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Trial record 1 of 1 for:    20140234
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Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4 (GAUSS-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02634580
Recruitment Status : Completed
First Posted : December 18, 2015
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypercholesterolemia
Interventions Biological: Evolocumab
Drug: Ezetimibe
Drug: Placebo to Evolocumab
Drug: Placebo Ezetimibe
Enrollment 61
Recruitment Details

This study was conducted at 30 centers in Japan. Participants were enrolled from 27 February 2016 to 18 May 2017.

Results are reported for the 12-week double-blind treatment period; the open-label period was ongoing at the time of this analysis.

Pre-assignment Details Participants were randomized 1:1:2:2 into 1 of 4 treatment groups for the 12-week, double-blind treatment period. Randomization was stratified by screening low-density lipoprotein cholesterol (LDL-C) level (< 180 mg/dL vs. ≥ 180 mg/dL) and baseline statin use (yes vs. no).
Arm/Group Title Ezetimibe (Q2W) Ezetimibe (QM) Evolocumab Q2W Evolocumab QM
Hide Arm/Group Description Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks. Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks. Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks. Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks.
Period Title: Overall Study
Started 10 11 19 21
Completed [1] 9 11 18 20
Not Completed 1 0 1 1
Reason Not Completed
Subject Request             1             0             1             1
[1]
Completed double-blind treatment period
Arm/Group Title Ezetimibe (Q2W) Ezetimibe (QM) Evolocumab Q2W Evolocumab QM Total
Hide Arm/Group Description Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks. Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks. Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks. Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 10 11 19 21 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
65.2  (10.8) 58.7  (12.5) 65.1  (10.5) 66.4  (9.3) 64.4  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
Female
5
  50.0%
5
  45.5%
9
  47.4%
12
  57.1%
31
  50.8%
Male
5
  50.0%
6
  54.5%
10
  52.6%
9
  42.9%
30
  49.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
Japanese
10
 100.0%
11
 100.0%
19
 100.0%
21
 100.0%
61
 100.0%
Intolerance to Statins  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
One statin
1
  10.0%
0
   0.0%
1
   5.3%
0
   0.0%
2
   3.3%
Two statins
7
  70.0%
10
  90.9%
14
  73.7%
14
  66.7%
45
  73.8%
Three statins
2
  20.0%
1
   9.1%
3
  15.8%
4
  19.0%
10
  16.4%
Four or more statins
0
   0.0%
0
   0.0%
1
   5.3%
3
  14.3%
4
   6.6%
Stratification Factor: Screening LDL-C Level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
< 180 mg/dL [4.66 mmol/L]
5
  50.0%
6
  54.5%
9
  47.4%
10
  47.6%
30
  49.2%
≥ 180 mg/dL [4.66 mmol/L]
5
  50.0%
5
  45.5%
10
  52.6%
11
  52.4%
31
  50.8%
Stratification Factor: Baseline Statin Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
Yes
3
  30.0%
3
  27.3%
3
  15.8%
5
  23.8%
14
  23.0%
No
7
  70.0%
8
  72.7%
16
  84.2%
16
  76.2%
47
  77.0%
LDL-C Concentration  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
181.0  (34.7) 182.7  (72.2) 198.1  (64.1) 188.0  (41.6) 189.0  (53.9)
Total Cholesterol Concentration  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
280.0  (34.4) 275.2  (79.7) 282.0  (63.9) 282.3  (49.6) 280.5  (57.3)
High-density Lipoprotein Cholesterol (HDL-C) Concentration  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
62.5  (15.6) 64.1  (16.1) 54.3  (18.2) 64.1  (20.9) 60.8  (18.6)
Very Low-density Lipoprotein Cholesterol (VLDL) Concentration  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
36.5  (21.9) 28.4  (16.1) 29.6  (12.0) 30.2  (12.3) 30.7  (14.7)
Triglycerides Concentration  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
183.1  (111.1) 142.3  (80.1) 148.0  (59.8) 151.0  (61.3) 153.8  (73.7)
Apolipoprotein B Concentration  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
132.1  (19.4) 121.9  (29.3) 140.4  (31.7) 138.7  (26.2) 135.1  (27.9)
Non-HDL-C Concentration  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
217.5  (37.3) 211.1  (71.2) 227.7  (63.3) 218.2  (42.2) 219.8  (53.7)
Total cholesterol/HDL-C ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
4.8  (1.4) 4.4  (1.1) 5.7  (2.0) 4.8  (1.4) 5.0  (1.6)
ApolipoproteinB/Apolipoprotein A1 Ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
0.8  (0.2) 0.8  (0.2) 1.0  (0.4) 0.9  (0.2) 0.9  (0.3)
Lipoprotein(a) Concentration  
Mean (Standard Deviation)
Unit of measure:  nmol/L
Number Analyzed 10 participants 11 participants 19 participants 21 participants 61 participants
48.0  (72.3) 66.0  (83.2) 61.3  (72.6) 66.2  (91.0) 61.7  (79.5)
1.Primary Outcome
Title Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12
Hide Description For all efficacy endpoints the two dosing regimens (every 2 weeks and every month) for each treatment were pooled for analysis.
Time Frame Baseline and Weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-20.39  (3.19) -59.75  (2.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -39.35
Confidence Interval (2-Sided) 95%
-47.23 to -31.48
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.93
Estimation Comments Evolocumab - Ezetimibe
2.Primary Outcome
Title Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-19.13  (3.45) -59.27  (2.50)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -40.14
Confidence Interval (2-Sided) 95%
-48.68 to -31.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.26
Estimation Comments Evolocumab - Ezetimibe
3.Secondary Outcome
Title Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Hide Description [Not Specified]
Time Frame Baseline and weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-35.6  (6.6) -113.2  (4.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -77.6
Confidence Interval (2-Sided) 95%
-93.9 to -61.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.1
Estimation Comments Evolocumab - Ezetimibe
4.Secondary Outcome
Title Change From Baseline in LDL-C at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-33.4  (7.0) -112.7  (5.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -79.4
Confidence Interval (2-Sided) 95%
-96.7 to -62.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 8.7
Estimation Comments Evolocumab - Ezetimibe
5.Secondary Outcome
Title Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Hide Description Mean low density lipoprotein-cholesterol response was defined as LDL-C < 70 mg/dL [1.8 mol/L].
Time Frame Weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.00
(0.00 to 16.11)
56.41
(40.98 to 70.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Cochran-Mantel-Haenszel
Comments Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 56.41
Confidence Interval (2-Sided) 95%
34.10 to 70.70
Estimation Comments Evolocumab - Ezetimibe
6.Secondary Outcome
Title Percentage of Participants Who Achieved a LDL-C of Less Than 70 mg/dL at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.00
(0.00 to 16.11)
52.63
(37.26 to 67.52)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Cochran-Mantel-Haenszel
Comments Cochran Mantel Haenszel (CMH) test adjusted by the stratification factor (screening LDL-C level).
Method of Estimation Estimation Parameter Treatment Difference
Estimated Value 52.63
Confidence Interval (2-Sided) 95%
30.36 to 67.52
Estimation Comments Evolocumab - Ezetimibe
7.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12
Hide Description [Not Specified]
Time Frame Baseline and weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-13.80  (2.17) -39.24  (1.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -25.44
Confidence Interval (2-Sided) 95%
-30.80 to -20.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.68
Estimation Comments Evolocumab - Ezetimibe
8.Secondary Outcome
Title Percent Change From Baseline in Total Cholesterol at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-12.69  (2.34) -38.52  (1.70)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -25.83
Confidence Interval (2-Sided) 95%
-31.63 to -20.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.89
Estimation Comments Evolocumab - Ezetimibe
9.Secondary Outcome
Title Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12
Hide Description [Not Specified]
Time Frame Baseline and weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-18.82  (2.77) -52.35  (2.01)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -33.53
Confidence Interval (2-Sided) 95%
-40.38 to -26.68
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.42
Estimation Comments Evolocumab - Ezetimibe
10.Secondary Outcome
Title Percent Change From Baseline in Non-HDL-C at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-18.28  (3.03) -51.71  (2.20)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -33.44
Confidence Interval (2-Sided) 95%
-40.94 to -25.94
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.75
Estimation Comments Evolocumab - Ezetimibe
11.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Hide Description [Not Specified]
Time Frame Baseline and Weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-13.23  (2.69) -48.90  (1.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -35.67
Confidence Interval (2-Sided) 95%
-42.30 to -29.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.31
Estimation Comments Evolocumab - Ezetimibe
12.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-11.32  (2.99) -47.91  (2.14)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -36.60
Confidence Interval (2-Sided) 95%
-43.98 to -29.22
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.68
Estimation Comments Evolocumab - Ezetimibe
13.Secondary Outcome
Title Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Hide Description [Not Specified]
Time Frame Baseline and weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-15.73  (2.69) -44.34  (1.94)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -28.61
Confidence Interval (2-Sided) 95%
-35.26 to -21.97
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.32
Estimation Comments Evolocumab - Ezetimibe
14.Secondary Outcome
Title Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-17.34  (2.81) -44.39  (2.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -27.05
Confidence Interval (2-Sided) 95%
-34.00 to -20.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.47
Estimation Comments Evolocumab - Ezetimibe
15.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12
Hide Description [Not Specified]
Time Frame Baseline and weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-15.39  (2.67) -52.46  (1.91)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -37.07
Confidence Interval (2-Sided) 95%
-43.65 to -30.50
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.28
Estimation Comments Evolocumab - Ezetimibe
16.Secondary Outcome
Title Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-15.62  (2.88) -51.91  (2.06)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -36.29
Confidence Interval (2-Sided) 95%
-43.39 to -29.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.54
Estimation Comments Evolocumab - Ezetimibe
17.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Hide Description [Not Specified]
Time Frame Baseline and weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-5.89  (4.34) -37.02  (3.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -31.13
Confidence Interval (2-Sided) 95%
-41.83 to -20.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.34
Estimation Comments Evolocumab - Ezetimibe
18.Secondary Outcome
Title Percent Change From Baseline in Lipoprotein(a) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-5.21  (5.02) -36.41  (3.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -31.21
Confidence Interval (2-Sided) 95%
-43.57 to -18.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.17
Estimation Comments Evolocumab - Ezetimibe
19.Secondary Outcome
Title Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Hide Description [Not Specified]
Time Frame Baseline and weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-5.21  (5.92) -1.73  (4.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value 3.49
Confidence Interval (2-Sided) 95%
-11.15 to 18.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.31
Estimation Comments Evolocumab - Ezetimibe
20.Secondary Outcome
Title Percent Change From Baseline in Triglycerides at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-9.87  (7.71) 1.92  (5.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value 11.79
Confidence Interval (2-Sided) 95%
-7.29 to 30.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.52
Estimation Comments Evolocumab - Ezetimibe
21.Secondary Outcome
Title Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Hide Description [Not Specified]
Time Frame Baseline and weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
3.10  (2.50) 11.06  (1.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value 7.96
Confidence Interval (2-Sided) 95%
1.78 to 14.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.08
Estimation Comments Evolocumab - Ezetimibe
22.Secondary Outcome
Title Percent Change From Baseline in HDL-C at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
6.45  (2.59) 12.04  (1.88)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value 5.59
Confidence Interval (2-Sided) 95%
-0.82 to 12.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.20
Estimation Comments Evolocumab - Ezetimibe
23.Secondary Outcome
Title Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12
Hide Description [Not Specified]
Time Frame Baseline and weeks 10 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-4.67  (5.89) -5.34  (4.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-15.22 to 13.87
Parameter Dispersion
Type: Standard Error of the Mean
Value: 7.26
Estimation Comments Evolocumab - Ezetimibe
24.Secondary Outcome
Title Percent Change From Baseline in VLDL-C at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug in the double-blind treatment period.
Arm/Group Title Ezetimibe Evolocumab
Hide Arm/Group Description:
Participants received placebo subcutaneous injection once every 2 weeks or once a month and 10 mg ezetimibe orally once a day for 12 weeks.
Participants received SC evolocumab 140 mg once every 2 weeks or 420 mg once a month and placebo tablets once a day for 12 weeks.
Overall Number of Participants Analyzed 21 40
Least Squares Mean (Standard Error)
Unit of Measure: percent change
-9.06  (8.00) -1.42  (5.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ezetimibe, Evolocumab
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.
Method Repeated measures linear effects model
Comments Model includes treatment group, stratification factor (screening LDL-C level), scheduled visit and the interaction of treatment with scheduled visit.
Method of Estimation Estimation Parameter LS Mean Treatment Difference
Estimated Value 7.64
Confidence Interval (2-Sided) 95%
-12.15 to 27.43
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.88
Estimation Comments Evolocumab - Ezetimibe
Time Frame 12 weeks
Adverse Event Reporting Description Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
 
Arm/Group Title Ezetimibe (Q2W) Ezetimibe (QM) Evolocumab Q2W Evolocumab QM
Hide Arm/Group Description Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for 12 weeks. Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for 12 weeks. Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for 12 weeks. Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for 12 weeks.
All-Cause Mortality
Ezetimibe (Q2W) Ezetimibe (QM) Evolocumab Q2W Evolocumab QM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%)   0/19 (0.00%)   0/21 (0.00%) 
Hide Serious Adverse Events
Ezetimibe (Q2W) Ezetimibe (QM) Evolocumab Q2W Evolocumab QM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   1/11 (9.09%)   0/19 (0.00%)   0/21 (0.00%) 
Cardiac disorders         
Acute myocardial infarction  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders         
Osteoarthritis  1  1/10 (10.00%)  0/11 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ezetimibe (Q2W) Ezetimibe (QM) Evolocumab Q2W Evolocumab QM
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/10 (40.00%)   8/11 (72.73%)   11/19 (57.89%)   12/21 (57.14%) 
Gastrointestinal disorders         
Abdominal discomfort  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  1/21 (4.76%) 
Abdominal distension  1  0/10 (0.00%)  0/11 (0.00%)  2/19 (10.53%)  0/21 (0.00%) 
Abdominal pain  1  0/10 (0.00%)  0/11 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Abdominal pain upper  1  0/10 (0.00%)  1/11 (9.09%)  1/19 (5.26%)  0/21 (0.00%) 
Constipation  1  1/10 (10.00%)  0/11 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Diarrhoea  1  0/10 (0.00%)  2/11 (18.18%)  1/19 (5.26%)  1/21 (4.76%) 
Gastrooesophageal reflux disease  1  0/10 (0.00%)  0/11 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Oral mucosa haematoma  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Tooth loss  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
General disorders         
Chest discomfort  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
Injection site bruising  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Injection site erythema  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
Injection site pain  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  2/21 (9.52%) 
Injection site reaction  1  1/10 (10.00%)  0/11 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Injection site swelling  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
Pyrexia  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
Infections and infestations         
Bronchitis  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Cystitis  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Nasopharyngitis  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  5/21 (23.81%) 
Pharyngitis  1  0/10 (0.00%)  0/11 (0.00%)  3/19 (15.79%)  1/21 (4.76%) 
Tonsillitis  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Injury, poisoning and procedural complications         
Ligament sprain  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Muscle strain  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Investigations         
Blood creatine phosphokinase increased  1  0/10 (0.00%)  0/11 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Metabolism and nutrition disorders         
Hypoglycaemia  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Muscular weakness  1  0/10 (0.00%)  0/11 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Myalgia  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  1/21 (4.76%) 
Myositis  1  1/10 (10.00%)  0/11 (0.00%)  0/19 (0.00%)  0/21 (0.00%) 
Pain in extremity  1  0/10 (0.00%)  0/11 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Plantar fasciitis  1  0/10 (0.00%)  0/11 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Synovial cyst  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
Tenosynovitis  1  0/10 (0.00%)  0/11 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Nervous system disorders         
Dizziness  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
Headache  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  0/10 (0.00%)  0/11 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Cough  1  1/10 (10.00%)  0/11 (0.00%)  1/19 (5.26%)  1/21 (4.76%) 
Skin and subcutaneous tissue disorders         
Dermatitis contact  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
Miliaria  1  0/10 (0.00%)  0/11 (0.00%)  1/19 (5.26%)  0/21 (0.00%) 
Onychomalacia  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Pruritus  1  0/10 (0.00%)  1/11 (9.09%)  1/19 (5.26%)  0/21 (0.00%) 
Urticaria  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  1/21 (4.76%) 
Vascular disorders         
Hypertension  1  0/10 (0.00%)  0/11 (0.00%)  0/19 (0.00%)  2/21 (9.52%) 
Varicose vein  1  0/10 (0.00%)  1/11 (9.09%)  0/19 (0.00%)  0/21 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
EMail: medinfo@amgen.com
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02634580    
Other Study ID Numbers: 20140234
First Submitted: December 16, 2015
First Posted: December 18, 2015
Results First Submitted: August 1, 2018
Results First Posted: August 31, 2018
Last Update Posted: August 31, 2018