Clinical trial NCT01507831: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-01-11
Enrollment: 2341
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Percentage of Participants Who Experienced Adverse Events (AEs)
timeFrame: Up to 10 weeks after last study drug administration (maximum of 86 weeks)
Secondary outcomes:
measure: Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Measured LDL-C at Week 24 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: 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
timeFrame: Up to Week 52
measure: 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
timeFrame: Up to Week 52
measure: Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
timeFrame: Up to Week 52
measure: Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
timeFrame: Up to Week 52
measure: Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Apo A1 at Week 24 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Apo A1 at Week 12 - ITT Analysis
timeFrame: From Baseline to Week 52
Other outcomes:
measure: Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis
timeFrame: From Baseline to Week 52
measure: Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis
timeFrame: From Baseline to Week 78
measure: Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis
timeFrame: From Baseline to Week 78
measure: Percentage of Participants Who Experienced Cardiovascular (CV) Events
timeFrame: Up to 10 weeks after last study drug administration (maximum of 86 weeks)
Locations:
city: Huntsville
country: United States
facility: Investigational Site Number 840159
state: Alabama
city: Gilbert
country: United States
facility: Investigational Site Number 840028
state: Arizona
city: Sierra Vista
country: United States
facility: Investigational Site Number 840035
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840052
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840065
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840079
state: Arizona
city: Tempe
country: United States
facility: Investigational Site Number 840094
state: Arizona
city: Tucson
country: United States
facility: Investigational Site Number 840103
state: Arizona
city: Beverly Hills
country: United States
facility: Investigational Site Number 840209
state: California
city: Beverly Hills
country: United States
facility: Investigational Site Number 840194
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840207
state: California
city: Lincoln
country: United States
facility: Investigational Site Number 840101
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840076
state: California
city: Pasadena
country: United States
facility: Investigational Site Number 840214
state: California
city: Sacramento
country: United States
facility: Investigational Site Number 840045
state: California
city: Santa Rosa
country: United States
facility: Investigational Site Number 840163
state: California
city: Colorado Springs
country: United States
facility: Investigational Site Number 840086
state: Colorado
city: Golden
country: United States
facility: Investigational Site Number 840077
state: Colorado
city: Bridgeport
country: United States
facility: Investigational Site Number 840224
state: Connecticut
city: Guilford
country: United States
facility: Investigational Site Number 840134
state: Connecticut
city: Hartford
country: United States
facility: Investigational Site Number 840246
state: Connecticut
city: Stamford
country: United States
facility: Investigational Site Number 840055
state: Connecticut
city: Stamford
country: United States
facility: Investigational Site Number 840091
state: Connecticut
city: Atlantis
country: United States
facility: Investigational Site Number 840150
state: Florida
city: Bradenton
country: United States
facility: Investigational Site Number 840020
state: Florida
city: Brandon
country: United States
facility: Investigational Site Number 840041
state: Florida
city: Clearwater
country: United States
facility: Investigational Site Number 840184
state: Florida
city: Clearwater
country: United States
facility: Investigational Site Number 840242
state: Florida
city: Clearwater
country: United States
facility: Investigational Site Number 840039
state: Florida
city: Crystal River
country: United States
facility: Investigational Site Number 840182
state: Florida
city: Daytona Beach
country: United States
facility: Investigational Site Number 840002
state: Florida
city: Daytona Beach
country: United States
facility: Investigational Site Number 840166
state: Florida
city: Fleming Island
country: United States
facility: Investigational Site Number 840167
state: Florida
city: Fort Lauderdale
country: United States
facility: Investigational Site Number 840018
state: Florida
city: Ft. Lauderdale
country: United States
facility: Investigational Site Number 840090
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840153
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840181
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840152
state: Florida
city: Lake Mary
country: United States
facility: Investigational Site Number 840154
state: Florida
city: Largo
country: United States
facility: Investigational Site Number 840059
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840221
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 840021
state: Florida
city: New Smyrna Beach
country: United States
facility: Investigational Site Number 840122
state: Florida
city: Ocala
country: United States
facility: Investigational Site Number 840151
state: Florida
city: Ormond Beach
country: United States
facility: Investigational Site Number 840108
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840067
state: Florida
city: Pembroke Pines
country: United States
facility: Investigational Site Number 840006
state: Florida
city: Ponte Vedra
country: United States
facility: Investigational Site Number 840168
state: Florida
city: Sarasota
country: United States
facility: Investigational Site Number 840164
state: Florida
city: Sarasota
country: United States
facility: Investigational Site Number 840175
state: Florida
city: St. Petersburg
country: United States
facility: Investigational Site Number 840001
state: Florida
city: St. Petersburg
country: United States
facility: Investigational Site Number 840003
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site Number 840036
state: Florida
city: Cumming
country: United States
facility: Investigational Site Number 840117
state: Georgia
city: Roswell
country: United States
facility: Investigational Site Number 840110
state: Georgia
city: Savannah
country: United States
facility: Investigational Site Number 840026
state: Georgia
city: Meridian
country: United States
facility: Investigational Site Number 840075
state: Idaho
city: Evansville
country: United States
facility: Investigational Site Number 840027
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site Number 840093
state: Indiana
city: Iowa City
country: United States
facility: Investigational Site Number 840222
state: Iowa
city: West Des Moines
country: United States
facility: Investigational Site Number 840165
state: Iowa
city: Kansas City
country: United States
facility: Investigational Site Number 840200
state: Kansas
city: Wichita
country: United States
facility: Investigational Site Number 840040
state: Kansas
city: Wichita
country: United States
facility: Investigational Site Number 840061
state: Kansas
city: Wichita
country: United States
facility: Investigational Site Number 840032
state: Kansas
city: Wichita
country: United States
facility: Investigational Site Number 840084
state: Kansas
city: Biddeford
country: United States
facility: Investigational Site Number 840244
state: Maine
city: Framingham
country: United States
facility: Investigational Site Number 840158
state: Maine
city: Novi
country: United States
facility: Investigational Site Number 840193
state: Michigan
city: Saginaw
country: United States
facility: Investigational Site Number 840162
state: Michigan
city: Saint Louis
country: United States
facility: Investigational Site Number 840033
state: Missouri
city: St. Louis
country: United States
facility: Investigational Site Number 840113
state: Missouri
city: Henderson
country: United States
facility: Investigational Site Number 840095
state: Nevada
city: Henderson
country: United States
facility: Investigational Site Number 840096
state: Nevada
city: Edison
country: United States
facility: Investigational Site Number 840022
state: New Jersey
city: Hillsborough
country: United States
facility: Investigational Site Number 840011
state: New Jersey
city: Trenton
country: United States
facility: Investigational Site Number 840049
state: New Jersey
city: Bronxville
country: United States
facility: Investigational Site Number 840097
state: New York
city: Brooklyn
country: United States
facility: Investigational Site Number 840129
state: New York
city: Poughkeepsie
country: United States
facility: Investigational Site Number 840160
state: New York
city: Asheville
country: United States
facility: Investigational Site Number 840217
state: North Carolina
city: Charlotte
country: United States
facility: Investigational Site Number 840023
state: North Carolina
city: Greensboro
country: United States
facility: Investigational Site Number 840083
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site Number 840104
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site Number 840068
state: Ohio
city: Dayton
country: United States
facility: Investigational Site Number 840007
state: Ohio
city: Marion
country: United States
facility: Investigational Site Number 840013
state: Ohio
city: Mentor
country: United States
facility: Investigational Site Number 840161
state: Ohio
city: Tulsa
country: United States
facility: Investigational Site Number 840005
state: Oklahoma
city: Beaver
country: United States
facility: Investigational Site Number 840170
state: Pennsylvania
city: Camp Hill
country: United States
facility: Investigational Site Number 840180
state: Pennsylvania
city: Duncansville
country: United States
facility: Investigational Site Number 840004
state: Pennsylvania
city: Jersey Shore
country: United States
facility: Investigational Site Number 840046
state: Pennsylvania
city: Phoenixville
country: United States
facility: Investigational Site Number 840155
state: Pennsylvania
city: Scranton
country: United States
facility: Investigational Site Number 840177
state: Pennsylvania
city: Wyomissing
country: United States
facility: Investigational Site Number 840202
state: Pennsylvania
city: Charleston
country: United States
facility: Investigational Site Number 840073
state: South Carolina
city: Greenville
country: United States
facility: Investigational Site Number 840087
state: South Carolina
city: Simpsonville
country: United States
facility: Investigational Site Number 840074
state: South Carolina
city: Varnville
country: United States
facility: Investigational Site Number 840105
state: South Carolina
city: Knoxville
country: United States
facility: Investigational Site Number 840190
state: Tennessee
city: Dallas
country: United States
facility: Investigational Site Number 840092
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840212
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840058
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840149
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840070
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840038
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840047
state: Texas
city: Plano
country: United States
facility: Investigational Site Number 840053
state: Texas
city: Sugar Land
country: United States
facility: Investigational Site Number 840072
state: Texas
city: Tyler
country: United States
facility: Investigational Site Number 840241
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Site Number 840031
state: Utah
city: Chesapeake
country: United States
facility: Investigational Site Number 840204
state: Virginia
city: Spokane
country: United States
facility: Investigational Site Number 840120
state: Washington
city: Milwaukee
country: United States
facility: Investigational Site Number 840111
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032006
city: Caba
country: Argentina
facility: Investigational Site Number 032010
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032008
city: Coronel Suarez
country: Argentina
facility: Investigational Site Number 032001
city: Resistencia
country: Argentina
facility: Investigational Site Number 032004
city: Zarate
country: Argentina
facility: Investigational Site Number 032007
city: Antwerpen
country: Belgium
facility: Investigational Site Number 056005
city: Genk
country: Belgium
facility: Investigational Site Number 056004
city: Natoye
country: Belgium
facility: Investigational Site Number 056001
city: Wetteren
country: Belgium
facility: Investigational Site Number 056002
city: Pleven
country: Bulgaria
facility: Investigational Site Number 100008
city: Plovdiv
country: Bulgaria
facility: Investigational Site Number 100014
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100005
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100012
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100015
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100009
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100001
city: Stara Zagora
country: Bulgaria
facility: Investigational Site Number 100013
city: Varna
country: Bulgaria
facility: Investigational Site Number 100007
city: Cambridge
country: Canada
facility: Investigational Site Number 124013
city: Coquitlam
country: Canada
facility: Investigational Site Number 124027
city: Hawkesbury
country: Canada
facility: Investigational Site Number 124001
city: London
country: Canada
facility: Investigational Site Number 124002
city: Mirabel
country: Canada
facility: Investigational Site Number 124009
city: Montreal
country: Canada
facility: Investigational Site Number 124018
city: Ottawa
country: Canada
facility: Investigational Site Number 124007
city: Quebec
country: Canada
facility: Investigational Site Number 124011
city: Saint John'S
country: Canada
facility: Investigational Site Number 124005
city: Sarnia
country: Canada
facility: Investigational Site Number 124008
city: Terrebonne
country: Canada
facility: Investigational Site Number 124022
city: Vancouver
country: Canada
facility: Investigational Site Number 124003
city: Victoria
country: Canada
facility: Investigational Site Number 124006
city: Woodstock
country: Canada
facility: Investigational Site Number 124015
city: Osorno
country: Chile
facility: Investigational Site Number 152007
city: Santiago
country: Chile
facility: Investigational Site Number 152008
city: Santiago
country: Chile
facility: Investigational Site Number 152006
city: Temuco
country: Chile
facility: Investigational Site Number 152004
city: Barranquilla
country: Colombia
facility: Investigational Site Number 170004
city: Barranquilla
country: Colombia
facility: Investigational Site Number 170005
city: Barranquilla
country: Colombia
facility: Investigational Site Number 170008
city: Manizales
country: Colombia
facility: Investigational Site Number 170001
city: Medellin
country: Colombia
facility: Investigational Site Number 170003
city: Praha 2
country: Czech Republic
facility: Investigational Site Number 203004
city: Praha 5
country: Czech Republic
facility: Investigational Site Number 203007
city: Praha 5
country: Czech Republic
facility: Investigational Site Number 203006
city: Aarhus
country: Denmark
facility: Investigational Site Number 208005
city: Hellerup
country: Denmark
facility: Investigational Site Number 208004
city: Slagelse
country: Denmark
facility: Investigational Site Number 208003
city: Svendborg
country: Denmark
facility: Investigational Site Number 208001
city: Viborg
country: Denmark
facility: Investigational Site Number 208002
city: Joensuu
country: Finland
facility: Investigational Site Number 246002
city: Kokkola
country: Finland
facility: Investigational Site Number 246001
city: Kuopio
country: Finland
facility: Investigational Site Number 246003
city: Vantaa
country: Finland
facility: Investigational Site Number 246004
city: Bandol
country: France
facility: Investigational Site Number 250007
city: Broglie
country: France
facility: Investigational Site Number 250003
city: Bron Cedex
country: France
facility: Investigational Site Number 250014
city: Dijon
country: France
facility: Investigational Site Number 250004
city: Lille Cedex
country: France
facility: Investigational Site Number 250006
city: Nantes
country: France
facility: Investigational Site Number 250009
city: Nantes
country: France
facility: Investigational Site Number 250001
city: Paris Cedex 13
country: France
facility: Investigational Site Number 250002
city: Pessac
country: France
facility: Investigational Site Number 250010
city: Rennes
country: France
facility: Investigational Site Number 250012
city: Vieux Conde
country: France
facility: Investigational Site Number 250005
city: Vihiers
country: France
facility: Investigational Site Number 250008
city: Bad Wörishofen
country: Germany
facility: Investigational Site Number 276001
city: Berlin
country: Germany
facility: Investigational Site Number 276007
city: Berlin
country: Germany
facility: Investigational Site Number 276005
city: Berlin
country: Germany
facility: Investigational Site Number 276014
city: Bochum
country: Germany
facility: Investigational Site Number 276008
city: Dresden
country: Germany
facility: Investigational Site Number 276009
city: Essen
country: Germany
facility: Investigational Site Number 276004
city: Frankfurt A.M.
country: Germany
facility: Investigational Site Number 276010
city: Görlitz
country: Germany
facility: Investigational Site Number 276011
city: Hannover
country: Germany
facility: Investigational Site Number 276019
city: Leipzig
country: Germany
facility: Investigational Site Number 276013
city: Magdeburg
country: Germany
facility: Investigational Site Number 276012
city: Magdeburg
country: Germany
facility: Investigational Site Number 276003
city: Schwerin
country: Germany
facility: Investigational Site Number 276006
city: Witten
country: Germany
facility: Investigational Site Number 276015
city: Baja
country: Hungary
facility: Investigational Site Number 348003
city: Budapest
country: Hungary
facility: Investigational Site Number 348007
city: Budapest
country: Hungary
facility: Investigational Site Number 348009
city: Budapest
country: Hungary
facility: Investigational Site Number 348008
city: Budapest
country: Hungary
facility: Investigational Site Number 348013
city: Debrecen
country: Hungary
facility: Investigational Site Number 348004
city: Nagykanizsa
country: Hungary
facility: Investigational Site Number 348002
city: Nyiregyhaza
country: Hungary
facility: Investigational Site Number 348006
city: Sopron
country: Hungary
facility: Investigational Site Number 348001
city: Urhida
country: Hungary
facility: Investigational Site Number 348011
city: Afula
country: Israel
facility: Investigational Site Number 376002
city: Holon
country: Israel
facility: Investigational Site Number 376003
city: Holon
country: Israel
facility: Investigational Site Number 376005
city: Nazareth
country: Israel
facility: Investigational Site Number 376004
city: Chieti
country: Italy
facility: Investigational Site Number 380006
city: Cinisello Balsamo
country: Italy
facility: Investigational Site Number 380002
city: Milano
country: Italy
facility: Investigational Site Number 380009
city: Napoli
country: Italy
facility: Investigational Site Number 380007
city: Palermo
country: Italy
facility: Investigational Site Number 380001
city: Pozzilli
country: Italy
facility: Investigational Site Number 380005
city: Vittorio Veneto
country: Italy
facility: Investigational Site Number 380008
city: Zingonia-Osio Sotto
country: Italy
facility: Investigational Site Number 380010
city: Df
country: Mexico
facility: Investigational Site Number 484010
city: Mexico
country: Mexico
facility: Investigational Site Number 484004
city: Not Provided
country: Mexico
facility: Investigational Site Number 484008
city: San Luis Potosi
country: Mexico
facility: Investigational Site Number 484001
city: Tijuana
country: Mexico
facility: Investigational Site Number 484002
city: Torreon
country: Mexico
facility: Investigational Site Number 484009
city: Xalapa
country: Mexico
facility: Investigational Site Number 484003
city: Amsterdam
country: Netherlands
facility: Investigational Site Number 528013
city: Amsterdam
country: Netherlands
facility: Investigational Site Number 528001
city: Breda
country: Netherlands
facility: Investigational Site Number 528004
city: Eindhoven
country: Netherlands
facility: Investigational Site Number 528005
city: Groningen
country: Netherlands
facility: Investigational Site Number 528007
city: Hoogeveen
country: Netherlands
facility: Investigational Site Number 528011
city: Hoorn
country: Netherlands
facility: Investigational Site Number 528002
city: Leiderdorp
country: Netherlands
facility: Investigational Site Number 528008
city: Rotterdam
country: Netherlands
facility: Investigational Site Number 528009
city: Velp
country: Netherlands
facility: Investigational Site Number 528006
city: Venlo
country: Netherlands
facility: Investigational Site Number 528012
city: Zoetermeer
country: Netherlands
facility: Investigational Site Number 528010
city: Elverum
country: Norway
facility: Investigational Site Number 578005
city: Hamar
country: Norway
facility: Investigational Site Number 578001
city: Oslo
country: Norway
facility: Investigational Site Number 578002
city: Skedsmokorset
country: Norway
facility: Investigational Site Number 578004
city: Stavanger
country: Norway
facility: Investigational Site Number 578003
city: Gdynia
country: Poland
facility: Investigational Site Number 616008
city: Gdynia
country: Poland
facility: Investigational Site Number 616003
city: Gniewkowo
country: Poland
facility: Investigational Site Number 616001
city: Katowice
country: Poland
facility: Investigational Site Number 616010
city: Krakow
country: Poland
facility: Investigational Site Number 616018
city: Piotrkow Trybunalski
country: Poland
facility: Investigational Site Number 616004
city: Pulawy
country: Poland
facility: Investigational Site Number 616013
city: Warszawa
country: Poland
facility: Investigational Site Number 616009
city: Wroclaw
country: Poland
facility: Investigational Site Number 616007
city: Funchal / Madeira
country: Portugal
facility: Investigational Site Number 620006
city: Lisboa
country: Portugal
facility: Investigational Site Number 620002
city: Lisboa
country: Portugal
facility: Investigational Site Number 620001
city: Porto
country: Portugal
facility: Investigational Site Number 620005
city: Baia Mare
country: Romania
facility: Investigational Site Number 642005
city: Brasov
country: Romania
facility: Investigational Site Number 642002
city: Targu Mures
country: Romania
facility: Investigational Site Number 642004
city: Timisoara
country: Romania
facility: Investigational Site Number 642001
city: Barnaul
country: Russian Federation
facility: Investigational Site Number 643005
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643012
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643008
city: Perm
country: Russian Federation
facility: Investigational Site Number 643014
city: St Petersburg
country: Russian Federation
facility: Investigational Site Number 643006
city: St.Petersburg
country: Russian Federation
facility: Investigational Site Number 643009
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 643004
city: Centurion
country: South Africa
facility: Investigational Site Number 710010
city: Meyerspark
country: South Africa
facility: Investigational Site Number 710008
city: Middelburg
country: South Africa
facility: Investigational Site Number 710011
city: Parktown
country: South Africa
facility: Investigational Site Number 710006
city: Pretoria
country: South Africa
facility: Investigational Site Number 710004
city: Pretoria
country: South Africa
facility: Investigational Site Number 710001
city: Pretoria
country: South Africa
facility: Investigational Site Number 710002
city: Roodepoort
country: South Africa
facility: Investigational Site Number 710009
city: Somerset West
country: South Africa
facility: Investigational Site Number 710003
city: Witbank
country: South Africa
facility: Investigational Site Number 710005
city: Worcester
country: South Africa
facility: Investigational Site Number 710007
city: Córdoba
country: Spain
facility: Investigational Site Number 724006
city: Granada
country: Spain
facility: Investigational Site Number 724003
city: Madrid
country: Spain
facility: Investigational Site Number 724002
city: Málaga
country: Spain
facility: Investigational Site Number 724007
city: Quart De Poblet
country: Spain
facility: Investigational Site Number 724008
city: Reus
country: Spain
facility: Investigational Site Number 724005
city: Sabadell
country: Spain
facility: Investigational Site Number 724001
city: Sevilla
country: Spain
facility: Investigational Site Number 724004
city: Rättvik
country: Sweden
facility: Investigational Site Number 752002
city: Stockholm
country: Sweden
facility: Investigational Site Number 752006
city: Stockholm
country: Sweden
facility: Investigational Site Number 752003
city: Stockholm
country: Sweden
facility: Investigational Site Number 752004
city: Örebro
country: Sweden
facility: Investigational Site Number 752001
city: Chernivtsi
country: Ukraine
facility: Investigational Site Number 804012
city: Dnipropetrovsk
country: Ukraine
facility: Investigational Site Number 804003
city: Donetsk
country: Ukraine
facility: Investigational Site Number 804002
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804014
city: Kiev
country: Ukraine
facility: Investigational Site Number 804016
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804011
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804010
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804001
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804008
city: Kyiv
country: Ukraine
facility: Investigational Site Number 804013
city: Zhytomyr
country: Ukraine
facility: Investigational Site Number 804005
city: Addlestone
country: United Kingdom
facility: Investigational Site Number 826004
city: Birmingham
country: United Kingdom
facility: Investigational Site Number 826009
city: Birmingham
country: United Kingdom
facility: Investigational Site Number 826016
city: Blackpool
country: United Kingdom
facility: Investigational Site Number 826021
city: Cambridge
country: United Kingdom
facility: Investigational Site Number 826023
city: Cardiff
country: United Kingdom
facility: Investigational Site Number 826012
city: Chichester
country: United Kingdom
facility: Investigational Site Number 826024
city: Chorley
country: United Kingdom
facility: Investigational Site Number 826006
city: Glasgow
country: United Kingdom
facility: Investigational Site Number 826010
city: Irvine
country: United Kingdom
facility: Investigational Site Number 826003
city: Liverpool
country: United Kingdom
facility: Investigational Site Number 826008
city: Liverpool
country: United Kingdom
facility: Investigational Site Number 826005
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826025
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826007
city: Middlesex
country: United Kingdom
facility: Investigational Site Number 826001
city: Penzance
country: United Kingdom
facility: Investigational Site Number 826019
city: Reading
country: United Kingdom
facility: Investigational Site Number 826011
city: Romford
country: United Kingdom
facility: Investigational Site Number 826013
city: Soham
country: United Kingdom
facility: Investigational Site Number 826014
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.