Open Label Study of Long Term Safety Evaluation of Alirocumab
NCT ID: NCT01954394
Last Updated: 2018-07-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
986 participants
INTERVENTIONAL
2013-12-17
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831).
Secondary Objectives:
* To evaluate the long-term efficacy of alirocumab on lipid parameters.
* To evaluate the long-term immunogenicity of alirocumab.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)
NCT01709500
Open-Label Extension of Study R727-CL-1003 (NCT01266876) to Evaluate the Long-Term Safety and Efficacy of Alirocumab (REGN727) in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)
NCT01576484
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
NCT01623115
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
NCT03510884
Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)
NCT01617655
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Alirocumab 75 or 150 mg Q2W
Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717.
Alirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
Lipid-Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Alirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
Lipid-Modifying Therapy (LMT)
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Investigational Site Number 840321
Huntsville, Alabama, United States
Investigational Site Number 840341
Tempe, Arizona, United States
Investigational Site Number 840334
Bell Gardens, California, United States
Investigational Site Number 840319
Fountain Valley, California, United States
Investigational Site Number 840336
Los Angeles, California, United States
Investigational Site Number 840339
Mission Viejo, California, United States
Investigational Site Number 840337
Newport Beach, California, United States
Investigational Site Number 840306
Golden, Colorado, United States
Investigational Site Number 840328
Washington D.C., District of Columbia, United States
Investigational Site Number 840344
Atlantis, Florida, United States
Investigational Site Number 840353
Clearwater, Florida, United States
Investigational Site Number 840318
Fort Lauderdale, Florida, United States
Investigational Site Number 840327
Jacksonville, Florida, United States
Investigational Site Number 840309
Miami, Florida, United States
Investigational Site Number 840351
Sarasota, Florida, United States
Investigational Site Number 840315
Evanston, Illinois, United States
Investigational Site Number 840305
Oakbrook Terrace, Illinois, United States
Investigational Site Number 840333
Iowa City, Iowa, United States
Investigational Site Number 840329
Kansas City, Kansas, United States
Investigational Site Number 840345
Auburn, Maine, United States
Investigational Site Number 840338
Biddeford, Maine, United States
Investigational Site Number 840322
Boston, Massachusetts, United States
Investigational Site Number 840346
Framingham, Massachusetts, United States
Investigational Site Number 840317
St Louis, Missouri, United States
Investigational Site Number 840349
St Louis, Missouri, United States
Investigational Site Number 840314
Morristown, New Jersey, United States
Investigational Site Number 840316
New York, New York, United States
Investigational Site Number 840324
Poughkeepsie, New York, United States
Investigational Site Number 840303
Charlotte, North Carolina, United States
Investigational Site Number 840320
Durham, North Carolina, United States
Investigational Site Number 840348
Raleigh, North Carolina, United States
Investigational Site Number 840340
Cincinnati, Ohio, United States
Investigational Site Number 840302
Marion, Ohio, United States
Investigational Site Number 840330
Portland, Oregon, United States
Investigational Site Number 840352
Beaver, Pennsylvania, United States
Investigational Site Number 840308
Philadelphia, Pennsylvania, United States
Investigational Site Number 840342
Scranton, Pennsylvania, United States
Investigational Site Number 840304
Summerville, South Carolina, United States
Investigational Site Number 840311
Dallas, Texas, United States
Investigational Site Number 840312
Dallas, Texas, United States
Investigational Site Number 840301
Fort Worth, Texas, United States
Investigational Site Number 840343
Bountiful, Utah, United States
Investigational Site Number 840354
Chesapeake, Virginia, United States
Investigational Site Number 840350
Spokane, Washington, United States
Investigational Site Number 032302
Caba, , Argentina
Investigational Site Number 032301
Coronel Suárez, , Argentina
Investigational Site Number 040302
Graz, , Austria
Investigational Site Number 040303
Sankt Stefan, , Austria
Investigational Site Number 040301
Vienna, , Austria
Investigational Site Number 056301
Natoye, , Belgium
Investigational Site Number 100302
Sofia, , Bulgaria
Investigational Site Number 100301
Sofia, , Bulgaria
Investigational Site Number 124303
Chicoutimi, , Canada
Investigational Site Number 124302
Montreal, , Canada
Investigational Site Number 124301
Québec, , Canada
Investigational Site Number 124306
Sherbrooke, , Canada
Investigational Site Number 124305
Toronto, , Canada
Investigational Site Number 124304
Victoria, , Canada
Investigational Site Number 203307
Hradec Králové, , Czechia
Investigational Site Number 203305
Prague, , Czechia
Investigational Site Number 203301
Prague, , Czechia
Investigational Site Number 203303
Prague, , Czechia
Investigational Site Number 203306
Praha 5 - Motol, , Czechia
Investigational Site Number 203309
Trutnov, , Czechia
Investigational Site Number 203304
Uherské Hradiště, , Czechia
Investigational Site Number 203302
Zlín, , Czechia
Investigational Site Number 208301
Aalborg, , Denmark
Investigational Site Number 208306
Aarhus, , Denmark
Investigational Site Number 208302
Esbjerg, , Denmark
Investigational Site Number 208303
Roskilde, , Denmark
Investigational Site Number 208304
Svendborg, , Denmark
Investigational Site Number 246302
Joensuu, , Finland
Investigational Site Number 246301
Kokkola, , Finland
Investigational Site Number 246304
Vantaa, , Finland
Investigational Site Number 250303
Dijon, , France
Investigational Site Number 250304
Lille, , France
Investigational Site Number 250302
Nantes, , France
Investigational Site Number 250301
Paris, , France
Investigational Site Number 250305
Pessac, , France
Investigational Site Number 250306
Rennes, , France
Investigational Site Number 276302
Berlin, , Germany
Investigational Site Number 276305
Frankfurt A.M., , Germany
Investigational Site Number 276306
Leipzig, , Germany
Investigational Site Number 276301
Magdeburg, , Germany
Investigational Site Number 276307
Witten, , Germany
Investigational Site Number 348301
Baja, , Hungary
Investigational Site Number 376302
Holon, , Israel
Investigational Site Number 376304
Jerusalem, , Israel
Investigational Site Number 376303
Safed, , Israel
Investigational Site Number 376301
Tel Litwinsky, , Israel
Investigational Site Number 380302
Chieti, , Italy
Investigational Site Number 380304
Milan, , Italy
Investigational Site Number 380303
Napoli, , Italy
Investigational Site Number 380301
Palermo, , Italy
Investigational Site Number 484301
México, , Mexico
Investigational Site Number 528317
Alkmaar, , Netherlands
Investigational Site Number 528301
Amsterdam-Zuidoost, , Netherlands
Investigational Site Number 528320
Apeldoorn, , Netherlands
Investigational Site Number 528309
Delfzijl, , Netherlands
Investigational Site Number 528313
Eindhoven, , Netherlands
Investigational Site Number 528319
Enschede, , Netherlands
Investigational Site Number 528322
Goes, , Netherlands
Investigational Site Number 528325
Groningen, , Netherlands
Investigational Site Number 528302
Groningen, , Netherlands
Investigational Site Number 528324
Hoogeveen, , Netherlands
Investigational Site Number 528318
Hoorn, , Netherlands
Investigational Site Number 528305
Leiden, , Netherlands
Investigational Site Number 528311
Maastricht, , Netherlands
Investigational Site Number 528312
Nijmegen, , Netherlands
Investigational Site Number 528315
Rotterdam, , Netherlands
Investigational Site Number 528326
Rotterdam, , Netherlands
Investigational Site Number 528303
Utrecht, , Netherlands
Investigational Site Number 528323
Utrecht, , Netherlands
Investigational Site Number 528321
Venlo, , Netherlands
Investigational Site Number 528316
Waalwijk, , Netherlands
Investigational Site Number 578301
Bodø, , Norway
Investigational Site Number 578305
Oslo, , Norway
Investigational Site Number 578304
Oslo, , Norway
Investigational Site Number 620302
Funchal, , Portugal
Investigational Site Number 620301
Lisbon, , Portugal
Investigational Site Number 642302
Timișoara, , Romania
Investigational Site Number 643304
Arkhangelsk, , Russia
Investigational Site Number 643303
Kazan', , Russia
Investigational Site Number 643302
Moscow, , Russia
Investigational Site Number 643308
Moscow, , Russia
Investigational Site Number 643305
Moscow, , Russia
Investigational Site Number 643310
Novosibirsk, , Russia
Investigational Site Number 643301
Saint Petersburg, , Russia
Investigational Site Number 643306
Saint Petersburg, , Russia
Investigational Site Number 643312
Saint Petersburg, , Russia
Investigational Site Number 710311
Bellville, , South Africa
Investigational Site Number 710307
Bloemfontein, , South Africa
Investigational Site Number 710306
Cape Town, , South Africa
Investigational Site Number 710302
Cape Town, , South Africa
Investigational Site Number 710309
Centurion, , South Africa
Investigational Site Number 710312
Parktown, , South Africa
Investigational Site Number 710304
Parow, , South Africa
Investigational Site Number 710313
Pretoria, , South Africa
Investigational Site Number 710303
Pretoria, , South Africa
Investigational Site Number 710305
Pretoria, , South Africa
Investigational Site Number 710314
Pretoria, , South Africa
Investigational Site Number 710315
Roodepoort, , South Africa
Investigational Site Number 710310
Somerset West, , South Africa
Investigational Site Number 710308
Witbank, , South Africa
Investigational Site Number 724303
A Coruña, , Spain
Investigational Site Number 724308
Barcelona, , Spain
Investigational Site Number 724306
Córdoba, , Spain
Investigational Site Number 724312
Granada, , Spain
Investigational Site Number 724307
L'Hospitalet de Llobregat, , Spain
Investigational Site Number 724301
Madrid, , Spain
Investigational Site Number 724309
Madrid, , Spain
Investigational Site Number 724305
Madrid, , Spain
Investigational Site Number 724311
Madrid, , Spain
Investigational Site Number 724314
Málaga, , Spain
Investigational Site Number 724315
Quart de Poblet, , Spain
Investigational Site Number 724310
Sabadell, , Spain
Investigational Site Number 724313
Seville, , Spain
Investigational Site Number 724304
Tarragona, , Spain
Investigational Site Number 724302
Zaragoza, , Spain
Investigational Site Number 752302
Gothenburg, , Sweden
Investigational Site Number 752301
Stockholm, , Sweden
Investigational Site Number 752304
Stockholm, , Sweden
Investigational Site Number 826318
Birmingham, , United Kingdom
Investigational Site Number 826304
Brighton, , United Kingdom
Investigational Site Number 826301
Bristol, , United Kingdom
Investigational Site Number 826311
Cambridge, , United Kingdom
Investigational Site Number 826310
Cardiff, , United Kingdom
Investigational Site Number 826302
Dundee, , United Kingdom
Investigational Site Number 826317
Liverpool, , United Kingdom
Investigational Site Number 826306
Liverpool, , United Kingdom
Investigational Site Number 826312
Manchester, , United Kingdom
Investigational Site Number 826303
Manchester, , United Kingdom
Investigational Site Number 826305
Middlesex, , United Kingdom
Investigational Site Number 826313
Newcastle upon Tyne, , United Kingdom
Investigational Site Number 826309
Reading, , United Kingdom
Investigational Site Number 826315
West Bromwich, , United Kingdom
Investigational Site Number 826316
West Bromwich, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Dufour R, Hovingh GK, Guyton JR, Langslet G, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial. J Clin Lipidol. 2019 Jan-Feb;13(1):138-147. doi: 10.1016/j.jacl.2018.11.007. Epub 2018 Nov 30.
Farnier M, Hovingh GK, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Guyton JR. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis. 2018 Nov;278:307-314. doi: 10.1016/j.atherosclerosis.2018.08.036. Epub 2018 Sep 1.
Hovingh GK, Guyton JR, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Alirocumab dosing patterns during 40 months of open-label treatment in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2018 Nov-Dec;12(6):1463-1470. doi: 10.1016/j.jacl.2018.08.011. Epub 2018 Aug 30.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2013-002572-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1143-3810
Identifier Type: OTHER
Identifier Source: secondary_id
LTS13463
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.