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 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.

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).

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: ALIROCUMAB SAR236553 (REGN727); Drug: placebo (for injection training only); Drug: ezetimibe; Drug: atorvastatin; Drug: rosuvastatin; Drug: simvastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 998
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Investigational Site Number 040001
  • Innsbruck, Austria, 6020
    • Investigational Site Number 040008
  • Linz, Austria, 4010
    • Investigational Site Number 040005
  • Linz, Austria, 4021
    • Investigational Site Number 040006
  • Wien, Austria, 1030
    • Investigational Site Number 040003
  • Wien, Austria, 1090
    • Investigational Site Number 040002
  • Wien, Austria, 1130
    • Investigational Site Number 040004
  • Wien, Austria, 1160
    • Investigational Site Number 040007
  • Wien, Austria, 1160
    • Investigational Site Number 040010
• Belgium
  • Aalst, Belgium, 9300
    • Investigational Site Number 056005
  • Antwerpen, Belgium, 2020
    • Investigational Site Number 056018
  • Arlon, Belgium, 6700
    • Investigational Site Number 056008
  • Brugge, Belgium, 8000
    • Investigational Site Number 056013
  • Brussel, Belgium, 1090
    • Investigational Site Number 056010
  • Bruxelles, Belgium, 1200
    • Investigational Site Number 056003
  • Charleroi, Belgium, 6000
    • Investigational Site Number 056006
  • Edegem, Belgium, 2650
    • Investigational Site Number 056007
  • Genk, Belgium, 3600
    • Investigational Site Number 056019
  • Gent, Belgium, 9000
    • Investigational Site Number 056001
  • Gent, Belgium, 9000
    • Investigational Site Number 056017
  • Haine St Paul, Belgium, 7100
    • Investigational Site Number 056002
  • Kortrijk, Belgium, 8500
    • Investigational Site Number 056015
  • La Louvière, Belgium, 7100
    • Investigational Site Number 056009
  • Leuven, Belgium, 3000
    • Investigational Site Number 056004
  • Liège, Belgium, 4000
    • Investigational Site Number 056014
  • Overpelt, Belgium, 3900
    • Investigational Site Number 056011
  • Roeselare, Belgium, 8800
    • Investigational Site Number 056016
• Canada
  • Calgary, Canada, T2E7C5
    • Investigational Site Number 124018
  • Cambridge, Canada, N1R6V6
    • Investigational Site Number 124015
  • Chicoutimi, Canada, G7H7K9
    • Investigational Site Number 124002
  • Coquitlam, Canada, V3K3P4
    • Investigational Site Number 124027
  • Edmonton, Canada, T6G2B7
    • Investigational Site Number 124025
  • Halifax, Canada, B3H1V7
    • Investigational Site Number 124017
  • Hamilton, Canada, L8L 2X2
    • Investigational Site Number 124013
  • London, Canada, N6A 4L6
    • Investigational Site Number 124008
  • Maple Ridge, Canada, V2X5Z6
    • Investigational Site Number 124026
  • Montreal, Canada, H2W1R7
    • Investigational Site Number 124020
  • Montreal, Canada, H4A3J1
    • Investigational Site Number 124022
  • Mount Pearl, Canada, A1N1W7
    • Investigational Site Number 124032
  • Ottawa, Canada, K1Y4W7
    • Investigational Site Number 124005
  • Peterborough, Canada, K9J0B2
    • Investigational Site Number 124024
  • Quebec, Canada, G1V4W2
    • Investigational Site Number 124003
  • Sarnia, Canada, N7T 4X3
    • Investigational Site Number 124007
  • Sherbrooke, Canada, J1H 5N4
    • Investigational Site Number 124001
  • Smiths Falls, Canada, K7A4W8
    • Investigational Site Number 124030
  • St-Charles Borromee, Canada, J6E6J2
    • Investigational Site Number 124019
  • Toronto, Canada, M4N3M5
    • Investigational Site Number 124023
  • Toronto, Canada, M5B1W8
    • Investigational Site Number 124014
  • Trois-Rivieres, Canada
    • Investigational Site Number 124028
  • Vancouver, Canada, V5Y3W2
    • Investigational Site Number 124011
  • Victoria, Canada, V8T5G4
    • Investigational Site Number 124012
  • Winnipeg, Canada, R2H2A6
    • Investigational Site Number 124031
  • Woodstock, Canada, N4S5P5
    • Investigational Site Number 124009
• Czechia
  • Brno, Czechia, 65691
    • Investigational Site Number 203004
  • Hradec Kralove, Czechia, 50005
    • Investigational Site Number 203002
  • Praha, Czechia, 12808
    • Investigational Site Number 203001
  • Uherske Hradiste, Czechia, 68601
    • Investigational Site Number 203005
• Denmark
  • Esbjerg, Denmark, 6700
    • Investigational Site Number 208001
  • Roskilde, Denmark, 4000
    • Investigational Site Number 208002
  • Ålborg, Denmark, 9000
    • Investigational Site Number 208003
• Finland
  • Turku, Finland, 20520
    • Investigational Site Number 246003
  • Varkaus, Finland, 78300
    • Investigational Site Number 246001
• France
  • Amiens Cedex 1, France, 80054
    • Investigational Site Number 250027
  • Auxerre, France, 89011
    • Investigational Site Number 250034
  • Avignon, France, 84000
    • Investigational Site Number 250016
  • BORDEAUX Cedex, France, 33075
    • Investigational Site Number 250045
  • Bayonne, France, 64100
    • Investigational Site Number 250021
  • Bobigny, France, 93009
    • Investigational Site Number 250030
  • Brest Cedex, France, 29610
    • Investigational Site Number 250049
  • Bron, France, 69677
    • Investigational Site Number 250054
  • Caen, France, 14000
    • Investigational Site Number 250015
  • Clermont Ferrand, France, 63003
    • Investigational Site Number 250047
  • Corbeil Essonnes, France, 91100
    • Investigational Site Number 250013
  • Coudray, France, 28630
    • Investigational Site Number 250032
  • Dijon, France, 21000
    • Investigational Site Number 250002
  • Dijon, France, 21000
    • Investigational Site Number 250040
  • GRENOBLE cedex, France, 38043
    • Investigational Site Number 250038
  • Grenoble, France, 38028
    • Investigational Site Number 250012
  • Jossigny, France
    • Investigational Site Number 250033
  • LE CHESNAY Cedex, France, 78157
    • Investigational Site Number 250035
  • Lens, France
    • Investigational Site Number 250036
  • Lille, France, 59000
    • Investigational Site Number 250042
  • Lille, France
    • Investigational Site Number 250004
  • Limoges Cedex, France, 87000
    • Investigational Site Number 250037
  • Lyon, France, 69009
    • Investigational Site Number 250057
  • Marseille, France, 13385
    • Investigational Site Number 250028
  • Marseille Cedex 05, France, 13385
    • Investigational Site Number 250048
  • Montpellier, France, 34295
    • Investigational Site Number 250024
  • NIMES Cedex 9, France, 30029
    • Investigational Site Number 250039
  • Nantes, France, 44277
    • Investigational Site Number 250022
  • Nantes cedex 01, France, 44093
    • Investigational Site Number 250006
  • Nice cedex 1, France, 06001
    • Investigational Site Number 250017
  • PARIS Cedex 04, France, 75181
    • Investigational Site Number 250044
  • POITIERS Cedex, France, 86021
    • Investigational Site Number 250011
  • Paris, France, 75014
    • Investigational Site Number 250014
  • Paris, France, 75014
    • Investigational Site Number 250041
  • Paris, France, 75018
    • Investigational Site Number 250026
  • Paris Cedex 10, France, 75475
    • Investigational Site Number 250001
  • Pessac, France, 33604
    • Investigational Site Number 250051
  • Poitiers, France, 86021
    • Investigational Site Number 250031
  • Reims Cedex, France, 51092
    • Investigational Site Number 250010
  • Rennes, France
    • Investigational Site Number 250008
  • Rouen, France, 76000
    • Investigational Site Number 250018
  • Saint-Mandé, France, 94160
    • Investigational Site Number 250023
  • TOULOUSE Cedex 9, France, 31059
    • Investigational Site Number 250025
  • Toulouse Cedex 3, France, 31076
    • Investigational Site Number 250046
  • Tours, France, 37000
    • Investigational Site Number 250007
  • VICHY Cedex, France, 03201
    • Investigational Site Number 250050
  • Venissieux, France, 69200
    • Investigational Site Number 250019
• Germany
  • Berlin, Germany, 12559
    • Investigational Site Number 276001
  • Magdeburg, Germany, 39120
    • Investigational Site Number 276003
• Greece
  • Ampelokipoi, Greece, 11522
    • Investigational Site Number 300003
  • Ioannina, Greece, 45500
    • Investigational Site Number 300002
  • Kallithea, Greece
    • Investigational Site Number 300001
• Hungary
  • Budapest, Hungary, 1125
    • Investigational Site Number 348001
  • Debrecen, Hungary, 4032
    • Investigational Site Number 348002
  • Pécs, Hungary
    • Investigational Site Number 348004
  • Szeged, Hungary, 6725
    • Investigational Site Number 348003
• Poland
  • Gdansk, Poland, 80-952
    • Investigational Site Number 616005
  • Krakow, Poland, 30-082
    • Investigational Site Number 616003
  • Lodz, Poland, 90-549
    • Investigational Site Number 616001
  • Olsztyn, Poland, 10-045
    • Investigational Site Number 616004
  • Warszawa, Poland, 04-628
    • Investigational Site Number 616002
• Romania
  • Bucuresti, Romania, 011461
    • Investigational Site Number 642-003
  • Iasi, Romania, 700661
    • Investigational Site Number 642-002
  • Timisoara, Romania, 300298
    • Investigational Site Number 642-001
• Slovakia
  • Bratislava, Slovakia, 81108
    • Investigational Site Number 703003
  • Bratislava, Slovakia, 83101
    • Investigational Site Number 703002
  • Kosice, Slovakia, 04011
    • Investigational Site Number 703001
• Slovenia
  • Maribor, Slovenia, 2000
    • Investigational Site Number 705001
• Spain
  • Alicante, Spain, 03010
    • Investigational Site Number 724009
  • Alicante, Spain, 3550
    • Investigational Site Number 724011
  • Córdoba, Spain, 14004
    • Investigational Site Number 724003
  • Donostia, Spain, 20014
    • Investigational Site Number 724012
  • Donostia, Spain, 20014
    • Investigational Site Number 724014
  • Elche, Spain, 03203
    • Investigational Site Number 724019
  • Galdakao, Spain, 48960
    • Investigational Site Number 724017
  • Hospitalet de Llobregat, Spain, 08907
    • Investigational Site Number 724001
  • Inca, Spain, 03700
    • Investigational Site Number 724020
  • Las Palmas de Gran Canaria, Spain, 35016
    • Investigational Site Number 724007
  • Madrid, Spain, 28007
    • Investigational Site Number 724004
  • Madrid, Spain, 28034
    • Investigational Site Number 724008
  • Madrid, Spain, 28046
    • Investigational Site Number 724010
  • Málaga, Spain, 29010
    • Investigational Site Number 724005
  • Santiago de Compostela, Spain, 15706
    • Investigational Site Number 724002
  • Valencia, Spain, 46010
    • Investigational Site Number 724006
  • Valencia, Spain, 46014
    • Investigational Site Number 724016
  • Valladolid, Spain, 47011
    • Investigational Site Number 724015
• Switzerland
  • Baden, Switzerland, 5404
    • Investigational Site Number 756005
  • Olten, Switzerland, 4600
    • Investigational Site Number 756002
  • Reinach, Switzerland, 4153
    • Investigational Site Number 756004
  • St. Gallen, Switzerland, 9007
    • Investigational Site Number 756003
  • Zürich, Switzerland, 8032
    • Investigational Site Number 756001

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:

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):

A. 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.

B. 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.
• 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.

C. 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).

D. 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).

E. 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).

Exclusion criteria:

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Alirocumab; Participants 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.

Drug: ALIROCUMAB SAR236553 (REGN727); Pharmaceutical form:solution Route of administration: subcutaneous; Other Names: Praluent®; Drug: placebo (for injection training only); Pharmaceutical form:solution Route of administration: subcutaneous; Drug: ezetimibe; Pharmaceutical form:capsule Route of administration: oral; Drug: atorvastatin; Pharmaceutical form:tablet Route of administration: oral; Drug: rosuvastatin; Pharmaceutical form:tablet Route of administration: oral; Drug: simvastatin; Pharmaceutical form:tablet Route of administration: oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 12
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.	At Week 12
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.	At Week 12
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.	At Week 12
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.	Baseline, Week 12
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.	Baseline, Week 12
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.	Baseline, Week 12
Percent Change From Baseline in Triglycerides at Week 12	Baseline value was defined as the last observation before the first dose of the treatment.	Baseline, Week 12
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.	Baseline (Pre-SIAQ), Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96
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.	Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• Cefalù 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2015
• Primary Completion (Actual): April 12, 2019
• Study Completion (Actual): April 12, 2019

Study Registration Dates

• First Submitted: June 16, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium; Simvastatin; Ezetimibe
• Other Study ID Numbers: LPS14245; 2015-000620-28 (EudraCT Number); U1111-1163-0984 (Other Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• product manufactured in and exported from the U.S.: Yes