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Study of the Safety and Efficacy of REGN727/SAR236553 in Patients With HeFH Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT01266876
Recruitment Status : Completed
First Posted : December 24, 2010
Results First Posted : September 22, 2015
Last Update Posted : September 22, 2015
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypercholesterolemia
Interventions Drug: Alirocumab
Drug: Placebo
Enrollment 77
Recruitment Details The study was conducted at 16 centers in the United States of America and Canada. Overall, 118 participants were screened between January 2011 and June 2011.
Pre-assignment Details Randomization was stratified by concomitant use of ezetimibe (Yes/No). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1:1 ratio after confirmation of selection criteria. 77 participants were randomized.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description Placebo subcutaneous (SC) injection once every two weeks (Q2W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 150 mg SC injection once every 4 weeks (Q4W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Period Title: Overall Study
Started 15 15 16 15 16
Completed 15 15 16 14 16
Not Completed 0 0 0 1 0
Reason Not Completed
Adverse Event             0             0             0             1             0
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W Total
Hide Arm/Group Description Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 15 15 16 15 16 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 16 participants 15 participants 16 participants 77 participants
51.9  (9.6) 51.3  (7.7) 52.9  (11.2) 54.3  (9.6) 56.3  (10.2) 53.4  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 16 participants 15 participants 16 participants 77 participants
Female
6
  40.0%
6
  40.0%
7
  43.8%
8
  53.3%
3
  18.8%
30
  39.0%
Male
9
  60.0%
9
  60.0%
9
  56.3%
7
  46.7%
13
  81.3%
47
  61.0%
Low Density Lipoprotein Cholesterol (LDL-C) in mg/dL   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 15 participants 15 participants 16 participants 15 participants 16 participants 77 participants
150.8  (34.0) 166.7  (50.1) 169.8  (57.0) 139.6  (24.7) 147.2  (32.6) 154.9  (42.1)
[1]
Measure Description: Calculated LDL-C from Friedewald formula.
1.Primary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis
Hide Description Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational medicinal product (IMP) injection up to 21 days after last IMP injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-10.7  (5.0) -28.9  (5.1) -31.5  (4.9) -42.5  (5.1) -67.9  (4.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alirocumab 150 mg Q2W
Comments

Each treatment group was compared to placebo using ANCOVA-derived contrasts.

A hierarchical testing procedure was applied to ensure strong control of overall Type-I error rate at 0.05 level. Order was following:

  1. Alirocumab 150 mg Q2W versus placebo
  2. Alirocumab 300 mg Q4W versus placebo
  3. Alirocumab 200 mg Q4W versus placebo
  4. Alirocumab 150 mg Q4W versus placebo

Testing continued only when high-order test was statistically significant at 5% level.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments Threshold for significance at ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alirocumab 300 mg Q4W
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments Threshold for significance at ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Alirocumab 200 mg Q4W
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments Threshold for significance at ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Alirocumab 150 mg Q4W
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0113
Comments Threshold for significance at ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change From Baseline in Calculated LDL-C at Week 12 - On-treatment Analysis
Hide Description Calculated LDL-C value was obtained from Friedewald formula. Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-19.1  (7.9) -42.2  (8.0) -51.3  (7.7) -66.9  (8.0) -102.5  (7.6)
3.Secondary Outcome
Title Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12 - On-treatment Analysis
Hide Description Calculated LDL-C value was obtained from Friedewald formula.
Time Frame Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Measure Type: Number
Unit of Measure: percentage of participants
13.3 26.7 18.8 66.7 93.8
4.Secondary Outcome
Title Percentage of Participants Achieving LDL-C < 70 mg/dL (1.81 mmol/L) at Week 12 - On-treatment Analysis
Hide Description Calculated LDL-C value was obtained from Friedewald formula.
Time Frame Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one on-treatment calculated LDL-C.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Measure Type: Number
Unit of Measure: percentage of participants
0.0 13.3 12.5 46.7 81.3
5.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one on-treatment total cholesterol value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-8.5  (3.8) -18.1  (3.9) -19.7  (3.7) -25.7  (3.8) -43.6  (3.7)
6.Secondary Outcome
Title Absolute Change From Baseline in Total Cholesterol at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment total cholesterol value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-20.3  (9.4) -40.3  (9.5) -50.1  (9.2) -61.7  (9.5) -99.9  (9.1)
7.Secondary Outcome
Title Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint..
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one on-treatment HDL-C value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.2  (3.7) 7.9  (3.7) 6.5  (3.5) 1.00  (3.8) 12.3  (3.6)
8.Secondary Outcome
Title Absolute Change From Baseline in HDL-C at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline HDL-C value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
0.4  (1.9) 4.2  (1.9) 3.3  (1.8) 4.5  (2.0) 6.0  (1.8)
9.Secondary Outcome
Title Percent Change From Baseline in Triglycerides at Week 12 - On-treatment Analysis
Hide Description Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Median (Inter-Quartile Range)
Unit of Measure: percent change
-10.6
(-28.5 to 9.5)
-16.7
(-30.1 to 21.1)
-13.2
(-30.9 to 7.4)
-4.9
(-17.0 to 10.3)
-16.2
(-30.7 to 25.1)
10.Secondary Outcome
Title Absolute Change From Baseline in Triglycerides at Week at 12 - On-treatment Analysis
Hide Description Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment fasting triglycerides value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
-11.0
(-89.5 to 7.5)
-20.0
(-37.0 to 13.0)
-13.5
(-35.3 to 9.5)
-3.5
(-33.0 to 6.0)
-14.8
(-64.5 to 34.0)
11.Secondary Outcome
Title Percent Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-11.3  (4.7) -26.8  (4.8) -27.4  (4.6) -39.0  (4.8) -57.9  (4.6)
12.Secondary Outcome
Title Absolute Change From Baseline in Non-HDL-C at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment non-HDL-C value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-22.8  (8.8) -46.0  (8.9) -52.3  (8.6) -70.6  (9.0) -103.6  (8.5)
13.Secondary Outcome
Title Percent Change From Baseline in Apo Lipoprotein B (Apo-B) at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-6.4  (4.2) -20.9  (4.2) -20.9  (4.0) -28.4  (4.3) -50.2  (4.0)
14.Secondary Outcome
Title Absolute Change From Baseline in Apo-B at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-9.3  (5.5) -24.3  (5.5) -28.7  (5.3) -34.7  (5.6) -64.4  (5.3)
15.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein - A1 (Apo-A1) at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-5.3  (3.1) 2.4  (3.1) 1.7  (2.9) 5.6  (3.1) 8.8  (2.9)
16.Secondary Outcome
Title Absolute Change From Baseline in Apo-A1 at Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-A1 value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-9.7  (4.6) 3.4  (4.5) 2.8  (4.3) 7.8  (4.6) 11.0  (4.4)
17.Secondary Outcome
Title Absolute Change in the Ratio ApoB/ApoA-1 From Baseline to Week 12 - On-treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame From Baseline to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment Apo-B and ApoA-1 value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Least Squares Mean (Standard Error)
Unit of Measure: ratio
-0.03  (0.04) -0.18  (0.04) -0.20  (0.04) -0.25  (0.04) -0.49  (0.04)
18.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis
Hide Description Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range)
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Median (Inter-Quartile Range)
Unit of Measure: percent change
-3.9
(-18.4 to 0.0)
-10.1
(-22.2 to 3.8)
-7.5
(-22.5 to 0.0)
-15.3
(-25.2 to 10.6)
-23.4
(-44.6 to -6.6)
19.Secondary Outcome
Title Absolute Change From Baseline in Lipoprotein(a) at Week 12 - On-treatment Analysis
Hide Description Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameter, percent changes were expressed as median (interquartile range)
Time Frame From Baseline to Week 12 (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population included all randomized participants with one baseline and at least one post baseline on-treatment lipoprotein(a) value.
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description:
Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
Overall Number of Participants Analyzed 15 15 16 15 16
Median (Inter-Quartile Range)
Unit of Measure: mg/dL
-2.0
(-7.0 to 0.0)
-1.5
(-10.0 to 1.5)
-1.8
(-5.0 to 0.0)
-8.0
(-19.0 to 5.0)
-11.5
(-26.0 to 1.8)
Time Frame From Baseline up to Week 12
Adverse Event Reporting Description Treatment emergent adverse events that developed during treatment emergent adverse events period (the time from the first dose of study drug to the last dose of study drug + 70 days (10 weeks) are reported.
 
Arm/Group Title Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Hide Arm/Group Description Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks. Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
All-Cause Mortality
Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      0/15 (0.00%)      0/16 (0.00%)      0/15 (0.00%)      0/16 (0.00%)    
Gastrointestinal disorders           
Intestinal obstruction  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Alirocumab 150 mg Q4W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Alirocumab 150 mg Q2W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/15 (60.00%)      12/15 (80.00%)      13/16 (81.25%)      13/15 (86.67%)      12/16 (75.00%)    
Blood and lymphatic system disorders           
Anaemia  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Ear and labyrinth disorders           
Cerumen impaction  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Tinnitus  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Eye disorders           
Conjunctivitis  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Ocular icterus  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Gastrointestinal disorders           
Abdominal discomfort  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Abdominal distension  1  0/15 (0.00%)  0 1/15 (6.67%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Abdominal pain  1  0/15 (0.00%)  0 1/15 (6.67%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0 1/16 (6.25%)  1
Abdominal pain upper  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Constipation  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Diarrhoea  1  0/15 (0.00%)  0 3/15 (20.00%)  4 3/16 (18.75%)  3 1/15 (6.67%)  1 0/16 (0.00%)  0
Flatulence  1  0/15 (0.00%)  0 1/15 (6.67%)  2 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Gastritis erosive  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Gingivitis  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Gingivitis ulcerative  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Haematochezia  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Haemorrhoids  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Intestinal obstruction  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Nausea  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 2/16 (12.50%)  4
Toothache  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
General disorders           
Chest discomfort  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Chills  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Fatigue  1  1/15 (6.67%)  1 2/15 (13.33%)  3 1/16 (6.25%)  1 2/15 (13.33%)  2 0/16 (0.00%)  0
Feeling hot  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Influenza like illness  1  0/15 (0.00%)  0 1/15 (6.67%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Injection site discolouration  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Injection site dryness  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/15 (6.67%)  2 0/16 (0.00%)  0
Injection site erythema  1  0/15 (0.00%)  0 2/15 (13.33%)  2 4/16 (25.00%)  6 4/15 (26.67%)  12 0/16 (0.00%)  0
Injection site exfoliation  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  2 2/15 (13.33%)  3 0/16 (0.00%)  0
Injection site haematoma  1  1/15 (6.67%)  1 3/15 (20.00%)  4 0/16 (0.00%)  0 2/15 (13.33%)  3 1/16 (6.25%)  1
Injection site haemorrhage  1  1/15 (6.67%)  1 0/15 (0.00%)  0 2/16 (12.50%)  2 0/15 (0.00%)  0 2/16 (12.50%)  2
Injection site oedema  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Injection site pain  1  0/15 (0.00%)  0 1/15 (6.67%)  2 0/16 (0.00%)  0 1/15 (6.67%)  1 2/16 (12.50%)  3
Injection site paraesthesia  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  3
Injection site pruritus  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 3/15 (20.00%)  6 0/16 (0.00%)  0
Injection site rash  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 2/16 (12.50%)  5
Injection site reaction  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1 0/16 (0.00%)  0
Injection site swelling  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  2 0/16 (0.00%)  0
Injection site urticaria  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  3 0/16 (0.00%)  0
Injection site vesicles  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Non-Cardiac chest pain  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Oedema peripheral  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Pyrexia  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Infections and infestations           
Bronchitis  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Diverticulitis  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Fungal skin infection  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Gastroenteritis  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Infected bites  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Influenza  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Nasopharyngitis  1  2/15 (13.33%)  3 0/15 (0.00%)  0 2/16 (12.50%)  2 1/15 (6.67%)  1 0/16 (0.00%)  0
Oral herpes  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Pharyngitis streptococcal  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Pneumonia  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Prostate infection  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Rhinitis  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Sinusitis  1  0/15 (0.00%)  0 2/15 (13.33%)  2 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Upper respiratory tract infection  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 2/15 (13.33%)  2 0/16 (0.00%)  0
Urinary tract infection  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1 0/16 (0.00%)  0
Vaginal infection  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  2 0/15 (0.00%)  0 0/16 (0.00%)  0
Injury, poisoning and procedural complications           
Concussion  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 1/16 (6.25%)  1
Epicondylitis  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Hand fracture  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Laceration  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Limb injury  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Muscle injury  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Muscle strain  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Rib fracture  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Tendon injury  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1 0/16 (0.00%)  0
Tendon rupture  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Investigations           
Bacterial test positive  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Blood pressure increased  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Blood pressure systolic decreased  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Cardiac murmur  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Thyroxine decreased  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Urinary sediment present  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
White blood cell count decreased  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Metabolism and nutrition disorders           
Glucose tolerance impaired  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/15 (6.67%)  1 2/15 (13.33%)  2 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Arthritis  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Exostosis  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Muscle spasms  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Musculoskeletal pain  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Musculoskeletal stiffness  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Myalgia  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Pain in extremity  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Plantar fasciitis  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Rotator cuff syndrome  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Tendonitis  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Nervous system disorders           
Dizziness  1  0/15 (0.00%)  0 1/15 (6.67%)  1 1/16 (6.25%)  1 0/15 (0.00%)  0 1/16 (6.25%)  1
Dizziness postural  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Headache  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 2/16 (12.50%)  2
Migraine  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Migraine with aura  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Sciatica  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  3 0/16 (0.00%)  0
Psychiatric disorders           
Depression  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Disorientation  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Panic attack  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Renal and urinary disorders           
Calculus urinary  1  0/15 (0.00%)  0 1/15 (6.67%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Dysuria  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Haematuria  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Micturition urgency  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Reproductive system and breast disorders           
Haematospermia  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Bronchial hyperreactivity  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Cough  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Nasal congestion  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Oropharyngeal pain  1  0/15 (0.00%)  0 2/15 (13.33%)  3 1/16 (6.25%)  1 1/15 (6.67%)  1 0/16 (0.00%)  0
Rales  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Rhinitis allergic  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Rhinorrhoea  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Skin and subcutaneous tissue disorders           
Dermatitis contact  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Erythema  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Petechiae  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Pruritus  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0
Rash  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1 0/16 (0.00%)  0
Rash erythematous  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Skin burning sensation  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0
Vascular disorders           
Flushing  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0
Hypertension  1  2/15 (13.33%)  2 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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.
Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.
Results Point of Contact
Name/Title: Clinical Trial Management
Organization: Regeneron Pharmaceuticals, Inc
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01266876     History of Changes
Other Study ID Numbers: R727-CL-1003
First Submitted: December 23, 2010
First Posted: December 24, 2010
Results First Submitted: August 20, 2015
Results First Posted: September 22, 2015
Last Update Posted: September 22, 2015