LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy (LAPLACE)
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ClinicalTrials.gov Identifier: NCT01380730 |
Recruitment Status :
Completed
First Posted : June 27, 2011
Results First Posted : October 1, 2015
Last Update Posted : January 5, 2021
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Sponsor:
Amgen
Collaborator:
TIMI Study Group
Information provided by (Responsible Party):
Amgen
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Hyperlipidemia |
Interventions |
Biological: Evolocumab Other: Placebo to Evolocumab |
Enrollment | 631 |
Participant Flow
Recruitment Details |
This study enrolled adults aged 18 - 80 years who were on a statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks, and fasting low-density lipoprotein cholesterol (LDL-C) ≥ 85 mg/dL. The first patient enrolled on 18 July 2011 and the last patient enrolled on 22 December 2011. |
Pre-assignment Details | Eligible participants were randomized equally into 1 of 8 treatment groups. Randomization was stratified by screening LDL-C level (< 130 mg/dL or ≥ 130 mg/dL) and ezetimibe use at baseline (yes or no). |
Arm/Group Title | Placebo Q2W | Placebo Q4W | Evolocumab 70 mg Q2W | Evolocumab 105 mg Q2W | Evolocumab 140 mg Q2W | Evolocumab 280 mg Q4W | Evolocumab 350 mg Q4W | Evolocumab 420 mg Q4W |
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Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks. | Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. |
Period Title: Overall Study | ||||||||
Started | 78 | 79 | 79 | 79 | 78 | 79 | 79 | 80 |
Received Treatment | 78 | 77 [1] | 79 | 79 | 78 | 79 | 79 | 80 |
Completed | 78 | 79 | 79 | 79 | 77 | 79 | 79 | 80 |
Not Completed | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Reason Not Completed | ||||||||
Death | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
[1]
2 participants did not receive treatment but were followed until the end of study
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Baseline Characteristics
Arm/Group Title | Placebo Q2W | Placebo Q4W | Evolocumab 70 mg Q2W | Evolocumab 105 mg Q2W | Evolocumab 140 mg Q2W | Evolocumab 280 mg Q4W | Evolocumab 350 mg Q4W | Evolocumab 420 mg Q4W | Total | |
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Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. | Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks. | Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. | Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. | Total of all reporting groups | |
Overall Number of Baseline Participants | 78 | 77 | 79 | 79 | 78 | 79 | 79 | 80 | 629 | |
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Full analysis set (all randomized participants who received at least 1 dose of investigational product).
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants | |
60.2 (8.8) | 60.1 (9.6) | 59.4 (9.9) | 58.8 (9.7) | 62.4 (10.2) | 60.3 (8.4) | 61.9 (8.8) | 60.9 (10.3) | 60.5 (9.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants | |
Female |
42 53.8%
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41 53.2%
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44 55.7%
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25 31.6%
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45 57.7%
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40 50.6%
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38 48.1%
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44 55.0%
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319 50.7%
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Male |
36 46.2%
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36 46.8%
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35 44.3%
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54 68.4%
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33 42.3%
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39 49.4%
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41 51.9%
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36 45.0%
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310 49.3%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants |
American Indian or Alaska Native | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 3 | |
Asian | 0 | 2 | 1 | 3 | 1 | 2 | 2 | 1 | 12 | |
Black or African American | 6 | 0 | 6 | 8 | 9 | 8 | 4 | 9 | 50 | |
Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 3 | |
White | 72 | 74 | 72 | 67 | 67 | 64 | 72 | 70 | 558 | |
Other | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 3 | |
Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants |
Hispanic or Latino | 1 | 6 | 5 | 0 | 6 | 1 | 0 | 2 | 21 | |
Not Hispanic or Latino | 77 | 71 | 74 | 79 | 72 | 78 | 79 | 78 | 608 | |
Stratification Factor: LDL-C Level
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants |
< 130 mg/dL | 51 | 51 | 51 | 51 | 52 | 51 | 52 | 53 | 412 | |
≥ 130 mg/dL | 27 | 26 | 28 | 28 | 26 | 28 | 27 | 27 | 217 | |
Stratification Factor: Baseline Ezetimibe Use
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants |
No | 71 | 69 | 72 | 72 | 71 | 72 | 72 | 73 | 572 | |
Yes | 7 | 8 | 7 | 7 | 7 | 7 | 7 | 7 | 57 | |
LDL-C Concentration
[1] Mean (Standard Deviation) Unit of measure: mg/dL |
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Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants | |
122.2 (27.1) | 124.9 (30.6) | 121.4 (24.4) | 127.4 (32.1) | 120.9 (25.1) | 122.0 (28.8) | 123.2 (27.1) | 120.8 (26.5) | 122.8 (27.7) | ||
[1]
Measure Description: LDL-C was measured using ultracentrifugation.
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Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
Mean (Standard Deviation) Unit of measure: mg/dL |
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Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants | |
146.9 (29.9) | 150.2 (36.5) | 145.3 (29.9) | 151.2 (37.2) | 145.3 (26.2) | 146.3 (33.3) | 150.0 (29.1) | 144.4 (31.2) | 147.4 (31.8) | ||
Apolipoprotein B Concentration
Mean (Standard Deviation) Unit of measure: mg/dL |
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Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants | |
99.9 (17.0) | 101.6 (20.0) | 99.9 (16.8) | 103.6 (22.3) | 98.8 (16.6) | 101.3 (21.2) | 102.6 (18.9) | 99.9 (18.6) | 100.9 (19.0) | ||
Total Cholesterol/HDL-C ratio
Mean (Standard Deviation) Unit of measure: Ratio |
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Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants | |
3.940 (1.016) | 4.057 (1.303) | 4.002 (1.243) | 4.128 (1.473) | 3.932 (1.022) | 4.007 (1.300) | 4.118 (0.963) | 3.885 (1.090) | 4.008 (1.184) | ||
Apolipoprotein B/Apolipoprotein A-1 Ratio
Mean (Standard Deviation) Unit of measure: Ratio |
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Number Analyzed | 78 participants | 77 participants | 79 participants | 79 participants | 78 participants | 79 participants | 79 participants | 80 participants | 629 participants | |
0.660 (0.155) | 0.676 (0.194) | 0.675 (0.191) | 0.695 (0.219) | 0.649 (0.155) | 0.662 (0.199) | 0.687 (0.175) | 0.653 (0.177) | 0.670 (0.184) |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Study Director |
Organization: | Amgen Inc. |
Phone: | 866-572-6436 |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT01380730 |
Other Study ID Numbers: |
20101155 |
First Submitted: | June 23, 2011 |
First Posted: | June 27, 2011 |
Results First Submitted: | September 1, 2015 |
Results First Posted: | October 1, 2015 |
Last Update Posted: | January 5, 2021 |