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LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2 (LAPLACE-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01763866
First received: January 7, 2013
Last updated: November 18, 2015
Last verified: November 2015
Results First Received: September 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hyperlipidemia
Interventions: Biological: Evolocumab
Drug: Ezetimibe
Drug: Placebo to Evolocumab
Drug: Placebo to Ezetimibe
Drug: Atorvastatin
Drug: Rosuvastatin
Drug: Simvastatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Adults aged 18 to 80 years with screening low-density lipoprotein cholesterol (LDL-C) ≥ 150 mg/dL (no statin at screening), ≥ 100 mg/dL (non-intensive statin at screening), or ≥ 80 mg/dL (intensive statin at screening) and fasting triglycerides ≤ 400 mg/dL.

First patient enrolled on 15 January 2013; Last patient enrolled on 10 July 2013.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

2067 patients were first randomized to 1 of the 5 open-label statin cohorts (atorvastatin 10 mg or 80 mg, rosuvastatin 5 mg or 40 mg, or simvastatin 40 mg); 1899 were then randomized to blinded investigational product.

Randomization into the statin dose cohorts was stratified by entry statin therapy and by use of certain concomitant medications.


Reporting Groups
  Description
A10 PBO Q2W Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
A10 PBO QM Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
A10 EZE (Q2W) Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
A10 EZE (QM) Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
A10 EvoMab Q2W Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
A10 EvoMab QM Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
A80 PBO Q2W Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
A80 PBO QM Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
A80 EZE (Q2W) Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
A80 EZE (QM) Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
A80 EvoMab Q2W Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
A80 EvoMab QM Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
R5 PBO Q2W Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
R5 PBO QM Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
R5 EvoMab Q2W Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
R5 EvoMab QM Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
R40 PBO Q2W Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
R40 PBO QM Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
R40 EvoMab Q2W Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
R40 EvoMab QM Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
S40 PBO Q2W Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
S40 PBO QM Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
S40 EvoMab Q2W Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
S40 EvoMab QM Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.

Participant Flow:   Overall Study
    A10 PBO Q2W   A10 PBO QM   A10 EZE (Q2W)   A10 EZE (QM)   A10 EvoMab Q2W   A10 EvoMab QM   A80 PBO Q2W   A80 PBO QM   A80 EZE (Q2W)   A80 EZE (QM)   A80 EvoMab Q2W   A80 EvoMab QM   R5 PBO Q2W   R5 PBO QM   R5 EvoMab Q2W   R5 EvoMab QM   R40 PBO Q2W   R40 PBO QM   R40 EvoMab Q2W   R40 EvoMab QM   S40 PBO Q2W   S40 PBO QM   S40 EvoMab Q2W   S40 EvoMab QM
STARTED   56   55   56   55   110   110   55   55   56   54   110   110   58   57   114   115   56   56   111   112   56   55   112   115 
Received Treatment   56   55   56   55   110   110   55   55   56   54   109   110   58   57   113   115   56   55   111   112   56   55   112   115 
COMPLETED   54   54   51   55   108   107   48   55   53   53   102   108   54   57   102   112   55   55   105   110   52   54   109   113 
NOT COMPLETED   2   1   5   0   2   3   7   0   3   1   8   2   4   0   12   3   1   1   6   2   4   1   3   2 
Withdrawal by Subject                2                1                4                0                0                3                4                0                1                1                2                2                2                0                6                3                0                1                1                1                2                1                2                1 
Decision by sponsor                0                0                1                0                2                0                2                0                2                0                6                0                1                0                5                0                0                0                4                0                2                0                1                0 
Lost to Follow-up                0                0                0                0                0                0                1                0                0                0                0                0                1                0                1                0                0                0                1                1                0                0                0                1 
Death                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                0                1                0                0                0                0                0                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
A10 PBO Q2W Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
A10 PBO QM Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
A10 EZE (Q2W) Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
A10 EZE (QM) Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
A10 EvoMab Q2W Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
A10 EvoMab QM Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
A80 PBO Q2W Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
A80 PBO QM Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
A80 EZE (Q2W) Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
A80 EZE (QM) Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
A80 EvoMab Q2W Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
A80 EvoMab QM Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
R5 PBO Q2W Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
R5 PBO QM Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
R5 EvoMab Q2W Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
R5 EvoMab QM Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
R40 PBO Q2W Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
R40 PBO QM Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
R40 EvoMab Q2W Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
R40 EvoMab QM Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
S40 PBO Q2W Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
S40 PBO QM Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
S40 EvoMab Q2W Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
S40 EvoMab QM Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Total Total of all reporting groups

Baseline Measures
   A10 PBO Q2W   A10 PBO QM   A10 EZE (Q2W)   A10 EZE (QM)   A10 EvoMab Q2W   A10 EvoMab QM   A80 PBO Q2W   A80 PBO QM   A80 EZE (Q2W)   A80 EZE (QM)   A80 EvoMab Q2W   A80 EvoMab QM   R5 PBO Q2W   R5 PBO QM   R5 EvoMab Q2W   R5 EvoMab QM   R40 PBO Q2W   R40 PBO QM   R40 EvoMab Q2W   R40 EvoMab QM   S40 PBO Q2W   S40 PBO QM   S40 EvoMab Q2W   S40 EvoMab QM   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   55   56   55   110   110   55   55   56   54   110   110   58   57   114   115   56   56   111   112   56   55   112   115   1899 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.3  (10.5)   62.2  (10.4)   61.0  (9.0)   60.6  (9.2)   58.3  (8.4)   59.6  (11.1)   57.1  (9.9)   58.8  (11.5)   60.5  (10.2)   61.1  (8.9)   59.7  (10.2)   60.1  (10.2)   61.2  (9.1)   59.6  (9.2)   58.9  (11.2)   59.3  (10.5)   60.2  (8.7)   58.3  (11.3)   59.5  (9.2)   59.6  (9.0)   61.9  (9.7)   61.5  (10.3)   59.7  (9.2)   61.5  (9.6)   59.8  (9.9) 
Gender 
[Units: Participants]
                                                 
Female   24   28   29   28   56   44   22   24   24   28   44   48   35   27   52   51   21   27   43   52   32   28   45   59   871 
Male   32   27   27   27   54   66   33   31   32   26   66   62   23   30   62   64   35   29   68   60   24   27   67   56   1028 
Race/Ethnicity, Customized 
[Units: Participants]
                                                 
Hispanic or Latino   3   2   2   1   5   2   5   5   4   4   5   7   2   4   6   3   2   3   6   5   1   2   3   5   87 
Not Hispanic or Latino   53   53   54   54   105   108   50   50   52   50   105   103   56   53   108   112   54   53   105   107   55   53   109   110   1812 
Race/Ethnicity, Customized 
[Units: Participants]
                                                 
American Indian or Alaska Native   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   0   1   0   1 
Asian   1   0   2   1   3   4   1   0   0   3   1   1   0   0   2   1   1   0   0   0   3   0   1   0   25 
Black or African American   3   0   1   2   9   4   1   2   3   4   3   4   2   1   7   5   0   3   5   3   3   1   4   5   75 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0   0   0   1   0   1   0   0   0   0   0   1   0   0   0   0   1   0   0   0   4 
White   52   55   53   52   97   101   51   52   53   46   105   105   56   56   104   107   55   52   105   109   49   54   106   110   1785 
Other   0   0   0   0   1   0   2   0   0   0   1   0   0   0   1   1   0   1   0   0   0   0   0   0   7 
Mixed Race   0   0   0   0   0   1   0   0   0   0   0   0   0   0   0   0   0   0   1   0   0   0   0   0   2 
Stratification Factor: Entry Statin Therapy [1] 
[Units: Participants]
                                                 
Intensive statin use   18   19   10   14   28   35   15   12   21   11   34   35   13   13   33   38   13   13   33   37   19   13   31   34   542 
Non-intensive statin use   20   25   30   21   52   40   22   27   22   21   47   46   25   28   49   42   23   22   50   44   21   26   45   48   796 
No statin use   18   11   16   20   30   35   18   16   13   22   29   29   20   16   32   35   20   21   28   31   16   16   36   33   561 
[1] Intensive statin use was defined as daily atorvastatin (40 mg or greater), rosuvastatin (20 mg or greater), simvastatin (80 mg), or any statin plus ezetimibe.
Low-Density Lipoprotein Cholesterol (LDL-C) Concentration [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 123.0  (46.6)   123.7  (47.9)   126.8  (49.6)   119.3  (28.1)   124.2  (43.4)   126.1  (50.4)   100.3  (36.2)   94.7  (31.9)   98.7  (34.0)   92.3  (19.3)   94.2  (34.8)   93.8  (32.3)   115.6  (39.8)   119.9  (39.1)   118.7  (40.9)   122.9  (42.0)   77.4  (20.9)   102.9  (49.3)   88.5  (31.5)   88.5  (31.3)   110.3  (28.0)   108.6  (30.9)   114.9  (34.5)   123.7  (48.5)   109.1  (41.1) 
[1] Data are provided for the full analysis set (all participants randomized to investigational product (IP) who received at least 1 dose of IP (subcutaneously or orally). Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 149.1  (46.9)   147.7  (51.4)   153.8  (53.2)   148.3  (36.8)   152.3  (45.6)   154.3  (53.1)   124.2  (39.3)   116.5  (35.7)   124.8  (35.4)   118.4  (25.5)   120.2  (42.3)   117.2  (36.3)   141.1  (41.6)   148.3  (43.3)   146.6  (43.2)   152.0  (46.4)   103.9  (25.7)   128.7  (53.4)   113.5  (36.0)   114.3  (34.7)   138.4  (29.3)   135.7  (38.4)   146.8  (41.8)   151.2  (51.5)   150.3  (27.6) 
[1] Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Apolipoprotein B Concentration [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 95.3  (26.0)   95.3  (29.6)   101.3  (31.2)   94.6  (20.4)   99.7  (26.4)   97.3  (28.9)   81.1  (22.1)   80.1  (21.4)   85.3  (23.1)   78.7  (16.9)   79.9  (25.1)   77.9  (21.5)   93.1  (27.3)   95.9  (25.2)   95.4  (27.0)   97.2  (26.9)   71.0  (16.6)   84.8  (29.7)   77.4  (22.3)   78.7  (23.1)   91.6  (18.4)   89.8  (20.7)   94.2  (24.0)   96.5  (27.5)   89.1  (26.1) 
[1] Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Total Cholesterol/HDL-C Ratio [1] 
[Units: Ratio]
Mean (Standard Deviation)
 3.988  (1.154)   3.859  (1.396)   4.112  (1.311)   4.002  (1.100)   3.980  (1.224)   4.100  (1.636)   3.704  (1.260)   3.461  (1.093)   3.748  (1.099)   3.540  (1.100)   3.696  (1.371)   3.462  (1.000)   4.044  (1.685)   3.891  (1.234)   3.915  (1.216)   4.178  (1.932)   3.086  (0.728)   3.547  (1.355)   3.413  (1.355)   3.307  (1.061)   3.733  (1.079)   3.595  (1.345)   4.196  (1.436)   3.924  (1.420)   3.786  (1.353) 
[1] Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Apolipoprotein B/Apolipoprotein A1 Ratio [1] 
[Units: Ratio]
Mean (Standard Deviation)
 0.666  (0.216)   0.647  (0.266)   0.692  (0.243)   0.640  (0.169)   0.663  (0.217)   0.659  (0.249)   0.603  (0.221)   0.571  (0.189)   0.640  (0.234)   0.560  (0.157)   0.593  (0.227)   0.562  (0.171)   0.661  (0.273)   0.636  (0.207)   0.640  (0.249)   0.676  (0.341)   0.479  (0.129)   0.562  (0.217)   0.538  (0.227)   0.536  (0.193)   0.611  (0.179)   0.581  (0.174)   0.657  (0.193)   0.639  (0.224)   0.614  (0.229) 
[1] Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Lipoprotein(a) Concentration [1] 
[Units: nmol/L]
Median (Inter-Quartile Range)
 31.5 
 (13.0 to 87.5) 
 41.0 
 (15.0 to 106.0) 
 37.0 
 (9.5 to 190.0) 
 33.0 
 (8.0 to 163.0) 
 27.0 
 (8.0 to 120.0) 
 49.0 
 (11.0 to 169.0) 
 53.0 
 (15.0 to 177.0) 
 50.0 
 (13.0 to 152.0) 
 25.0 
 (12.0 to 108.0) 
 61.5 
 (12.0 to 192.0) 
 32.0 
 (11.5 to 135.5) 
 24.5 
 (8.0 to 93.0) 
 34.0 
 (8.0 to 158.0) 
 35.0 
 (14.0 to 156.5) 
 38.0 
 (11.0 to 165.0) 
 32.0 
 (9.0 to 172.0) 
 28.5 
 (7.0 to 171.0) 
 33.0 
 (11.0 to 148.0) 
 41.0 
 (10.0 to 183.0) 
 49.5 
 (11.0 to 184.5) 
 36.5 
 (17.5 to 140.5) 
 28.0 
 (13.0 to 180.0) 
 32.5 
 (13.0 to 157.0) 
 37.0 
 (11.0 to 141.0) 
 34.0 
 (11.0 to 161.5) 
[1] Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Triglyceride Concentration [1] 
[Units: mg/dL]
Median (Inter-Quartile Range)
 112.0 
 (83.0 to 176.0) 
 108.0 
 (83.0 to 145.0) 
 129.5 
 (94.0 to 151.5) 
 119.0 
 (87.0 to 168.0) 
 135.0 
 (99.0 to 189.0) 
 119.0 
 (84.0 to 161.0) 
 104.0 
 (82.0 to 142.0) 
 104.0 
 (76.0 to 124.0) 
 133.0 
 (89.0 to 155.0) 
 109.0 
 (80.0 to 171.0) 
 104.0 
 (81.0 to 163.0) 
 106.5 
 (79.0 to 137.0) 
 112.5 
 (89.0 to 148.0) 
 134.0 
 (86.0 to 184.0) 
 116.0 
 (90.0 to 168.0) 
 121.0 
 (93.0 to 161.0) 
 128.0 
 (91.5 to 162.0) 
 116.0 
 (78.0 to 160.0) 
 102.0 
 (79.0 to 151.0) 
 119.5 
 (87.0 to 149.5) 
 124.0 
 (90.0 to 173.0) 
 106.0 
 (87.0 to 139.0) 
 129.0 
 (91.5 to 195.0) 
 110.0 
 (84.0 to 161.0) 
 116.0 
 (86.0 to 158.0) 
[1] Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
Very Low Density Lipoprotein Cholesterol (VLDL-C) Concentration [1] 
[Units: mg/dL]
Median (Inter-Quartile Range)
 22.0 
 (17.0 to 35.0) 
 22.0 
 (17.0 to 29.0) 
 25.5 
 (19.0 to 30.0) 
 24.0 
 (17.0 to 33.0) 
 27.0 
 (20.0 to 38.0) 
 24.0 
 (17.0 to 32.0) 
 21.0 
 (16.0 to 28.0) 
 21.0 
 (15.0 to 25.0) 
 26.5 
 (18.0 to 31.0) 
 22.0 
 (16.0 to 34.0) 
 21.0 
 (16.0 to 33.0) 
 21.0 
 (16.0 to 27.0) 
 22.5 
 (18.0 to 30.0) 
 27.0 
 (17.0 to 37.0) 
 23.0 
 (18.0 to 34.0) 
 24.0 
 (19.0 to 32.0) 
 26.0 
 (18.5 to 32.5) 
 23.0 
 (16.0 to 32.0) 
 20.0 
 (16.0 to 30.0) 
 24.0 
 (17.0 to 30.0) 
 25.0 
 (18.0 to 34.5) 
 21.0 
 (17.0 to 26.0) 
 26.0 
 (18.5 to 39.0) 
 22.0 
 (17.0 to 32.0) 
 23.0 
 (17.0 to 32.0) 
[1] Data are provided for the full analysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.
HDL-C Concentration [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 54.1  (16.6)   57.9  (18.4)   54.1  (17.2)   52.7  (13.7)   56.0  (17.9)   56.1  (17.8)   50.6  (15.6)   50.9  (13.0)   48.7  (12.6)   51.6  (15.1)   48.5  (12.9)   50.8  (13.5)   52.1  (14.9)   55.5  (16.0)   54.5  (15.0)   54.0  (16.0)   52.8  (12.9)   56.0  (18.7)   53.2  (16.4)   53.8  (14.6)   55.0  (14.2)   59.9  (21.8)   49.7  (12.6)   57.3  (17.4)   53.5  (15.9) 
[1] Data are provided for the full anlaysis set. Baseline was measured after the lipid stabilization period and before administration of first dose of study drug.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Primary:   Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12   [ Time Frame: Baseline and Weeks 10 and 12 ]

3.  Secondary:   Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12   [ Time Frame: Baseline and Weeks 10 and 12 ]

4.  Secondary:   Change From Baseline in LDL-C at Week 12   [ Time Frame: Baseline and Week 12 ]

5.  Secondary:   Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12   [ Time Frame: Baseline and Weeks 10 and 12 ]

6.  Secondary:   Percent Change From Baseline in Non-HDL-C at Week 12   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12   [ Time Frame: Baseline and Weeks 10 and 12 ]

8.  Secondary:   Percent Change From Baseline in Apolipoprotein B at Week 12   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12   [ Time Frame: Baseline and Weeks 10 and 12 ]

10.  Secondary:   Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12   [ Time Frame: Baseline and Weeks 10 and 12 ]

12.  Secondary:   Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12   [ Time Frame: Baseline and Week 12 ]

13.  Secondary:   Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL   [ Time Frame: Weeks 10 and 12 ]

14.  Secondary:   Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12   [ Time Frame: Week 12 ]

15.  Secondary:   Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12   [ Time Frame: Baseline and Weeks 10 and 12 ]

16.  Secondary:   Percent Change From Baseline in Lipoprotein(a) at Week 12   [ Time Frame: Baseline and Week 12 ]

17.  Secondary:   Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12   [ Time Frame: Baseline and Weeks 10 and 12 ]

18.  Secondary:   Percent Change From Baseline in Triglycerides at Week 12   [ Time Frame: Baseline and Week 12 ]

19.  Secondary:   Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12   [ Time Frame: Baseline and Weeks 10 and 12 ]

20.  Secondary:   Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12   [ Time Frame: Baseline and Week 12 ]

21.  Secondary:   Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12   [ Time Frame: Baseline and Weeks 10 and 12 ]

22.  Secondary:   Percent Change From Baseline in HDL-C at Week 12   [ Time Frame: Baseline and Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01763866     History of Changes
Other Study ID Numbers: 20110115
2012-001363-70 ( EudraCT Number )
Study First Received: January 7, 2013
Results First Received: September 1, 2015
Last Updated: November 18, 2015
Health Authority: Hong Kong: Department of Health
Czech Republic: State Institute for Drug Control
Russia: Ministry of Health of the Russian Federation
Australia: Department of Health and Ageing Therapeutic Goods Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Health and Medicines Authority
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
United States: Food and Drug Administration
Hungary: National Institute of Pharmacy
Italy: Ethics Committee