Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY EAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715726
Recruitment Status : Completed
First Posted : March 22, 2016
Results First Posted : September 30, 2019
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypercholesterolemia
Interventions Drug: Alirocumab
Drug: Placebo for alirocumab
Drug: ezetimibe
Drug: placebo for ezetimibe
Drug: atorvastatin
Drug: rosuvastatin
Drug: simvastatin
Enrollment 615
Recruitment Details The study was conducted at 61 centers in China, India and Thailand. Overall 1163 participants were screened between 27 July 2016 and 18 December 2017, of whom 548 were screen failures. Screen failures were mainly due to exclusion criteria met. A total of 615 participants were randomized in 2:1 ratio to alirocumab: ezetimibe.
Pre-assignment Details Randomization was stratified according to prior history of myocardial infarction (MI) or ischemic stroke [Yes/No], and high-intensity statin treatment (Yes: atorvastatin 40 to 80 mg daily or rosuvastatin 20 to 40 mg daily, no: atorvastatin below 40 mg daily, rosuvastatin below 20 mg daily or simvastatin whatever the dose daily) and country.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description Oral ezetimibe 10 mg capsule once daily with or without food for 24 Weeks and subcutaneous placebo injection for alirocumab every 2 weeks (Q2W) for 22 weeks added to lipid modifying therapy (LMT). Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when low-density lipoprotein cholesterol (LDL-C) level was >=70 milligrams per deciliter (mg/dL) (1.81 millimoles per liter [mmol/L]) at Week 8.
Period Title: Overall Study
Started 208 [1] 407 [1]
Treated 207 405
Safety Population [2] 206 406
Completed 190 380
Not Completed 18 27
Reason Not Completed
Adverse Event             2             6
Protocol Violation             1             0
Death             2             1
Participant moved             1             3
Other than specified above             11             15
Randomized but not treated             1             2
[1]
Randomized
[2]
1 participant of ezetimibe arm received alirocumab: counted in alirocumab arm for safety analysis.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W Total
Hide Arm/Group Description Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT. Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8. Total of all reporting groups
Overall Number of Baseline Participants 208 407 615
Hide Baseline Analysis Population Description
Analysis was performed on randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 208 participants 407 participants 615 participants
58.3  (11.2) 58.8  (10.7) 58.6  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 407 participants 615 participants
Female
62
  29.8%
92
  22.6%
154
  25.0%
Male
146
  70.2%
315
  77.4%
461
  75.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 208 participants 407 participants 615 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
208
 100.0%
407
 100.0%
615
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Calculated LDL-C in mmol/L   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 208 participants 407 participants 615 participants
2.875  (1.287) 2.862  (1.253) 2.866  (1.264)
[1]
Measure Description: Calculated LDL-C in mmol/L from Friedewald formula (LDL-C = Total cholesterol - High-density lipoprotein cholesterol [HDL-C] - [Triglyceride/2.2]).
1.Primary Outcome
Title Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: Intent-to-treat (ITT) Analysis
Hide Description Adjusted least square (LS) means and standard errors at Week 24 were obtained from mixed models analysis with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-20.3  (2.0) -56.0  (1.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Alirocumab group was compared to ezetimibe group using an appropriate contrast statement.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -35.6
Confidence Interval (2-Sided) 95%
-40.6 to -30.7
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
2.Secondary Outcome
Title Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified ITT (mITT) population included all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 204 401
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-21.3  (2.0) -58.7  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments A hierarchical testing method 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 0.05 level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -37.3
Confidence Interval (2-Sided) 95%
-42.1 to -32.6
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
3.Secondary Outcome
Title Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-22.2  (1.9) -57.1  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -34.9
Confidence Interval (2-Sided) 95%
-39.5 to -30.2
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
4.Secondary Outcome
Title Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol at Week 12: On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 204 401
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-22.7  (1.9) -58.1  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -35.4
Confidence Interval (2-Sided) 95%
-40.0 to -30.7
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
5.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24: ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment (Apo B ITT population).
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 203 398
Least Squares Mean (Standard Error)
Unit of Measure: percent Change
-16.2  (1.4) -43.5  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments Threshold for significance at 0.05 level.
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -27.4
Confidence Interval (2-Sided) 95%
-30.8 to -23.9
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
6.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B at Week 24: On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment (Apo B mITT population).
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 197 392
Least Squares Mean (Standard Error)
Unit of Measure: percent Change
-17.4  (1.4) -45.2  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -27.8
Confidence Interval (2-Sided) 95%
-31.2 to -24.4
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
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 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment (non-HDL-C ITT population).
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Least Squares Mean (Standard Error)
Unit of Measure: percent Change
-19.4  (1.7) -47.0  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -27.7
Confidence Interval (2-Sided) 95%
-31.8 to -23.6
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
8.Secondary Outcome
Title Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 24: On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline non-HDL-C value on-treatment (non-HDL-C mITT population).
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 204 401
Least Squares Mean (Standard Error)
Unit of Measure: percent Change
-20.4  (1.7) -49.1  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -28.7
Confidence Interval (2-Sided) 95%
-32.6 to -24.7
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
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 were obtained from MMRM model including all available post-baseline data from Week 4 up to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment (Total-C ITT population).
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Least Squares Mean (Standard Error)
Unit of Measure: percent Change
-13.8  (1.2) -33.9  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -20.2
Confidence Interval (2-Sided) 95%
-23.1 to -17.2
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
10.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B at Week 12: ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Apo B ITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 203 398
Least Squares Mean (Standard Error)
Unit of Measure: percent Change
-16.5  (1.4) -43.0  (1.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -26.5
Confidence Interval (2-Sided) 95%
-29.8 to -23.2
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
11.Secondary Outcome
Title Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Non-HDL-C ITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Least Squares Mean (Standard Error)
Unit of Measure: percent Change
-20.7  (1.6) -47.4  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -26.7
Confidence Interval (2-Sided) 95%
-30.5 to -22.8
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
12.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol at Week 12: ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Total-C ITT population
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Least Squares Mean (Standard Error)
Unit of Measure: percent Change
-14.9  (1.2) -34.2  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -19.3
Confidence Interval (2-Sided) 95%
-22.1 to -16.5
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
13.Secondary Outcome
Title Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: ITT Analysis
Hide Description Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Measure Type: Number
Unit of Measure: percentage of participants
40.5 85.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Regression, Logistic
Comments Multiple imputation approach followed by logistic regression model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 11.2
Confidence Interval (2-Sided) 95%
7.1 to 17.7
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe
14.Secondary Outcome
Title Percentage of Participants Reaching Calculated Low Density Lipoprotein Cholesterol <70 mg/dL (1.81 mmol/L) at Week 24: On-Treatment Analysis
Hide Description Adjusted percentages at Week 24 were obtained from multiple imputation approach including all available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule, whichever came first) (on-treatment analysis).
Time Frame Up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 204 401
Measure Type: Number
Unit of Measure: percentage of participants
42.1 87.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Regression, Logistic
Comments Multiple imputation approach followed by logistic regression model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 13.6
Confidence Interval (2-Sided) 95%
8.3 to 22.3
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs Ezetimibe
15.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 24: ITT Analysis
Hide Description Adjusted means and standard errors at Week 24 were obtained from multiple imputation approach followed by robust regression model for handling missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were included in the imputation model.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Mean (Standard Error)
Unit of Measure: percent Change
3.956  (2.095) -30.317  (1.461)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance at 0.05 level.
Method Regression, Robust
Comments Multiple imputation approach followed by a robust regression model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -34.273
Confidence Interval (2-Sided) 95%
-39.262 to -29.285
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
16.Secondary Outcome
Title Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 24: ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment (HDL-C ITT population).
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Least Squares Mean (Standard Error)
Unit of Measure: percent change
6.5  (1.3) 8.3  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe 10 mg, Alirocumab 75 mg Q2W/up to 150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2280
Comments Threshold for significance at 0.05 level.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.9
Confidence Interval (2-Sided) 95%
-1.2 to 4.9
Estimation Comments Alirocumab 75 mg Q2W/up to 150 mg Q2W vs. Ezetimibe
17.Secondary Outcome
Title Percent Change From Baseline in Fasting Triglycerides (TG) at Week 24: ITT Analysis
Hide Description Adjusted means and standard errors at Week 24 were obtained by using multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Mean (Standard Error)
Unit of Measure: percent change
-14.409  (1.904) -14.462  (1.341)
18.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24: ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment (Apo A-1 ITT population).
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 203 398
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-0.2  (0.8) 3.2  (0.6)
19.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 were obtained from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Mean (Standard Error)
Unit of Measure: percent Change
6.313  (2.056) -30.064  (1.449)
20.Secondary Outcome
Title Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12: ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
HDL-C ITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Least Squares Mean (Standard Error)
Unit of Measure: percent change
6.1  (1.2) 7.3  (0.9)
21.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 were obtained by using multiple imputation approach followed by a robust regression model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 208 403
Mean (Standard Error)
Unit of Measure: percent change
-13.585  (1.929) -9.965  (1.379)
22.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein A-1 at Week 12 : ITT Analysis
Hide Description Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Time Frame From Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Apo A-1 ITT population.
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up to 150 mg Q2W
Hide Arm/Group Description:
Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT.
Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 203 398
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.1  (0.8) 3.7  (0.6)
Time Frame All Adverse Events (AEs) were collected from signature of the informed consent form up to 32 weeks of the study regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs were treatment emergent AEs that developed or worsened during ‘the treatment emergent period’ (time from first dose of double-blind study drug intake [capsule or injection, whichever came first] to the day of last dose of double blind study drug injection + 70 days). Analysis was performed on safety population (participants who received at least 1 dose or partial dose of study drug [injection or capsule)]. Participants were analyzed according to the treatment actually received.
 
Arm/Group Title Ezetimibe 10 mg Alirocumab 75 mg Q2W/up150 mg Q2W
Hide Arm/Group Description Oral ezetimibe 10 mg capsule once daily with or without food for 24 weeks and subcutaneous placebo injection for alirocumab Q2W for 22 weeks added to LMT. Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe once daily with or without food added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C level was >=70 mg/dL (1.81 mmol/L) at Week 8.
All-Cause Mortality
Ezetimibe 10 mg Alirocumab 75 mg Q2W/up150 mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   3/206 (1.46%)      2/406 (0.49%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ezetimibe 10 mg Alirocumab 75 mg Q2W/up150 mg Q2W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/206 (11.17%)      41/406 (10.10%)    
Cardiac disorders     
Acute Coronary Syndrome  1  1/206 (0.49%)  1 1/406 (0.25%)  1
Acute Myocardial Infarction  1  3/206 (1.46%)  3 3/406 (0.74%)  3
Angina Unstable  1  0/206 (0.00%)  0 9/406 (2.22%)  9
Arrhythmia Supraventricular  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Arteriosclerosis Coronary Artery  1  1/206 (0.49%)  1 2/406 (0.49%)  2
Atrial Fibrillation  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Cardiac Failure  1  1/206 (0.49%)  1 2/406 (0.49%)  2
Cardiac Failure Acute  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Cardiac Failure Congestive  1  2/206 (0.97%)  3 0/406 (0.00%)  0
Cardio-Respiratory Arrest  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Coronary Artery Disease  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Myocardial Ischaemia  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Ear and labyrinth disorders     
Sudden Hearing Loss  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Eye disorders     
Cataract  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal Haemorrhage  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Gastrointestinal Perforation  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Haemorrhagic Erosive Gastritis  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Obstructive Pancreatitis  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Tongue Haemorrhage  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Upper Gastrointestinal Haemorrhage  1  1/206 (0.49%)  1 0/406 (0.00%)  0
General disorders     
Death  1  2/206 (0.97%)  2 0/406 (0.00%)  0
Non-Cardiac Chest Pain  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Infections and infestations     
Anal Abscess  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Appendicitis  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Bronchitis  1  0/206 (0.00%)  0 2/406 (0.49%)  2
Lung Infection  1  1/206 (0.49%)  1 1/406 (0.25%)  1
Necrotising Soft Tissue Infection  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Pneumonia  1  0/206 (0.00%)  0 4/406 (0.99%)  5
Sepsis  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Tuberculosis  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Injury, poisoning and procedural complications     
Brain Herniation  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Femoral Neck Fracture  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Femur Fracture  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Spinal Compression Fracture  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Subarachnoid Haemorrhage  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Investigations     
Alanine Aminotransferase Increased  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Metabolism and nutrition disorders     
Diabetes Mellitus  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Hypokalaemia  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Intervertebral Disc Protrusion  1  0/206 (0.00%)  0 2/406 (0.49%)  2
Limb Mass  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Lumbar Spinal Stenosis  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lung Adenocarcinoma  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Prostate Cancer  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Small Cell Lung Cancer  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Nervous system disorders     
Brain Oedema  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Cerebral Arteriosclerosis  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Cerebral Artery Occlusion  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Cerebral Infarction  1  0/206 (0.00%)  0 1/406 (0.25%)  2
Cerebral Ischaemia  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Cerebrovascular Insufficiency  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Coma  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Ischaemic Cerebral Infarction  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Ischaemic Stroke  1  2/206 (0.97%)  2 0/406 (0.00%)  0
Loss Of Consciousness  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Ureterolithiasis  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Reproductive system and breast disorders     
Adnexa Uteri Cyst  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Benign Prostatic Hyperplasia  1  0/206 (0.00%)  0 1/406 (0.25%)  2
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Lung Disorder  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Respiratory Failure  1  0/206 (0.00%)  0 1/406 (0.25%)  1
Upper-Airway Cough Syndrome  1  1/206 (0.49%)  1 0/406 (0.00%)  0
Vascular disorders     
Peripheral Arterial Occlusive Disease  1  0/206 (0.00%)  0 1/406 (0.25%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ezetimibe 10 mg Alirocumab 75 mg Q2W/up150 mg Q2W
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/206 (19.90%)      71/406 (17.49%)    
Infections and infestations     
Upper Respiratory Tract Infection  1  29/206 (14.08%)  39 54/406 (13.30%)  69
Injury, poisoning and procedural complications     
Accidental Overdose  1  15/206 (7.28%)  21 27/406 (6.65%)  40
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi aventis recherche & développement
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02715726     History of Changes
Other Study ID Numbers: EFC13889
U1111-1150-8859 ( Other Identifier: UTN )
First Submitted: March 16, 2016
First Posted: March 22, 2016
Results First Submitted: August 5, 2019
Results First Posted: September 30, 2019
Last Update Posted: September 30, 2019