Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02476006
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02476006
Recruitment Status : Completed
First Posted : June 19, 2015
Results First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypercholesterolemia
Interventions Drug: ALIROCUMAB SAR236553 (REGN727)
Drug: placebo (for injection training only)
Drug: ezetimibe
Drug: atorvastatin
Drug: rosuvastatin
Drug: simvastatin
Enrollment 998
Recruitment Details The study was conducted at 156 sites in 17 countries. A total of 1305 participants were screened between 23-June-2015 to 27-December 2016, of whom 307 were screen failures. Screen failures were mainly due to exclusion criteria met.
Pre-assignment Details A total of 998 participants were enrolled in the study.
Arm/Group Title Alirocumab
Hide Arm/Group Description Participants received Alirocumab 150 milligram (mg) subcutaneously (SC) once every two weeks (Q2W) or 75 mg SC Q2W added to stable lipid modifying therapies (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.
Period Title: Overall Study
Started 998
Treated 994
Completed 878
Not Completed 120
Reason Not Completed
Death             4
Lack of treatment efficacy             2
Pregnancy             1
Participant did not wish to continue             39
Adverse Event             41
Poor compliance to study protocol             3
Sponsor decision             6
Lost to Follow-up             5
Physician Decision             5
Study ended treatment not available             4
Switched to commercial drug             4
Excluded from study             1
Protocol Violation             1
Enrolled but not treated             4
Arm/Group Title Alirocumab
Hide Arm/Group Description Participants received Alirocumab 150 mg SC 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.
Overall Number of Baseline Participants 994
Hide Baseline Analysis Population Description
Analysis was performed on safety population that included all participants who had signed the informed consent form (ICF) and who had received at least one dose or partial dose of alirocumab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 994 participants
56.6  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 994 participants
Female
369
  37.1%
Male
625
  62.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 994 participants
White/Caucasian
969
  97.5%
Black
10
   1.0%
Asian/Oriental
6
   0.6%
Multiracial
1
   0.1%
Other
8
   0.8%
1.Primary Outcome
Title Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population.
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 994
Measure Type: Number
Unit of Measure: percentage of participants
Any TEAE 71.6
Any treatment emergent SAE 16.2
Any TEAE leading to death 0.2
Any TEAE leading to treatment discontinuation 4.5
2.Secondary Outcome
Title Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 12
Hide Description 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.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on modified intent-to-treat population (mITT): all enrolled participants who received at least one dose or part of a dose of alirocumab and had an evaluable efficacy endpoint during the efficacy treatment period (defined as time period from the first injection of alirocumab up to the day of last injection +21 days).
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 921
Mean (Standard Deviation)
Unit of Measure: percent change
-54.84  (20.06)
3.Secondary Outcome
Title Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12
Hide Description 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.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on mITT population.
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 921
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.6
(71.7 to 77.4)
4.Secondary Outcome
Title Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 12
Hide Description 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.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on mITT population.
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 921
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.2
(46.9 to 53.4)
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame At Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on mITT population.
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 921
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
69.1
(66.0 to 72.0)
6.Secondary Outcome
Title Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Hide Description Baseline value was defined as the last observation before the first dose of the treatment.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on mITT population.
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 921
Mean (Standard Deviation)
Unit of Measure: percent change
-45.89  (35.82)
7.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12
Hide Description Baseline value was defined as the last observation before the first dose of the treatment.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on mITT population.
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 921
Mean (Standard Deviation)
Unit of Measure: percent change
-38.28  (15.20)
8.Secondary Outcome
Title Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12
Hide Description Baseline value was defined as the last observation before the first dose of the treatment.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on mITT population.
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 921
Mean (Standard Deviation)
Unit of Measure: percent change
4.37  (17.29)
9.Secondary Outcome
Title Percent Change From Baseline in Triglycerides at Week 12
Hide Description Baseline value was defined as the last observation before the first dose of the treatment.
Time Frame Baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on mITT population.
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 921
Mean (Standard Deviation)
Unit of Measure: percent change
-8.28  (33.99)
10.Secondary Outcome
Title Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections
Hide Description 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.
Time Frame Baseline (Pre-SIAQ), Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Pre and Post-SIAQ population: participants from the safety population who self-injected the training injection & completed a Pre-SIAQ before first self-injection, who self-injected study drug at least once during the study and completed a Post-SIAQ. Here, number analyzed = participants with available data at specified time points.
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 952
Mean (Standard Deviation)
Unit of Measure: units on a scale
Feelings about injections: Baseline Number Analyzed 952 participants
8.6  (1.8)
Feeling about injections: Week 4 Number Analyzed 909 participants
9.1  (1.4)
Feeling about injections: Week 8 Number Analyzed 894 participants
9.1  (1.4)
Feeling about injections: Week 12 Number Analyzed 847 participants
9.2  (1.4)
Feeling about injections: Week 24 Number Analyzed 668 participants
9.2  (1.4)
Feeling about injections: Week 48 Number Analyzed 547 participants
9.2  (1.4)
Feeling about injections: Week 72 Number Analyzed 423 participants
9.2  (1.4)
Feeling about injections: Week 96 Number Analyzed 343 participants
9.3  (1.3)
Self confidence: Baseline Number Analyzed 943 participants
6.9  (2.4)
Self Confidence: Week 4 Number Analyzed 905 participants
8.0  (2.1)
Self Confidence: Week 8 Number Analyzed 889 participants
8.1  (2.0)
Self Confidence: Week 12 Number Analyzed 844 participants
8.1  (1.9)
Self Confidence: Week 24 Number Analyzed 666 participants
8.0  (2.1)
Self Confidence: Week 48 Number Analyzed 548 participants
8.1  (2.1)
Self Confidence: Week 72 Number Analyzed 420 participants
8.3  (2.0)
Self Confidence: Week 96 Number Analyzed 340 participants
8.4  (2.0)
Satisfaction with self injection: Baseline Number Analyzed 918 participants
7.2  (2.5)
Satisfaction with self-injections: Week 4 Number Analyzed 906 participants
8.5  (1.6)
Satisfaction with self-injections: Week 8 Number Analyzed 889 participants
8.7  (1.6)
Satisfaction with self-injections: Week 12 Number Analyzed 842 participants
8.7  (1.6)
Satisfaction with self-injections: Week 24 Number Analyzed 667 participants
8.6  (1.8)
Satisfaction with self-injections: Week 48 Number Analyzed 542 participants
8.7  (1.5)
Satisfaction with self-injections: Week 72 Number Analyzed 418 participants
8.8  (1.7)
Satisfaction with self-injections: Week 96 Number Analyzed 338 participants
8.8  (1.4)
11.Secondary Outcome
Title Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use
Hide Description 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.
Time Frame Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
POST-SIAQ population: participants from safety population who self-injected at least once during the study and completed a POST-SIAQ regardless of completion of PRE-SIAQ. Here, number analyzed = participants with available data at specified time points.
Arm/Group Title Alirocumab
Hide Arm/Group Description:
Participants received Alirocumab 150 mg SC 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.
Overall Number of Participants Analyzed 979
Mean (Standard Deviation)
Unit of Measure: units on a scale
Self Image: Week 4 Number Analyzed 929 participants
9.4  (1.4)
Self Image: Week 8 Number Analyzed 915 participants
9.4  (1.4)
Self Image: Week 12 Number Analyzed 866 participants
9.4  (1.4)
Self Image: Week 24 Number Analyzed 682 participants
9.3  (1.5)
Self Image: Week 48 Number Analyzed 560 participants
9.4  (1.4)
Self Image: Week 72 Number Analyzed 433 participants
9.3  (1.5)
Self Image: Week 96 Number Analyzed 349 participants
9.4  (1.4)
Injection-site reactions: Week 4 Number Analyzed 925 participants
9.6  (0.7)
Injection-site reactions: Week 8 Number Analyzed 907 participants
9.6  (0.8)
Injection-site reactions: Week 12 Number Analyzed 862 participants
9.6  (0.7)
Injection-site reactions: Week 24 Number Analyzed 679 participants
9.5  (0.9)
Injection-site reactions: Week 48 Number Analyzed 549 participants
9.5  (0.8)
Injection-site reactions: Week 72 Number Analyzed 431 participants
9.5  (0.8)
Injection-site reactions: Week 96 Number Analyzed 353 participants
9.5  (0.8)
Ease of use: Week 4 Number Analyzed 927 participants
8.7  (1.5)
Ease of use: Week 8 Number Analyzed 914 participants
8.7  (1.6)
Ease of use: Week 12 Number Analyzed 866 participants
8.8  (1.6)
Ease of use: Week 24 Number Analyzed 676 participants
8.8  (1.6)
Ease of use: Week 48 Number Analyzed 559 participants
8.9  (1.4)
Ease of use: Week 72 Number Analyzed 432 participants
9.0  (1.5)
Ease of use: Week 96 Number Analyzed 353 participants
9.0  (1.4)
Time Frame All AEs were collected from first injection of IMP up to 2 weeks after last dose of study drug (Week 120).
Adverse Event Reporting Description Reported AEs and deaths were TEAEs that developed or worsened or became serious and deaths that occurred 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). Analysis was performed on safety population.
 
Arm/Group Title Alirocumab
Hide Arm/Group Description Participants received Alirocumab 150 mg SC 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.
All-Cause Mortality
Alirocumab
Affected / at Risk (%)
Total   2/994 (0.20%)    
Hide Serious Adverse Events
Alirocumab
Affected / at Risk (%) # Events
Total   161/994 (16.20%)    
Blood and lymphatic system disorders   
Anaemia  1  2/994 (0.20%)  2
Cardiac disorders   
Acute Coronary Syndrome  1  5/994 (0.50%)  5
Acute Myocardial Infarction  1  5/994 (0.50%)  5
Angina Pectoris  1  15/994 (1.51%)  15
Angina Unstable  1  12/994 (1.21%)  14
Aortic Valve Stenosis  1  1/994 (0.10%)  1
Arteriosclerosis Coronary Artery  1  1/994 (0.10%)  1
Atrial Fibrillation  1  5/994 (0.50%)  5
Atrial Flutter  1  1/994 (0.10%)  1
Atrial Tachycardia  1  1/994 (0.10%)  1
Atrioventricular Block Second Degree  1  1/994 (0.10%)  1
Cardiac Failure  1  3/994 (0.30%)  3
Cardiac Failure Congestive  1  1/994 (0.10%)  1
Coronary Artery Disease  1  6/994 (0.60%)  6
Coronary Artery Stenosis  1  6/994 (0.60%)  7
Coronary Ostial Stenosis  1  1/994 (0.10%)  1
Mitral Valve Stenosis  1  1/994 (0.10%)  1
Myocardial Infarction  1  3/994 (0.30%)  3
Myocardial Ischaemia  1  5/994 (0.50%)  5
Subendocardial Ischaemia  1  1/994 (0.10%)  1
Ventricular Fibrillation  1  1/994 (0.10%)  1
Congenital, familial and genetic disorders   
Accessory Navicular Syndrome  1  1/994 (0.10%)  1
Eye disorders   
Cataract  1  2/994 (0.20%)  2
Gastrointestinal disorders   
Colitis Ischaemic  1  1/994 (0.10%)  1
Diverticular Perforation  1  1/994 (0.10%)  1
Diverticulum Intestinal  1  1/994 (0.10%)  1
Dyspepsia  1  1/994 (0.10%)  1
Gastrooesophageal Reflux Disease  1  1/994 (0.10%)  1
Haemorrhoidal Haemorrhage  1  1/994 (0.10%)  1
Hypoaesthesia Oral  1  1/994 (0.10%)  1
Lower Gastrointestinal Haemorrhage  1  1/994 (0.10%)  1
Melaena  1  1/994 (0.10%)  1
Perianal Erythema  1  1/994 (0.10%)  1
Rectal Haemorrhage  1  1/994 (0.10%)  1
Umbilical Hernia  1  1/994 (0.10%)  1
General disorders   
Chest Discomfort  1  1/994 (0.10%)  1
Chest Pain  1  2/994 (0.20%)  2
Non-Cardiac Chest Pain  1  2/994 (0.20%)  2
Vascular Stent Stenosis  1  4/994 (0.40%)  4
Hepatobiliary disorders   
Bile Duct Stone  1  1/994 (0.10%)  1
Cholelithiasis  1  1/994 (0.10%)  1
Chronic Hepatitis  1  1/994 (0.10%)  1
Hepatocellular Injury  1  1/994 (0.10%)  1
Hypertransaminasaemia  1  1/994 (0.10%)  1
Infections and infestations   
Bronchitis  1  1/994 (0.10%)  1
Campylobacter Colitis  1  1/994 (0.10%)  1
Diabetic Foot Infection  1  1/994 (0.10%)  1
Diverticulitis  1  3/994 (0.30%)  3
Escherichia Sepsis  1  1/994 (0.10%)  1
Gastroenteritis Viral  1  2/994 (0.20%)  2
Liver Abscess  1  1/994 (0.10%)  1
Pneumonia  1  3/994 (0.30%)  3
Urinary Tract Infection  1  1/994 (0.10%)  1
Urosepsis  1  1/994 (0.10%)  1
Viral Infection  1  1/994 (0.10%)  1
Wound Infection  1  1/994 (0.10%)  1
Injury, poisoning and procedural complications   
Fall  1  2/994 (0.20%)  2
Hip Fracture  1  1/994 (0.10%)  1
Injury  1  1/994 (0.10%)  1
Joint Injury  1  1/994 (0.10%)  1
Lower Limb Fracture  1  1/994 (0.10%)  1
Meniscus Injury  1  2/994 (0.20%)  3
Peripheral Artery Restenosis  1  1/994 (0.10%)  1
Post Procedural Complication  1  1/994 (0.10%)  1
Post Procedural Haematoma  1  1/994 (0.10%)  1
Rib Fracture  1  2/994 (0.20%)  2
Scapula Fracture  1  1/994 (0.10%)  1
Spinal Column Injury  1  1/994 (0.10%)  1
Tendon Rupture  1  3/994 (0.30%)  3
Tibia Fracture  1  1/994 (0.10%)  1
Upper Limb Fracture  1  2/994 (0.20%)  2
Vascular Graft Occlusion  1  1/994 (0.10%)  1
Investigations   
Transaminases Increased  1  1/994 (0.10%)  1
Metabolism and nutrition disorders   
Dehydration  1  1/994 (0.10%)  1
Diabetes Mellitus  1  3/994 (0.30%)  3
Diabetes Mellitus Inadequate Control  1  1/994 (0.10%)  1
Musculoskeletal and connective tissue disorders   
Fibromyalgia  1  1/994 (0.10%)  1
Intervertebral Disc Protrusion  1  1/994 (0.10%)  1
Myopathy  1  1/994 (0.10%)  1
Osteoarthritis  1  3/994 (0.30%)  3
Polymyalgia Rheumatica  1  1/994 (0.10%)  1
Spondylolisthesis  1  1/994 (0.10%)  1
Tendonitis  1  1/994 (0.10%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Benign Neoplasm Of Prostate  1  1/994 (0.10%)  1
Bladder Cancer Stage 0, With Cancer In Situ  1  1/994 (0.10%)  1
Breast Cancer  1  1/994 (0.10%)  1
Clear Cell Renal Cell Carcinoma  1  1/994 (0.10%)  1
Colon Adenoma  1  1/994 (0.10%)  1
Gastrointestinal Tract Adenoma  1  1/994 (0.10%)  1
Lung Adenocarcinoma  1  2/994 (0.20%)  2
Myelodysplastic Syndrome  1  1/994 (0.10%)  1
Prostate Cancer  1  3/994 (0.30%)  3
Rectal Adenocarcinoma  1  1/994 (0.10%)  1
Transitional Cell Carcinoma  1  1/994 (0.10%)  1
Uterine Cancer  1  1/994 (0.10%)  1
Nervous system disorders   
Amnesia  1  1/994 (0.10%)  1
Ataxia  1  1/994 (0.10%)  1
Carotid Artery Stenosis  1  3/994 (0.30%)  3
Carpal Tunnel Syndrome  1  1/994 (0.10%)  1
Cerebrovascular Accident  1  1/994 (0.10%)  1
Facial Paralysis  1  1/994 (0.10%)  1
Headache  1  1/994 (0.10%)  1
Ischaemic Stroke  1  1/994 (0.10%)  1
Paraesthesia  1  1/994 (0.10%)  1
Seizure  1  1/994 (0.10%)  2
Syncope  1  3/994 (0.30%)  3
Transient Ischaemic Attack  1  1/994 (0.10%)  1
Product Issues   
Device Dislocation  1  1/994 (0.10%)  1
Psychiatric disorders   
Completed Suicide  1  1/994 (0.10%)  1
Depression  1  2/994 (0.20%)  2
Schizophrenia  1  1/994 (0.10%)  1
Renal and urinary disorders   
Bladder Trabeculation  1  1/994 (0.10%)  1
Nephrolithiasis  1  1/994 (0.10%)  1
Renal Impairment  1  1/994 (0.10%)  1
Reproductive system and breast disorders   
Metrorrhagia  1  1/994 (0.10%)  1
Prostatitis  1  2/994 (0.20%)  2
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  1/994 (0.10%)  1
Lung Disorder  1  2/994 (0.20%)  2
Pulmonary Embolism  1  1/994 (0.10%)  1
Skin and subcutaneous tissue disorders   
Actinic Keratosis  1  1/994 (0.10%)  1
Parapsoriasis  1  1/994 (0.10%)  1
Rash  1  1/994 (0.10%)  1
Social circumstances   
Pregnancy Of Partner  1  1/994 (0.10%)  1
Vascular disorders   
Aortic Aneurysm  1  1/994 (0.10%)  1
Aortic Dissection  1  1/994 (0.10%)  1
Deep Vein Thrombosis  1  2/994 (0.20%)  2
Hypertension  1  1/994 (0.10%)  1
Intermittent Claudication  1  2/994 (0.20%)  2
Peripheral Arterial Occlusive Disease  1  2/994 (0.20%)  2
Peripheral Artery Aneurysm  1  1/994 (0.10%)  1
Peripheral Artery Stenosis  1  2/994 (0.20%)  2
Peripheral Artery Thrombosis  1  1/994 (0.10%)  1
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alirocumab
Affected / at Risk (%) # Events
Total   221/994 (22.23%)    
Infections and infestations   
Influenza  1  53/994 (5.33%)  61
Nasopharyngitis  1  78/994 (7.85%)  86
Musculoskeletal and connective tissue disorders   
Myalgia  1  71/994 (7.14%)  93
Nervous system disorders   
Headache  1  61/994 (6.14%)  94
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi aventis recherche & développement
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02476006    
Other Study ID Numbers: LPS14245
2015-000620-28 ( EudraCT Number )
U1111-1163-0984 ( Other Identifier: UTN )
First Submitted: June 16, 2015
First Posted: June 19, 2015
Results First Submitted: March 13, 2020
Results First Posted: March 30, 2020
Last Update Posted: March 30, 2020