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Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

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ClinicalTrials.gov Identifier: NCT01644175
Recruitment Status : Completed
First Posted : July 18, 2012
Results First Posted : November 6, 2015
Last Update Posted : November 6, 2015
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: Placebo (for alirocumab)
Drug: Alirocumab
Drug: Lipid-Modifying Therapy (LMT)
Enrollment 316
Recruitment Details The study was conducted at 76 centers in the United States of America. Overall, 640 participants were screened between July 2012 and February 2013, 324 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.
Pre-assignment Details Randomization was stratified according to prior history of myocardial infarction (MI) or ischemic stroke, and intensity of statin treatment. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:2 ratio (placebo: alirocumab) after confirmation of selection criteria. 316 participants were randomized.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks. Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Period Title: Overall Study
Started 107 [1] 209 [1]
Treated 107 207
Completed 75 156
Not Completed 32 53
Reason Not Completed
Randomized But Not Treated             0             2
Adverse Event             8             13
Death             1             2
Poor compliance to protocol             9             10
Physician Decision             1             2
Participant Moved             1             2
Consent withdrawn by participant             3             4
Related to Autoinjector Administration             2             1
Last visit outside protocol visit window             4             11
Selection criteria finally not met             0             1
Site closure             2             2
Lost to Follow-up             1             0
Other than specified above             0             3
[1]
Randomized
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W Total
Hide Arm/Group Description Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks. Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8. Total of all reporting groups
Overall Number of Baseline Participants 107 209 316
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 209 participants 316 participants
63.0  (8.8) 63.0  (9.5) 63.0  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 209 participants 316 participants
Female
30
  28.0%
78
  37.3%
108
  34.2%
Male
77
  72.0%
131
  62.7%
208
  65.8%
Calculated LDL-C in mmol/L   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 107 participants 209 participants 316 participants
2.746  (0.915) 2.595  (0.764) 2.646  (0.820)
[1]
Measure Description: Calculated LDL-C in mmol/L from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/2.2]).
Calculated LDL-C in mg/dL   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 107 participants 209 participants 316 participants
106.0  (35.3) 100.2  (29.5) 102.2  (31.6)
[1]
Measure Description: Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/5]).
1.Primary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis
Hide Description 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 (ITT analysis).
Time Frame From Baseline to Week 52
Hide 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 Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-2.3  (2.7) -48.2  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Alirocumab group was compared to 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 -45.9
Confidence Interval (2-Sided) 95%
-52.5 to -39.3
Estimation Comments Alirocumab vs. placebo
2.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-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) (on-treatment analysis).
Time Frame From Baseline to Week 52
Hide 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 Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 105 204
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-0.8  (2.6) -50.7  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
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 0.05 level.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance was ≤ 0.05.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -49.9
Confidence Interval (2-Sided) 95%
-56.2 to -43.6
Estimation Comments Alirocumab vs. placebo
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.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.1  (2.5) -46.3  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -47.4
Confidence Interval (2-Sided) 95%
-53.6 to -41.3
Estimation Comments Alirocumab vs. placebo
4.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors at Week 12 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
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 105 204
Least Squares Mean (Standard Error)
Unit of Measure: percent change
1.7  (2.5) -47.6  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -49.3
Confidence Interval (2-Sided) 95%
-55.3 to -43.3
Estimation Comments Alirocumab vs. placebo
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
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 Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 96 185
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-0.9  (2.3) -36.7  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -35.8
Confidence Interval (2-Sided) 95%
-41.3 to -30.3
Estimation Comments Alirocumab vs. placebo
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 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
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 Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 93 181
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-0.4  (2.3) -37.9  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -37.5
Confidence Interval (2-Sided) 95%
-43.0 to -32.0
Estimation Comments Alirocumab vs. placebo
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
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 Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-1.6  (2.5) -39.1  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -37.5
Confidence Interval (2-Sided) 95%
-43.5 to -31.4
Estimation Comments Alirocumab vs. placebo
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 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
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 Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 105 204
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-0.5  (2.5) -40.9  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -40.4
Confidence Interval (2-Sided) 95%
-46.4 to -34.4
Estimation Comments Alirocumab vs. placebo
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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of 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 Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-2.9  (1.8) -27.9  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -25.0
Confidence Interval (2-Sided) 95%
-29.3 to -20.7
Estimation Comments Alirocumab vs. placebo
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
Hide Outcome Measure Data
Hide Analysis Population Description
Apo B ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 96 185
Least Squares Mean (Standard Error)
Unit of Measure: percent change
3.4  (2.3) -34.8  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -38.2
Confidence Interval (2-Sided) 95%
-43.7 to -32.7
Estimation Comments Alirocumab vs. placebo
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
Hide Outcome Measure Data
Hide Analysis Population Description
Non-HDL-C ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Least Squares Mean (Standard Error)
Unit of Measure: percent change
2.6  (2.6) -37.4  (1.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -40.1
Confidence Interval (2-Sided) 95%
-46.2 to -33.9
Estimation Comments Alirocumab vs. placebo
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
Hide Outcome Measure Data
Hide Analysis Population Description
Total-C ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.9  (2.0) -25.4  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -26.4
Confidence Interval (2-Sided) 95%
-31.1 to -21.7
Estimation Comments Alirocumab vs. placebo
13.Secondary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis
Hide Description 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.
Time Frame From Baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.5  (3.6) -42.5  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 -43.0
Confidence Interval (2-Sided) 95%
-51.6 to -34.3
Estimation Comments Alirocumab vs. placebo
14.Secondary Outcome
Title Percentage of Participants Reaching Calculated LDL-C <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 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.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Measure Type: Number
Unit of Measure: percentage of participants
9.0 75.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Logistic
Comments Multiple imputation approach followed by logistic regression model.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 38.5
Confidence Interval (2-Sided) 95%
16.5 to 89.8
Estimation Comments Alirocumab vs. placebo
15.Secondary Outcome
Title Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-treatment Analysis
Hide Description Adjusted percentages at Week 24 from 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.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 105 204
Measure Type: Number
Unit of Measure: percentage of participants
8.0 77.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05
Method Regression, Logistic
Comments Multiple imputation approach followed by logistic regression model
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 50.0
Confidence Interval (2-Sided) 95%
20.6 to 121.0
Estimation Comments Alirocumab vs. placebo
16.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 were obtained from multiple imputation approach followed by robust regression 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.
Time Frame From baseline to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Mean (Standard Error)
Unit of Measure: percent change
-5.9  (2.8) -20.5  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method Regression, Robust
Comments Multiple imputation approach followed by a robust regression model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -14.6
Confidence Interval (2-Sided) 95%
-21.3 to -7.9
Estimation Comments Alirocumab vs. placebo
17.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
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 Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-3.8  (1.5) 3.5  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority 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 7.3
Confidence Interval (2-Sided) 95%
3.6 to 11.0
Estimation Comments Alirocumab vs. placebo
18.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 multiple imputation approach followed be robust regression 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Mean (Standard Error)
Unit of Measure: percent change
-5.4  (3.2) -6.0  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Q2W, Alirocumab 75/150 mg Q2W
Comments Testing according to the hierarchical testing procedure (only performed if the previous endpoint was statistically significant).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8699
Comments Threshold for significance ≤ 0.05.
Method Regression, Robust
Comments Multiple imputation approach followed by a robust regression model.
Method of Estimation Estimation Parameter Adjusted Mean Difference
Estimated Value -0.6
Confidence Interval (2-Sided) 95%
-8.3 to 7.0
Estimation Comments Alirocumab vs. placebo
19.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of 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 Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 96 185
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-2.5  (1.2) 3.3  (0.9)
20.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 multiple imputation approach followed by robust regression 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Mean (Standard Error)
Unit of Measure: percent change
0.0  (2.7) -19.7  (1.9)
21.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
Hide Outcome Measure Data
Hide Analysis Population Description
HDL-C ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-2.4  (1.4) 6.7  (1.0)
22.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 multiple imputation approach followed by a robust regression 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 106 205
Mean (Standard Error)
Unit of Measure: percent change
3.0  (2.9) -11.3  (2.0)
23.Secondary Outcome
Title Percent Change From Baseline in Apo A-1 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
Hide Outcome Measure Data
Hide Analysis Population Description
Apo A-1 ITT population.
Arm/Group Title Placebo Q2W Alirocumab 75/150 mg Q2W
Hide Arm/Group Description:
Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
Overall Number of Participants Analyzed 96 185
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-1.8  (1.3) 3.8  (0.9)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 60 post-treatment follow-up visit) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘treatment emergent period’ (the time from the first dose of study drug up to the last dose of study drug +70 days).
 
Arm/Group Title Placebo Q2W Alirocumab 75 /up to 150 mg Q2W
Hide Arm/Group Description Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 45 weeks). Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 46 weeks).
All-Cause Mortality
Placebo Q2W Alirocumab 75 /up to 150 mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Q2W Alirocumab 75 /up to 150 mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   14/107 (13.08%)   26/207 (12.56%) 
Cardiac disorders     
Angina pectoris  1  0/107 (0.00%)  1/207 (0.48%) 
Coronary artery disease  1  0/107 (0.00%)  2/207 (0.97%) 
Acute myocardial infarction  1  0/107 (0.00%)  2/207 (0.97%) 
Atrial fibrillation  1  1/107 (0.93%)  0/207 (0.00%) 
Cardiac failure congestive  1  0/107 (0.00%)  1/207 (0.48%) 
Ventricular tachycardia  1  0/107 (0.00%)  1/207 (0.48%) 
Atrial flutter  1  1/107 (0.93%)  0/207 (0.00%) 
Intracardiac thrombus  1  1/107 (0.93%)  0/207 (0.00%) 
Ischaemic cardiomyopathy  1  1/107 (0.93%)  0/207 (0.00%) 
Myocardial infarction  1  1/107 (0.93%)  0/207 (0.00%) 
Eye disorders     
Retinal detachment  1  0/107 (0.00%)  1/207 (0.48%) 
Gastrointestinal disorders     
Gastrooesophageal reflux disease  1  1/107 (0.93%)  0/207 (0.00%) 
Ileus  1  0/107 (0.00%)  1/207 (0.48%) 
Intussusception  1  0/107 (0.00%)  1/207 (0.48%) 
Enteritis  1  1/107 (0.93%)  0/207 (0.00%) 
Mesenteric vein thrombosis  1  1/107 (0.93%)  0/207 (0.00%) 
Small intestinal obstruction  1  1/107 (0.93%)  0/207 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/107 (0.93%)  0/207 (0.00%) 
General disorders     
Chest pain  1  0/107 (0.00%)  1/207 (0.48%) 
Non-cardiac chest pain  1  3/107 (2.80%)  0/207 (0.00%) 
Sudden cardiac death  1  1/107 (0.93%)  0/207 (0.00%) 
Infections and infestations     
Bronchitis  1  0/107 (0.00%)  1/207 (0.48%) 
Gastroenteritis  1  1/107 (0.93%)  0/207 (0.00%) 
Osteomyelitis  1  0/107 (0.00%)  1/207 (0.48%) 
Subcutaneous abscess  1  0/107 (0.00%)  1/207 (0.48%) 
Clostridium difficile infection  1  1/107 (0.93%)  0/207 (0.00%) 
Wound infection  1  1/107 (0.93%)  0/207 (0.00%) 
Injury, poisoning and procedural complications     
Fall  1  1/107 (0.93%)  1/207 (0.48%) 
Traumatic haematoma  1  0/107 (0.00%)  1/207 (0.48%) 
Intentional overdose  1  0/107 (0.00%)  1/207 (0.48%) 
Wound  1  1/107 (0.93%)  0/207 (0.00%) 
Jaw fracture  1  1/107 (0.93%)  0/207 (0.00%) 
Muscle rupture  1  1/107 (0.93%)  0/207 (0.00%) 
Postoperative ileus  1  1/107 (0.93%)  0/207 (0.00%) 
Tooth injury  1  1/107 (0.93%)  0/207 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  0/107 (0.00%)  1/207 (0.48%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  0/107 (0.00%)  1/207 (0.48%) 
Pain in extremity  1  1/107 (0.93%)  1/207 (0.48%) 
Intervertebral disc protrusion  1  0/107 (0.00%)  1/207 (0.48%) 
Muscle spasms  1  0/107 (0.00%)  1/207 (0.48%) 
Muscular weakness  1  0/107 (0.00%)  1/207 (0.48%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon adenoma  1  1/107 (0.93%)  0/207 (0.00%) 
Transitional cell carcinoma  1  0/107 (0.00%)  1/207 (0.48%) 
Chronic myeloid leukaemia  1  1/107 (0.93%)  0/207 (0.00%) 
Oesophageal adenocarcinoma metastatic  1  1/107 (0.93%)  0/207 (0.00%) 
Nervous system disorders     
Syncope  1  0/107 (0.00%)  1/207 (0.48%) 
Cerebrovascular accident  1  0/107 (0.00%)  1/207 (0.48%) 
Ischaemic stroke  1  0/107 (0.00%)  1/207 (0.48%) 
Dementia  1  1/107 (0.93%)  0/207 (0.00%) 
Hypoglycaemic coma  1  1/107 (0.93%)  0/207 (0.00%) 
Psychiatric disorders     
Suicide attempt  1  0/107 (0.00%)  1/207 (0.48%) 
Renal and urinary disorders     
Renal failure acute  1  1/107 (0.93%)  0/207 (0.00%) 
Renal failure  1  1/107 (0.93%)  1/207 (0.48%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/107 (0.00%)  2/207 (0.97%) 
Dyspnoea  1  0/107 (0.00%)  1/207 (0.48%) 
Interstitial lung disease  1  0/107 (0.00%)  1/207 (0.48%) 
Pulmonary embolism  1  0/107 (0.00%)  1/207 (0.48%) 
Vascular disorders     
Hypertension  1  0/107 (0.00%)  1/207 (0.48%) 
Extremity necrosis  1  0/107 (0.00%)  1/207 (0.48%) 
Peripheral ischaemia  1  0/107 (0.00%)  1/207 (0.48%) 
Thrombosis  1  0/107 (0.00%)  1/207 (0.48%) 
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%
Placebo Q2W Alirocumab 75 /up to 150 mg Q2W
Affected / at Risk (%) Affected / at Risk (%)
Total   31/107 (28.97%)   72/207 (34.78%) 
General disorders     
Injection site reaction  1  3/107 (2.80%)  11/207 (5.31%) 
Infections and infestations     
Upper respiratory tract infection  1  11/107 (10.28%)  16/207 (7.73%) 
Nasopharyngitis  1  5/107 (4.67%)  15/207 (7.25%) 
Urinary tract infection  1  4/107 (3.74%)  13/207 (6.28%) 
Sinusitis  1  4/107 (3.74%)  11/207 (5.31%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  8/107 (7.48%)  8/207 (3.86%) 
Nervous system disorders     
Dizziness  1  6/107 (5.61%)  11/207 (5.31%) 
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.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
Name/Title: Trial Transparency Team
Organization: Sanofi
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01644175     History of Changes
Other Study ID Numbers: EFC11568
U1111-1121-4356 ( Other Identifier: UTN )
First Submitted: July 16, 2012
First Posted: July 18, 2012
Results First Submitted: August 20, 2015
Results First Posted: November 6, 2015
Last Update Posted: November 6, 2015