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OpenTrials
Completed

NCT Number: NCT01380730

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

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.

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Key information

Conditions

Hyperlipidemia Dyslipidemias Hypercholesterolemia Hypercholesterolemia, Autosomal Dominant, 3 Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Burnaby, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evolocumab

Biological

Administered by subcutaneous injection

Other names: AMG 145, Repatha

Placebo to Evolocumab

Other

Administered by subcutaneous injection

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and Week 12

    LDL-C was measured using ultracentrifugation.

  2. Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

    Time frame: Baseline and Week 12

  3. Percent Change From Baseline in Apolipoprotein B at Week 12

    Time frame: Baseline and Week 12

  4. Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12

    Time frame: Baseline and Week 12

  5. Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

  • The TIMI Study Group

Registry information

Official study title

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

Acronym: LAPLACE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 27, 2011
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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