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HypercholesterolemiaPhase 3ODYSSEY OLENCT01954394

Open Label Study of Long Term Safety Evaluation of Alirocumab

A Phase 3 study testing Alirocumab and Lipid-Modifying Therapy (LMT) in people with Hypercholesterolemia, run by Sanofi at 177 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypercholesterolemia
What is being tested?
Alirocumab and Lipid-Modifying Therapy (LMT)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
986 participants
Where
177 sitesin 24 countries
Study dates
17 Dec 2013to 30 Jun 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with heFH who had completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).

Who cannot join

  • 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.

Trial locations and contacts

177 sites in 24 countries.

177 sites in 24 countries

United States44 sites

  • Investigational Site Number 840344

    Atlantis, Florida, 33462

  • Investigational Site Number 840345

    Auburn, Maine, 04210

  • Investigational Site Number 840352

    Beaver, Pennsylvania, 15009

  • Investigational Site Number 840334

    Bell Gardens, California, 90201

  • Investigational Site Number 840338

    Biddeford, Maine, 04005

  • Investigational Site Number 840322

    Boston, Massachusetts, 02114

  • Investigational Site Number 840343

    Bountiful, Utah, 84010

  • Investigational Site Number 840303

    Charlotte, North Carolina, 28204

  • Investigational Site Number 840354

    Chesapeake, Virginia, 23320

  • Investigational Site Number 840340

    Cincinnati, Ohio, 45227

  • Investigational Site Number 840353

    Clearwater, Florida, 33756

  • Investigational Site Number 840311

    Dallas, Texas, 75216

  • Investigational Site Number 840312

    Dallas, Texas, 75226

  • Investigational Site Number 840320

    Durham, North Carolina, 27710

  • Investigational Site Number 840315

    Evanston, Illinois, 60201

  • Investigational Site Number 840318

    Fort Lauderdale, Florida, 33308-4311

  • Investigational Site Number 840301

    Fort Worth, Texas, 76104

  • Investigational Site Number 840319

    Fountain Valley, California, 92708

  • Investigational Site Number 840346

    Framingham, Massachusetts, 01702

  • Investigational Site Number 840306

    Golden, Colorado, 80401

  • Investigational Site Number 840321

    Huntsville, Alabama, 35801

  • Investigational Site Number 840333

    Iowa City, Iowa, 52242

  • Investigational Site Number 840327

    Jacksonville, Florida, 32216

  • Investigational Site Number 840329

    Kansas City, Kansas, 66160

  • Investigational Site Number 840336

    Los Angeles, California, 90048

  • Investigational Site Number 840302

    Marion, Ohio, 43302

  • Investigational Site Number 840309

    Miami, Florida, 33174

  • Investigational Site Number 840339

    Mission Viejo, California, 92691

  • Investigational Site Number 840314

    Morristown, New Jersey, 07901

  • Investigational Site Number 840316

    New York, New York, 10032

  • Investigational Site Number 840337

    Newport Beach, California, 92663

  • Investigational Site Number 840305

    Oakbrook Terrace, Illinois, 60181

  • Investigational Site Number 840308

    Philadelphia, Pennsylvania, 19104

  • Investigational Site Number 840330

    Portland, Oregon, 97239

  • Investigational Site Number 840324

    Poughkeepsie, New York, 12601

  • Investigational Site Number 840348

    Raleigh, North Carolina, 27609

  • Investigational Site Number 840351

    Sarasota, Florida, 34239

  • Investigational Site Number 840342

    Scranton, Pennsylvania, 18503

  • Investigational Site Number 840350

    Spokane, Washington, 99204

  • Investigational Site Number 840317

    St Louis, Missouri, 63110

  • Investigational Site Number 840349

    St Louis, Missouri, 63136

  • Investigational Site Number 840304

    Summerville, South Carolina, 29485

  • Investigational Site Number 840341

    Tempe, Arizona, 85282

  • Investigational Site Number 840328

    Washington D.C., District of Columbia, 20037

Other trials in United States

Netherlands20 sites

  • Investigational Site Number 528317

    Alkmaar, 1815 JD

  • Investigational Site Number 528301

    Amsterdam-Zuidoost, 1105 AZ

  • Investigational Site Number 528320

    Apeldoorn, 7314 ET

  • Investigational Site Number 528309

    Delfzijl, 9934 JD

  • Investigational Site Number 528313

    Eindhoven, 5616GB

  • Investigational Site Number 528319

    Enschede, 7513 ER

  • Investigational Site Number 528322

    Goes, 4462 RA

  • Investigational Site Number 528325

    Groningen, 9713 GZ

  • Investigational Site Number 528302

    Groningen, 9728 NT

  • Investigational Site Number 528324

    Hoogeveen, 7909 AA

  • Investigational Site Number 528318

    Hoorn, 1624 NP

  • Investigational Site Number 528305

    Leiden, 2333 ZA

  • Investigational Site Number 528311

    Maastricht, 6229 HX

  • Investigational Site Number 528312

    Nijmegen, 6500 HB

  • Investigational Site Number 528315

    Rotterdam, 3021 HC

  • Investigational Site Number 528326

    Rotterdam, 3045 PM

  • Investigational Site Number 528303

    Utrecht, 3582 KE

  • Investigational Site Number 528323

    Utrecht, 3584 CX

  • Investigational Site Number 528321

    Venlo, 5912 BL

  • Investigational Site Number 528316

    Waalwijk, 5141 BM

Other trials in Netherlands

Spain15 sites

  • Investigational Site Number 724303

    A Coruña, 15001

  • Investigational Site Number 724308

    Barcelona, 08036

  • Investigational Site Number 724306

    Córdoba, 14004

  • Investigational Site Number 724312

    Granada, 18012

  • Investigational Site Number 724307

    L'Hospitalet de Llobregat, 08907

  • Investigational Site Number 724301

    Madrid, 28007

  • Investigational Site Number 724309

    Madrid, 28029

  • Investigational Site Number 724305

    Madrid, 28040

  • Investigational Site Number 724311

    Madrid, 28040

  • Investigational Site Number 724314

    Málaga, 29010

  • Investigational Site Number 724315

    Quart de Poblet, 46930

  • Investigational Site Number 724310

    Sabadell, 08208

  • Investigational Site Number 724313

    Seville, 41013

  • Investigational Site Number 724304

    Tarragona, 43204

  • Investigational Site Number 724302

    Zaragoza, 50009

Other trials in Spain

United Kingdom15 sites

  • Investigational Site Number 826318

    Birmingham, B15 2SQ

  • Investigational Site Number 826304

    Brighton, BN1 9PH

  • Investigational Site Number 826301

    Bristol, BS2 8HW

  • Investigational Site Number 826311

    Cambridge, CB2 OQQ

  • Investigational Site Number 826310

    Cardiff, CF14 5GJ

  • Investigational Site Number 826302

    Dundee, DD1 9SY

  • Investigational Site Number 826317

    Liverpool, L22 0LG

  • Investigational Site Number 826306

    Liverpool, L7 8XP

  • Investigational Site Number 826312

    Manchester, M13 9WL

  • Investigational Site Number 826303

    Manchester, M23 9LT

  • Investigational Site Number 826305

    Middlesex, HA6 2RN

  • Investigational Site Number 826313

    Newcastle upon Tyne, NEI 4LP

  • Investigational Site Number 826309

    Reading, RG2 0TG

  • Investigational Site Number 826315

    West Bromwich, B71 4HJ

  • Investigational Site Number 826316

    West Bromwich, B71 4HJ

Other trials in United Kingdom

South Africa14 sites

  • Investigational Site Number 710311

    Bellville, 7530

  • Investigational Site Number 710307

    Bloemfontein, 9301

  • Investigational Site Number 710306

    Cape Town, 7700

  • Investigational Site Number 710302

    Cape Town, 7925

  • Investigational Site Number 710309

    Centurion, 0158

  • Investigational Site Number 710312

    Parktown, 2193

  • Investigational Site Number 710304

    Parow, 7500

  • Investigational Site Number 710313

    Pretoria, 0002

  • Investigational Site Number 710303

    Pretoria, 0084

  • Investigational Site Number 710305

    Pretoria, 0157

  • Investigational Site Number 710314

    Pretoria, 0184

  • Investigational Site Number 710315

    Roodepoort, 1724

  • Investigational Site Number 710310

    Somerset West, 7130

  • Investigational Site Number 710308

    Witbank

Other trials in South Africa

Russia9 sites

  • Investigational Site Number 643304

    Arkhangelsk, 163000

  • Investigational Site Number 643303

    Kazan', 420012

  • Investigational Site Number 643302

    Moscow, 111539

  • Investigational Site Number 643308

    Moscow, 121552

  • Investigational Site Number 643305

    Moscow, 129301

  • Investigational Site Number 643310

    Novosibirsk, 630089

  • Investigational Site Number 643301

    Saint Petersburg, 194156

  • Investigational Site Number 643306

    Saint Petersburg, 194291

  • Investigational Site Number 643312

    Saint Petersburg, 196084

Other trials in Russia

Czechia8 sites

  • Investigational Site Number 203307

    Hradec Králové, 500 05

  • Investigational Site Number 203305

    Prague, 12808

  • Investigational Site Number 203301

    Prague, 14021

  • Investigational Site Number 203303

    Prague, 180 81

  • Investigational Site Number 203306

    Praha 5 - Motol, 15006

  • Investigational Site Number 203309

    Trutnov, 54121

  • Investigational Site Number 203304

    Uherské Hradiště, 68601

  • Investigational Site Number 203302

    Zlín, 76275

Other trials in Czechia

Canada6 sites

  • Investigational Site Number 124303

    Chicoutimi, G7H 7K9

  • Investigational Site Number 124302

    Montreal, H1W 2R7

  • Investigational Site Number 124301

    Québec, G1V 4W2

  • Investigational Site Number 124306

    Sherbrooke, J1H 5N4

  • Investigational Site Number 124305

    Toronto, M5C 2T2

  • Investigational Site Number 124304

    Victoria, V8T 5G4

Other trials in Canada

France6 sites

  • Investigational Site Number 250303

    Dijon, 21000

  • Investigational Site Number 250304

    Lille, 59037

  • Investigational Site Number 250302

    Nantes, 44093

  • Investigational Site Number 250301

    Paris, 75013

  • Investigational Site Number 250305

    Pessac, 33604

  • Investigational Site Number 250306

    Rennes, 35033

Other trials in France

Denmark5 sites

  • Investigational Site Number 208301

    Aalborg, 9000

  • Investigational Site Number 208306

    Aarhus, 8200

  • Investigational Site Number 208302

    Esbjerg, 6700

  • Investigational Site Number 208303

    Roskilde, 4000

  • Investigational Site Number 208304

    Svendborg, 5700

Other trials in Denmark

Germany5 sites

  • Investigational Site Number 276302

    Berlin, 10117

  • Investigational Site Number 276305

    Frankfurt A.M., 60596

  • Investigational Site Number 276306

    Leipzig, 04103

  • Investigational Site Number 276301

    Magdeburg, 39120

  • Investigational Site Number 276307

    Witten, 58455

Other trials in Germany

Israel4 sites

  • Investigational Site Number 376302

    Holon, 58100

  • Investigational Site Number 376304

    Jerusalem, 91120

  • Investigational Site Number 376303

    Safed, 13110

  • Investigational Site Number 376301

    Tel HaShomer, 52621

Other trials in Israel

Italy4 sites

  • Investigational Site Number 380302

    Chieti, 66100

  • Investigational Site Number 380304

    Milan, 20138

  • Investigational Site Number 380303

    Naples, 80131

  • Investigational Site Number 380301

    Palermo, 90127

Other trials in Italy

Austria3 sites

  • Investigational Site Number 040302

    Graz, 8036

  • Investigational Site Number 040303

    Sankt Stefan, 8511

  • Investigational Site Number 040301

    Vienna, 1130

Other trials in Austria

Finland3 sites

  • Investigational Site Number 246302

    Joensuu, 80100

  • Investigational Site Number 246301

    Kokkola, 67100

  • Investigational Site Number 246304

    Vantaa, 01600

Other trials in Finland

Norway3 sites

  • Investigational Site Number 578301

    Bodø, 8092

  • Investigational Site Number 578305

    Oslo, 0407

  • Investigational Site Number 578304

    Oslo

Other trials in Norway

Sweden3 sites

  • Investigational Site Number 752302

    Gothenburg, 41345

  • Investigational Site Number 752301

    Stockholm, 111 35

  • Investigational Site Number 752304

    Stockholm, 14186

Other trials in Sweden

Argentina2 sites

  • Investigational Site Number 032302

    Caba, C1119ACN

  • Investigational Site Number 032301

    Coronel Suárez, B7540GHD

Other trials in Argentina

Bulgaria2 sites

  • Investigational Site Number 100302

    Sofia, 1233

  • Investigational Site Number 100301

    Sofia, 1527

Other trials in Bulgaria

Portugal2 sites

  • Investigational Site Number 620302

    Funchal, 9004-514

  • Investigational Site Number 620301

    Lisbon, 1169-024

Other trials in Portugal

Belgium1 site

  • Investigational Site Number 056301

    Natoye, 5360

Other trials in Belgium

Hungary1 site

  • Investigational Site Number 348301

    Baja, 6500

Other trials in Hungary

Mexico1 site

  • Investigational Site Number 484301

    México, 03300

Other trials in Mexico

Romania1 site

  • Investigational Site Number 642302

    Timișoara, 300358

Other trials in Romania

About this study

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

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.
Read the detailed description

The maximum study duration will be 176 weeks per participant.

Being tested
Alirocumab, Lipid-Modifying Therapy (LMT)
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlirocumabDrug

    Also called SAR236553, REGN727, Praluent

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

  • Lipid-Modifying Therapy (LMT)Drug

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

Study groups in NCT01954394
Study groupRoleWhat they receive
Alirocumab 75 or 150 mg Q2WExperimentalAlirocumab 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.
Receives: Drug: Alirocumab; Drug: Lipid-Modifying Therapy (LMT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 10 weeks after last study drug administration (maximum of 176 weeks)

Secondary outcomes (14)

  1. 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.

    Measured: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

  2. 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.

    Measured: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

  3. 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.

    Measured: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

  4. 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.

    Measured: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

  5. 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.

    Measured: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

  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

    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.

    Measured: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

  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

    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.

    Measured: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

  8. 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.

    Measured: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

  9. 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.

    Measured: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

  10. 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.

    Measured: Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168

  11. 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.

    Measured: Parent Baseline, Weeks 48, 96, 144, and 168

  12. 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.

    Measured: Parent Baseline, Weeks 48, 96, 144, and 168

  13. 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.

    Measured: Parent Baseline, Weeks 48, 96, 144, and 168

  14. 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.

    Measured: Parent Baseline, Weeks 48, 96, 144, and 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2013 (estimated)
  2. Study start17 Dec 2013
  3. Primary completion30 Jun 2017
  4. Study completion30 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
986 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01954394
Sponsor's protocol ID
LTS13463
Other IDs
2013-002572-40, U1111-1143-3810
Acronym
ODYSSEY OLE
Status last verified
Jun 2018
First submitted
16 Sep 2013
Last updated
24 Jul 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 30591415

  • 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.

    PubMed 30293878

  • 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.

    PubMed 30287210

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alirocumab and Lipid-Modifying Therapy (LMT) in people with Hypercholesterolemia, run by Sanofi at 177 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 177 sites in United States, Netherlands, Spain, United Kingdom, South Africa and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experienced Adverse Events (AEs) (time frame: Up to 10 weeks after last study drug administration (maximum of 176 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01954394, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.

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