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LAPLACE-TIMI 57: LDL-C Assessment Wtih PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy

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: July 8, 2014
Last verified: July 2014

June 23, 2011
July 8, 2014
July 2011
May 2012   (final data collection date for primary outcome measure)
The primary endpoint is the percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
  • Absolute change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in non-High Density Lipoprotein Cholesterol (HDL-C) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in Apolipoprotein B (ApoB) at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in the total cholesterol/High Density Lipoprotein Cholesterol (HDL-C) ratio at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in Apolipoprotein B (ApoB)/Apolipoprotein A-1 (ApoA1) ratio at week 12 [ Time Frame: 12 weeks ] [ 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: LDL-C Assessment Wtih PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy
TIMI-57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on Low-Density Lipoprotein Cholesterol (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) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, or percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) when used in addition to a statin in subjects 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 (AMG 145)
    Dose 1 - every 2 weeks
  • Biological: evolocumab (AMG 145)
    Dose 2 - every 2 weeks
  • Biological: evolocumab (AMG 145)
    Dose 3 - every 2 weeks
  • Biological: evolocumab (AMG 145)
    Dose 4 - every 4 weeks
  • Biological: evolocumab (AMG 145)
    Dose 5 - every 4 weeks
  • Biological: evolocumab (AMG 145)
    Dose 6 - every 4 weeks
  • Other: PLACEBO
    Dose 7 - every 2 weeks
  • Other: PLACEBO
    Dose 8 - every 4 weeks
  • Experimental: Group 4
    evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Placebo Comparator: Group 7
    Placebo
    Intervention: Other: PLACEBO
  • Experimental: Group 1
    evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Experimental: Group 5
    evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Experimental: Group 3
    evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Experimental: Group 6
    evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)
  • Placebo Comparator: Group 8
    Placebo
    Intervention: Other: PLACEBO
  • Experimental: Group 2
    evolocumab (AMG 145)
    Intervention: Biological: evolocumab (AMG 145)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
631
May 2012
May 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 Low-Density Lipoprotein Cholesterol (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 (Glycated Hemoglobin (HbA1c) > 8.5%)
  • Uncontrolled hypertension defined
  • 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
Amgen
Amgen
TIMI Study Group
Study Director: MD Amgen
Amgen
July 2014

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