LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy (LAPLACE)

This study has been completed.
Sponsor:
Collaborator:
TIMI Study Group
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01380730
First received: June 23, 2011
Last updated: September 1, 2015
Last verified: August 2015

June 23, 2011
September 1, 2015
July 2011
April 2012   (final data collection date for primary outcome measure)
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
LDL-C was measured using ultracentrifugation.
The primary endpoint is the percent change from baseline in LDL-C at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01380730 on ClinicalTrials.gov Archive Site
  • Change From Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percent change from baseline in non-HDL-C at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in ApoB at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in the total cholesterol/HDL-C ratio at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in ApoB/ApoA1 ratio at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Absolute change from baseline in LDL-C at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hyperlipidemia
  • Biological: Evolocumab
    Administered by subcutaneous injection
    Other Names:
    • AMG 145
    • Repatha
  • Other: Placebo to Evolocumab
    Administered by subcutaneous injection
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
631
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Denmark,   Hungary
 
NCT01380730
20101155
Yes
Not Provided
Not Provided
Amgen
Amgen
TIMI Study Group
Study Director: MD Amgen
Amgen
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP