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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
Sponsor:
Collaborator:
TIMI Study Group
Information provided by (Responsible Party):
Amgen

Tracking Information
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
 (submitted: September 1, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
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
 (submitted: September 1, 2015)
  • Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ]
    LDL-C was measured using ultracentrifugation.
  • Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
  • Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2011)
  • Percent change from baseline in non-HDL-C at week 12 [ Time Frame: 12 weeks ]
  • Percent change from baseline in ApoB at week 12 [ Time Frame: 12 weeks ]
  • Percent change from baseline in the total cholesterol/HDL-C ratio at week 12 [ Time Frame: 12 weeks ]
  • Percent change from baseline in ApoB/ApoA1 ratio at week 12 [ Time Frame: 12 weeks ]
  • Absolute change from baseline in LDL-C at week 12 [ Time Frame: 12 weeks ]
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
Condition  ICMJE Hyperlipidemia
Intervention  ICMJE
  • Biological: Evolocumab
    Administered by subcutaneous injection
    Other Names:
    • AMG 145
    • Repatha
  • Other: Placebo to Evolocumab
    Administered by subcutaneous injection
Study Arms  ICMJE
  • Placebo Comparator: Placebo Q2W
    Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
    Intervention: Other: Placebo to Evolocumab
  • Placebo Comparator: Placebo Q4W
    Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
    Intervention: Other: Placebo to Evolocumab
  • Experimental: Evolocumab 70 mg Q2W
    Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 105 mg Q2W
    Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 140 mg Q2W
    Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 280 mg Q4W
    Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 350 mg Q4W
    Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
  • Experimental: Evolocumab 420 mg Q4W
    Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
    Intervention: Biological: Evolocumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2012)
631
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2011)
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:

  • Male or female ≥ 18 to ≤ 80 years of age
  • On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
  • Fasting LDL-C ≥ 85 mg/dL
  • Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

  • Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
  • Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) > 8.5%)
  • Uncontrolled hypertension
  • New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30%
  • Uncontrolled cardiac arrhythmia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: MD Amgen
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