Efficacy and Safety of Alirocumab SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy (ODYSSEY FH I)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01623115
First received: June 15, 2012
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

Primary Objective:

To evaluate the effect of alirocumab SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo

Secondary Objectives:

  • To evaluate the effect of alirocumab SAR236553 (REGN727) in comparison with placebo on LDL-C at other time points
  • To evaluate the effects of alirocumab SAR236553 (REGN727) on other lipid parameters
  • To evaluate the safety and tolerability of alirocumab SAR236553 (REGN727)

Condition Intervention Phase
Hypercholesterolemia
Drug: alirocumab SAR236553 (REGN727)
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Secondary Outcome Measures:
  • Percent change in LDL-C [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]

Estimated Enrollment: 471
Study Start Date: July 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alirocumab SAR236553 (REGN727)

Injection through subcutaneous (SC) administration.

Background statin therapy or other lipid lowering therapy will be administered according to site investigator discretion as background therapy.

Drug: alirocumab SAR236553 (REGN727)

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

Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Placebo Comparator: Placebo

Injection through subcutaneous (SC) administration.

Background statin therapy or other lipid lowering therapy will be administered according to site investigator discretion as background therapy.

Other: placebo
Pharmaceutical form:Solution for injection Route of administration: subcutaneous

Detailed Description:

The maximum study duration will be 89 weeks per patient, including a 78-week randomized treatment period.

  Eligibility

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

Inclusion criteria:

  • Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid-modifying therapy

Exclusion criteria:

  • Age < 18 years or legal age of adulthood, whichever is greater -LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
  • LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
  • Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L)
  • Known history of homozygous familial hypercholesterolemia
  • The above information is not intended to contain all considerations relevant to a patient'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: NCT01623115

  Hide Study Locations
Locations
United States, California
Investigational Site Number 840417
Bell Gardens, California, United States, 90201
Investigational Site Number 840429
Long Beach, California, United States, 90801
Investigational Site Number 840419
Los Angeles, California, United States, 90048
Investigational Site Number 840421
Mission Viejo, California, United States, 92691
Investigational Site Number 840412
Newport Beach, California, United States, 92660
Investigational Site Number 840428
Newport Beach, California, United States
Investigational Site Number 840461
Northridge, California, United States, 91324
United States, District of Columbia
Investigational Site Number 840452
Washington, District of Columbia, United States, 20037
United States, Florida
Investigational Site Number 840456
Miami, Florida, United States, 33165
Investigational Site Number 840418
Ponte Vedra, Florida, United States, 32081
United States, Illinois
Investigational Site Number 840455
Evanston, Illinois, United States, 60201
United States, Kansas
Investigational Site Number 840415
Kansas City, Kansas, United States, 66160-7321
United States, Maine
Investigational Site Number 840425
Auburn, Maine, United States, 04210
United States, Massachusetts
Investigational Site Number 840411
Boston, Massachusetts, United States, 02114
United States, Missouri
Investigational Site Number 840409
St Louis, Missouri, United States, 63110
United States, New Jersey
Investigational Site Number 840407
Morristown, New Jersey, United States, 07962
United States, New York
Investigational Site Number 840408
New York, New York, United States, 10032
United States, North Carolina
Investigational Site Number 840401
Charlotte, North Carolina, United States, 28207
Investigational Site Number 840410
Durham, North Carolina, United States, 27710
United States, Ohio
Investigational Site Number 840430
Cincinnati, Ohio, United States, 45219
United States, Oregon
Investigational Site Number 840424
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Investigational Site Number 840404
Philadelphia, Pennsylvania, United States, 19104
Investigational Site Number 840426
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Investigational Site Number 840406
Nashville, Tennessee, United States, 37232
United States, Texas
Investigational Site Number 840460
Dallas, Texas, United States, 75216
United States, Utah
Investigational Site Number 840422
Bountiful, Utah, United States, 84010
Austria
Investigational Site Number 040403
Graz, Austria, 8036
Investigational Site Number 040402
Wien, Austria, 1130
Investigational Site Number 040405
Wien, Austria
Canada
Investigational Site Number 124404
Chicoutimi, Canada, G7H 5H6
Investigational Site Number 124401
Montreal, Canada, H2W 1R7
Investigational Site Number 124403
Quebec, Canada, G1V 4M6
Investigational Site Number 124406
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 124407
Toronto, Canada, M5C 2T2
Czech Republic
Investigational Site Number 203401
Praha, Czech Republic, 140 00
Investigational Site Number 203403
Praha, Czech Republic, 180 00
Investigational Site Number 203405
Uherske Hradiste, Czech Republic
Investigational Site Number 203402
Zlin, Czech Republic, 760 00
Denmark
Investigational Site Number 208401
Copenhagen, Denmark
Investigational Site Number 208403
Esbjerg, Denmark, 6700
France
Investigational Site Number 250403
Dijon, France, 21000
Investigational Site Number 250401
Paris Cedex 13, France, 75651
Investigational Site Number 250402
Saint Herblain, France, 44093
Israel
Investigational Site Number 376402
Holon, Israel, 76100
Investigational Site Number 376405
Jerusalem, Israel
Investigational Site Number 376404
Safed, Israel, 13100
Investigational Site Number 376401
Tel Hashomer, Israel, 52621
Netherlands
Investigational Site Number 528406
Amsterdam, Netherlands, 1105 AZ
Investigational Site Number 528410
Amsterdam, Netherlands
Investigational Site Number 528408
Den Helder, Netherlands, 1782 GZ
Investigational Site Number 528402
Groningen, Netherlands, 9728 NT
Investigational Site Number 528411
Leiden, Netherlands, 2333 ZA
Investigational Site Number 528416
Maastricht, Netherlands, 6229 HX
Investigational Site Number 528409
Nieuwegein, Netherlands, 3435 CM
Investigational Site Number 528412
Sliedrecht, Netherlands
Norway
Investigational Site Number 578401
Bodø, Norway, 8092
Russian Federation
Investigational Site Number 643402
Arkhangelsk, Russian Federation, 163000
Investigational Site Number 643407
Kazan, Russian Federation, 420012
Investigational Site Number 643409
Moscow, Russian Federation, 111539
Investigational Site Number 643413
Moscow, Russian Federation, 121552
Investigational Site Number 643401
Moscow, Russian Federation, 129301
Investigational Site Number 643412
Novisibirsk, Russian Federation
Investigational Site Number 643408
St-Petersburg, Russian Federation, 193079
Investigational Site Number 643404
St-Petersburg, Russian Federation, 197341
Investigational Site Number 643406
St-Petersburg, Russian Federation, 194291
Investigational Site Number 643410
Yaroslavl, Russian Federation, 150062
South Africa
Investigational Site Number 710405
Bloemfontein, South Africa
Investigational Site Number 710401
Bloemfontein, South Africa
Investigational Site Number 710406
Cap Town, South Africa, 7530
Investigational Site Number 710402
Cape Town, South Africa, 7708
Investigational Site Number 710407
Parktown, South Africa, 2193
Investigational Site Number 710403
Parow, South Africa, 7500
Investigational Site Number 710408
Pretoria, South Africa
Investigational Site Number 710404
Rondebosch, South Africa
Investigational Site Number 710409
Somerset West, South Africa, 7130
Spain
Investigational Site Number 724403
A Coruna, Spain, 15006
Investigational Site Number 724408
Barcelona, Spain, 08036
Investigational Site Number 724406
Córdoba, Spain, 14004
Investigational Site Number 724407
Hospitalet De Llobregat, Spain, 08907
Investigational Site Number 724409
Madrid, Spain, 28029
Investigational Site Number 724401
Madrid, Spain, 28040
Investigational Site Number 724405
Madrid, Spain, 28040
Investigational Site Number 724404
Reus, Spain, 43201
Investigational Site Number 724402
Zaragoza, Spain, 50009
Sweden
Investigational Site Number 752404
Goteborg, Sweden, 41345
Investigational Site Number 752401
Stockholm, Sweden, 111 35
United Kingdom
Investigational Site Number 826402
London, United Kingdom
Investigational Site Number 826403
London, United Kingdom
Investigational Site Number 826409
London, United Kingdom
Investigational Site Number 826408
London, United Kingdom
Investigational Site Number 826405
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01623115     History of Changes
Other Study ID Numbers: EFC12492, U1111-1121-4275
Study First Received: June 15, 2012
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
PCSK9

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias

ClinicalTrials.gov processed this record on August 20, 2014