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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Tracking Information | ||||
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First Submitted Date ICMJE | June 23, 2011 | |||
First Posted Date ICMJE | June 27, 2011 | |||
Results First Submitted Date ICMJE | September 1, 2015 | |||
Results First Posted Date ICMJE | October 1, 2015 | |||
Last Update Posted Date | January 5, 2021 | |||
Actual Study Start Date ICMJE | July 1, 2011 | |||
Actual Primary Completion Date | April 5, 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] LDL-C was measured using ultracentrifugation.
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Original Primary Outcome Measures ICMJE |
The primary endpoint is the percent change from baseline in LDL-C at week 12 [ Time Frame: 12 weeks ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy | |||
Official Title ICMJE | LAPLACE TIMI 57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects | |||
Brief Summary | To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Hyperlipidemia | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
631 | |||
Original Estimated Enrollment ICMJE |
600 | |||
Actual Study Completion Date ICMJE | April 5, 2012 | |||
Actual Primary Completion Date | April 5, 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, Czechia, Denmark, Hungary, United States | |||
Removed Location Countries | Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01380730 | |||
Other Study ID Numbers ICMJE | 20101155 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Amgen | |||
Study Sponsor ICMJE | Amgen | |||
Collaborators ICMJE | TIMI Study Group | |||
Investigators ICMJE |
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PRS Account | Amgen | |||
Verification Date | January 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |