands, 1105 AZ
Investigational Site Number 528004
Breda, Netherlands, 4811 SW
Investigational Site Number 528005
Eindhoven, Netherlands, 5616GB
Investigational Site Number 528007
Groningen, Netherlands, 9711 SG
Investigational Site Number 528011
Hoogeveen, Netherlands, 7909 AA
Investigational Site Number 528002
Hoorn, Netherlands, 1625 HV
Investigational Site Number 528008
Leiderdorp, Netherlands, 2352 RA
Investigational Site Number 528009
Rotterdam, Netherlands, 3021 HC
Investigational Site Number 528006
Velp, Netherlands, 6883 ES
Investigational Site Number 528012
Venlo, Netherlands, 5912 BL
Investigational Site Number 528010
Zoetermeer, Netherlands, 2724 EK
Norway
Investigational Site Number 578005
Elverum, Norway, 2402
Investigational Site Number 578001
Hamar, Norway, 2317
Investigational Site Number 578002
Oslo, Norway
Investigational Site Number 578004
Skedsmokorset, Norway, 2020
Investigational Site Number 578003
Stavanger, Norway, 4005
Poland
Investigational Site Number 616008
Gdynia, Poland, 81-384
Investigational Site Number 616003
Gdynia, Poland, 81423
Investigational Site Number 616001
Gniewkowo, Poland, 88-140
Investigational Site Number 616010
Katowice, Poland, 40-748
Investigational Site Number 616018
Krakow, Poland, 31-315
Investigational Site Number 616004
Piotrkow Trybunalski, Poland, 97-300
Investigational Site Number 616013
Pulawy, Poland, 24-100
Investigational Site Number 616009
Warszawa, Poland, 02-777
Investigational Site Number 616007
Wroclaw, Poland, 50-088
Portugal
Investigational Site Number 620006
Funchal / Madeira, Portugal, 9050
Investigational Site Number 620002
Lisboa, Portugal, 1169-024
Investigational Site Number 620001
Lisboa, Portugal, 1549-008
Investigational Site Number 620005
Porto, Portugal, 4200-319
Romania
Investigational Site Number 642005
Baia Mare, Romania, 430031
Investigational Site Number 642002
Brasov, Romania, 500283
Investigational Site Number 642004
Targu Mures, Romania, 540099
Investigational Site Number 642001
Timisoara, Romania, 300358
Russian Federation
Investigational Site Number 643005
Barnaul, Russian Federation
Investigational Site Number 643012
Moscow, Russian Federation, 119415
Investigational Site Number 643008
Moscow, Russian Federation, 125284
Investigational Site Number 643014
Perm, Russian Federation, 614097
Investigational Site Number 643006
St Petersburg, Russian Federation, 196084
Investigational Site Number 643009
St.Petersburg, Russian Federation, 196084
Investigational Site Number 643004
Yaroslavl, Russian Federation, 150002
South Africa
Investigational Site Number 710010
Centurion, South Africa, 0158
Investigational Site Number 710008
Meyerspark, South Africa, 0184
Investigational Site Number 710011
Middelburg, South Africa, 1055
Investigational Site Number 710006
Parktown, South Africa, 2193
Investigational Site Number 710004
Pretoria, South Africa, 0002
Investigational Site Number 710001
Pretoria, South Africa, 0084
Investigational Site Number 710002
Pretoria, South Africa, 181
Investigational Site Number 710009
Roodepoort, South Africa, 1724
Investigational Site Number 710003
Somerset West, South Africa, 7130
Investigational Site Number 710005
Witbank, South Africa
Investigational Site Number 710007
Worcester, South Africa, 6850
Spain
Investigational Site Number 724006
Córdoba, Spain, 14004
Investigational Site Number 724003
Granada, Spain, 18012
Investigational Site Number 724002
Madrid, Spain, 28040
Investigational Site Number 724007
Málaga, Spain, 29010
Investigational Site Number 724008
Quart De Poblet, Spain, 46930
Investigational Site Number 724005
Reus, Spain, 43201
Investigational Site Number 724001
Sabadell, Spain, 08208
Investigational Site Number 724004
Sevilla, Spain, 41013
Sweden
Investigational Site Number 752002
Rättvik, Sweden, 79530
Investigational Site Number 752006
Stockholm, Sweden, 111 35
Investigational Site Number 752003
Stockholm, Sweden, 111 57
Investigational Site Number 752004
Stockholm, Sweden, 14186
Investigational Site Number 752001
Örebro, Sweden, 70146
Ukraine
Investigational Site Number 804012
Chernivtsi, Ukraine, 58013
Investigational Site Number 804003
Dnipropetrovsk, Ukraine, 49006
Investigational Site Number 804002
Donetsk, Ukraine, 83114
Investigational Site Number 804014
Kharkiv, Ukraine, 61002
Investigational Site Number 804016
Kiev, Ukraine, 02091
Investigational Site Number 804011
Kyiv, Ukraine, 01103
Investigational Site Number 804010
Kyiv, Ukraine, 03115
Investigational Site Number 804001
Kyiv, Ukraine, 03680
Investigational Site Number 804008
Kyiv, Ukraine, 04053
Investigational Site Number 804013
Kyiv, Ukraine
Investigational Site Number 804005
Zhytomyr, Ukraine, 10002
United Kingdom
Investigational Site Number 826004
Addlestone, United Kingdom, KT15 2BH
Investigational Site Number 826009
Birmingham, United Kingdom, B15 2SQ
Investigational Site Number 826016
Birmingham, United Kingdom, B18 7QH
Investigational Site Number 826021
Blackpool, United Kingdom, FY3 7EN
Investigational Site Number 826023
Cambridge, United Kingdom, CB2 OQQ
Investigational Site Number 826012
Cardiff, United Kingdom, CF14 5GJ
Investigational Site Number 826024
Chichester, United Kingdom, PO19 4SE
Investigational Site Number 826006
Chorley, United Kingdom, PR7 7NA
Investigational Site Number 826010
Glasgow, United Kingdom, G20 0SP
Investigational Site Number 826003
Irvine, United Kingdom, KA12 0AY
Investigational Site Number 826008
Liverpool, United Kingdom, L22 0LG
Investigational Site Number 826005
Liverpool, United Kingdom, L7 8XP
Investigational Site Number 826025
Manchester, United Kingdom, M13 9WL
Investigational Site Number 826007
Manchester, United Kingdom, M15 6SX
Investigational Site Number 826001
Middlesex, United Kingdom, HA6 2RN
Investigational Site Number 826019
Penzance, United Kingdom, TR19 7HH
Investigational Site Number 826011
Reading, United Kingdom, RG2 7AG
Investigational Site Number 826013
Romford, United Kingdom, RM7 0AG
Investigational Site Number 826014
Soham, United Kingdom, CB7 5JD
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01507831     History of Changes
Other Study ID Numbers: LTS11717  2011-002806-59  U1111-1121-3928 
Study First Received: January 6, 2012
Results First Received: November 18, 2015
Last Updated: November 18, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016