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

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Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States, 35294
United States, Arizona
Research Site
Tucson, Arizona, United States, 85710
United States, Arkansas
Research Site
Malvern, Arkansas, United States, 72104
United States, California
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Anaheim, California, United States, 92801
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Carmichael, California, United States, 95608
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Newport Beach, California, United States, 92663
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Roseville, California, United States, 95747
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Westlake Village, California, United States, 91361
United States, Colorado
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Colorado Springs, Colorado, United States, 80909
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Littleton, Colorado, United States, 80120
United States, Florida
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Daytona Beach, Florida, United States, 32117
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Green Cove Springs, Florida, United States, 32043
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Melbourne, Florida, United States, 32901
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Miami, Florida, United States, 33173
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Miami, Florida, United States, 33143
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Port Charlotte, Florida, United States, 33952
United States, Illinois
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Peoria, Illinois, United States, 61614
United States, Indiana
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Hammond, Indiana, United States, 46320
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Indianapolis, Indiana, United States, 46237
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Valparaiso, Indiana, United States, 46383
United States, Iowa
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Iowa City, Iowa, United States, 52242
United States, Kentucky
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Lexington, Kentucky, United States, 40536
United States, Maine
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Auburn, Maine, United States, 04210
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Bangor, Maine, United States, 04401
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Portland, Maine, United States, 04101
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Kalamazoo, Michigan, United States, 49048
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Marquette, Michigan, United States, 49855
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Ypsilanti, Michigan, United States, 48197
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Tupelo, Mississippi, United States, 38801
United States, Montana
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Great Falls, Montana, United States, 59405
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Vorhees, New Jersey, United States, 08043
United States, New York
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Cortlandt Manor, New York, United States, 10567
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Williamsville, New York, United States, 14221
United States, North Carolina
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Smithfield, North Carolina, United States, 27577
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Winston-Salem, North Carolina, United States, 27103
United States, Ohio
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Canton, Ohio, United States, 44708
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Cincinnati, Ohio, United States, 45212
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Cincinnati, Ohio, United States, 45219
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Dayton, Ohio, United States, 45414
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Mansfield, Ohio, United States, 44906
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Marion, Ohio, United States, 43302
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Sandusky, Ohio, United States, 44870
United States, Pennsylvania
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Camp Hill, Pennsylvania, United States, 17011
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Philadelphia, Pennsylvania, United States, 19104
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Pittsburgh, Pennsylvania, United States, 15216
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York, Pennsylvania, United States, 17405
United States, South Carolina
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Florence, South Carolina, United States, 29501
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Spartanburg, South Carolina, United States, 29302
United States, South Dakota
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Rapid City, South Dakota, United States, 57701
United States, Tennessee
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Jackson, Tennessee, United States, 38301
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Jackson, Tennessee, United States, 38305
United States, Texas
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Houston, Texas, United States, 77002
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Houston, Texas, United States, 77074
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Tacoma, Washington, United States, 98405
United States, Wisconsin
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Madison, Wisconsin, United States, 53713
Canada, British Columbia
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Burnaby, British Columbia, Canada, V5G 1T4
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Kelowna, British Columbia, Canada, V1Y 1V6
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Vancouver, British Columbia, Canada, V6Z 1Y6
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Victoria, British Columbia, Canada, V8T 5G1
Canada, Ontario
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Cambridge, Ontario, Canada, N1R 6V6
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Hamilton, Ontario, Canada, L8L 2X2
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London, Ontario, Canada, N5W 6A2
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London, Ontario, Canada, N6A 5K8
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Newmarket, Ontario, Canada, L3Y 5G8
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Oshawa, Ontario, Canada, L1J 2K1
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Oshawa, Ontario, Canada, L1J 2J9
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Sarnia, Ontario, Canada, N7T 4X3
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Scarborough, Ontario, Canada, M1P 2T7
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Sudbury, Ontario, Canada, P3C 5K7
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Toronto, Ontario, Canada, M9V 4B4
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Toronto, Ontario, Canada, M8V 3X8
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Woodstock, Ontario, Canada, N4S 5P5
Canada, Quebec
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Gatineau, Quebec, Canada, J8Y 6S9
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Lachine, Quebec, Canada, H8S 2E4
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Longueuil, Quebec, Canada, J4N 0C9
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Pointe-Claire, Quebec, Canada, H9R 3J1
Canada
Research Site
Quebec, Canada, G1V 4M6
Czech Republic
Research Site
Brno, Czech Republic, 656 91
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Brno, Czech Republic, 603 00
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Brno, Czech Republic, 625 00
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Olomouc, Czech Republic, 775 20
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Praha 2, Czech Republic, 120 00
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Praha 4, Czech Republic, 140 21
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Slany, Czech Republic, 274 01
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Svitavy, Czech Republic, 568 25
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Usti nad Orlici, Czech Republic, 562 18
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Znojmo, Czech Republic, 669 02
Denmark
Research Site
Aalborg, Denmark, 9000
Research Site
Ballerup, Denmark, 2750
Research Site
Vejle, Denmark, 7100
Hungary
Research Site
Budapest, Hungary, 1096
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Debrecen, Hungary, 4032
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Dunaujvaros, Hungary, 2400
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Eger, Hungary, 3300
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Gyula, Hungary, 5700
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Kecskemet, Hungary, 6000
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Komarom, Hungary, 2991
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Mosonmagyarovar, Hungary, 9200
Research Site
Szolnok, Hungary, 5004
Research Site
Zalaegerszeg, Hungary, 8900
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 17, 2014