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: January 24, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Hyperlipidemia
Drug: evolocumab (AMG 145)
Drug: PLACEBO
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 631
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 4
evolocumab (AMG 145)
Drug: evolocumab (AMG 145)
Dose 4 - every 4 weeks
Placebo Comparator: Group 7
Placebo
Drug: PLACEBO
Dose 7 - every 2 weeks
Experimental: Group 1
evolocumab (AMG 145)
Drug: evolocumab (AMG 145)
Dose 1 - every 2 weeks
Experimental: Group 5
evolocumab (AMG 145)
Drug: evolocumab (AMG 145)
Dose 5 - every 4 weeks
Experimental: Group 3
evolocumab (AMG 145)
Drug: evolocumab (AMG 145)
Dose 3 - every 2 weeks
Experimental: Group 6
evolocumab (AMG 145)
Drug: evolocumab (AMG 145)
Dose 6 - every 4 weeks
Placebo Comparator: Group 8
Placebo
Drug: PLACEBO
Dose 8 - every 4 weeks
Experimental: Group 2
evolocumab (AMG 145)
Drug: evolocumab (AMG 145)
Dose 2 - every 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01380730

  Show 100 Study Locations
Sponsors and Collaborators
Amgen
TIMI Study Group
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01380730     History of Changes
Other Study ID Numbers: 20101155
Study First Received: June 23, 2011
Last Updated: January 24, 2014
Health Authority: Canada: Health Canada
Czech Republic: Statni ustav pro kontrolu leciv
Denmark: Laegemiddelstyrelsen
Hungary: National Institute of Pharmacy
United States: Food and Drug Administration

Keywords provided by Amgen:
Hypercholesterolemia

Additional relevant MeSH terms:
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014