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)

NCT01507831 | Completed Phase 3 Results DMC

• 3 other identifiers: LTS117172011-002806-59U1111-1121-3928
• Study Type: interventional
• Target: 2,341
• Locations: 27 countries
• Sites: 320

Brief Summary

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Experienced Adverse Events (AEs)

  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).

  Up to 10 weeks after last study drug administration (maximum of 86 weeks)

Secondary Outcomes (25)

• Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis

  From Baseline to Week 52

• Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis

  From Baseline to Week 52

• Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

  From Baseline to Week 52

• Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis

  From Baseline to Week 52

• Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis

  From Baseline to Week 52

Other Outcomes (5)

• Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis

  From Baseline to Week 52

• Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis

  From Baseline to Week 52

• Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis

  From Baseline to Week 78

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 78 weeks.

Drug: Placebo (for alirocumab); Drug: Lipid-Modifying Therapy (LMT)

Alirocumab

EXPERIMENTAL

Alirocumab 150 mg Q2W added to stable LMT for 78 weeks.

Drug: Alirocumab; Drug: Lipid-Modifying Therapy (LMT)

Interventions

Placebo (for alirocumab) DRUG

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.

Placebo

Alirocumab DRUG

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.

Also known as: SAR236553, REGN727, Praluent

Alirocumab

Lipid-Modifying Therapy (LMT) DRUG

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Alirocumab; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (320)

Investigational Site Number 840159

Huntsville, Alabama, 35801, United States

Location

Investigational Site Number 840028

Gilbert, Arizona, 85295, United States

Location

Investigational Site Number 840035

Sierra Vista, Arizona, 85635, United States

Location

Investigational Site Number 840052

Tempe, Arizona, 85282, United States

Location

Investigational Site Number 840065

Tempe, Arizona, 85282, United States

Location

Investigational Site Number 840079

Tempe, Arizona, 85282, United States

Location

Investigational Site Number 840094

Tempe, Arizona, 85282, United States

Location

Investigational Site Number 840103

Tucson, Arizona, 85741-3565, United States

Location

Investigational Site Number 840209

Beverly Hills, California, 90210, United States

Location

Investigational Site Number 840194

Beverly Hills, California, 90211, United States

Location

Investigational Site Number 840207

Fresno, California, 93720, United States

Location

Investigational Site Number 840101

Lincoln, California, 95648, United States

Location

Investigational Site Number 840076

Long Beach, California, 90807, United States

Location

Investigational Site Number 840214

Pasadena, California, 91105, United States

Location

Investigational Site Number 840045

Sacramento, California, 95842, United States

Location

Investigational Site Number 840163

Santa Rosa, California, 95405, United States

Location

Investigational Site Number 840086

Colorado Springs, Colorado, 80906, United States

Location

Investigational Site Number 840077

Golden, Colorado, 80401, United States

Location

Investigational Site Number 840224

Bridgeport, Connecticut, 06610, United States

Location

Investigational Site Number 840134

Guilford, Connecticut, 06437, United States

Location

Investigational Site Number 840246

Hartford, Connecticut, 06102, United States

Location

Investigational Site Number 840055

Stamford, Connecticut, 06905, United States

Location

Investigational Site Number 840091

Stamford, Connecticut, 06905, United States

Location

Investigational Site Number 840150

Atlantis, Florida, 33462, United States

Location

Investigational Site Number 840020

Bradenton, Florida, 34208, United States

Location

Investigational Site Number 840041

Brandon, Florida, 33511, United States

Location

Investigational Site Number 840184

Clearwater, Florida, 33756, United States

Location

Investigational Site Number 840242

Clearwater, Florida, 33756, United States

Location

Investigational Site Number 840039

Clearwater, Florida, 33765, United States

Location

Investigational Site Number 840182

Crystal River, Florida, 34429, United States

Location

Investigational Site Number 840002

Daytona Beach, Florida, 32117, United States

Location

Investigational Site Number 840166

Daytona Beach, Florida, 32117, United States

Location

Investigational Site Number 840167

Fleming Island, Florida, 32003, United States

Location

Investigational Site Number 840090

Fort Lauderdale, Florida, 33308, United States

Location

Investigational Site Number 840018

Fort Lauderdale, Florida, 33309, United States

Location

Investigational Site Number 840153

Jacksonville, Florida, 32204, United States

Location

Investigational Site Number 840181

Jacksonville, Florida, 32205, United States

Location

Investigational Site Number 840152

Jacksonville, Florida, 32216, United States

Location

Investigational Site Number 840154

Lake Mary, Florida, 32746, United States

Location

Investigational Site Number 840059

Largo, Florida, 33773, United States

Location

Investigational Site Number 840221

Miami, Florida, 33176, United States

Location

Investigational Site Number 840021

New Port Richey, Florida, 34652, United States

Location

Investigational Site Number 840122

New Smyrna Beach, Florida, 32169, United States

Location

Investigational Site Number 840151

Ocala, Florida, 34471, United States

Location

Investigational Site Number 840108

Ormond Beach, Florida, 32174, United States

Location

Investigational Site Number 840067

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 840006

Pembroke Pines, Florida, 33026, United States

Location

Investigational Site Number 840168

Ponte Vedra, Florida, 32081, United States

Location

Investigational Site Number 840164

Sarasota, Florida, 34239, United States

Location

Investigational Site Number 840175

Sarasota, Florida, 34239, United States

Location

Investigational Site Number 840001

St. Petersburg, Florida, United States

Location

Investigational Site Number 840003

St. Petersburg, Florida, United States

Location

Investigational Site Number 840036

West Palm Beach, Florida, 33401, United States

Location

Investigational Site Number 840117

Cumming, Georgia, 30041, United States

Location

Investigational Site Number 840110

Roswell, Georgia, 30076, United States

Location

Investigational Site Number 840026

Savannah, Georgia, 31405, United States

Location

Investigational Site Number 840075

Meridian, Idaho, 83646, United States

Location

Investigational Site Number 840027

Evansville, Indiana, 47714, United States

Location

Investigational Site Number 840093

Indianapolis, Indiana, 46260, United States

Location

Investigational Site Number 840222

Iowa City, Iowa, 52242, United States

Location

Investigational Site Number 840165

West Des Moines, Iowa, 50266, United States

Location

Investigational Site Number 840200

Kansas City, Kansas, 66160-7321, United States

Location

Investigational Site Number 840040

Wichita, Kansas, 67203, United States

Location

Investigational Site Number 840061

Wichita, Kansas, 67205, United States

Location

Investigational Site Number 840032

Wichita, Kansas, 67207, United States

Location

Investigational Site Number 840084

Wichita, Kansas, 67207, United States

Location

Investigational Site Number 840244

Biddeford, Maine, 04005, United States

Location

Investigational Site Number 840158

Framingham, Maine, 01702, United States

Location

Investigational Site Number 840193

Novi, Michigan, 48374, United States

Location

Investigational Site Number 840162

Saginaw, Michigan, 48604, United States

Location

Investigational Site Number 840033

St Louis, Missouri, 63117, United States

Location

Investigational Site Number 840113

St Louis, Missouri, 63131, United States

Location

Investigational Site Number 840095

Henderson, Nevada, 89052, United States

Location

Investigational Site Number 840096

Henderson, Nevada, 89052, United States

Location

Investigational Site Number 840022

Edison, New Jersey, 08817, United States

Location

Investigational Site Number 840011

Hillsborough, New Jersey, 08844, United States

Location

Investigational Site Number 840049

Trenton, New Jersey, 08611, United States

Location

Investigational Site Number 840097

Bronxville, New York, 10708, United States

Location

Investigational Site Number 840129

Brooklyn, New York, 11215, United States

Location

Investigational Site Number 840160

Poughkeepsie, New York, 12601, United States

Location

Investigational Site Number 840217

Asheville, North Carolina, 28803, United States

Location

Investigational Site Number 840023

Charlotte, North Carolina, 28211, United States

Location

Investigational Site Number 840083

Greensboro, North Carolina, 27408, United States

Location

Investigational Site Number 840104

Raleigh, North Carolina, 27609, United States

Location

Investigational Site Number 840068

Cincinnati, Ohio, 45236, United States

Location

Investigational Site Number 840007

Dayton, Ohio, 45406, United States

Location

Investigational Site Number 840013

Marion, Ohio, 43302, United States

Location

Investigational Site Number 840161

Mentor, Ohio, 44060, United States

Location

Investigational Site Number 840005

Tulsa, Oklahoma, 74136, United States

Location

Investigational Site Number 840170

Beaver, Pennsylvania, 15009, United States

Location

Investigational Site Number 840180

Camp Hill, Pennsylvania, 17011, United States

Location

Investigational Site Number 840004

Duncansville, Pennsylvania, 16635, United States

Location

Investigational Site Number 840046

Jersey Shore, Pennsylvania, 17740, United States

Location

Investigational Site Number 840155

Phoenixville, Pennsylvania, 19460, United States

Location

Investigational Site Number 840177

Scranton, Pennsylvania, 18508, United States

Location

Investigational Site Number 840202

Wyomissing, Pennsylvania, 19610, United States

Location

Investigational Site Number 840073

Charleston, South Carolina, 29485, United States

Location

Investigational Site Number 840087

Greenville, South Carolina, 29615, United States

Location

Investigational Site Number 840074

Simpsonville, South Carolina, 29681, United States

Location

Investigational Site Number 840105

Varnville, South Carolina, 29944, United States

Location

Investigational Site Number 840190

Knoxville, Tennessee, 37917, United States

Location

Investigational Site Number 840092

Dallas, Texas, 75216, United States

Location

Investigational Site Number 840212

Dallas, Texas, 75226, United States

Location

Investigational Site Number 840058

Fort Worth, Texas, 76104, United States

Location

Investigational Site Number 840149

Fort Worth, Texas, 76104, United States

Location

Investigational Site Number 840070

Fort Worth, Texas, 76117, United States

Location

Investigational Site Number 840038

Houston, Texas, 77024, United States

Location

Investigational Site Number 840047

Houston, Texas, 77074, United States

Location

Investigational Site Number 840053

Plano, Texas, 75023, United States

Location

Investigational Site Number 840072

Sugar Land, Texas, 77479, United States

Location

Investigational Site Number 840241

Tyler, Texas, 75701, United States

Location

Investigational Site Number 840031

Salt Lake City, Utah, 84107, United States

Location

Investigational Site Number 840204

Chesapeake, Virginia, 23320, United States

Location

Investigational Site Number 840120

Spokane, Washington, 99204, United States

Location

Investigational Site Number 840111

Milwaukee, Wisconsin, 53209-0996, United States

Location

Investigational Site Number 032006

Buenos Aires, C1425DES, Argentina

Location

Investigational Site Number 032010

Caba, C1440AAD, Argentina

Location

Investigational Site Number 032008

Capital Federal, 1119, Argentina

Location

Investigational Site Number 032001

Coronel Suárez, B7540GHD, Argentina

Location

Investigational Site Number 032004

Resistencia, H3500CDM, Argentina

Location

Investigational Site Number 032007

Zárate, B2800DGH, Argentina

Location

Investigational Site Number 056005

Antwerp, 2020, Belgium

Location

Investigational Site Number 056004

Genk, 3600, Belgium

Location

Investigational Site Number 056001

Natoye, 5360, Belgium

Location

Investigational Site Number 056002

Wetteren, 9230, Belgium

Location

Investigational Site Number 100008

Pleven, 5800, Bulgaria

Location

Investigational Site Number 100014

Plovdiv, 4000, Bulgaria

Location

Investigational Site Number 100005

Sofia, 1203, Bulgaria

Location

Investigational Site Number 100012

Sofia, 1233, Bulgaria

Location

Investigational Site Number 100015

Sofia, 1233, Bulgaria

Location

Investigational Site Number 100009

Sofia, 1527, Bulgaria

Location

Investigational Site Number 100001

Sofia, 1606, Bulgaria

Location

Investigational Site Number 100013

Stara Zagora, 6000, Bulgaria

Location

Investigational Site Number 100007

Varna, 9010, Bulgaria

Location

Investigational Site Number 124013

Cambridge, N1R 6V6, Canada

Location

Investigational Site Number 124027

Coquitlam, V3K 3P4, Canada

Location

Investigational Site Number 124001

Hawkesbury, K6A 1A1, Canada

Location

Investigational Site Number 124002

London, N5W 6A2, Canada

Location

Investigational Site Number 124009

Mirabel, J7J 2K8, Canada

Location

Investigational Site Number 124018

Montreal, H1T 3Y7, Canada

Location

Investigational Site Number 124007

Ottawa, K1K 4L2, Canada

Location

Investigational Site Number 124011

Québec, G1V 4M6, Canada

Location

Investigational Site Number 124008

Sarnia, N7T 4X3, Canada

Location

Investigational Site Number 124005

St. John's, A1A 3R5, Canada

Location

Investigational Site Number 124022

Terrebonne, J6V 1S8, Canada

Location

Investigational Site Number 124003

Vancouver, V5Z 1M9, Canada

Location

Investigational Site Number 124006

Victoria, V8T 5G4, Canada

Location

Investigational Site Number 124015

Woodstock, N4S 5P5, Canada

Location

Investigational Site Number 152007

Osorno, 5311092, Chile

Location

Investigational Site Number 152008

Santiago, 7980378, Chile

Location

Investigational Site Number 152006

Santiago, 8053095, Chile

Location

Investigational Site Number 152004

Temuco, 4790869, Chile

Location

Investigational Site Number 170004

Barranquilla, Colombia

Location

Investigational Site Number 170005

Barranquilla, Colombia

Location

Investigational Site Number 170008

Barranquilla, Colombia

Location

Investigational Site Number 170001

Manizales, Colombia

Location

Investigational Site Number 170003

Medellín, Colombia

Location

Investigational Site Number 203004

Prague, 128 08, Czechia

Location

Investigational Site Number 203007

Prague, 15006, Czechia

Location

Investigational Site Number 203006

Prague, 15800, Czechia

Location

Investigational Site Number 208005

Aarhus, 8200, Denmark

Location

Investigational Site Number 208004

Hellerup, 2900, Denmark

Location

Investigational Site Number 208003

Slagelse, 4200, Denmark

Location

Investigational Site Number 208001

Svendborg, 5700, Denmark

Location

Investigational Site Number 208002

Viborg, 8800, Denmark

Location

Investigational Site Number 246002

Joensuu, 80100, Finland

Location

Investigational Site Number 246001

Kokkola, 67100, Finland

Location

Investigational Site Number 246003

Kuopio, 70210, Finland

Location

Investigational Site Number 246004

Vantaa, 01600, Finland

Location

Investigational Site Number 250007

Bandol, 83150, France

Location

Investigational Site Number 250003

Broglie, 27270, France

Location

Investigational Site Number 250014

Bron, 69677, France

Location

Investigational Site Number 250004

Dijon, 21000, France

Location

Investigational Site Number 250006

Lille, 59037, France

Location

Investigational Site Number 250009

Nantes, 44093, France

Location

Investigational Site Number 250001

Nantes, 44300, France

Location

Investigational Site Number 250002

Paris, 75651, France

Location

Investigational Site Number 250010

Pessac, 33604, France

Location

Investigational Site Number 250012

Rennes, 35033, France

Location

Investigational Site Number 250005

Vieux-Condé, 59690, France

Location

Investigational Site Number 250008

Vihiers, 49310, France

Location

Investigational Site Number 276001

Bad Wörishofen, 86825, Germany

Location

Investigational Site Number 276007

Berlin, 12627, Germany

Location

Investigational Site Number 276005

Berlin, 13125, Germany

Location

Investigational Site Number 276014

Berlin, 13158, Germany

Location

Investigational Site Number 276008

Bochum, 44787, Germany

Location

Investigational Site Number 276009

Dresden, 01067, Germany

Location

Investigational Site Number 276004

Essen, 45355, Germany

Location

Investigational Site Number 276010

Frankfurt A.M., 60596, Germany

Location

Investigational Site Number 276011

Görlitz, 02826, Germany

Location

Investigational Site Number 276019

Hanover, 30159, Germany

Location

Investigational Site Number 276013

Leipzig, 04103, Germany

Location

Investigational Site Number 276012

Magdeburg, 39104, Germany

Location

Investigational Site Number 276003

Magdeburg, 39120, Germany

Location

Investigational Site Number 276006

Schwerin, 19055, Germany

Location

Investigational Site Number 276015

Witten, 58455, Germany

Location

Investigational Site Number 348003

Baja, 6500, Hungary

Location

Investigational Site Number 348007

Budapest, 1036, Hungary

Location

Investigational Site Number 348009

Budapest, 1036, Hungary

Location

Investigational Site Number 348008

Budapest, 1135, Hungary

Location

Investigational Site Number 348013

Budapest, 1136, Hungary

Location

Investigational Site Number 348004

Debrecen, 4032, Hungary

Location

Investigational Site Number 348002

Nagykanizsa, 8800, Hungary

Location

Investigational Site Number 348006

Nyíregyháza, 4400, Hungary

Location

Investigational Site Number 348001

Sopron, 9400, Hungary

Location

Investigational Site Number 348011

Úrhida, 8142, Hungary

Location

Investigational Site Number 376002

Afula, 18101, Israel

Location

Investigational Site Number 376003

Holon, 58100, Israel

Location

Investigational Site Number 376005

Holon, 58100, Israel

Location

Investigational Site Number 376004

Nazareth, 16100, Israel

Location

Investigational Site Number 380006

Chieti, 66013, Italy

Location

Investigational Site Number 380002

Cinisello Balsamo, 20092, Italy

Location

Investigational Site Number 380009

Milan, 20138, Italy

Location

Investigational Site Number 380007

Napoli, 80131, Italy

Location

Investigational Site Number 380001

Palermo, 90127, Italy

Location

Investigational Site Number 380005

Pozzilli, 86077, Italy

Location

Investigational Site Number 380008

Vittorio Veneto, 31029, Italy

Location

Investigational Site Number 380010

Zingonia-Osio Sotto, Italy

Location

Investigational Site Number 484010

Df, 03300, Mexico

Location

Investigational Site Number 484004

México, 06090, Mexico

Location

Investigational Site Number 484008

Not Provided, Mexico

Location

Investigational Site Number 484001

San Luis Potosí City, 78200, Mexico

Location

Investigational Site Number 484002

Tijuana, 22500, Mexico

Location

Investigational Site Number 484009

Torreón, 27000, Mexico

Location

Investigational Site Number 484003

Xalapa, 91020, Mexico

Location

Investigational Site Number 528013

Amsterdam, 1091 AC, Netherlands

Location

Investigational Site Number 528001

Amsterdam, 1105 AZ, Netherlands

Location

Investigational Site Number 528004

Breda, 4811 SW, Netherlands

Location

Investigational Site Number 528005

Eindhoven, 5616GB, Netherlands

Location

Investigational Site Number 528007

Groningen, 9711 SG, Netherlands

Location

Investigational Site Number 528011

Hoogeveen, 7909 AA, Netherlands

Location

Investigational Site Number 528002

Hoorn, 1625 HV, Netherlands

Location

Investigational Site Number 528008

Leiderdorp, 2352 RA, Netherlands

Location

Investigational Site Number 528009

Rotterdam, 3021 HC, Netherlands

Location

Investigational Site Number 528006

Velp, 6883 ES, Netherlands

Location

Investigational Site Number 528012

Venlo, 5912 BL, Netherlands

Location

Investigational Site Number 528010

Zoetermeer, 2724 EK, Netherlands

Location

Investigational Site Number 578005

Elverum, 2402, Norway

Location

Investigational Site Number 578001

Hamar, 2317, Norway

Location

Investigational Site Number 578002

Oslo, Norway

Location

Investigational Site Number 578004

Skedsmokorset, 2020, Norway

Location

Investigational Site Number 578003

Stavanger, 4005, Norway

Location

Investigational Site Number 616008

Gdynia, 81-384, Poland

Location

Investigational Site Number 616003

Gdynia, 81423, Poland

Location

Investigational Site Number 616001

Gniewkowo, 88-140, Poland

Location

Investigational Site Number 616010

Katowice, 40-748, Poland

Location

Investigational Site Number 616018

Krakow, 31-315, Poland

Location

Investigational Site Number 616004

Piotrkow Trybunalski, 97-300, Poland

Location

Investigational Site Number 616013

Puławy, 24-100, Poland

Location

Investigational Site Number 616009

Warsaw, 02-777, Poland

Location

Investigational Site Number 616007

Wroclaw, 50-088, Poland

Location

Investigational Site Number 620006

Funchal / Madeira, 9050, Portugal

Location

Investigational Site Number 620002

Lisbon, 1169-024, Portugal

Location

Investigational Site Number 620001

Lisbon, 1549-008, Portugal

Location

Investigational Site Number 620005

Porto, 4200-319, Portugal

Location

Investigational Site Number 642005

Baia Mare, 430031, Romania

Location

Investigational Site Number 642002

Brasov, 500283, Romania

Location

Investigational Site Number 642004

Târgu Mureş, 540099, Romania

Location

Investigational Site Number 642001

Timișoara, 300358, Romania

Location

Investigational Site Number 643005

Barnaul, Russia

Location

Investigational Site Number 643012

Moscow, 119415, Russia

Location

Investigational Site Number 643008

Moscow, 125284, Russia

Location

Investigational Site Number 643014

Perm, 614097, Russia

Location

Investigational Site Number 643006

Saint Petersburg, 196084, Russia

Location

Investigational Site Number 643009

Saint Petersburg, 196084, Russia

Location

Investigational Site Number 643004

Yaroslavl, 150002, Russia

Location

Investigational Site Number 710010

Centurion, 0158, South Africa

Location

Investigational Site Number 710008

Meyerspark, 0184, South Africa

Location

Investigational Site Number 710011

Middelburg, 1055, South Africa

Location

Investigational Site Number 710006

Parktown, 2193, South Africa

Location

Investigational Site Number 710004

Pretoria, 0002, South Africa

Location

Investigational Site Number 710001

Pretoria, 0084, South Africa

Location

Investigational Site Number 710002

Pretoria, 181, South Africa

Location

Investigational Site Number 710009

Roodepoort, 1724, South Africa

Location

Investigational Site Number 710003

Somerset West, 7130, South Africa

Location

Investigational Site Number 710005

Witbank, South Africa

Location

Investigational Site Number 710007

Worcester, 6850, South Africa

Location

Investigational Site Number 724006

Córdoba, 14004, Spain

Location

Investigational Site Number 724003

Granada, 18012, Spain

Location

Investigational Site Number 724002

Madrid, 28040, Spain

Location

Investigational Site Number 724007

Málaga, 29010, Spain

Location

Investigational Site Number 724008

Quart de Poblet, 46930, Spain

Location

Investigational Site Number 724005

Reus, 43201, Spain

Location

Investigational Site Number 724001

Sabadell, 08208, Spain

Location

Investigational Site Number 724004

Seville, 41013, Spain

Location

Investigational Site Number 752001

Örebro, 70146, Sweden

Location

Investigational Site Number 752002

Rättvik, 79530, Sweden

Location

Investigational Site Number 752006

Stockholm, 111 35, Sweden

Location

Investigational Site Number 752003

Stockholm, 111 57, Sweden

Location

Investigational Site Number 752004

Stockholm, 14186, Sweden

Location

Investigational Site Number 804012

Chernivtsi, 58013, Ukraine

Location

Investigational Site Number 804003

Dnipropetrovsk, 49006, Ukraine

Location

Investigational Site Number 804002

Donetsk, 83114, Ukraine

Location

Investigational Site Number 804014

Kharkiv, 61002, Ukraine

Location

Investigational Site Number 804016

Kiev, 02091, Ukraine

Location

Investigational Site Number 804011

Kyiv, 01103, Ukraine

Location

Investigational Site Number 804010

Kyiv, 03115, Ukraine

Location

Investigational Site Number 804001

Kyiv, 03680, Ukraine

Location

Investigational Site Number 804008

Kyiv, 04053, Ukraine

Location

Investigational Site Number 804013

Kyiv, Ukraine

Location

Investigational Site Number 804005

Zhytomyr, 10002, Ukraine

Location

Investigational Site Number 826004

Addlestone, KT15 2BH, United Kingdom

Location

Investigational Site Number 826009

Birmingham, B15 2SQ, United Kingdom

Location

Investigational Site Number 826016

Birmingham, B18 7QH, United Kingdom

Location

Investigational Site Number 826021

Blackpool, FY3 7EN, United Kingdom

Location

Investigational Site Number 826023

Cambridge, CB2 OQQ, United Kingdom

Location

Investigational Site Number 826012

Cardiff, CF14 5GJ, United Kingdom

Location

Investigational Site Number 826024

Chichester, PO19 4SE, United Kingdom

Location

Investigational Site Number 826006

Chorley, PR7 7NA, United Kingdom

Location

Investigational Site Number 826010

Glasgow, G20 0SP, United Kingdom

Location

Investigational Site Number 826003

Irvine, KA12 0AY, United Kingdom

Location

Investigational Site Number 826008

Liverpool, L22 0LG, United Kingdom

Location

Investigational Site Number 826005

Liverpool, L7 8XP, United Kingdom

Location

Investigational Site Number 826025

Manchester, M13 9WL, United Kingdom

Location

Investigational Site Number 826007

Manchester, M15 6SX, United Kingdom

Location

Investigational Site Number 826001

Middlesex, HA6 2RN, United Kingdom

Location

Investigational Site Number 826019

Penzance, TR19 7HH, United Kingdom

Location

Investigational Site Number 826011

Reading, RG2 7AG, United Kingdom

Location

Investigational Site Number 826013

Romford, RM7 0AG, United Kingdom

Location

Investigational Site Number 826014

Soham, CB7 5JD, United Kingdom

Location

Related Publications (6)

• Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, Stroes ES, Langslet G, Raal FJ, El Shahawy M, Koren MJ, Lepor NE, Lorenzato C, Pordy R, Chaudhari U, Kastelein JJ; ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99. doi: 10.1056/NEJMoa1501031. Epub 2015 Mar 15.

  PMID: 25773378 RESULT

• Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

  PMID: 34298554 DERIVED

• Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

  PMID: 30183102 DERIVED

• Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4.

  PMID: 28964736 DERIVED

• Kastelein JJ, Hovingh GK, Langslet G, Baccara-Dinet MT, Gipe DA, Chaudhari U, Zhao J, Minini P, Farnier M. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Jan-Feb;11(1):195-203.e4. doi: 10.1016/j.jacl.2016.12.004. Epub 2016 Dec 28.

  PMID: 28391886 DERIVED

• Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.

  PMID: 27777279 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

alirocumab

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

Manual reclassification was done by the Sponsor for the "other reasons" of non-completion of study as specified in the electronic case report (eCRF) form.

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 11, 2012
• Study Start: January 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 22, 2015
• Results First Posted: December 22, 2015

Record last verified: 2015-11

Locations

FI (4); AR (6); US (115); CL (4); BU (9); BE (4); DK (5); DE (15); IT (8); ZA (11); ME (7); ES (8); SE (5); FR (12); CZ (3); NL (12); NO (5); HU (10); PL (9); CA (14); PT (4); RO (4); RU (7); UA (11); GB (19); IL (4); CO (5)