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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Lipid-Modifying Therapy (LMT); Drug: Alirocumab

Detailed Description

The maximum study duration will be 176 weeks per participant.

• Study Type: Interventional
• Enrollment (Actual): 986
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1119ACN
    • Investigational Site Number 032302
  • Coronel Suarez, Argentina, B7540GHD
    • Investigational Site Number 032301
• Austria
  • Graz, Austria, 8036
    • Investigational Site Number 040302
  • Sankt Stefan, Austria, 8511
    • Investigational Site Number 040303
  • Wien, Austria, 1130
    • Investigational Site Number 040301
• Belgium
  • Natoye, Belgium, 5360
    • Investigational Site Number 056301
• Bulgaria
  • Sofia, Bulgaria, 1233
    • Investigational Site Number 100302
  • Sofia, Bulgaria, 1527
    • Investigational Site Number 100301
• Canada
  • Chicoutimi, Canada, G7H 7K9
    • Investigational Site Number 124303
  • Montreal, Canada, H1W 2R7
    • Investigational Site Number 124302
  • Quebec, Canada, G1V 4W2
    • Investigational Site Number 124301
  • Sherbrooke, Canada, J1H 5N4
    • Investigational Site Number 124306
  • Toronto, Canada, M5C 2T2
    • Investigational Site Number 124305
  • Victoria, Canada, V8T 5G4
    • Investigational Site Number 124304
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Investigational Site Number 203307
  • Praha 2, Czechia, 12808
    • Investigational Site Number 203305
  • Praha 4, Czechia, 14021
    • Investigational Site Number 203301
  • Praha 5 - Motol, Czechia, 15006
    • Investigational Site Number 203306
  • Praha 8, Czechia, 180 81
    • Investigational Site Number 203303
  • Trutnov, Czechia, 54121
    • Investigational Site Number 203309
  • Uherske Hradiste, Czechia, 68601
    • Investigational Site Number 203304
  • Zlin, Czechia, 76275
    • Investigational Site Number 203302
• Denmark
  • Aalborg, Denmark, 9000
    • Investigational Site Number 208301
  • Aarhus, Denmark, 8200
    • Investigational Site Number 208306
  • Esbjerg, Denmark, 6700
    • Investigational Site Number 208302
  • Roskilde, Denmark, 4000
    • Investigational Site Number 208303
  • Svendborg, Denmark, 5700
    • Investigational Site Number 208304
• Finland
  • Joensuu, Finland, 80100
    • Investigational Site Number 246302
  • Kokkola, Finland, 67100
    • Investigational Site Number 246301
  • Vantaa, Finland, 01600
    • Investigational Site Number 246304
• France
  • Dijon, France, 21000
    • Investigational Site Number 250303
  • Lille Cedex, France, 59037
    • Investigational Site Number 250304
  • Nantes, France, 44093
    • Investigational Site Number 250302
  • Paris, France, 75013
    • Investigational Site Number 250301
  • Pessac, France, 33604
    • Investigational Site Number 250305
  • Rennes, France, 35033
    • Investigational Site Number 250306
• Germany
  • Berlin, Germany, 10117
    • Investigational Site Number 276302
  • Frankfurt A.M., Germany, 60596
    • Investigational Site Number 276305
  • Leipzig, Germany, 04103
    • Investigational Site Number 276306
  • Magdeburg, Germany, 39120
    • Investigational Site Number 276301
  • Witten, Germany, 58455
    • Investigational Site Number 276307
• Hungary
  • Baja, Hungary, 6500
    • Investigational Site Number 348301
• Israel
  • Holon, Israel, 58100
    • Investigational Site Number 376302
  • Jerusalem, Israel, 91120
    • Investigational Site Number 376304
  • Safed, Israel, 13110
    • Investigational Site Number 376303
  • Tel Hashomer, Israel, 52621
    • Investigational Site Number 376301
• Italy
  • Chieti, Italy, 66100
    • Investigational Site Number 380302
  • Milano, Italy, 20138
    • Investigational Site Number 380304
  • Napoli, Italy, 80131
    • Investigational Site Number 380303
  • Palermo, Italy, 90127
    • Investigational Site Number 380301
• Mexico
  • Mexico, Mexico, 03300
    • Investigational Site Number 484301
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Investigational Site Number 528317
  • Amsterdam-Zuidoost, Netherlands, 1105 AZ
    • Investigational Site Number 528301
  • Apeldoorn, Netherlands, 7314 ET
    • Investigational Site Number 528320
  • Delfzijl, Netherlands, 9934 JD
    • Investigational Site Number 528309
  • Eindhoven, Netherlands, 5616GB
    • Investigational Site Number 528313
  • Enschede, Netherlands, 7513 ER
    • Investigational Site Number 528319
  • Goes, Netherlands, 4462 RA
    • Investigational Site Number 528322
  • Groningen, Netherlands, 9713 GZ
    • Investigational Site Number 528325
  • Groningen, Netherlands, 9728 NT
    • Investigational Site Number 528302
  • Hoogeveen, Netherlands, 7909 AA
    • Investigational Site Number 528324
  • Hoorn, Netherlands, 1624 NP
    • Investigational Site Number 528318
  • Leiden, Netherlands, 2333 ZA
    • Investigational Site Number 528305
  • Maastricht, Netherlands, 6229 HX
    • Investigational Site Number 528311
  • Nijmegen, Netherlands, 6500 HB
    • Investigational Site Number 528312
  • Rotterdam, Netherlands, 3021 HC
    • Investigational Site Number 528315
  • Rotterdam, Netherlands, 3045 PM
    • Investigational Site Number 528326
  • Utrecht, Netherlands, 3582 KE
    • Investigational Site Number 528303
  • Utrecht, Netherlands, 3584 CX
    • Investigational Site Number 528323
  • Venlo, Netherlands, 5912 BL
    • Investigational Site Number 528321
  • Waalwijk, Netherlands, 5141 BM
    • Investigational Site Number 528316
• Norway
  • Bodo, Norway, 8092
    • Investigational Site Number 578301
  • Oslo, Norway, 0407
    • Investigational Site Number 578305
  • Oslo, Norway
    • Investigational Site Number 578304
• Portugal
  • Funchal, Portugal, 9004-514
    • Investigational Site Number 620302
  • Lisboa, Portugal, 1169-024
    • Investigational Site Number 620301
• Romania
  • Timisoara, Romania, 300358
    • Investigational Site Number 642302
• Russian Federation
  • Arkhangelsk, Russian Federation, 163000
    • Investigational Site Number 643304
  • Kazan, Russian Federation, 420012
    • Investigational Site Number 643303
  • Moscow, Russian Federation, 111539
    • Investigational Site Number 643302
  • Moscow, Russian Federation, 121552
    • Investigational Site Number 643308
  • Moscow, Russian Federation, 129301
    • Investigational Site Number 643305
  • Novosibirsk, Russian Federation, 630089
    • Investigational Site Number 643310
  • St Petersbourg, Russian Federation, 194156
    • Investigational Site Number 643301
  • St. Petersburg, Russian Federation, 194291
    • Investigational Site Number 643306
  • St.Petersburg, Russian Federation, 196084
    • Investigational Site Number 643312
• South Africa
  • Bellville, South Africa, 7530
    • Investigational Site Number 710311
  • Bloemfontein, South Africa, 9301
    • Investigational Site Number 710307
  • Cape Town, South Africa, 7700
    • Investigational Site Number 710306
  • Cape Town, South Africa, 7925
    • Investigational Site Number 710302
  • Centurion, South Africa, 0158
    • Investigational Site Number 710309
  • Parktown, South Africa, 2193
    • Investigational Site Number 710312
  • Parow, South Africa, 7500
    • Investigational Site Number 710304
  • Pretoria, South Africa, 0002
    • Investigational Site Number 710313
  • Pretoria, South Africa, 0084
    • Investigational Site Number 710303
  • Pretoria, South Africa, 0157
    • Investigational Site Number 710305
  • Pretoria, South Africa, 0184
    • Investigational Site Number 710314
  • Roodepoort, South Africa, 1724
    • Investigational Site Number 710315
  • Somerset West, South Africa, 7130
    • Investigational Site Number 710310
  • Witbank, South Africa
    • Investigational Site Number 710308
• Spain
  • A Coruna, Spain, 15001
    • Investigational Site Number 724303
  • Barcelona, Spain, 08036
    • Investigational Site Number 724308
  • Córdoba, Spain, 14004
    • Investigational Site Number 724306
  • Granada, Spain, 18012
    • Investigational Site Number 724312
  • Hospitalet De Llobregat, Spain, 08907
    • Investigational Site Number 724307
  • Madrid, Spain, 28007
    • Investigational Site Number 724301
  • Madrid, Spain, 28029
    • Investigational Site Number 724309
  • Madrid, Spain, 28040
    • Investigational Site Number 724305
  • Madrid, Spain, 28040
    • Investigational Site Number 724311
  • Málaga, Spain, 29010
    • Investigational Site Number 724314
  • Quart De Poblet, Spain, 46930
    • Investigational Site Number 724315
  • Sabadell, Spain, 08208
    • Investigational Site Number 724310
  • Sevilla, Spain, 41013
    • Investigational Site Number 724313
  • Tarragona, Spain, 43204
    • Investigational Site Number 724304
  • Zaragoza, Spain, 50009
    • Investigational Site Number 724302
• Sweden
  • Goteborg, Sweden, 41345
    • Investigational Site Number 752302
  • Stockholm, Sweden, 111 35
    • Investigational Site Number 752301
  • Stockholm, Sweden, 14186
    • Investigational Site Number 752304
• United Kingdom
  • Birmingham, United Kingdom, B15 2SQ
    • Investigational Site Number 826318
  • Brighton, United Kingdom, BN1 9PH
    • Investigational Site Number 826304
  • Bristol, United Kingdom, BS2 8HW
    • Investigational Site Number 826301
  • Cambridge, United Kingdom, CB2 OQQ
    • Investigational Site Number 826311
  • Cardiff, United Kingdom, CF14 5GJ
    • Investigational Site Number 826310
  • Dundee, United Kingdom, DD1 9SY
    • Investigational Site Number 826302
  • Liverpool, United Kingdom, L22 0LG
    • Investigational Site Number 826317
  • Liverpool, United Kingdom, L7 8XP
    • Investigational Site Number 826306
  • Manchester, United Kingdom, M13 9WL
    • Investigational Site Number 826312
  • Manchester, United Kingdom, M23 9LT
    • Investigational Site Number 826303
  • Middlesex, United Kingdom, HA6 2RN
    • Investigational Site Number 826305
  • Newcastle Upon Tyne, United Kingdom, NEI 4LP
    • Investigational Site Number 826313
  • Reading, United Kingdom, RG2 0TG
    • Investigational Site Number 826309
  • West Bromwich, United Kingdom, B71 4HJ
    • Investigational Site Number 826315
  • West Bromwich, United Kingdom, B71 4HJ
    • Investigational Site Number 826316
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Investigational Site Number 840321
  • Arizona
    • Tempe, Arizona, United States, 85282
      • Investigational Site Number 840341
  • California
    • Bell Gardens, California, United States, 90201
      • Investigational Site Number 840334
    • Fountain Valley, California, United States, 92708
      • Investigational Site Number 840319
    • Los Angeles, California, United States, 90048
      • Investigational Site Number 840336
    • Mission Viejo, California, United States, 92691
      • Investigational Site Number 840339
    • Newport Beach, California, United States, 92663
      • Investigational Site Number 840337
  • Colorado
    • Golden, Colorado, United States, 80401
      • Investigational Site Number 840306
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Investigational Site Number 840328
  • Florida
    • Atlantis, Florida, United States, 33462
      • Investigational Site Number 840344
    • Clearwater, Florida, United States, 33756
      • Investigational Site Number 840353
    • Fort Lauderdale, Florida, United States, 33308-4311
      • Investigational Site Number 840318
    • Jacksonville, Florida, United States, 32216
      • Investigational Site Number 840327
    • Miami, Florida, United States, 33174
      • Investigational Site Number 840309
    • Sarasota, Florida, United States, 34239
      • Investigational Site Number 840351
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Investigational Site Number 840315
    • Oakbrook Terrace, Illinois, United States, 60181
      • Investigational Site Number 840305
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Investigational Site Number 840333
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Investigational Site Number 840329
  • Maine
    • Auburn, Maine, United States, 04210
      • Investigational Site Number 840345
    • Biddeford, Maine, United States, 04005
      • Investigational Site Number 840338
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Investigational Site Number 840322
    • Framingham, Massachusetts, United States, 01702
      • Investigational Site Number 840346
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Investigational Site Number 840317
    • Saint Louis, Missouri, United States, 63136
      • Investigational Site Number 840349
  • New Jersey
    • Morristown, New Jersey, United States, 07901
      • Investigational Site Number 840314
  • New York
    • New York, New York, United States, 10032
      • Investigational Site Number 840316
    • Poughkeepsie, New York, United States, 12601
      • Investigational Site Number 840324
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Investigational Site Number 840303
    • Durham, North Carolina, United States, 27710
      • Investigational Site Number 840320
    • Raleigh, North Carolina, United States, 27609
      • Investigational Site Number 840348
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Investigational Site Number 840340
    • Marion, Ohio, United States, 43302
      • Investigational Site Number 840302
  • Oregon
    • Portland, Oregon, United States, 97239
      • Investigational Site Number 840330
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Investigational Site Number 840352
    • Philadelphia, Pennsylvania, United States, 19104
      • Investigational Site Number 840308
    • Scranton, Pennsylvania, United States, 18503
      • Investigational Site Number 840342
  • South Carolina
    • Summerville, South Carolina, United States, 29485
      • Investigational Site Number 840304
  • Texas
    • Dallas, Texas, United States, 75216
      • Investigational Site Number 840311
    • Dallas, Texas, United States, 75226
      • Investigational Site Number 840312
    • Fort Worth, Texas, United States, 76104
      • Investigational Site Number 840301
  • Utah
    • Bountiful, Utah, United States, 84010
      • Investigational Site Number 840343
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Investigational Site Number 840354
  • Washington
    • Spokane, Washington, United States, 99204
      • Investigational Site Number 840350

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Experienced Adverse Events (AEs)	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.	Up to 10 weeks after last study drug administration (maximum of 176 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Calculated LDL-C at 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.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at 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.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at 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.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time	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.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time	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.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
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	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.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at 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.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Percent Change From Baseline in Total-cholesterol at 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.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at 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.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Percent Change From Baseline in Fasting Triglycerides (TGs) at 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.	Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Percent Change From Baseline in Lipoprotein (a) at 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.	Parent Baseline, Weeks 48, 96, 144, and 168
Percent Change From Baseline in Apolipoprotein-B (Apo-B) at 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.	Parent Baseline, Weeks 48, 96, 144, and 168
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at 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.	Parent Baseline, Weeks 48, 96, 144, and 168
Absolute Change From Baseline in Apo B/Apo A-1 Ratio at 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.	Parent Baseline, Weeks 48, 96, 144, and 168

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• Dufour R, Hovingh GK, Guyton JR, Langslet G, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial. J Clin Lipidol. 2019 Jan-Feb;13(1):138-147. doi: 10.1016/j.jacl.2018.11.007. Epub 2018 Nov 30.
• Farnier M, Hovingh GK, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Guyton JR. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis. 2018 Nov;278:307-314. doi: 10.1016/j.atherosclerosis.2018.08.036. Epub 2018 Sep 1.
• Hovingh GK, Guyton JR, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Alirocumab dosing patterns during 40 months of open-label treatment in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2018 Nov-Dec;12(6):1463-1470. doi: 10.1016/j.jacl.2018.08.011. Epub 2018 Aug 30.

Study record dates

Study Major Dates

• Study Start: December 17, 2013
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: September 16, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (ESTIMATE): October 1, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2018
• Last Update Submitted That Met QC Criteria: June 29, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: LTS13463; 2013-002572-40 (EUDRACT_NUMBER); U1111-1143-3810 (OTHER: UTN)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No