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AzTrials

HypercholesterolemiaPhase 3NCT02476006

Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

A Phase 3 study testing ALIROCUMAB SAR236553 (REGN727), ezetimibe and atorvastatin in people with Hypercholesterolemia, run by Sanofi at 153 sites in 16 countries.

Completed

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

Official record
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Trial summary

Primary Objective: To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of… 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 SAR236553 (REGN727), ezetimibe and atorvastatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
998 participants
Where
153 sitesin 16 countries
Study dates
23 Jun 2015to 12 Apr 2019
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

  • Either A, B, C, D, or E below and not adequately controlled with a maximally tolerated dose of statin with or without other LMTs, all at stable doses for at least 4 weeks prior to the screening visit (Week-3):
  • Participants suffering from heterozygous familial hypercholesterolemia (heFH) with LDL-C concentrations greater than or equal to (>=)160 mg/dL (4.14 millimoles per liter [mmol/L]) despite treatment.
  • Participants suffering from heFH with LDL-C concentrations >=130 mg/dL (3.36 mmol/L) despite treatment and two or more CV risk factors among this list:
  • LDL-C greater than (>) 250 milligrams per deciliter (mg/dL) (6.46 mmol/L) at the time of the familial hypercholesterolemia (FH) diagnosis (before treatment).
  • Family history of premature-onset coronary heart disease (CHD; first-degree male relative with onset before age 55 years; first-degree female relative with onset before age 65 years).
  • Metabolic syndrome.
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  • HDL-C less than (<) 40 mg/dL (1.03 mmol/L).
  • Hypertension (blood pressure >140/90 mmHg or drug treatment).
  • Lipoprotein a (Lp[a]) >=50 mg/dL (1.78 µmol/L).
  • Tendon xanthoma.
  • Participants suffering from heFH with LDL-C concentrations >=130 mg/dL (3.36 mmol/L) despite treatment and one of the following characteristics:
  • Established CHD or other cardiovascular disease (CVD; history of acute myocardial infarction, ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis >=50 percent (%), or aortic abdominal aneurysm).
  • Drug-treated type 2 diabetes mellitus or type 1 with target organ damage.
  • Family history of first- or second-degree relative with very premature onset CHD (first- or second-degree male relative with onset before age 45; first- or second-degree female relative with onset before age 55).
  • Non-FH participants suffering from established CHD or other CVD (history of acute myocardial infarction (MI), ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis >=50%, or aortic abdominal aneurysm) and with LDL-C concentrations >=130 mg/dL (3.36 mmol/L).
  • Participants suffering from progressive CVD (coronary artery disease, or peripheral arterial occlusive disease or cerebrovascular disease as documented clinically or by imaging techniques, with a subsequent CV event [acute MI, ischemic stroke, ischemia-driven revascularization, unstable angina, transient ischemic attack] occurring despite stable doses of maximally tolerated LMT) with LDL-C concentrations >=100 mg/dL (2.59 mmol/L).

Who cannot join

  • Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) and from screening to enrollment.
  • Use of a fibrate other than fenofibrate within 4 weeks of the screening visit (Week-3) or between screening and enrollment.
  • Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg (except for participants on simvastatin 80 mg for more than one year, who were eligible).
  • Use of statin other than simvastatin, atorvastatin, or rosuvastatin prior to the screening visit (Week-3) or between screening and enrollment, except when there was a documented reason for intolerance to the above mentioned potent statins (in which case the use of a different statin was allowed).
  • Fasting serum TG >400 mg/dL (>4.52 mmol/L) at the screening visit (Week -3). Uncontrolled hypertension (>180 mmHg systolic and/or >110 mmHg diastolic at randomization visit).
  • New York Heart Association Class III or IV congestive heart failure persisting despite treatment.
Show all 11Show fewer
  • History of hemorrhagic stroke. Liver transaminases >3 times the upper limit of normal. Laboratory evidence of current hepatitis B or C infection. Creatine kinase >3 times the upper limit of normal. Estimated glomerular filtration rate <30 mL/min/1.73 m^2. Pregnant or breastfeeding woman or with childbearing potential without appropriate contraception.
  • Male participant with a female partner of childbearing potential not protected by a highly-effective method(s) of birth control.
  • Participants eligible for enrollment into an ongoing clinical study of alirocumab conducted at the same investigational site.
  • Hypersensitivity to alirocumab or any of the excipients.
  • 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

153 sites in 16 countries.

153 sites in 16 countries

France47 sites

  • Investigational Site Number 250027

    Amiens, 80054

  • Investigational Site Number 250034

    Auxerre, 89011

  • Investigational Site Number 250016

    Avignon, 84000

  • Investigational Site Number 250021

    Bayonne, 64100

  • Investigational Site Number 250030

    Bobigny, 93009

  • Investigational Site Number 250045

    Bordeaux, 33075

  • Investigational Site Number 250049

    Brest, 29610

  • Investigational Site Number 250054

    Bron, 69677

  • Investigational Site Number 250015

    Caen, 14000

  • Investigational Site Number 250047

    Clermont-Ferrand, 63003

  • Investigational Site Number 250013

    Corbeil-Essonnes, 91100

  • Investigational Site Number 250032

    Coudray, 28630

  • Investigational Site Number 250002

    Dijon, 21000

  • Investigational Site Number 250040

    Dijon, 21000

  • Investigational Site Number 250012

    Grenoble, 38028

  • Investigational Site Number 250038

    Grenoble, 38043

  • Investigational Site Number 250033

    Jossigny

  • Investigational Site Number 250035

    Le Chesnay, 78157

  • Investigational Site Number 250036

    Lens

  • Investigational Site Number 250042

    Lille, 59000

  • Investigational Site Number 250004

    Lille

  • Investigational Site Number 250037

    Limoges, 87000

  • Investigational Site Number 250057

    Lyon, 69009

  • Investigational Site Number 250028

    Marseille, 13385

  • Investigational Site Number 250048

    Marseille, 13385

  • Investigational Site Number 250024

    Montpellier, 34295

  • Investigational Site Number 250006

    Nantes, 44093

  • Investigational Site Number 250022

    Nantes, 44277

  • Investigational Site Number 250017

    Nice, 06001

  • Investigational Site Number 250039

    Nîmes, 30029

  • Investigational Site Number 250014

    Paris, 75014

  • Investigational Site Number 250041

    Paris, 75014

  • Investigational Site Number 250026

    Paris, 75018

  • Investigational Site Number 250044

    Paris, 75181

  • Investigational Site Number 250001

    Paris, 75475

  • Investigational Site Number 250051

    Pessac, 33604

  • Investigational Site Number 250011

    Poitiers, 86021

  • Investigational Site Number 250031

    Poitiers, 86021

  • Investigational Site Number 250010

    Reims, 51092

  • Investigational Site Number 250008

    Rennes

  • Investigational Site Number 250018

    Rouen, 76000

  • Investigational Site Number 250023

    Saint-Mandé, 94160

  • Investigational Site Number 250025

    Toulouse, 31059

  • Investigational Site Number 250046

    Toulouse, 31076

  • Investigational Site Number 250007

    Tours, 37000

  • Investigational Site Number 250019

    Vénissieux, 69200

  • Investigational Site Number 250050

    Vichy, 03201

Other trials in France

Canada26 sites

  • Investigational Site Number 124018

    Calgary, T2E7C5

  • Investigational Site Number 124015

    Cambridge, N1R6V6

  • Investigational Site Number 124002

    Chicoutimi, G7H7K9

  • Investigational Site Number 124027

    Coquitlam, V3K3P4

  • Investigational Site Number 124025

    Edmonton, T6G2B7

  • Investigational Site Number 124017

    Halifax, B3H1V7

  • Investigational Site Number 124013

    Hamilton, L8L 2X2

  • Investigational Site Number 124008

    London, N6A 4L6

  • Investigational Site Number 124026

    Maple Ridge, V2X5Z6

  • Investigational Site Number 124020

    Montreal, H2W1R7

  • Investigational Site Number 124022

    Montreal, H4A3J1

  • Investigational Site Number 124032

    Mount Pearl, A1N1W7

  • Investigational Site Number 124005

    Ottawa, K1Y4W7

  • Investigational Site Number 124024

    Peterborough, K9J0B2

  • Investigational Site Number 124003

    Québec, G1V4W2

  • Investigational Site Number 124019

    Saint-Charles-Borromée, J6E6J2

  • Investigational Site Number 124007

    Sarnia, N7T 4X3

  • Investigational Site Number 124001

    Sherbrooke, J1H 5N4

  • Investigational Site Number 124030

    Smiths Falls, K7A4W8

  • Investigational Site Number 124023

    Toronto, M4N3M5

  • Investigational Site Number 124014

    Toronto, M5B1W8

  • Investigational Site Number 124028

    Trois-Rivières

  • Investigational Site Number 124011

    Vancouver, V5Y3W2

  • Investigational Site Number 124012

    Victoria, V8T5G4

  • Investigational Site Number 124031

    Winnipeg, R2H2A6

  • Investigational Site Number 124009

    Woodstock, N4S5P5

Other trials in Canada

Belgium18 sites

  • Investigational Site Number 056005

    Aalst, 9300

  • Investigational Site Number 056018

    Antwerp, 2020

  • Investigational Site Number 056008

    Arlon, 6700

  • Investigational Site Number 056013

    Bruges, 8000

  • Investigational Site Number 056010

    Brussels, 1090

  • Investigational Site Number 056003

    Brussels, 1200

  • Investigational Site Number 056006

    Charleroi, 6000

  • Investigational Site Number 056007

    Edegem, 2650

  • Investigational Site Number 056019

    Genk, 3600

  • Investigational Site Number 056001

    Ghent, 9000

  • Investigational Site Number 056017

    Ghent, 9000

  • Investigational Site Number 056002

    Haine-Saint-Paul, 7100

  • Investigational Site Number 056015

    Kortrijk, 8500

  • Investigational Site Number 056009

    La Louvière, 7100

  • Investigational Site Number 056004

    Leuven, 3000

  • Investigational Site Number 056014

    Liège, 4000

  • Investigational Site Number 056011

    Overpelt, 3900

  • Investigational Site Number 056016

    Roeselare, 8800

Other trials in Belgium

Spain18 sites

  • Investigational Site Number 724009

    Alicante, 03010

  • Investigational Site Number 724011

    Alicante, 3550

  • Investigational Site Number 724003

    Córdoba, 14004

  • Investigational Site Number 724012

    Donostia / San Sebastian, 20014

  • Investigational Site Number 724014

    Donostia / San Sebastian, 20014

  • Investigational Site Number 724019

    Elche, 03203

  • Investigational Site Number 724017

    Galdakao, 48960

  • Investigational Site Number 724020

    Inca, 03700

  • Investigational Site Number 724001

    L'Hospitalet de Llobregat, 08907

  • Investigational Site Number 724007

    Las Palmas de Gran Canaria, 35016

  • Investigational Site Number 724004

    Madrid, 28007

  • Investigational Site Number 724008

    Madrid, 28034

  • Investigational Site Number 724010

    Madrid, 28046

  • Investigational Site Number 724005

    Málaga, 29010

  • Investigational Site Number 724002

    Santiago de Compostela, 15706

  • Investigational Site Number 724006

    Valencia, 46010

  • Investigational Site Number 724016

    Valencia, 46014

  • Investigational Site Number 724015

    Valladolid, 47011

Other trials in Spain

Austria9 sites

  • Investigational Site Number 040001

    Graz

  • Investigational Site Number 040008

    Innsbruck, 6020

  • Investigational Site Number 040005

    Linz, 4010

  • Investigational Site Number 040006

    Linz, 4021

  • Investigational Site Number 040003

    Vienna, 1030

  • Investigational Site Number 040002

    Vienna, 1090

  • Investigational Site Number 040004

    Vienna, 1130

  • Investigational Site Number 040007

    Vienna, 1160

  • Investigational Site Number 040010

    Vienna, 1160

Other trials in Austria

Poland5 sites

  • Investigational Site Number 616005

    Gdansk, 80-952

  • Investigational Site Number 616003

    Krakow, 30-082

  • Investigational Site Number 616001

    Lodz, 90-549

  • Investigational Site Number 616004

    Olsztyn, 10-045

  • Investigational Site Number 616002

    Warsaw, 04-628

Other trials in Poland

Switzerland5 sites

  • Investigational Site Number 756005

    Baden, 5404

  • Investigational Site Number 756002

    Olten, 4600

  • Investigational Site Number 756004

    Reinach, 4153

  • Investigational Site Number 756003

    Sankt Gallen, 9007

  • Investigational Site Number 756001

    Zurich, 8032

Other trials in Switzerland

Czechia4 sites

  • Investigational Site Number 203004

    Brno, 65691

  • Investigational Site Number 203002

    Hradec Králové, 50005

  • Investigational Site Number 203001

    Prague, 12808

  • Investigational Site Number 203005

    Uherské Hradiště, 68601

Other trials in Czechia

Hungary4 sites

  • Investigational Site Number 348001

    Budapest, 1125

  • Investigational Site Number 348002

    Debrecen, 4032

  • Investigational Site Number 348004

    Pécs

  • Investigational Site Number 348003

    Szeged, 6725

Other trials in Hungary

Denmark3 sites

  • Investigational Site Number 208003

    Aalborg, 9000

  • Investigational Site Number 208001

    Esbjerg, 6700

  • Investigational Site Number 208002

    Roskilde, 4000

Other trials in Denmark

Greece3 sites

  • Investigational Site Number 300003

    Ampelokipoi, 11522

  • Investigational Site Number 300002

    Ioannina, 45500

  • Investigational Site Number 300001

    Kallithea

Other trials in Greece

Romania3 sites

  • Investigational Site Number 642-003

    Bucharest, 011461

  • Investigational Site Number 642-002

    Iași, 700661

  • Investigational Site Number 642-001

    Timișoara, 300298

Other trials in Romania

Slovakia3 sites

  • Investigational Site Number 703003

    Bratislava, 81108

  • Investigational Site Number 703002

    Bratislava, 83101

  • Investigational Site Number 703001

    Košice, 04011

Other trials in Slovakia

Finland2 sites

  • Investigational Site Number 246003

    Turku, 20520

  • Investigational Site Number 246001

    Varkaus, 78300

Other trials in Finland

Germany2 sites

  • Investigational Site Number 276001

    Berlin, 12559

  • Investigational Site Number 276003

    Magdeburg, 39120

Other trials in Germany

Slovenia1 site

  • Investigational Site Number 705001

    Maribor, 2000

Other trials in Slovenia

About this study

Official title: A Multi-country, Multicenter, Single-arm, Open-label Study to Document the Safety, Tolerability and Effect of Alirocumab on Atherogenic Lipoproteins in High Cardio-vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies

Primary Objective:

To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this participant population.

Read more

Secondary Objectives:

To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of treatment.

To document participant's acceptability of self-injection (Self Injection Assessment Questionnaire, SIAQ).

Read the detailed description

The study duration included a screening period of up to 3 weeks, a treatment period of a minimum of 12 weeks and up to a maximum of 120 weeks (30 months), and at least 2 weeks after the last study treatment injection.

Being tested
ALIROCUMAB SAR236553 (REGN727), placebo (for injection training only), ezetimibe, atorvastatin, rosuvastatin
Medical subject headings
Hypercholesterolemia

What participants receive

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

  • ALIROCUMAB SAR236553 (REGN727)Drug

    Also called Praluent®

    Pharmaceutical form:solution Route of administration: subcutaneous

  • placebo (for injection training only)Drug

    Pharmaceutical form:solution Route of administration: subcutaneous

  • ezetimibeDrug

    Pharmaceutical form:capsule Route of administration: oral

  • atorvastatinDrug

    Pharmaceutical form:tablet Route of administration: oral

  • rosuvastatinDrug

    Pharmaceutical form:tablet Route of administration: oral

  • simvastatinDrug

    Pharmaceutical form:tablet Route of administration: oral

Study groups in NCT02476006
Study groupRoleWhat they receive
AlirocumabExperimentalParticipants received Alirocumab 150 milligram (mg) subcutaneously (SC) once every two weeks (Q2W) or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response.
Receives: Drug: ALIROCUMAB SAR236553 (REGN727); Drug: placebo (for injection training only); Drug: ezetimibe; Drug: atorvastatin; Drug: rosuvastatin; Drug: simvastatin

What is being measured

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

  1. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Treatment-emergent AEs (TEAEs) were defined as AEs that that developed or worsened or became serious during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.

    Measured: From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)

Secondary outcomes (10)

  1. Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

    Calculated LDL-C values were obtained using the Friedewald formula. Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/5]). Baseline value was defined as the last observation before the first dose of the treatment.

    Measured: Baseline, Week 12

  2. Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12

    LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C <100 mg/dL (2.59 mmol/L) at week 12 were reported.

    Measured: At Week 12

  3. Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 12

    LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C <70 mg/dL (1.81 mmol/L) at week 12 were reported.

    Measured: At Week 12

  4. Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) and/or >=50% Reduction From Baseline in LDL-C at Week 12

    LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached LDL-C <70 mg/dL at Week 12 and/or >=50% reduction from baseline in LDL-C at Week 12 are reported.

    Measured: At Week 12

  5. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

    Baseline value was defined as the last observation before the first dose of the treatment.

    Measured: Baseline, Week 12

  6. Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12

    Baseline value was defined as the last observation before the first dose of the treatment.

    Measured: Baseline, Week 12

  7. Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12

    Baseline value was defined as the last observation before the first dose of the treatment.

    Measured: Baseline, Week 12

  8. Percent Change From Baseline in Triglycerides at Week 12

    Baseline value was defined as the last observation before the first dose of the treatment.

    Measured: Baseline, Week 12

  9. Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections

    Pre-SIAQ: self-completed before first self-injection \& Post-SIAQ: self-completed after self-injection. Pre-SIAQ consisted of 7 items grouped into 3 domains:feelings about injections,self-confidence \& satisfaction with self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains:feelings about injections,self-image,self-confidence,injection-site reactions,ease of use \& satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicate a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience). Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores common to the Pre \& Post SIAQ were analyzed on participants belonging to Pre \& Post-SIAQ population and are reported.

    Measured: Baseline (Pre-SIAQ), Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96

  10. Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use

    SIAQ: contained 2 modules: Pre-SIAQ and Post-SIAQ. Post-SIAQ: self-completed after self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains: feelings about injections, self-image, self-confidence, injection-site reactions, ease of use \& satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicated a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item. Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores which are not in common with Pre-SIAQ were analyzed on the Post-SIAQ population and are reported here.

    Measured: Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96

Timeline

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

  1. First posted19 Jun 2015 (estimated)
  2. Study start23 Jun 2015
  3. Primary completion12 Apr 2019
  4. Study completion12 Apr 2019

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
998 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02476006
Sponsor's protocol ID
LPS14245
Other IDs
2015-000620-28, U1111-1163-0984, 2015
Status last verified
Mar 2022
First submitted
16 Jun 2015
Last updated
28 Mar 2022
Data monitoring committee
No
FDA-regulated drug
Yes
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Cefalu AB, Garbelotto R, Mombelli G, Pirro M, Rubba P, Arca M, Borghi C, Bonomo K, Gonnelli S, Massaroni K, Tirone G, Averna M; ODYSSEY APPRISE Study Italian Investigators. A subgroup analysis of the ODYSSEY APPRISE study: Safety and efficacy of alirocumab in the Italian cohort. Nutr Metab Cardiovasc Dis. 2022 Nov;32(11):2638-2646. doi: 10.1016/j.numecd.2022.07.020. Epub 2022 Aug 9.

    PubMed 36064689

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ALIROCUMAB SAR236553 (REGN727), ezetimibe and atorvastatin in people with Hypercholesterolemia, run by Sanofi at 153 sites in 16 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 16 inclusion and 11 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 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in France, Canada, Belgium, Spain, Austria and 11 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 30 Mar 2020). 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 With Treatment Emergent Adverse Events (TEAEs) (time frame: From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)). 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 NCT02476006, which also lists 1 linked publication.

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 28 Mar 2022.

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