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  
Number of Participants  
[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  
Low-Density Lipoprotein Cholesterol (LDL-C) Concentration [2]
[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)  
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration [3]
[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)  
Apolipoprotein B Concentration [3]
[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)  
Total Cholesterol/HDL-C Ratio [3]
[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)  
Apolipoprotein B/Apolipoprotein A1 Ratio [3]
[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)  
Lipoprotein(a) Concentration [3]
[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)  
Triglyceride Concentration [3]
[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)  
Very Low Density Lipoprotein Cholesterol (VLDL-C) Concentration [3]
[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)  
HDL-C Concentration [4]
[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] 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.
[2] 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.
[3] 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.
[4] 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