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Trial record 1 of 1 for:    DFI11565
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Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

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ClinicalTrials.gov Identifier: NCT01288443
Recruitment Status : Completed
First Posted : February 2, 2011
Results First Posted : September 24, 2015
Last Update Posted : September 24, 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: Alirocumab
Drug: Placebo (for alirocumab)
Drug: Atorvastatin
Enrollment 183
Recruitment Details The study was conducted at 38 centers in the United States of America. Overall, 514 participants were screened between January 2011 and August 2011, 331 of whom were screen failures and screen failures were mainly due to exclusion criteria met.
Pre-assignment Details Randomization was stratified according to atorvastatin dose. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1:1:1 ratio after confirmation of selection criteria. 183 participants were randomized.
Arm/Group Title Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Hide Arm/Group Description Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose. Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Period Title: Overall Study
Started 31 [1] 30 [1] 31 [1] 31 [1] 30 [1] 30 [1]
Treated 31 30 31 31 29 30
Completed 31 29 30 27 23 25
Not Completed 0 1 1 4 7 5
Reason Not Completed
Adverse Event             0             0             1             1             3             1
Poor compliance to protocol             0             0             0             0             0             1
Participant Moved             0             0             0             1             2             1
Consent withdrawn by Participant             0             0             0             0             0             1
Lost to Follow-up             0             1             0             0             0             0
Study drug auto-injector administration             0             0             0             0             1             1
Other than above             0             0             0             2             1             0
[1]
Randomized
Arm/Group Title Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W Total
Hide Arm/Group Description Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose. Total of all reporting groups
Overall Number of Baseline Participants 31 30 31 31 30 30 183
Hide Baseline Analysis Population Description
Randomized population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 30 participants 31 participants 31 participants 30 participants 30 participants 183 participants
53.3  (8.5) 58.5  (9.1) 58.1  (9.2) 59.9  (11.1) 54.9  (10.8) 55.5  (10.1) 56.7  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 30 participants 31 participants 31 participants 30 participants 30 participants 183 participants
Female
15
  48.4%
13
  43.3%
18
  58.1%
21
  67.7%
13
  43.3%
16
  53.3%
96
  52.5%
Male
16
  51.6%
17
  56.7%
13
  41.9%
10
  32.3%
17
  56.7%
14
  46.7%
87
  47.5%
Low-Density Lipoprotein Cholesterol (LDL-C) in mmol/L   [1] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 31 participants 30 participants 31 participants 31 participants 30 participants 30 participants 183 participants
3.4  (0.7) 3.2  (0.7) 3.3  (0.8) 3.2  (0.7) 3.3  (0.5) 3.4  (0.6) 3.3  (0.7)
[1]
Measure Description: Number of participants analysed = 31, 30, 31, 31, 29, 30 and 182, respectively.
LDL-C in mg/dL   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 31 participants 30 participants 31 participants 31 participants 30 participants 30 participants 183 participants
130.2  (27.3) 123.2  (27.9) 127.0  (30.4) 124.7  (26.9) 127.2  (19.6) 131.6  (24.8) 127.3  (26.2)
[1]
Measure Description: Number of participants analysed = 31, 30, 31, 31, 29, 30 and 182, respectively.
1.Primary Outcome
Title Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
Hide Description Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first study drug injection up to 21 days after last study drug injection (on-treatment analysis). Missing Week 12 data were imputed by last observation carried forward [LOCF] method.
Time Frame Baseline to Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-To-Treat (mITT) population included all randomized participants with one baseline and at least one post baseline on-treatment calculated LDL-C.
Arm/Group Title Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Hide Arm/Group Description:
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Overall Number of Participants Analyzed 31 30 31 29 28 30
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-5.1  (3.1) -39.6  (3.2) -64.2  (3.1) -72.4  (3.2) -43.2  (3.3) -47.7  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alirocumab 150 mg Q2W
Comments

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

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

  1. Alirocumab 150 mg Q2W versus placebo
  2. Alirocumab 300 mg Q4W versus placebo
  3. Alirocumab 100 mg Q2W versus placebo
  4. Alirocumab 200 mg Q4W versus placebo
  5. Alirocumab 50 mg Q2W versus placebo

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

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Alirocumab 300 mg Q4W
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Alirocumab 100 mg Q2W
Comments [Not Specified]
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 ANCOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Alirocumab 200 mg Q4W
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Threshold for significance ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Alirocumab 50 mg Q2W
Comments [Not Specified]
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 ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 12 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame Baseline to Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Hide Arm/Group Description:
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Overall Number of Participants Analyzed 31 30 31 29 28 30
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.20  (0.10) -1.37  (0.10) -2.10  (0.10) -2.38  (0.10) -1.46  (0.11) -1.62  (0.10)
3.Secondary Outcome
Title Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 12 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame Baseline to Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Hide Arm/Group Description:
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Overall Number of Participants Analyzed 31 30 31 29 28 30
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-7.6  (3.9) -53.0  (4.0) -81.2  (3.9) -92.0  (4.0) -56.4  (4.1) -62.5  (4.0)
4.Secondary Outcome
Title Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and <70 mg/dL (1.81 mmol/L) at Week 12 - On-Treatment Analysis
Hide Description [Not Specified]
Time Frame Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
mITT population.
Arm/Group Title Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Hide Arm/Group Description:
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Overall Number of Participants Analyzed 31 30 31 29 28 30
Measure Type: Number
Unit of Measure: percentage of participants
LDL-C <100 mg/dL (2.59 mmol/L) 16.1 93.3 96.8 100.0 89.3 96.7
LDL-C <70 mg/dL (1.81 mmol/L) 3.2 46.7 83.9 100.0 46.4 56.7
5.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol, High-density Lipoprotein Cholesterol (HDL-C), Non-HDL-C and Apolipoprotein B (Apo-B) at Week 12 - On-Treatment Analysis
Hide Description Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
Time Frame Baseline to Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies the number of participants analysed for each lipid parameter.
Arm/Group Title Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Hide Arm/Group Description:
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Overall Number of Participants Analyzed 31 30 31 29 28 30
Least Squares Mean (Standard Error)
Unit of Measure: percent change
Total Cholesterol (n= 31, 30, 31, 29, 28, 30) -1.6  (2.3) -23.0  (2.3) -39.7  (2.3) -45.2  (2.3) -28.0  (2.4) -29.8  (2.3)
HDL-C (n= 31, 30, 31, 29, 28, 30) -1.0  (2.3) 6.7  (2.4) 4.1  (2.3) 5.5  (2.4) 6.3  (2.5) 8.5  (2.4)
Non-HDL-C (n= 31, 30, 31, 29, 28, 30) -2.2  (2.9) -33.6  (2.9) -55.6  (2.9) -62.5  (3.0) -37.4  (3.0) -40.7  (2.9)
Apo-B (n= 30, 30, 30, 29, 27, 30) 2.2  (2.9) -27.3  (2.9) -48.1  (2.9) -56.1  (2.9) -28.7  (3.1) -33.1  (2.9)
6.Secondary Outcome
Title Percent Change From Baseline in Fasting Triglycerides and Lipoprotein(a) at Week 12 - On-Treatment Analysis
Hide Description Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (inter-quartile range).
Time Frame Baseline to Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for lipid parameters analyzed. Here, n signifies number of participants analysed for each lipid parameter.
Arm/Group Title Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Hide Arm/Group Description:
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Overall Number of Participants Analyzed 31 30 31 29 28 30
Median (Inter-Quartile Range)
Unit of Measure: percent change
Fasting Triglycerides (n= 31, 30, 31, 29, 28, 30)
9.7
(-15 to 30.7)
-6.6
(-17.7 to 7.1)
-5.5
(-22.1 to 10.7)
-18.9
(-31.7 to -6.1)
-10.8
(-25.4 to 13.3)
-8.4
(-21.5 to 10.1)
Lipoprotein(a) (n= 30, 30, 30, 29, 27, 30)
0.0
(-11.8 to 11.5)
-13.3
(-33.3 to 0.0)
-26.1
(-36.7 to -8.0)
-28.6
(-46.9 to -22.2)
-16.7
(-33.3 to -6.3)
-7.9
(-18.8 to 0.0)
7.Secondary Outcome
Title Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 12 - On-Treatment Analysis
Hide Description Adjusted LS mean and standard errors were estimated using the same ANCOVA as for primary endpoint.
Time Frame Baseline to Week 12 (LOCF)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants of the mITT population with one baseline and at least one post-baseline on-treatment value for ApoB/ApoA-1 ratio analyzed.
Arm/Group Title Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Hide Arm/Group Description:
Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
Overall Number of Participants Analyzed 30 30 30 29 27 30
Least Squares Mean (Standard Error)
Unit of Measure: ratio
0.05  (0.03) -0.23  (0.03) -0.35  (0.03) -0.42  (0.03) -0.23  (0.03) -0.29  (0.03)
Time Frame All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 20) regardless of seriousness or relationship to investigational medicinal product (IMP).
Adverse Event Reporting Description AEs that developed/worsened during ‘treatment emergent period’ (from 1st dose to last dose of IMP+70 days) are reported. Safety population:participants who received at least 1 dose or partial dose of IMP. 2 participants in 300 mg Q4W group received at least 1 dose of 150 mg and as per pre-specified algorithm they were included in 200 mg Q4W group.
 
Arm/Group Title Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Hide Arm/Group Description Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose. Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
All-Cause Mortality
Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/31 (3.23%)   0/30 (0.00%)   1/31 (3.23%)   0/31 (0.00%)   1/31 (3.23%)   1/28 (3.57%) 
Injury, poisoning and procedural complications             
Humerus fracture  1  0/31 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  1/28 (3.57%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/31 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  1/31 (3.23%)  0/28 (0.00%) 
Vertebral foraminal stenosis  1  1/31 (3.23%)  0/30 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  0/28 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease  1  0/31 (0.00%)  0/30 (0.00%)  1/31 (3.23%)  0/31 (0.00%)  0/31 (0.00%)  0/28 (0.00%) 
Skin and subcutaneous tissue disorders             
Leukocytoclastic vasculitis  1  0/31 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  1/28 (3.57%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Alirocumab 50 mg Q2W Alirocumab 100 mg Q2W Alirocumab 150 mg Q2W Alirocumab 200 mg Q4W Alirocumab 300 mg Q4W
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/31 (32.26%)   14/30 (46.67%)   14/31 (45.16%)   12/31 (38.71%)   12/31 (38.71%)   10/28 (35.71%) 
Blood and lymphatic system disorders             
Anaemia  1  0/31 (0.00%)  1/30 (3.33%)  0/31 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  2/28 (7.14%) 
Cardiac disorders             
Bundle branch block left  1  2/31 (6.45%)  0/30 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  0/28 (0.00%) 
Gastrointestinal disorders             
Diarrhoea  1  0/31 (0.00%)  0/30 (0.00%)  1/31 (3.23%)  1/31 (3.23%)  1/31 (3.23%)  2/28 (7.14%) 
Nausea  1  2/31 (6.45%)  2/30 (6.67%)  2/31 (6.45%)  0/31 (0.00%)  2/31 (6.45%)  1/28 (3.57%) 
General disorders             
Injection site erythema  1  0/31 (0.00%)  0/30 (0.00%)  3/31 (9.68%)  3/31 (9.68%)  1/31 (3.23%)  1/28 (3.57%) 
Injection site pruritus  1  0/31 (0.00%)  0/30 (0.00%)  2/31 (6.45%)  3/31 (9.68%)  1/31 (3.23%)  0/28 (0.00%) 
Fatigue  1  0/31 (0.00%)  1/30 (3.33%)  1/31 (3.23%)  2/31 (6.45%)  0/31 (0.00%)  0/28 (0.00%) 
Injection site swelling  1  0/31 (0.00%)  1/30 (3.33%)  1/31 (3.23%)  2/31 (6.45%)  1/31 (3.23%)  0/28 (0.00%) 
Injection site haematoma  1  0/31 (0.00%)  2/30 (6.67%)  1/31 (3.23%)  1/31 (3.23%)  0/31 (0.00%)  0/28 (0.00%) 
Injection site rash  1  0/31 (0.00%)  2/30 (6.67%)  0/31 (0.00%)  1/31 (3.23%)  1/31 (3.23%)  0/28 (0.00%) 
Influenza like illness  1  2/31 (6.45%)  0/30 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  0/28 (0.00%) 
Infections and infestations             
Sinusitis  1  3/31 (9.68%)  0/30 (0.00%)  1/31 (3.23%)  2/31 (6.45%)  1/31 (3.23%)  0/28 (0.00%) 
Influenza  1  0/31 (0.00%)  2/30 (6.67%)  0/31 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  0/28 (0.00%) 
Nasopharyngitis  1  1/31 (3.23%)  4/30 (13.33%)  3/31 (9.68%)  0/31 (0.00%)  1/31 (3.23%)  1/28 (3.57%) 
Upper respiratory tract infection  1  1/31 (3.23%)  0/30 (0.00%)  1/31 (3.23%)  0/31 (0.00%)  2/31 (6.45%)  1/28 (3.57%) 
Urinary tract infection  1  0/31 (0.00%)  1/30 (3.33%)  0/31 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  2/28 (7.14%) 
Injury, poisoning and procedural complications             
Fall  1  0/31 (0.00%)  0/30 (0.00%)  0/31 (0.00%)  1/31 (3.23%)  1/31 (3.23%)  2/28 (7.14%) 
Procedural pain  1  0/31 (0.00%)  0/30 (0.00%)  2/31 (6.45%)  0/31 (0.00%)  0/31 (0.00%)  0/28 (0.00%) 
Investigations             
Blood creatine phosphokinase increased  1  2/31 (6.45%)  1/30 (3.33%)  0/31 (0.00%)  2/31 (6.45%)  0/31 (0.00%)  0/28 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  1/31 (3.23%)  0/30 (0.00%)  1/31 (3.23%)  1/31 (3.23%)  0/31 (0.00%)  2/28 (7.14%) 
Back pain  1  0/31 (0.00%)  1/30 (3.33%)  0/31 (0.00%)  0/31 (0.00%)  2/31 (6.45%)  1/28 (3.57%) 
Pain in extremity  1  1/31 (3.23%)  0/30 (0.00%)  0/31 (0.00%)  0/31 (0.00%)  2/31 (6.45%)  2/28 (7.14%) 
Nervous system disorders             
Headache  1  1/31 (3.23%)  1/30 (3.33%)  2/31 (6.45%)  1/31 (3.23%)  1/31 (3.23%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders             
Cough  1  1/31 (3.23%)  2/30 (6.67%)  1/31 (3.23%)  0/31 (0.00%)  0/31 (0.00%)  0/28 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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: NCT01288443     History of Changes
Other Study ID Numbers: DFI11565
U1111-1116-5252 ( Other Identifier: UTN )
First Submitted: February 1, 2011
First Posted: February 2, 2011
Results First Submitted: August 21, 2015
Results First Posted: September 24, 2015
Last Update Posted: September 24, 2015