Trial Outcomes & Findings for Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I) (NCT NCT01730040)
NCT ID: NCT01730040
Last Updated: 2015-08-31
Results Overview
Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
355 participants
Primary outcome timeframe
From Baseline to Week 24
Results posted on
2015-08-31
Participant Flow
The study was conducted at 85 sites in 9 countries. Overall, 859 subjects were screened between 24 October 2012 and 26 September 2013, 504 of whom were screen failures. Screen failures ware mainly due to exclusion criteria met.
Randomization was stratified according to prior history of myocardial infarction or ischemic stroke, and intensity of statin treatment (atorvastatin 20 or 40 mg). Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1:1:1:1:1:1 ratio after confirmation of selection criteria.
Participant milestones
| Measure |
Atorvastatin 40 mg
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
57
|
55
|
57
|
47
|
45
|
47
|
47
|
|
Overall Study
Treated
|
57
|
55
|
57
|
47
|
45
|
46
|
47
|
|
Overall Study
COMPLETED
|
44
|
40
|
46
|
39
|
39
|
40
|
38
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
11
|
8
|
6
|
7
|
9
|
Reasons for withdrawal
| Measure |
Atorvastatin 40 mg
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Randomized but not treated
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Subject moved
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Other than specified
|
7
|
8
|
5
|
5
|
5
|
4
|
4
|
|
Overall Study
Adverse Event
|
4
|
3
|
5
|
3
|
1
|
1
|
2
|
|
Overall Study
Poor compliance to protocol
|
2
|
4
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
Baseline characteristics by cohort
| Measure |
Atorvastatin 40 mg
n=57 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=57 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 8.96 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 10.03 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 10.89 • n=4 Participants
|
57.5 years
STANDARD_DEVIATION 9.96 • n=21 Participants
|
63.9 years
STANDARD_DEVIATION 10.33 • n=10 Participants
|
64.2 years
STANDARD_DEVIATION 10.36 • n=115 Participants
|
62.9 years
STANDARD_DEVIATION 10.2 • n=6 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
124 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
36 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
231 Participants
n=6 Participants
|
|
Low density lipoprotein cholesterol (LDL-C) in mg/dL
|
100.3 mg/dL
STANDARD_DEVIATION 29.8 • n=5 Participants
|
100.4 mg/dL
STANDARD_DEVIATION 29.5 • n=7 Participants
|
103.9 mg/dL
STANDARD_DEVIATION 34.9 • n=5 Participants
|
108.6 mg/dL
STANDARD_DEVIATION 37.5 • n=4 Participants
|
109.8 mg/dL
STANDARD_DEVIATION 39.0 • n=21 Participants
|
98.9 mg/dL
STANDARD_DEVIATION 29.2 • n=10 Participants
|
116.4 mg/dL
STANDARD_DEVIATION 37.4 • n=115 Participants
|
105.1 mg/dL
STANDARD_DEVIATION 34.1 • n=6 Participants
|
|
LDL-C in mmol/L
|
2.957 mmol/L
STANDARD_DEVIATION 0.773 • n=5 Participants
|
2.599 mmol/L
STANDARD_DEVIATION 0.765 • n=7 Participants
|
2.692 mmol/L
STANDARD_DEVIATION 0.905 • n=5 Participants
|
2.813 mmol/L
STANDARD_DEVIATION 0.97 • n=4 Participants
|
2.844 mmol/L
STANDARD_DEVIATION 1.011 • n=21 Participants
|
2.562 mmol/L
STANDARD_DEVIATION 0.756 • n=10 Participants
|
3.016 mmol/L
STANDARD_DEVIATION 0.968 • n=115 Participants
|
2.723 mmol/L
STANDARD_DEVIATION 0.884 • n=6 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 24Population: ITT population: all randomized participants with one baseline and at least one post-baseline calculated LDL-C value on- or off-treatment.
Calculated LDL-C values were obtained from Friedewald formula. Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis
|
-5 percent change
Standard Error 4.6
|
-20.5 percent change
Standard Error 4.7
|
-44.1 percent change
Standard Error 4.5
|
-4.8 percent change
Standard Error 4.2
|
-21.4 percent change
Standard Error 4.2
|
-22.6 percent change
Standard Error 4.3
|
-54 percent change
Standard Error 4.3
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Modified ITT (mITT) population: all randomized and treated participants with one baseline and at least one post-baseline calculated LDL-C value on-treatment.
Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 24 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever atorvastatin, rosuvastatin or ezetimibe\], whichever came first) (on-treatment analysis).
Outcome measures
| Measure |
Atorvastatin 40 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis
|
-6.1 percent change
Standard Error 4.6
|
-23.7 percent change
Standard Error 4.7
|
-48.6 percent change
Standard Error 4.5
|
-5.0 percent change
Standard Error 4.4
|
-22.9 percent change
Standard Error 4.4
|
-24.5 percent change
Standard Error 4.5
|
-57.8 percent change
Standard Error 4.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment (ITT analysis).
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis
|
-8.5 percent change
Standard Error 3.9
|
-22.6 percent change
Standard Error 3.9
|
-48.4 percent change
Standard Error 3.8
|
-14.5 percent change
Standard Error 3.2
|
-23.3 percent change
Standard Error 3.2
|
-29.7 percent change
Standard Error 3.2
|
-50.5 percent change
Standard Error 3.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: mITT population.
Calculated LDL-C values were obtained from Friedewald formula. Adjusted LS means and standard errors at Week 12 were obtained from MMRM model including available post-baseline on-treatment data from Week 4 to Week 24 (i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever atorvastatin, rosuvastatin or ezetimibe\], whichever came first) (on-treatment analysis).
Outcome measures
| Measure |
Atorvastatin 40 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis
|
-9.2 percent change
Standard Error 3.1
|
-27.1 percent change
Standard Error 3.1
|
-53.7 percent change
Standard Error 3.1
|
-14.6 percent change
Standard Error 3.2
|
-23.3 percent change
Standard Error 3.2
|
-30.7 percent change
Standard Error 3.2
|
-50.9 percent change
Standard Error 3.2
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo B value on- or off-treatment.
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=51 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=50 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=44 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=42 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis
|
-4.4 percent change
Standard Error 3.5
|
-10.1 percent change
Standard Error 3.6
|
-33.7 percent change
Standard Error 3.4
|
-3.5 percent change
Standard Error 3.3
|
-10.9 percent change
Standard Error 3.2
|
-14.3 percent change
Standard Error 3.3
|
-41.9 percent change
Standard Error 3.4
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Apo B value on-treatment.
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 24 (ie. up to 21 days after last injection or 3 days after the last capsule \[whatever atorvastatin, rosuvastatin or ezetimibe\], whichever came first).
Outcome measures
| Measure |
Atorvastatin 40 mg
n=48 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=47 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=50 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=44 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=44 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=44 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=41 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis
|
-5.1 percent change
Standard Error 3.3
|
-12.6 percent change
Standard Error 3.5
|
-37.7 percent change
Standard Error 3.2
|
-4.4 percent change
Standard Error 3.4
|
-12.8 percent change
Standard Error 3.4
|
-16.3 percent change
Standard Error 3.4
|
-42.7 percent change
Standard Error 3.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline non-HDL-C value on- or off-treatment.
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis
|
-6.3 percent change
Standard Error 3.9
|
-15.1 percent change
Standard Error 4.0
|
-36.7 percent change
Standard Error 3.9
|
-6.5 percent change
Standard Error 3.6
|
-17.4 percent change
Standard Error 3.6
|
-21.0 percent change
Standard Error 3.7
|
-47.6 percent change
Standard Error 3.7
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Participants analyzed: participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C value on-treatment.
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 24 (i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever atorvastatin, rosuvastatin or ezetimibe\], whichever came first).
Outcome measures
| Measure |
Atorvastatin 40 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis
|
-7.5 percent change
Standard Error 3.8
|
-18.1 percent change
Standard Error 4.0
|
-40.5 percent change
Standard Error 3.7
|
-7.0 percent change
Standard Error 3.7
|
-18.4 percent change
Standard Error 3.7
|
-23.3 percent change
Standard Error 3.8
|
-50.5 percent change
Standard Error 3.8
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Total-C value on- or off-treatment.
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis
|
-4.0 percent change
Standard Error 2.7
|
-11.2 percent change
Standard Error 2.8
|
-27.1 percent change
Standard Error 2.7
|
-4.8 percent change
Standard Error 2.8
|
-11.7 percent change
Standard Error 2.8
|
-15.2 percent change
Standard Error 2.9
|
-33.6 percent change
Standard Error 2.9
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Apo B ITT population.
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=51 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=50 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=44 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=42 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apo B at Week 12 - ITT Analysis
|
-6.9 percent change
Standard Error 2.8
|
-13.1 percent change
Standard Error 2.8
|
-38.4 percent change
Standard Error 2.7
|
-9.5 percent change
Standard Error 2.5
|
-14.1 percent change
Standard Error 2.5
|
-20.3 percent change
Standard Error 2.5
|
-36.2 percent change
Standard Error 2.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Non-HDL-C ITT population.
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis
|
-7.1 percent change
Standard Error 3.2
|
-17.2 percent change
Standard Error 3.2
|
-40.6 percent change
Standard Error 3.2
|
-13.0 percent change
Standard Error 2.6
|
-19.8 percent change
Standard Error 2.7
|
-27.5 percent change
Standard Error 2.7
|
-42.3 percent change
Standard Error 2.7
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Total-C ITT population.
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Total-C at Week 12 - ITT Analysis
|
-6.5 percent change
Standard Error 2.4
|
-13.2 percent change
Standard Error 2.4
|
-29.0 percent change
Standard Error 2.4
|
-9.9 percent change
Standard Error 2.1
|
-13.5 percent change
Standard Error 2.1
|
-19.2 percent change
Standard Error 2.1
|
-29.0 percent change
Standard Error 2.1
|
SECONDARY outcome
Timeframe: Up to Week 24Population: ITT population.
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - ITT Analysis
|
34.5 percentage of participants
|
68.4 percentage of participants
|
87.2 percentage of participants
|
18.5 percentage of participants
|
62.2 percentage of participants
|
65.1 percentage of participants
|
84.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: mITT population.
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever atorvastatin, rosuvastatin or ezetimibe\], whichever came first (on-treatment analysis).
Outcome measures
| Measure |
Atorvastatin 40 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Very High CV Risk Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) or High CV Risk Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 24 - On-Treatment Analysis
|
37.8 percentage of participants
|
72.2 percentage of participants
|
91.2 percentage of participants
|
18.5 percentage of participants
|
64.0 percentage of participants
|
66.2 percentage of participants
|
90.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: ITT population.
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model for handling of missing data. All available post-baseline data from Week 4 to week 24 regardless of status on- or off-treatment were included in the imputation model (ITT analysis).
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis
|
16.0 percentage of participants
|
50.3 percentage of participants
|
79.2 percentage of participants
|
10.2 percentage of participants
|
42.2 percentage of participants
|
54.2 percentage of participants
|
77.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 24Population: mITT population.
Adjusted percentages at Week 24 were obtained from a multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 24 i.e. up to 21 days after last injection or 3 days after the last capsule \[whatever atorvastatin, rosuvastatin or ezetimibe\], whichever came first (on-treatment analysis).
Outcome measures
| Measure |
Atorvastatin 40 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=52 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis
|
20.0 percentage of participants
|
55.1 percentage of participants
|
82.3 percentage of participants
|
10.5 percentage of participants
|
42.4 percentage of participants
|
55.3 percentage of participants
|
83.7 percentage of participants
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Participants analyzed: participants of the ITT population.
Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis
|
-20.2 percent change
Standard Error 4.0
|
-10.6 percent change
Standard Error 4.4
|
-23.6 percent change
Standard Error 4.0
|
-9.7 percent change
Standard Error 4.1
|
-4.9 percent change
Standard Error 3.7
|
0.2 percent change
Standard Error 3.9
|
-30.8 percent change
Standard Error 4.1
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline HDL-C value on- or off-treatment.
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis
|
1.9 percent change
Standard Error 2.0
|
-0.1 percent change
Standard Error 2.1
|
4.8 percent change
Standard Error 2.0
|
4.7 percent change
Standard Error 2.7
|
5.7 percent change
Standard Error 2.7
|
2.0 percent change
Standard Error 2.7
|
7.7 percent change
Standard Error 2.7
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population: all randomized and treated participants with one baseline and at least one post-baseline fasting triglycerides value on- or off-treatment.
Adjusted means and standard errors at Week 24 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis
|
-6.7 percent change
Standard Error 3.7
|
-3.3 percent change
Standard Error 4.1
|
-12.0 percent change
Standard Error 3.7
|
-7.3 percent change
Standard Error 4.1
|
-0.5 percent change
Standard Error 4.0
|
-13.9 percent change
Standard Error 4.1
|
-19.1 percent change
Standard Error 4.10
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Participants analyzed: participants of the ITT population with one baseline and at least one post-baseline Apo A-1 value on- or off-treatment.
Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=51 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=50 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=44 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=42 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apo A-1 at Week 24 - ITT Analysis
|
1.2 percent change
Standard Error 1.5
|
1.0 percent change
Standard Error 1.6
|
7.6 percent change
Standard Error 1.5
|
2.2 percent change
Standard Error 2.0
|
4.7 percent change
Standard Error 1.9
|
-1.8 percent change
Standard Error 1.9
|
5.8 percent change
Standard Error 2.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Lipoprotein (a) ITT population.
Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis
|
-11.7 percent change
Standard Error 4.0
|
-5.4 percent change
Standard Error 4.0
|
-24.0 percent change
Standard Error 4.0
|
-1.6 percent change
Standard Error 4.5
|
11.5 percent change
Standard Error 4.6
|
7.9 percent change
Standard Error 4.5
|
-27.9 percent change
Standard Error 4.5
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: HDL-C ITT population.
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis
|
-3.2 percent change
Standard Error 1.8
|
-1.7 percent change
Standard Error 1.8
|
4.1 percent change
Standard Error 1.8
|
3.0 percent change
Standard Error 2.6
|
4.6 percent change
Standard Error 2.7
|
4.6 percent change
Standard Error 2.7
|
8.5 percent change
Standard Error 2.7
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: ITT population.
Adjusted means and standard errors at Week 12 from from a multiple imputation approach model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=55 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=46 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis
|
-4.7 percent change
Standard Error 4.2
|
0.5 percent change
Standard Error 4.2
|
-12.4 percent change
Standard Error 4.2
|
-4.6 percent change
Standard Error 4.0
|
-3.7 percent change
Standard Error 4.1
|
-16.8 percent change
Standard Error 4.0
|
-12.1 percent change
Standard Error 4.0
|
SECONDARY outcome
Timeframe: From Baseline to Week 24Population: Apo A-1 ITT population.
Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 24 regardless of status on- or off-treatment.
Outcome measures
| Measure |
Atorvastatin 40 mg
n=51 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=50 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=53 Participants
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=44 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=45 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=42 Participants
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis
|
-0.8 percent change
Standard Error 1.5
|
1.7 percent change
Standard Error 1.4
|
5.4 percent change
Standard Error 1.4
|
1.6 percent change
Standard Error 1.7
|
5.6 percent change
Standard Error 1.7
|
1.6 percent change
Standard Error 1.7
|
9.4 percent change
Standard Error 1.7
|
Adverse Events
Atorvastatin 40 mg
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Ezetimibe 10 mg + Atorvastatin 20 mg
Serious events: 5 serious events
Other events: 24 other events
Deaths: 0 deaths
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Atorvastatin 80 mg
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
Rosuvastatin 40 mg
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Ezetimibe 10 mg + Atorvastatin 40 mg
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atorvastatin 40 mg
n=57 participants at risk
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=55 participants at risk
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=57 participants at risk
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up¬-titrated to 150 mg Q2W from Week 12 when LDL-¬C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 participants at risk
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 participants at risk
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 participants at risk
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection.Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=47 participants at risk
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Angina unstable
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
3.5%
2/57 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/46 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
General disorders
Chest pain
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
General disorders
Non-Cardiac chest pain
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/45 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Infections and infestations
Diverticulitis
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/46 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Injury, poisoning and procedural complications
Seroma
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/45 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
Other adverse events
| Measure |
Atorvastatin 40 mg
n=57 participants at risk
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 20 mg
n=55 participants at risk
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg
n=57 participants at risk
Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up¬-titrated to 150 mg Q2W from Week 12 when LDL-¬C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
Atorvastatin 80 mg
n=47 participants at risk
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Rosuvastatin 40 mg
n=45 participants at risk
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
|
Ezetimibe 10 mg + Atorvastatin 40 mg
n=46 participants at risk
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection.Q2W added to stable LMT for 24 weeks.
|
Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg
n=47 participants at risk
Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.0%
4/57 • Number of events 4 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.7%
3/45 • Number of events 6 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
4.3%
2/46 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
3/57 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
5.5%
3/55 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
10.6%
5/47 • Number of events 5 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.7%
3/45 • Number of events 4 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/46 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
General disorders
Fatigue
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/55 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.4%
3/47 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
4.4%
2/45 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Infections and infestations
Influenza
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.7%
3/45 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
4.3%
2/47 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
5.5%
3/55 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.4%
3/47 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
8.9%
4/45 • Number of events 4 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
8.5%
4/47 • Number of events 5 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.5%
2/57 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
7.3%
4/55 • Number of events 4 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
3.5%
2/57 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
4.3%
2/47 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.7%
3/45 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
10.9%
5/46 • Number of events 6 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.4%
3/47 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
3/57 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
9.1%
5/55 • Number of events 6 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
8.5%
4/47 • Number of events 4 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/45 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.5%
3/46 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
4.3%
2/47 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
3.5%
2/57 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
3.6%
2/55 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
4.3%
2/47 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.7%
3/45 • Number of events 4 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.4%
3/47 • Number of events 4 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 5 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.7%
3/45 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
5.3%
3/57 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
5.5%
3/55 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/45 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.5%
3/46 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/57 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
5.5%
3/55 • Number of events 4 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
3.5%
2/57 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/45 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/46 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.5%
2/57 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
5.5%
3/55 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
5.3%
3/57 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
4.3%
2/47 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
4.4%
2/45 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
8.5%
4/47 • Number of events 4 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
7.0%
4/57 • Number of events 6 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/45 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/46 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
3.6%
2/55 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.7%
3/45 • Number of events 6 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.2%
1/46 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/47 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
|
Vascular disorders
Hypertension
|
0.00%
0/57 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
1.8%
1/55 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
3.5%
2/57 • Number of events 2 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
2.1%
1/47 • Number of events 1 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
0.00%
0/45 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
10.9%
5/46 • Number of events 6 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
6.4%
3/47 • Number of events 3 • From Baseline up to Week 24
Treatment emergent adverse events that developed during on¬-treatment period (the time period from the first double¬-blind injection of study drug up to the day of last injection + 70 days) were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Not less than 45 days prior to submission for publication or presentation, the Institution shall, or cause the Principal Investigator to, provide the Sponsor with a copy of the Manuscript. The Institution shall consider in good faith any comments from the Sponsor regarding the content, and shall delete Confidential Information upon written request of the Sponsor. At the Sponsor's request, the Institution shall delay publication for an additional 60 days to allow patent applications to be filed.
- Publication restrictions are in place
Restriction type: OTHER