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Open Label Study of Long Term Safety Evaluation of Alirocumab (ODYSSEY OLE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01954394
First Posted: October 1, 2013
Last Update Posted: December 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
  Purpose

Primary Objective:

To assess the long-term safety of alirocumab when added to lipid-lowering therapy in patients with heterozygous familial hypercholesterolemia (heFH).

Secondary Objectives:

To evaluate the long-term efficacy of alirocumab on lipid parameters. To evaluate the long-term immunogenicity of alirocumab.


Condition Intervention Phase
Hypercholesterolemia Drug: Alirocumab SAR236553 (REGN727) Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Assessment of safety parameters (adverse events, laboratory data, vital signs) [ Time Frame: Up to 176 weeks ]

Secondary Outcome Measures:
  • Percent change from baseline in low density lipoprotein cholesterol (LDL-C) [ Time Frame: Up to 168 weeks ]
  • Percent change from baseline in other lipid parameters [ Time Frame: Up to 168 weeks ]

Estimated Enrollment: 1000
Study Start Date: December 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alirocumab
Injection through subcutaneous (SC) administration
Drug: Alirocumab SAR236553 (REGN727)
Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
Other Name: Praluent

Detailed Description:
The maximum study duration will be 176 weeks per patient.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion criteria:

Patients with heFH who have completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).

Exclusion criteria:

Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954394


  Hide Study Locations
Locations
United States, Alabama
Investigational Site Number 840321
Huntsville, Alabama, United States, 35801
United States, Arizona
Investigational Site Number 840341
Tempe, Arizona, United States, 85282
United States, California
Investigational Site Number 840334
Bell Gardens, California, United States, 90201
Investigational Site Number 840319
Fountain Valley, California, United States, 92708
Investigational Site Number 840336
Los Angeles, California, United States, 90048
Investigational Site Number 840339
Mission Viejo, California, United States, 92691
Investigational Site Number 840337
Newport Beach, California, United States
United States, Colorado
Investigational Site Number 840306
Golden, Colorado, United States, 80401
United States, District of Columbia
Investigational Site Number 840328
Washington, District of Columbia, United States, 20037
United States, Florida
Investigational Site Number 840344
Atlantis, Florida, United States, FL 33462
Investigational Site Number 840353
Clearwater, Florida, United States, 33756
Investigational Site Number 840318
Ft. Lauderdale, Florida, United States, 33308-4311
Investigational Site Number 840327
Jacksonville, Florida, United States, 32216
Investigational Site Number 840309
Miami, Florida, United States, 33174
Investigational Site Number 840351
Sarasota, Florida, United States, 34239
United States, Illinois
Investigational Site Number 840315
Evanston, Illinois, United States, 60201
Investigational Site Number 840305
Oakbrook Terrace, Illinois, United States, 60181
United States, Iowa
Investigational Site Number 840333
Iowa City, Iowa, United States, 52242
United States, Kansas
Investigational Site Number 840329
Kansas City, Kansas, United States, 66160
United States, Maine
Investigational Site Number 840345
Auburn, Maine, United States, 04210
Investigational Site Number 840338
Biddeford, Maine, United States, 04005
Investigational Site Number 840346
Framingham, Maine, United States, 01702
United States, Massachusetts
Investigational Site Number 840322
Boston, Massachusetts, United States, 2114
United States, Missouri
Investigational Site Number 840317
St Louis, Missouri, United States, 63110
Investigational Site Number 840349
St Louis, Missouri, United States, 63136
United States, New Jersey
Investigational Site Number 840314
Morristown, New Jersey, United States, NJ 07901
United States, New York
Investigational Site Number 840316
New York, New York, United States, 10032
Investigational Site Number 840324
Poughkeepsie, New York, United States, 12601
United States, North Carolina
Investigational Site Number 840303
Charlotte, North Carolina, United States, 28204
Investigational Site Number 840320
Durham, North Carolina, United States, 27710
Investigational Site Number 840348
Raleigh, North Carolina, United States, 27609
United States, Ohio
Investigational Site Number 840340
Cincinnati, Ohio, United States, 45227
Investigational Site Number 840302
Marion, Ohio, United States, 43302
United States, Oregon
Investigational Site Number 840330
L607 Portland, Oregon, United States, 97239
United States, Pennsylvania
Investigational Site Number 840352
Beaver, Pennsylvania, United States, 15009
Investigational Site Number 840308
Philadelphia, Pennsylvania, United States, 19104
Investigational Site Number 840342
Scranton, Pennsylvania, United States, 18503
United States, South Carolina
Investigational Site Number 840304
Summerville, South Carolina, United States, 29485
United States, Texas
Investigational Site Number 840311
Dallas, Texas, United States, 75216
Investigational Site Number 840312
Dallas, Texas, United States, 75226
Investigational Site Number 840301
Fort Worth, Texas, United States, 76104
United States, Utah
Investigational Site Number 840343
Bountiful, Utah, United States, 84010
United States, Virginia
Investigational Site Number 840354
Chesapeake, Virginia, United States, 23320
United States, Washington
Investigational Site Number 840350
Spokane, Washington, United States, 99204
Argentina
Investigational Site Number 032302
Caba, Argentina, C1119ACN
Investigational Site Number 032301
Coronel Suarez, Argentina, B7540GHD
Austria
Investigational Site Number 040302
Graz, Austria, 8036
Investigational Site Number 040303
St. Stefan, Austria, 8511
Investigational Site Number 040301
Wien, Austria, 1130
Belgium
Investigational Site Number 056301
Natoye, Belgium, 5360
Bulgaria
Investigational Site Number 100302
Sofia, Bulgaria, 1233
Investigational Site Number 100301
Sofia, Bulgaria, 1527
Canada
Investigational Site Number 124303
Chicoutimi, Canada, G7H 7K9
Investigational Site Number 124302
Montreal, Canada, H1W 2R7
Investigational Site Number 124301
Quebec, Canada, G1V 4W2
Investigational Site Number 124306
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 124305
Toronto, Canada, M5C 2T2
Investigational Site Number 124304
Victoria, Canada, V8T 5G4
Czech Republic
Investigational Site Number 203307
Hradec Kralove, Czech Republic, 500 05
Investigational Site Number 203305
Praha 2, Czech Republic, 12808
Investigational Site Number 203301
Praha 4, Czech Republic, 14021
Investigational Site Number 203306
Praha 5 - Motol, Czech Republic, 15006
Investigational Site Number 203303
Praha 8, Czech Republic, 180 81
Investigational Site Number 203309
Trutnov, Czech Republic, 54121
Investigational Site Number 203304
Uherske Hradiste, Czech Republic, 68601
Investigational Site Number 203302
Zlin, Czech Republic, 76275
Denmark
Investigational Site Number 208301
Aalborg, Denmark, 9000
Investigational Site Number 208306
Aarhus, Denmark, 8200
Investigational Site Number 208302
Esbjerg, Denmark, 6700
Investigational Site Number 208303
Roskilde, Denmark, 4000
Investigational Site Number 208304
Svendborg, Denmark, 5700
Finland
Investigational Site Number 246302
Joensuu, Finland, 80100
Investigational Site Number 246301
Kokkola, Finland, 67100
Investigational Site Number 246304
Vantaa, Finland, 01600
France
Investigational Site Number 250303
Dijon, France, 21000
Investigational Site Number 250304
Lille Cedex, France, 59037
Investigational Site Number 250302
Nantes, France, 44093
Investigational Site Number 250301
Paris, France, 75013
Investigational Site Number 250305
Pessac, France, 33604
Investigational Site Number 250306
Rennes, France, 35033
Germany
Investigational Site Number 276305
Frankfurt A.M., Germany, 60596
Investigational Site Number 276306
Leipzig, Germany, 04103
Investigational Site Number 276301
Magdeburg, Germany, 39120
Investigational Site Number 276307
Witten, Germany, 58455
Hungary
Investigational Site Number 348301
Baja, Hungary, 6500
Israel
Investigational Site Number 376302
Holon, Israel, 58100
Investigational Site Number 376304
Jerusalem, Israel, 91120
Investigational Site Number 376303
Safed, Israel, 13110
Investigational Site Number 376301
Tel Hashomer, Israel, 52621
Italy
Investigational Site Number 380302
Chiete, Italy, 66100
Investigational Site Number 380304
Milano, Italy, 20138
Investigational Site Number 380303
Napoli, Italy, 80131
Investigational Site Number 380301
Palermo, Italy, 90127
Mexico
Investigational Site Number 484301
Mexico, Mexico, 03300
Netherlands
Investigational Site Number 528317
Alkmaar, Netherlands, 1815 JD
Investigational Site Number 528301
Amsterdam-Zuidoost, Netherlands, 1105 AZ
Investigational Site Number 528320
Apeldoorn, Netherlands, 7314 ET
Investigational Site Number 528309
Delfzijl, Netherlands, 9934 JD
Investigational Site Number 528313
Eindhoven, Netherlands, 5616GB
Investigational Site Number 528319
Enschede, Netherlands, 7513 ER
Investigational Site Number 528322
Goes, Netherlands, 4462 RA
Investigational Site Number 528325
Groningen, Netherlands, 9713 GZ
Investigational Site Number 528302
Groningen, Netherlands, 9728 NT
Investigational Site Number 528324
Hoogeveen, Netherlands, 7909 AA
Investigational Site Number 528318
Hoorn, Netherlands, 1624 NP
Investigational Site Number 528305
Leiden, Netherlands, 2333 ZA
Investigational Site Number 528311
Maastricht, Netherlands, 6229 HX
Investigational Site Number 528312
Nijmegen, Netherlands, 6500 HB
Investigational Site Number 528315
Rotterdam, Netherlands, 3021 HC
Investigational Site Number 528326
Rotterdam, Netherlands, 3045 PM
Investigational Site Number 528303
Utrecht, Netherlands, 3582 KE
Investigational Site Number 528323
Utrecht, Netherlands, 3584 CX
Investigational Site Number 528321
Venlo, Netherlands, 5912 BL
Investigational Site Number 528316
Waalwijk, Netherlands, 5141 BM
Investigational Site Number 528327
Zoetermeer, Netherlands, 2724 EK
Norway
Investigational Site Number 578301
Bodo, Norway, 8092
Investigational Site Number 578305
Oslo, Norway, 0407
Investigational Site Number 578304
Oslo, Norway
Portugal
Investigational Site Number 620302
Funchal, Portugal, 9004-514
Investigational Site Number 620301
Lisboa, Portugal, 1169-024
Romania
Investigational Site Number 642302
Timisoara, Romania, 300358
Russian Federation
Investigational Site Number 643304
Arkhangelsk, Russian Federation, 163000
Investigational Site Number 643303
Kazan, Russian Federation, 420012
Investigational Site Number 643302
Moscow, Russian Federation, 111539
Investigational Site Number 643308
Moscow, Russian Federation, 121552
Investigational Site Number 643305
Moscow, Russian Federation, 129301
Investigational Site Number 643310
Novosibirsk, Russian Federation, 630089
Investigational Site Number 643301
St Petersbourg, Russian Federation, 194156
Investigational Site Number 643306
St. Petersburg, Russian Federation, 194291
Investigational Site Number 643312
St.Petersburg, Russian Federation, 196084
South Africa
Investigational Site Number 710311
Bellville, South Africa, 7530
Investigational Site Number 710307
Bloemfontein, South Africa, 9301
Investigational Site Number 710306
Cape Town, South Africa, 7700
Investigational Site Number 710302
Cape Town, South Africa, 7925
Investigational Site Number 710309
Centurion, South Africa, 0158
Investigational Site Number 710312
Parktown, South Africa, 2193
Investigational Site Number 710304
Parow, South Africa, 7500
Investigational Site Number 710313
Pretoria, South Africa, 0002
Investigational Site Number 710303
Pretoria, South Africa, 0084
Investigational Site Number 710305
Pretoria, South Africa, 0157
Investigational Site Number 710314
Pretoria, South Africa, 0184
Investigational Site Number 710315
Roodepoort, South Africa, 1724
Investigational Site Number 710310
Western Cape, South Africa, 7130
Investigational Site Number 710308
Witbank, South Africa
Investigational Site Number 710316
Worcester, South Africa, 6850
Spain
Investigational Site Number 724303
A Coruna, Spain, 15001
Investigational Site Number 724308
Barcelona, Spain, 08036
Investigational Site Number 724306
Córdoba, Spain, 14004
Investigational Site Number 724312
Granada, Spain, 18012
Investigational Site Number 724307
Hospitalet De Llobregat, Spain, 08907
Investigational Site Number 724301
Madrid, Spain, 28007
Investigational Site Number 724309
Madrid, Spain, 28029
Investigational Site Number 724305
Madrid, Spain, 28040
Investigational Site Number 724311
Madrid, Spain, 28040
Investigational Site Number 724314
Málaga, Spain, 29010
Investigational Site Number 724315
Quart De Poblet, Spain, 46930
Investigational Site Number 724304
Reus-Tarragona, Spain, 43204
Investigational Site Number 724310
Sabadell, Spain, 08208
Investigational Site Number 724313
Sevilla, Spain, 41013
Investigational Site Number 724302
Zaragoza, Spain, 50009
Sweden
Investigational Site Number 752302
Goteborg, Sweden, 41345
Investigational Site Number 752301
Stockholm, Sweden, 111 35
Investigational Site Number 752304
Stockholm, Sweden, 14186
United Kingdom
Investigational Site Number 826318
Birmingham, United Kingdom, B15 2SQ
Investigational Site Number 826304
Brighton, United Kingdom, BN1 9PH
Investigational Site Number 826301
Bristol, United Kingdom, BS2 8HW
Investigational Site Number 826311
Cambridge, United Kingdom, CB2 OQQ
Investigational Site Number 826310
Cardiff, United Kingdom, CF14 5GJ
Investigational Site Number 826302
Dundee, United Kingdom, DD1 9SY
Investigational Site Number 826317
Liverpool, United Kingdom, L22 0LG
Investigational Site Number 826306
Liverpool, United Kingdom, L7 8XP
Investigational Site Number 826312
Manchester, United Kingdom, M13 9WL
Investigational Site Number 826303
Manchester, United Kingdom, M23 9LT
Investigational Site Number 826305
Middlesex, United Kingdom, HA6 2RN
Investigational Site Number 826313
Newcastle Upon Tyne, United Kingdom, NEI 4LP
Investigational Site Number 826309
Reading, United Kingdom, RG2 0TG
Investigational Site Number 826315
West Bromwich, United Kingdom, B71 4HJ
Investigational Site Number 826316
West Bromwich, United Kingdom, B71 4HJ
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01954394     History of Changes
Other Study ID Numbers: LTS13463
2013-002572-40 ( EudraCT Number )
U1111-1143-3810 ( Other Identifier: UTN )
First Submitted: September 16, 2013
First Posted: October 1, 2013
Last Update Posted: December 15, 2016
Last Verified: December 2016

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