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Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) (ODYSSEY FH II)

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ClinicalTrials.gov Identifier: NCT01709500
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Heterozygous Familial Hypercholesterolemia
Interventions Drug: LMT (atorvastatin, simvastatin, or rosuvastatin)
Drug: alirocumab
Drug: Placebo
Enrollment 249

Recruitment Details The study was conducted at 26 sites in 4 countries. Overall, 322 participants were screened between 28 Nov 2012 and 26 Apr 2013, 73 of whom were screen failures.
Pre-assignment Details Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, and intensity of statin treatment. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 2:1 (alirocumab: placebo) ratio after confirmation of selection criteria.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8. Placebo matched to alirocumab SC injection for 78-week treatment duration.
Period Title: Overall Study
Started 167 82
Treated 167 81
Completed 0 0
Not Completed 167 82
Reason Not Completed
Randomized but not treated             0             1
Adverse Event             5             1
Poor compliance to protocol             2             1
Other             3             1
Related to IMP administration             1             0
Treatment ongoing             156             78
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo Total
Hide Arm/Group Description Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8. Placebo matched to alirocumab SC injection for 78­-week treatment duration. Total of all reporting groups
Overall Number of Baseline Participants 167 82 249
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 167 participants 82 participants 249 participants
53.2  (12.93) 53.2  (12.55) 53.2  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 167 participants 82 participants 249 participants
Female
81
  48.5%
37
  45.1%
118
  47.4%
Male
86
  51.5%
45
  54.9%
131
  52.6%
Calculated LDL-C in mmol/L   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 167 participants 82 participants 249 participants
3.485  (1.065) 3.471  (1.071) 3.480  (1.065)
[1]
Measure Description: Calculated LDL-C values were obtained using Friedewald formula.
Calculated LDL-C in mg/dL   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 167 participants 82 participants 249 participants
134.6  (41.1) 134.0  (41.4) 134.4  (41.1)
[1]
Measure Description: Calculated LDL-C values were obtained using Friedewald formula.
1.Primary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent­-to­-Treat (ITT) Analysis
Hide Description Calculated LDL-C values were obtained using the Friedewald formula. Adjusted Least­ squares (LS) means and standard errors at Week 24 were obtained from a mixed ­effect model with repeated measures (MMRM) to account for missing data. All available post ­baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were used in the model.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-48.7  (1.9) 2.8  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Alirocumab group was compared to the placebo group using an appropriate contrast statement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -51.4
Confidence Interval (2-Sided) 95%
-58.1 to -44.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
Hide Description Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-49.4  (1.9) 2.7  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when previous endpoint was statistically significant at 5% level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -52.2
Confidence Interval (2-Sided) 95%
-58.7 to -45.6
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment (ITT analysis).
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-43.8  (1.8) 4.6  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -48.4
Confidence Interval (2-Sided) 95%
-54.7 to -42.2
Estimation Comments [Not Specified]
4.Secondary 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. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-44.2  (1.8) 4.6  (2.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -48.8
Confidence Interval (2-Sided) 95%
-55 to -42.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 163 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-42.8  (1.4) -3.5  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -39.3
Confidence Interval (2-Sided) 95%
-44.1 to -34.5
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on­treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 162 80
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-43.2  (1.4) -3.5  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -39.8
Confidence Interval (2-Sided) 95%
-44.5 to -35.1
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percent Change From Baseline in Non-High ­Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-42.6  (1.8) 3.1  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -45.7
Confidence Interval (2-Sided) 95%
-51.8 to -39.7
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-43.2  (1.7) 3.1  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -46.4
Confidence Interval (2-Sided) 95%
-52.3 to -40.4
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline total-C value on- or off-treatment.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-30.6  (1.4) 2.1  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -32.8
Confidence Interval (2-Sided) 95%
-37.4 to -28.1
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Apo B ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 163 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-35.4  (1.4) -0.9  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -34.5
Confidence Interval (2-Sided) 95%
-39.2 to -29.8
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Non-HDL-C ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-37.9  (1.7) 4.1  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -42
Confidence Interval (2-Sided) 95%
-47.8 to -36.2
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post baseline data from Week 4 to Week 52 regardless of status on- or off treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total-­C ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-26.6  (1.3) 3.4  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Threshold for significance ≤ 0.05.
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -29.9
Confidence Interval (2-Sided) 95%
-34.5 to -25.4
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
Hide Description Calculated LDL-C values were obtained using the Friedewald formula. Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on­ or off treatment (ITT analysis).
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-50.3  (2.3) 8.4  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -58.8
Confidence Interval (2-Sided) 95%
-66.8 to -50.8
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Very High CV Risk Participants Reaching Calculated LDL­C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL­C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis
Hide Description Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on­ or off-treatment were included in the imputation model (ITT analysis).
Time Frame Up to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Measure Type: Number
Unit of Measure: percentage of participants
81.4 11.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 52.2
Confidence Interval (2-Sided) 95%
20.9 to 130
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Very High CV Risk Participants Reaching Calculated LDL­-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL­-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis
Hide Description Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).
Time Frame Up to week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Measure Type: Number
Unit of Measure: percentage of participants
82.1 11.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 53.3
Confidence Interval (2-Sided) 95%
21.4 to 132.6
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants Reaching Calculated LDL­C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
Hide Description Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).
Time Frame Up to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Measure Type: Number
Unit of Measure: percentage of participants
68.2 1.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 239.7
Confidence Interval (2-Sided) 95%
31.6 to 1820.3
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants Reaching Calculated LDL­-C <70 mg/dL (1.81 mmol/L) at Week 52 - On-Treatment Analysis
Hide Description Adjusted percentages at Week 52 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection (on-treatment analysis).
Time Frame Up to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Measure Type: Number
Unit of Measure: percentage of participants
68.8 1.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a Logistic regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 240.6
Confidence Interval (2-Sided) 95%
31.4 to 1841.7
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis
Hide Description Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed: participants of the ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Mean (Standard Error)
Unit of Measure: percent change
-30.3  (1.8) -10  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Robust
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -20.3
Confidence Interval (2-Sided) 95%
-26.4 to -14.2
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
6.0  (1.2) -0.8  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0009
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 6.8
Confidence Interval (2-Sided) 95%
2.8 to 10.7
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
Hide Description Adjusted means and standard errors at Week 24 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed: participants of the ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Mean (Standard Error)
Unit of Measure: percent change
-10.4  (2) 0.5  (2.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure. Statistical analysis used a multiple imputation approach followed by a robust regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0012
Comments Threshold for significance ≤ 0.05.
Method Regression, Robust
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -10.9
Confidence Interval (2-Sided) 95%
-17.5 to -4.3
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 163 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.8  (0.9) -1.6  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0062
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.4
Confidence Interval (2-Sided) 95%
1.3 to 7.5
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis
Hide Description Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Lipoprotein (a) ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Mean (Standard Deviation)
Unit of Measure: percent change
-24.7  (1.7) -5.6  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Robust
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -19.1
Confidence Interval (2-Sided) 95%
-25 to -13.1
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
HDL-C ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
6.0  (1.0) -0.8  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.0147
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 4.3
Confidence Interval (2-Sided) 95%
0.9 to 7.8
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
Hide Description Adjusted means and standard errors at Week 12 from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Fasting triglycerides ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 166 81
Mean (Standard Error)
Unit of Measure: percent change
-8.1  (2.2) 0.6  (3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant). Statistical analysis used a multiple imputation approach followed by a robust regression model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.024
Comments Threshold for significance ≤ 0.05.
Method Regression, Robust
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -8.6
Confidence Interval (2-Sided) 95%
-16.1 to -1.1
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Percent Change From Baseline in Apo A­1 at Week 12 - ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.
Time Frame From Baseline to Week 52
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Apo A-1 ITT population.
Arm/Group Title Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description:
Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
Placebo matched to alirocumab SC injection for 78-week treatment duration.
Overall Number of Participants Analyzed 163 81
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.4  (0.9) -1.9  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Alirocumab 75 mg/up to 150 mg, Placebo
Comments Testing according to the hierarchical testing procedure (previous endpoints were statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.1475
Comments Threshold for significance ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-0.8 to 5.5
Estimation Comments [Not Specified]
Time Frame From Baseline up to Week 78
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 Alirocumab 75 mg/up to 150 mg Placebo
Hide Arm/Group Description Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 76 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8. Placebo matched to alirocumab SC injection for 78-week treatment duration.
All-Cause Mortality
Alirocumab 75 mg/up to 150 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Alirocumab 75 mg/up to 150 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/167 (5.99%)      7/81 (8.64%)    
Cardiac disorders     
Acute coronary syndrome  1  0/167 (0.00%)  0 1/81 (1.23%) 
Angina pectoris  1  1/167 (0.60%)  0/81 (0.00%) 
Angina unstable  1  0/167 (0.00%)  1/81 (1.23%) 
Cardiogenic shock  1  0/167 (0.00%)  1/81 (1.23%) 
Coronary artery stenosis  1  1/167 (0.60%)  1 0/81 (0.00%) 
Myocardial infarction  1  0/167 (0.00%)  1/81 (1.23%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage  1  0/167 (0.00%)  1/81 (1.23%) 
General disorders     
Device dislocation  1  1/167 (0.60%)  0/81 (0.00%) 
Non-Cardiac chest pain  1  0/167 (0.00%)  1/81 (1.23%) 
Infections and infestations     
Appendicitis  1  1/167 (0.60%)  0/81 (0.00%) 
Endocarditis  1  0/167 (0.00%)  1/81 (1.23%) 
Hepatitis a  1  1/167 (0.60%)  0/81 (0.00%) 
Lower respiratory tract infection  1  0/167 (0.00%)  1/81 (1.23%) 
Viral infection  1  0/167 (0.00%)  1/81 (1.23%) 
Injury, poisoning and procedural complications     
Femoral neck fracture  1  0/167 (0.00%)  1/81 (1.23%) 
Lumbar vertebral fracture  1  1/167 (0.60%)  0/81 (0.00%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain  1  1/167 (0.60%)  1/81 (1.23%) 
Osteoarthritis  1  1/167 (0.60%)  0/81 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Rectal adenocarcinoma  1  1/167 (0.60%)  0/81 (0.00%) 
Nervous system disorders     
Syncope  1  0/167 (0.00%)  1/81 (1.23%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/167 (0.60%)  0/81 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, meddra (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Alirocumab 75 mg/up to 150 mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/167 (38.92%)      35/81 (43.21%)    
Gastrointestinal disorders     
Diarrhoea  1  9/167 (5.39%)  1/81 (1.23%) 
General disorders     
Injection site reaction  1  18/167 (10.78%)  6/81 (7.41%) 
Infections and infestations     
Influenza  1  24/167 (14.37%)  6/81 (7.41%) 
Nasopharyngitis  1  18/167 (10.78%)  16/81 (19.75%) 
Musculoskeletal and connective tissue disorders     
Myalgia  1  10/167 (5.99%)  5/81 (6.17%) 
Nervous system disorders     
Headache  1  14/167 (8.38%)  7/81 (8.64%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, meddra (17.0)
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: NCT01709500     History of Changes
Other Study ID Numbers: R727-CL-1112
First Submitted: October 8, 2012
First Posted: October 18, 2012
Results First Submitted: July 29, 2015
Results First Posted: October 28, 2015
Last Update Posted: October 28, 2015