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ODYSSEY OLE: Open Label Study of Long Term Safety Evaluation of Alirocumab

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT01954394
Collaborator
Regeneron Pharmaceuticals (Industry)
986
Enrollment
177
Locations
1
Arm
42.4
Duration (Months)
5.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The maximum study duration will be 176 weeks per participant.

Study Design

Study Type:
Interventional
Actual Enrollment :
986 participants
Allocation:
N/A
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
Study Start Date :
Dec 17, 2013
Actual Primary Completion Date :
Jun 30, 2017
Actual Study Completion Date :
Jun 30, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Alirocumab
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
Other Names:
  • SAR236553
  • REGN727
  • Praluent

    • Drug: Lipid-Modifying Therapy (LMT)
    Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Experienced Adverse Events (AEs) [Up to 10 weeks after last study drug administration (maximum of 176 weeks)]

      Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.

    Secondary Outcome Measures

    1. Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    2. Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    3. Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    4. Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time [Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    5. Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time [Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    6. Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time [Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    7. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    8. Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    9. Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    10. Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168 [Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    11. Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168 [Parent Baseline, Weeks 48, 96, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    12. Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168 [Parent Baseline, Weeks 48, 96, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    13. Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168 [Parent Baseline, Weeks 48, 96, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    14. Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168 [Parent Baseline, Weeks 48, 96, 144, and 168]

      Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    Participants with heFH who had 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 840321 Huntsville Alabama United States 35801
    2 Investigational Site Number 840341 Tempe Arizona United States 85282
    3 Investigational Site Number 840334 Bell Gardens California United States 90201
    4 Investigational Site Number 840319 Fountain Valley California United States 92708
    5 Investigational Site Number 840336 Los Angeles California United States 90048
    6 Investigational Site Number 840339 Mission Viejo California United States 92691
    7 Investigational Site Number 840337 Newport Beach California United States 92663
    8 Investigational Site Number 840306 Golden Colorado United States 80401
    9 Investigational Site Number 840328 Washington District of Columbia United States 20037
    10 Investigational Site Number 840344 Atlantis Florida United States 33462
    11 Investigational Site Number 840353 Clearwater Florida United States 33756
    12 Investigational Site Number 840318 Fort Lauderdale Florida United States 33308-4311
    13 Investigational Site Number 840327 Jacksonville Florida United States 32216
    14 Investigational Site Number 840309 Miami Florida United States 33174
    15 Investigational Site Number 840351 Sarasota Florida United States 34239
    16 Investigational Site Number 840315 Evanston Illinois United States 60201
    17 Investigational Site Number 840305 Oakbrook Terrace Illinois United States 60181
    18 Investigational Site Number 840333 Iowa City Iowa United States 52242
    19 Investigational Site Number 840329 Kansas City Kansas United States 66160
    20 Investigational Site Number 840345 Auburn Maine United States 04210
    21 Investigational Site Number 840338 Biddeford Maine United States 04005
    22 Investigational Site Number 840322 Boston Massachusetts United States 02114
    23 Investigational Site Number 840346 Framingham Massachusetts United States 01702
    24 Investigational Site Number 840317 Saint Louis Missouri United States 63110
    25 Investigational Site Number 840349 Saint Louis Missouri United States 63136
    26 Investigational Site Number 840314 Morristown New Jersey United States 07901
    27 Investigational Site Number 840316 New York New York United States 10032
    28 Investigational Site Number 840324 Poughkeepsie New York United States 12601
    29 Investigational Site Number 840303 Charlotte North Carolina United States 28204
    30 Investigational Site Number 840320 Durham North Carolina United States 27710
    31 Investigational Site Number 840348 Raleigh North Carolina United States 27609
    32 Investigational Site Number 840340 Cincinnati Ohio United States 45227
    33 Investigational Site Number 840302 Marion Ohio United States 43302
    34 Investigational Site Number 840330 Portland Oregon United States 97239
    35 Investigational Site Number 840352 Beaver Pennsylvania United States 15009
    36 Investigational Site Number 840308 Philadelphia Pennsylvania United States 19104
    37 Investigational Site Number 840342 Scranton Pennsylvania United States 18503
    38 Investigational Site Number 840304 Summerville South Carolina United States 29485
    39 Investigational Site Number 840311 Dallas Texas United States 75216
    40 Investigational Site Number 840312 Dallas Texas United States 75226
    41 Investigational Site Number 840301 Fort Worth Texas United States 76104
    42 Investigational Site Number 840343 Bountiful Utah United States 84010
    43 Investigational Site Number 840354 Chesapeake Virginia United States 23320
    44 Investigational Site Number 840350 Spokane Washington United States 99204
    45 Investigational Site Number 032302 Caba Argentina C1119ACN
    46 Investigational Site Number 032301 Coronel Suarez Argentina B7540GHD
    47 Investigational Site Number 040302 Graz Austria 8036
    48 Investigational Site Number 040303 Sankt Stefan Austria 8511
    49 Investigational Site Number 040301 Wien Austria 1130
    50 Investigational Site Number 056301 Natoye Belgium 5360
    51 Investigational Site Number 100302 Sofia Bulgaria 1233
    52 Investigational Site Number 100301 Sofia Bulgaria 1527
    53 Investigational Site Number 124303 Chicoutimi Canada G7H 7K9
    54 Investigational Site Number 124302 Montreal Canada H1W 2R7
    55 Investigational Site Number 124301 Quebec Canada G1V 4W2
    56 Investigational Site Number 124306 Sherbrooke Canada J1H 5N4
    57 Investigational Site Number 124305 Toronto Canada M5C 2T2
    58 Investigational Site Number 124304 Victoria Canada V8T 5G4
    59 Investigational Site Number 203307 Hradec Kralove Czechia 500 05
    60 Investigational Site Number 203305 Praha 2 Czechia 12808
    61 Investigational Site Number 203301 Praha 4 Czechia 14021
    62 Investigational Site Number 203306 Praha 5 - Motol Czechia 15006
    63 Investigational Site Number 203303 Praha 8 Czechia 180 81
    64 Investigational Site Number 203309 Trutnov Czechia 54121
    65 Investigational Site Number 203304 Uherske Hradiste Czechia 68601
    66 Investigational Site Number 203302 Zlin Czechia 76275
    67 Investigational Site Number 208301 Aalborg Denmark 9000
    68 Investigational Site Number 208306 Aarhus Denmark 8200
    69 Investigational Site Number 208302 Esbjerg Denmark 6700
    70 Investigational Site Number 208303 Roskilde Denmark 4000
    71 Investigational Site Number 208304 Svendborg Denmark 5700
    72 Investigational Site Number 246302 Joensuu Finland 80100
    73 Investigational Site Number 246301 Kokkola Finland 67100
    74 Investigational Site Number 246304 Vantaa Finland 01600
    75 Investigational Site Number 250303 Dijon France 21000
    76 Investigational Site Number 250304 Lille Cedex France 59037
    77 Investigational Site Number 250302 Nantes France 44093
    78 Investigational Site Number 250301 Paris France 75013
    79 Investigational Site Number 250305 Pessac France 33604
    80 Investigational Site Number 250306 Rennes France 35033
    81 Investigational Site Number 276302 Berlin Germany 10117
    82 Investigational Site Number 276305 Frankfurt A.M. Germany 60596
    83 Investigational Site Number 276306 Leipzig Germany 04103
    84 Investigational Site Number 276301 Magdeburg Germany 39120
    85 Investigational Site Number 276307 Witten Germany 58455
    86 Investigational Site Number 348301 Baja Hungary 6500
    87 Investigational Site Number 376302 Holon Israel 58100
    88 Investigational Site Number 376304 Jerusalem Israel 91120
    89 Investigational Site Number 376303 Safed Israel 13110
    90 Investigational Site Number 376301 Tel Hashomer Israel 52621
    91 Investigational Site Number 380302 Chieti Italy 66100
    92 Investigational Site Number 380304 Milano Italy 20138
    93 Investigational Site Number 380303 Napoli Italy 80131
    94 Investigational Site Number 380301 Palermo Italy 90127
    95 Investigational Site Number 484301 Mexico Mexico 03300
    96 Investigational Site Number 528317 Alkmaar Netherlands 1815 JD
    97 Investigational Site Number 528301 Amsterdam-Zuidoost Netherlands 1105 AZ
    98 Investigational Site Number 528320 Apeldoorn Netherlands 7314 ET
    99 Investigational Site Number 528309 Delfzijl Netherlands 9934 JD
    100 Investigational Site Number 528313 Eindhoven Netherlands 5616GB
    101 Investigational Site Number 528319 Enschede Netherlands 7513 ER
    102 Investigational Site Number 528322 Goes Netherlands 4462 RA
    103 Investigational Site Number 528325 Groningen Netherlands 9713 GZ
    104 Investigational Site Number 528302 Groningen Netherlands 9728 NT
    105 Investigational Site Number 528324 Hoogeveen Netherlands 7909 AA
    106 Investigational Site Number 528318 Hoorn Netherlands 1624 NP
    107 Investigational Site Number 528305 Leiden Netherlands 2333 ZA
    108 Investigational Site Number 528311 Maastricht Netherlands 6229 HX
    109 Investigational Site Number 528312 Nijmegen Netherlands 6500 HB
    110 Investigational Site Number 528315 Rotterdam Netherlands 3021 HC
    111 Investigational Site Number 528326 Rotterdam Netherlands 3045 PM
    112 Investigational Site Number 528303 Utrecht Netherlands 3582 KE
    113 Investigational Site Number 528323 Utrecht Netherlands 3584 CX
    114 Investigational Site Number 528321 Venlo Netherlands 5912 BL
    115 Investigational Site Number 528316 Waalwijk Netherlands 5141 BM
    116 Investigational Site Number 578301 Bodo Norway 8092
    117 Investigational Site Number 578305 Oslo Norway 0407
    118 Investigational Site Number 578304 Oslo Norway
    119 Investigational Site Number 620302 Funchal Portugal 9004-514
    120 Investigational Site Number 620301 Lisboa Portugal 1169-024
    121 Investigational Site Number 642302 Timisoara Romania 300358
    122 Investigational Site Number 643304 Arkhangelsk Russian Federation 163000
    123 Investigational Site Number 643303 Kazan Russian Federation 420012
    124 Investigational Site Number 643302 Moscow Russian Federation 111539
    125 Investigational Site Number 643308 Moscow Russian Federation 121552
    126 Investigational Site Number 643305 Moscow Russian Federation 129301
    127 Investigational Site Number 643310 Novosibirsk Russian Federation 630089
    128 Investigational Site Number 643301 St Petersbourg Russian Federation 194156
    129 Investigational Site Number 643306 St. Petersburg Russian Federation 194291
    130 Investigational Site Number 643312 St.Petersburg Russian Federation 196084
    131 Investigational Site Number 710311 Bellville South Africa 7530
    132 Investigational Site Number 710307 Bloemfontein South Africa 9301
    133 Investigational Site Number 710306 Cape Town South Africa 7700
    134 Investigational Site Number 710302 Cape Town South Africa 7925
    135 Investigational Site Number 710309 Centurion South Africa 0158
    136 Investigational Site Number 710312 Parktown South Africa 2193
    137 Investigational Site Number 710304 Parow South Africa 7500
    138 Investigational Site Number 710313 Pretoria South Africa 0002
    139 Investigational Site Number 710303 Pretoria South Africa 0084
    140 Investigational Site Number 710305 Pretoria South Africa 0157
    141 Investigational Site Number 710314 Pretoria South Africa 0184
    142 Investigational Site Number 710315 Roodepoort South Africa 1724
    143 Investigational Site Number 710310 Somerset West South Africa 7130
    144 Investigational Site Number 710308 Witbank South Africa
    145 Investigational Site Number 724303 A Coruna Spain 15001
    146 Investigational Site Number 724308 Barcelona Spain 08036
    147 Investigational Site Number 724306 Córdoba Spain 14004
    148 Investigational Site Number 724312 Granada Spain 18012
    149 Investigational Site Number 724307 Hospitalet De Llobregat Spain 08907
    150 Investigational Site Number 724301 Madrid Spain 28007
    151 Investigational Site Number 724309 Madrid Spain 28029
    152 Investigational Site Number 724305 Madrid Spain 28040
    153 Investigational Site Number 724311 Madrid Spain 28040
    154 Investigational Site Number 724314 Málaga Spain 29010
    155 Investigational Site Number 724315 Quart De Poblet Spain 46930
    156 Investigational Site Number 724310 Sabadell Spain 08208
    157 Investigational Site Number 724313 Sevilla Spain 41013
    158 Investigational Site Number 724304 Tarragona Spain 43204
    159 Investigational Site Number 724302 Zaragoza Spain 50009
    160 Investigational Site Number 752302 Goteborg Sweden 41345
    161 Investigational Site Number 752301 Stockholm Sweden 111 35
    162 Investigational Site Number 752304 Stockholm Sweden 14186
    163 Investigational Site Number 826318 Birmingham United Kingdom B15 2SQ
    164 Investigational Site Number 826304 Brighton United Kingdom BN1 9PH
    165 Investigational Site Number 826301 Bristol United Kingdom BS2 8HW
    166 Investigational Site Number 826311 Cambridge United Kingdom CB2 OQQ
    167 Investigational Site Number 826310 Cardiff United Kingdom CF14 5GJ
    168 Investigational Site Number 826302 Dundee United Kingdom DD1 9SY
    169 Investigational Site Number 826317 Liverpool United Kingdom L22 0LG
    170 Investigational Site Number 826306 Liverpool United Kingdom L7 8XP
    171 Investigational Site Number 826312 Manchester United Kingdom M13 9WL
    172 Investigational Site Number 826303 Manchester United Kingdom M23 9LT
    173 Investigational Site Number 826305 Middlesex United Kingdom HA6 2RN
    174 Investigational Site Number 826313 Newcastle Upon Tyne United Kingdom NEI 4LP
    175 Investigational Site Number 826309 Reading United Kingdom RG2 0TG
    176 Investigational Site Number 826315 West Bromwich United Kingdom B71 4HJ
    177 Investigational Site Number 826316 West Bromwich United Kingdom B71 4HJ

    Sponsors and Collaborators

    • Sanofi
    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT01954394
    Other Study ID Numbers:
    • LTS13463
    • 2013-002572-40
    • U1111-1143-3810
    First Posted:
    Oct 1, 2013
    Last Update Posted:
    Jul 24, 2018
    Last Verified:
    Jun 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypercholesterolemia

    Study Results

    Participant Flow

    Recruitment Details The study was conducted at 177 centers in 24 countries. Overall, 986 participants who completed study EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831) were enrolled between December 2013 and December 2014.
    Pre-assignment Detail The Day 1 visit of this study was: the end of treatment visit of the 78-week treatment period for participants who completed EFC12492, R727-CL-1112 and EFC12732; and the end of study visit i.e. 8 weeks after completion of the 78-week treatment period for participants who completed LTS11717.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W
    Arm/Group Description Alirocumab 75 mg or 150 mg subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and low-density lipoprotein cholesterol (LDL-C) values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values.
    Period Title: Overall Study
    STARTED 331 655
    Treated 330 655
    COMPLETED 301 598
    NOT COMPLETED 30 57

    Baseline Characteristics

    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Total
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Total of all reporting groups
    Overall Participants 330 655 985
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54.8
    (11.4)
    54.1
    (12.1)
    54.4
    (11.9)
    Sex: Female, Male (Count of Participants)
    Female
    148
    44.8%
    287
    43.8%
    435
    44.2%
    Male
    182
    55.2%
    368
    56.2%
    550
    55.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    12
    3.6%
    27
    4.1%
    39
    4%
    Not Hispanic or Latino
    317
    96.1%
    623
    95.1%
    940
    95.4%
    Unknown or Not Reported
    1
    0.3%
    5
    0.8%
    6
    0.6%
    Race/Ethnicity, Customized (Count of Participants)
    White
    310
    93.9%
    628
    95.9%
    938
    95.2%
    Black or African American
    2
    0.6%
    2
    0.3%
    4
    0.4%
    Asian
    2
    0.6%
    6
    0.9%
    8
    0.8%
    American Indian or Alaska Native
    1
    0.3%
    2
    0.3%
    3
    0.3%
    Native Hawaiian or Other Pacific Islander
    1
    0.3%
    0
    0%
    1
    0.1%
    Other
    4
    1.2%
    7
    1.1%
    11
    1.1%
    White/Black or African American
    6
    1.8%
    5
    0.8%
    11
    1.1%
    White/Asian
    2
    0.6%
    5
    0.8%
    7
    0.7%
    White/American Indian or Alaska Native
    1
    0.3%
    0
    0%
    1
    0.1%
    Black or African American/Asian
    1
    0.3%
    0
    0%
    1
    0.1%
    Calculated LDL-C in mg/dL (mg/dL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dL]
    148.8
    (48.8)
    153.5
    (55.3)
    152.0
    (53.2)
    Calculated LDL-C in mmol/L (mmol/L) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mmol/L]
    3.854
    (1.265)
    3.977
    (1.432)
    3.936
    (1.379)

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Who Experienced Adverse Events (AEs)
    Description Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.
    Time Frame Up to 10 weeks after last study drug administration (maximum of 176 weeks)

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants who received at least one dose or part of a dose of alirocumab in this study.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 330 655 985
    Any AE
    83.9
    25.4%
    87.3
    13.3%
    86.2
    8.8%
    Any Serious AE
    20.6
    6.2%
    22.0
    3.4%
    21.5
    2.2%
    Any AE leading to treatment discontinuation
    3.0
    0.9%
    3.5
    0.5%
    3.4
    0.3%
    2. Secondary Outcome
    Title Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    Modified ITT (mITT) population: all enrolled and treated participants with 1 baseline (from parent study) and at least 1 post-baseline calculated LDL-C value on-treatment. "Number analyzed" = participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 8
    -44.9
    (25.9)
    -43.8
    (28.7)
    -44.2
    (27.8)
    Week 24
    -46.9
    (27.5)
    -46.9
    (29.3)
    -46.9
    (28.7)
    Week 48
    -45.6
    (28.0)
    -47.5
    (28.8)
    -46.9
    (28.6)
    Week 72
    -47.7
    (23.5)
    -47.3
    (28.4)
    -47.4
    (26.8)
    Week 96
    -47.4
    (23.8)
    -48.2
    (28.2)
    -47.9
    (26.8)
    Week 120
    -47.4
    (24.0)
    -46.6
    (31.1)
    -46.8
    (28.8)
    Week 144
    -46.5
    (25.8)
    -49.6
    (24.6)
    -48.5
    (25.0)
    Week 168
    -43.6
    (13.4)
    -52.2
    (20.7)
    -48.8
    (17.8)
    3. Secondary Outcome
    Title Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 8
    -66.8
    (45.6)
    -67.1
    (49.2)
    -67.0
    (48.0)
    Week 24
    -70.3
    (49.5)
    -72.7
    (52.4)
    -71.9
    (51.4)
    Week 48
    -67.8
    (49.7)
    -73.9
    (54.3)
    -71.9
    (52.8)
    Week 72
    -71.2
    (44.5)
    -74.9
    (54.5)
    -73.7
    (51.4)
    Week 96
    -70.2
    (45.9)
    -75.9
    (55.0)
    -74.0
    (52.2)
    Week 120
    -72.3
    (45.6)
    -75.2
    (59.7)
    -74.2
    (55.2)
    Week 144
    -73.1
    (50.0)
    -86.2
    (57.8)
    -81.6
    (55.4)
    Week 168
    -66.1
    (24.7)
    -99.4
    (48.3)
    -86.1
    (42.4)
    4. Secondary Outcome
    Title Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 8
    -1.729
    (1.180)
    -1.738
    (1.273)
    -1.735
    (1.242)
    Week 24
    -1.821
    (1.282)
    -1.883
    (1.356)
    -1.863
    (1.332)
    Week 48
    -1.757
    (1.286)
    -1.914
    (1.405)
    -1.861
    (1.368)
    Week 72
    -1.843
    (1.154)
    -1.940
    (1.411)
    -1.908
    (1.332)
    Week 96
    -1.818
    (1.190)
    -1.965
    (1.426)
    -1.916
    (1.353)
    Week 120
    -1.874
    (1.180)
    -1.949
    (1.546)
    -1.923
    (1.428)
    Week 144
    -1.894
    (1.294)
    -2.232
    (1.498)
    -2.114
    (1.436)
    Week 168
    -1.712
    (0.641)
    -2.574
    (1.252)
    -2.229
    (1.098)
    5. Secondary Outcome
    Title Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Baseline
    12.1
    3.7%
    11.5
    1.8%
    11.7
    1.2%
    Week 8
    71.0
    21.5%
    86.1
    13.1%
    81.1
    8.2%
    Week 24
    77.0
    23.3%
    75.7
    11.6%
    76.1
    7.7%
    Week 48
    77.7
    23.5%
    76.4
    11.7%
    76.8
    7.8%
    Week 72
    82.9
    25.1%
    77.6
    11.8%
    79.4
    8.1%
    Week 96
    79.2
    24%
    76.8
    11.7%
    77.6
    7.9%
    Week 120
    78.2
    23.7%
    76.7
    11.7%
    77.2
    7.8%
    Week 144
    72.5
    22%
    74.4
    11.4%
    73.7
    7.5%
    Week 168
    75.0
    22.7%
    83.3
    12.7%
    80.0
    8.1%
    6. Secondary Outcome
    Title Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Baseline
    0.9
    0.3%
    1.2
    0.2%
    1.1
    0.1%
    Week 8
    47.4
    14.4%
    66.4
    10.1%
    60.1
    6.1%
    Week 24
    53.4
    16.2%
    53.1
    8.1%
    53.2
    5.4%
    Week 48
    51.1
    15.5%
    53.5
    8.2%
    52.7
    5.4%
    Week 72
    57.0
    17.3%
    53.2
    8.1%
    54.5
    5.5%
    Week 96
    53.0
    16.1%
    56.4
    8.6%
    55.3
    5.6%
    Week 120
    52.7
    16%
    50.9
    7.8%
    51.5
    5.2%
    Week 144
    46.4
    14.1%
    48.1
    7.3%
    47.5
    4.8%
    Week 168
    50.0
    15.2%
    33.3
    5.1%
    40.0
    4.1%
    7. Secondary Outcome
    Title Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Baseline
    0.9
    0.3%
    1.2
    0.2%
    1.1
    0.1%
    Week 8
    49.5
    15%
    67.1
    10.2%
    61.3
    6.2%
    Week 24
    54.1
    16.4%
    54.3
    8.3%
    54.2
    5.5%
    Week 48
    52.1
    15.8%
    54.5
    8.3%
    53.7
    5.5%
    Week 72
    57.3
    17.4%
    54.4
    8.3%
    55.4
    5.6%
    Week 96
    53.0
    16.1%
    57.7
    8.8%
    56.1
    5.7%
    Week 120
    53.2
    16.1%
    53.1
    8.1%
    53.1
    5.4%
    Week 144
    46.4
    14.1%
    48.8
    7.5%
    48.0
    4.9%
    Week 168
    50.0
    15.2%
    33.3
    5.1%
    40.0
    4.1%
    8. Secondary Outcome
    Title Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 8
    -38.1
    (24.8)
    -37.6
    (26.6)
    -37.8
    (26.0)
    Week 24
    -40.6
    (25.5)
    -40.4
    (27.9)
    -40.5
    (27.1)
    Week 48
    -39.7
    (25.5)
    -40.6
    (27.6)
    -40.3
    (26.9)
    Week 72
    -40.8
    (22.6)
    -40.3
    (26.5)
    -40.5
    (25.3)
    Week 96
    -39.9
    (23.5)
    -40.5
    (26.6)
    -40.3
    (25.6)
    Week 120
    -41.4
    (22.1)
    -38.4
    (29.7)
    -39.5
    (27.3)
    Week 144
    -39.8
    (22.9)
    -41.8
    (24.0)
    -41.1
    (23.6)
    Week 168
    -40.7
    (12.3)
    -47.7
    (18.8)
    -44.9
    (16.1)
    9. Secondary Outcome
    Title Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 8
    -27.9
    (19.3)
    -27.7
    (20.7)
    -27.7
    (20.2)
    Week 24
    -30.1
    (20.3)
    -30.2
    (21.6)
    -30.1
    (21.2)
    Week 48
    -29.0
    (20.5)
    -30.0
    (21.6)
    -29.7
    (21.2)
    Week 72
    -29.9
    (18.0)
    -30.1
    (20.8)
    -30.0
    (19.9)
    Week 96
    -28.9
    (18.3)
    -29.9
    (21.1)
    -29.6
    (20.2)
    Week 120
    -30.2
    (17.2)
    -28.4
    (22.8)
    -29.0
    (21.0)
    Week 144
    -29.1
    (18.2)
    -31.3
    (19.1)
    -30.5
    (18.8)
    Week 168
    -32.3
    (12.4)
    -39.1
    (14.3)
    -36.4
    (13.3)
    10. Secondary Outcome
    Title Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 8
    5.6
    (17.1)
    6.6
    (17.3)
    6.3
    (17.3)
    Week 24
    5.7
    (17.4)
    5.8
    (16.9)
    5.8
    (17.1)
    Week 48
    7.1
    (17.8)
    7.2
    (19.2)
    7.2
    (18.7)
    Week 72
    6.7
    (17.6)
    7.2
    (19.9)
    7.0
    (19.1)
    Week 96
    7.2
    (18.8)
    7.2
    (18.7)
    7.2
    (18.7)
    Week 120
    8.0
    (18.4)
    8.1
    (18.7)
    8.1
    (18.6)
    Week 144
    8.8
    (19.2)
    8.8
    (24.8)
    8.8
    (23.0)
    Week 168
    -6.6
    (26.2)
    -0.3
    (9.9)
    -2.8
    (17.1)
    11. Secondary Outcome
    Title Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 8
    3.4
    (40.5)
    3.5
    (47.0)
    3.5
    (44.9)
    Week 24
    0.6
    (39.9)
    1.0
    (45.9)
    0.9
    (44.0)
    Week 48
    0.8
    (37.5)
    5.1
    (78.0)
    3.7
    (67.2)
    Week 72
    4.3
    (43.3)
    3.6
    (42.9)
    3.8
    (43.0)
    Week 96
    9.1
    (53.2)
    9.3
    (55.2)
    9.2
    (54.5)
    Week 120
    -1.2
    (35.3)
    10.8
    (48.5)
    6.7
    (44.8)
    Week 144
    5.0
    (38.0)
    7.7
    (49.8)
    6.8
    (45.9)
    Week 168
    -22.1
    (21.9)
    -10.3
    (27.1)
    -15.0
    (24.6)
    12. Secondary Outcome
    Title Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 48, 96, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 48
    -15.0
    (158.4)
    -26.4
    (40.2)
    -22.6
    (97.6)
    Week 96
    -13.9
    (171.7)
    -21.4
    (132.7)
    -18.9
    (146.9)
    Week 144
    -20.1
    (46.1)
    -33.0
    (25.0)
    -28.5
    (34.3)
    Week 168
    -30.3
    (18.2)
    -29.2
    (15.4)
    -29.6
    (15.6)
    13. Secondary Outcome
    Title Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 48, 96, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 48
    -36.9
    (21.7)
    -37.8
    (23.4)
    -37.5
    (22.9)
    Week 96
    -36.9
    (20.9)
    -38.0
    (22.9)
    -37.6
    (22.3)
    Week 144
    -33.9
    (20.9)
    -36.9
    (21.3)
    -35.9
    (21.2)
    Week 168
    -38.0
    (9.0)
    -43.1
    (20.7)
    -41.1
    (16.5)
    14. Secondary Outcome
    Title Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 48, 96, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 48
    5.6
    (14.5)
    5.8
    (17.2)
    5.7
    (16.3)
    Week 96
    7.8
    (15.4)
    8.5
    (14.1)
    8.3
    (14.5)
    Week 144
    11.2
    (16.3)
    10.2
    (18.7)
    10.6
    (17.8)
    Week 168
    0.9
    (19.3)
    3.9
    (9.3)
    2.7
    (13.2)
    15. Secondary Outcome
    Title Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168
    Description Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
    Time Frame Parent Baseline, Weeks 48, 96, 144, and 168

    Outcome Measure Data

    Analysis Population Description
    mITT population. Here, "Number analyzed" signifies participants evaluable at specified time-points. This number decreased significantly with visit because of the possibility to switch to commercial alirocumab.
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 additional weeks in this study.
    Measure Participants 323 651 974
    Week 48
    -0.340
    (0.245)
    -0.361
    (0.304)
    -0.354
    (0.286)
    Week 96
    -0.340
    (0.228)
    -0.375
    (0.268)
    -0.363
    (0.256)
    Week 144
    -0.342
    (0.242)
    -0.414
    (0.433)
    -0.389
    (0.379)
    Week 168
    -0.370
    (0.161)
    -0.498
    (0.280)
    -0.447
    (0.238)

    Adverse Events

    Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 176 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
    Adverse Event Reporting Description Reported AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during the 'on treatment' period (from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study + 70 days).
    Arm/Group Title Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Arm/Group Description Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received placebo in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. Alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in participants who received Alirocumab in the parent studies. Participants from parent study EFC12732 (NCT01617655) started with alirocumab 150 mg Q2W and participants from parent studies EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500) and LTS11717 (NCT01507831) started with alirocumab 75 mg Q2W. Alirocumab doses could be either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W from Week 12 or maintained according to the investigator judgement and LDL-C values. All participants who received alirocumab/placebo in the parent studies and received alirocumab 75 mg or 150 mg SC injection Q2W added to stable LMT for up to 168 weeks in this study.
    All Cause Mortality
    Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/330 (1.2%) 7/655 (1.1%) 11/985 (1.1%)
    Serious Adverse Events
    Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 68/330 (20.6%) 144/655 (22%) 212/985 (21.5%)
    Blood and lymphatic system disorders
    Haemorrhagic anaemia 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Anaemia 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Leukocytosis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Cardiac disorders
    Angina pectoris 6/330 (1.8%) 8/655 (1.2%) 14/985 (1.4%)
    Angina unstable 4/330 (1.2%) 5/655 (0.8%) 9/985 (0.9%)
    Acute myocardial infarction 2/330 (0.6%) 4/655 (0.6%) 6/985 (0.6%)
    Coronary artery disease 2/330 (0.6%) 4/655 (0.6%) 6/985 (0.6%)
    Coronary artery stenosis 3/330 (0.9%) 3/655 (0.5%) 6/985 (0.6%)
    Myocardial infarction 2/330 (0.6%) 3/655 (0.5%) 5/985 (0.5%)
    Atrial fibrillation 1/330 (0.3%) 3/655 (0.5%) 4/985 (0.4%)
    Cardiac failure 2/330 (0.6%) 2/655 (0.3%) 4/985 (0.4%)
    Cardiac failure congestive 3/330 (0.9%) 1/655 (0.2%) 4/985 (0.4%)
    Ventricular tachycardia 1/330 (0.3%) 3/655 (0.5%) 4/985 (0.4%)
    Aortic valve stenosis 2/330 (0.6%) 1/655 (0.2%) 3/985 (0.3%)
    Supraventricular tachycardia 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Aortic valve disease 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Aortic valve disease mixed 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Arrhythmia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Arteriosclerosis coronary artery 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Atrial flutter 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Bradycardia 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Coronary artery occlusion 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Coronary artery thrombosis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Ischaemic cardiomyopathy 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Mitral valve incompetence 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Mitral valve stenosis 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Pericarditis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Prinzmetal angina 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Ventricular dysfunction 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Congenital, familial and genetic disorders
    Hereditary non-polyposis colorectal cancer syndrome 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Ear and labyrinth disorders
    Acute vestibular syndrome 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Vertigo positional 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Eye disorders
    Glaucoma 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Optic ischaemic neuropathy 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Corneal decompensation 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Open angle glaucoma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Retinal detachment 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Retinal tear 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Retinal vein occlusion 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Gastrointestinal disorders
    Hiatus hernia 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Inguinal hernia 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Rectal haemorrhage 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Small intestinal obstruction 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Abdominal hernia 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Abdominal pain 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Barrett's oesophagus 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Colitis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Colitis ischaemic 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Diverticulum intestinal 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Dysphagia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Gastric polyps 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Gastric ulcer haemorrhage 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Gastritis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Gastritis haemorrhagic 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Gastrointestinal haemorrhage 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Haematemesis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Haematochezia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Ileus 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Internal hernia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Lower gastrointestinal haemorrhage 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Pancreatitis acute 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Pancreatitis chronic 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Rectal ulcer haemorrhage 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Umbilical hernia 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Volvulus 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Vomiting 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    General disorders
    Non-cardiac chest pain 2/330 (0.6%) 4/655 (0.6%) 6/985 (0.6%)
    Chest pain 1/330 (0.3%) 2/655 (0.3%) 3/985 (0.3%)
    Death 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Malaise 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Sudden cardiac death 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Vascular stent occlusion 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Hepatobiliary disorders
    Cholecystitis 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Cholelithiasis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Hepatic steatosis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Hepatocellular injury 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Infections and infestations
    Pneumonia 2/330 (0.6%) 3/655 (0.5%) 5/985 (0.5%)
    Cellulitis 0/330 (0%) 3/655 (0.5%) 3/985 (0.3%)
    Bronchitis 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Gastroenteritis 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Hepatitis E 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Catheter site infection 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Clostridium difficile colitis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Corneal abscess 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Cystitis bacterial 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Device related sepsis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Diverticulitis 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Haematoma infection 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Lung infection 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Peritoneal abscess 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Pneumonia pseudomonal 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Postoperative abscess 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Postoperative wound infection 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Pyelonephritis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Stitch abscess 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Viral myocarditis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Injury, poisoning and procedural complications
    Muscle rupture 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Subarachnoid haemorrhage 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Acetabulum fracture 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Alcohol poisoning 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Animal bite 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Arthropod bite 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Cardiac valve replacement complication 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Fall 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Femoral neck fracture 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Humerus fracture 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Intentional overdose 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Ligament sprain 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Lumbar vertebral fracture 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Multiple injuries 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Post procedural haemorrhage 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Procedural haemorrhage 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Pubis fracture 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Rib fracture 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Road traffic accident 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Sternal fracture 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Subdural haematoma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Tendon rupture 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Thermal burn 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Thoracic vertebral fracture 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Tibia fracture 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Upper limb fracture 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Vascular bypass dysfunction 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Vascular graft thrombosis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Wound dehiscence 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Investigations
    Alanine aminotransferase increased 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Anticoagulation drug level above therapeutic 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Aspartate aminotransferase increased 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Heart rate irregular 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Transaminases increased 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Weight decreased 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Metabolism and nutrition disorders
    Hyperglycaemia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Malnutrition 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Type 2 diabetes mellitus 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Musculoskeletal and connective tissue disorders
    Osteoarthritis 2/330 (0.6%) 5/655 (0.8%) 7/985 (0.7%)
    Intervertebral disc protrusion 1/330 (0.3%) 5/655 (0.8%) 6/985 (0.6%)
    Arthritis 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Rheumatoid arthritis 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Acquired claw toe 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Arthralgia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Bone pain 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Bursitis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Exostosis 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Fracture pain 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Musculoskeletal pain 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Neck pain 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Osteonecrosis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Pain in extremity 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Periarthritis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Rotator cuff syndrome 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Spinal column stenosis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Colon cancer 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Adenocarcinoma gastric 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Adenocarcinoma of colon 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Basal cell carcinoma 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Benign pancreatic neoplasm 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Bladder transitional cell carcinoma recurrent 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Breast cancer recurrent 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Chronic lymphocytic leukaemia stage 0 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Colon adenoma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Colon cancer metastatic 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Hodgkin's disease 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Invasive ductal breast carcinoma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Invasive lobular breast carcinoma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Laryngeal papilloma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Lobular breast carcinoma in situ 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Lung adenocarcinoma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Lymphocytic leukaemia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Malignant melanoma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Meningioma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Metastatic glioma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Ovarian adenoma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Ovarian cancer stage III 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Papillary cystadenoma lymphomatosum 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Phyllodes tumour 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Prostate cancer metastatic 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Prostate cancer stage II 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Rectal cancer metastatic 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Salivary gland adenoma 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Squamous cell carcinoma of skin 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Nervous system disorders
    Syncope 1/330 (0.3%) 6/655 (0.9%) 7/985 (0.7%)
    Transient ischaemic attack 0/330 (0%) 6/655 (0.9%) 6/985 (0.6%)
    Amnesia 2/330 (0.6%) 0/655 (0%) 2/985 (0.2%)
    Ischaemic stroke 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Presyncope 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Carotid arteriosclerosis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Cervical radiculopathy 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Dementia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Embolic cerebral infarction 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Focal dyscognitive seizures 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Headache 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Hemiparesis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Hemiplegia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Normal pressure hydrocephalus 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Sensory loss 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Toxic encephalopathy 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Vascular dementia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Product Issues
    Device defective 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Device loosening 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Psychiatric disorders
    Alcohol withdrawal syndrome 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Alcoholism 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Anxiety 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Delirium tremens 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Depressed mood 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Major depression 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Suicidal ideation 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Renal and urinary disorders
    Acute kidney injury 2/330 (0.6%) 2/655 (0.3%) 4/985 (0.4%)
    Nephrolithiasis 1/330 (0.3%) 3/655 (0.5%) 4/985 (0.4%)
    Renal colic 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Renal failure 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Renal impairment 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Renal pain 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Ureterolithiasis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Urinary incontinence 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Bartholin's cyst 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Ovarian cyst 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Uterine polyp 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Vaginal dysplasia 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Dyspnoea 0/330 (0%) 2/655 (0.3%) 2/985 (0.2%)
    Acute pulmonary oedema 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Acute respiratory failure 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Asthma 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Pleural effusion 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Pulmonary embolism 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Pulmonary hypertension 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Pulmonary oedema 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Skin and subcutaneous tissue disorders
    Hypersensitivity vasculitis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Rash generalised 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Vascular disorders
    Hypertension 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Neurogenic shock 1/330 (0.3%) 1/655 (0.2%) 2/985 (0.2%)
    Air embolism 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Aortic aneurysm 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Aortic dissection 1/330 (0.3%) 0/655 (0%) 1/985 (0.1%)
    Iliac artery occlusion 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Intermittent claudication 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Malignant hypertension 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Peripheral arterial occlusive disease 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Peripheral artery stenosis 0/330 (0%) 1/655 (0.2%) 1/985 (0.1%)
    Other (Not Including Serious) Adverse Events
    Placebo to Alirocumab 75 or 150 mg Q2W Alirocumab to Alirocumab 75 or 150 mg Q2W Alirocumab: All Participants
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 183/330 (55.5%) 366/655 (55.9%) 549/985 (55.7%)
    Gastrointestinal disorders
    Diarrhoea 19/330 (5.8%) 43/655 (6.6%) 62/985 (6.3%)
    General disorders
    Influenza like illness 12/330 (3.6%) 40/655 (6.1%) 52/985 (5.3%)
    Injection site reaction 26/330 (7.9%) 28/655 (4.3%) 54/985 (5.5%)
    Infections and infestations
    Bronchitis 19/330 (5.8%) 41/655 (6.3%) 60/985 (6.1%)
    Influenza 34/330 (10.3%) 61/655 (9.3%) 95/985 (9.6%)
    Upper respiratory tract infection 31/330 (9.4%) 71/655 (10.8%) 102/985 (10.4%)
    Urinary tract infection 21/330 (6.4%) 28/655 (4.3%) 49/985 (5%)
    Viral upper respiratory tract infection 51/330 (15.5%) 93/655 (14.2%) 144/985 (14.6%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 34/330 (10.3%) 53/655 (8.1%) 87/985 (8.8%)
    Back pain 26/330 (7.9%) 56/655 (8.5%) 82/985 (8.3%)
    Myalgia 15/330 (4.5%) 44/655 (6.7%) 59/985 (6%)
    Pain in extremity 18/330 (5.5%) 31/655 (4.7%) 49/985 (5%)
    Vascular disorders
    Hypertension 13/330 (3.9%) 37/655 (5.6%) 50/985 (5.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.

    Results Point of Contact

    Name/Title Trial Transparency Team
    Organization Sanofi
    Phone 800-633-1610 ext 1#
    Email Contact-US@sanofi.com
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT01954394
    Other Study ID Numbers:
    • LTS13463
    • 2013-002572-40
    • U1111-1143-3810
    First Posted:
    Oct 1, 2013
    Last Update Posted:
    Jul 24, 2018
    Last Verified:
    Jun 1, 2018