Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels - Full Text View

Purpose

Primary hypothesis is that a dose regimen of AMG 145 when used as monotherapy will be well tolerated and will result in greater lowering of low density lipoprotein cholesterol (LDL-C) than placebo.

Condition	Intervention	Phase
Hyperlipidemia	Biological: AMG 145 Other: Ezetimibe Other: 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:	A Randomized, Placebo and Ezetimibe Controlled, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on Low Density Lipoprotein Cholesterol (LDL-C) in Hypercholesterolemic Subjects With a 10 Year Framingham Risk Score of 10% or Less

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Drug Information available for: Ezetimibe

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Percent change from baseline in low density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute change from baseline in low density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in non-high density lipoprotein cholesterol (non-HDL-C) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in apolipoprotein B (ApoB) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in the total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Percent change from baseline in apolipoprotein B/apolipoprotein A1 (ApoB/ApoA1) ratio after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	411
Study Start Date:	June 2011
Study Completion Date:	April 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 5 Dose 5 of subcutaneous AMG 145	Biological: AMG 145 Patients will receive AMG 145 every 2 or 4 weeks
Placebo Comparator: Group 9 Subcutaneous placebo	Other: Placebo Patients will receive Placebo every 2 weeks or 4 weeks. All patients at screening will participate in the placebo run-in.
Experimental: Group 6 Dose 6 of subcutaneous AMG 145	Biological: AMG 145 Patients will receive AMG 145 every 2 or 4 weeks
Experimental: Group 4 Dose 4 of subcutaneous AMG 145	Biological: AMG 145 Patients will receive AMG 145 every 2 or 4 weeks
Experimental: Group 3 Dose 3 of subcutaneous AMG 145	Biological: AMG 145 Patients will receive AMG 145 every 2 or 4 weeks
Experimental: Group 2 Dose 2 of subcutaneous AMG 145	Biological: AMG 145 Patients will receive AMG 145 every 2 or 4 weeks
Active Comparator: Group 7 Oral Ezetimibe	Other: Ezetimibe Patients will take Ezetimibe daily
Placebo Comparator: Group 8 Subcutaneous placebo	Other: Placebo Patients will receive Placebo every 2 weeks or 4 weeks. All patients at screening will participate in the placebo run-in.
Experimental: Group 1 Dose 1 of subcutaneous AMG 145	Biological: AMG 145 Patients will receive AMG 145 every 2 or 4 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female ≥ 18 to ≤ 75 years of age
Low density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL and < 190 mg/dL
Framingham risk score of 10% or less
Fasting triglycerides < 400 mg/dL

Exclusion Criteria:

History of coronary heart disease
NYHA II - IV heart failure
Uncontrolled cardiac arrhythmia
Uncontrolled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375777

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Locations

United States, Alabama
Research Site
Birmingham, Alabama, United States, 35216
United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72205
United States, California
Research Site
Encinitas, California, United States, 92024
Research Site
Inglewood, California, United States, 90301
Research Site
San Diego, California, United States, 92111
Research Site
Tustin, California, United States, 92780
United States, Florida
Research Site
DeLand, Florida, United States, 32720
Research Site
Jacksonville, Florida, United States, 32216
Research Site
Jacksonville, Florida, United States, 32223
Research Site
Miami, Florida, United States, 33144
Research Site
Miami, Florida, United States, 33143
Research Site
Ponte Vedra, Florida, United States, 32081
Research Site
Sanford, Florida, United States, 32771
United States, Georgia
Research Site
Decatur, Georgia, United States, 30035
United States, Illinois
Research Site
Chicago, Illinois, United States, 60610
United States, Indiana
Research Site
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40213
United States, Maryland
Research Site
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Research Site
Brockton, Massachusetts, United States, 02301
United States, Minnesota
Research Site
Brooklyn Center, Minnesota, United States, 55430
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89148
United States, New York
Research Site
Endwell, New York, United States, 13760
Research Site
New Windsor, New York, United States, 12553
United States, North Carolina
Research Site
Raleigh, North Carolina, United States, 27612
Research Site
Raleigh, North Carolina, United States, 27609
United States, North Dakota
Research Site
Fargo, North Dakota, United States, 58103
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45246
Research Site
Cincinnati, Ohio, United States, 45219
Research Site
Cleveland, Ohio, United States, 44122
United States, Oklahoma
Research Site
Norman, Oklahoma, United States, 73069
Research Site
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Research Site
Mt. Pleasant, South Carolina, United States, 29464
United States, South Dakota
Research Site
Rapid City, South Dakota, United States, 57702
United States, Texas
Research Site
Arlington, Texas, United States, 76014
Research Site
Boerne, Texas, United States, 78006
Research Site
San Antoio, Texas, United States, 78205
United States, Virginia
Research Site
Norfolk, Virginia, United States, 23502
Research Site
Richmond, Virginia, United States, 23294
United States, Washington
Research Site
Renton, Washington, United States, 98057
Research Site
Seattle, Washington, United States, 98122
Australia, New South Wales
Research Site
Maroubra, New South Wales, Australia, 2035
Australia, Queensland
Research Site
Carina Heights, Queensland, Australia, 4152
Belgium
Research Site
AnthÃ©e, Belgium, 5520
Research Site
Dour, Belgium, 7370
Research Site
Gozee, Belgium, 6534
Research Site
Gribomont, Belgium, 6887
Research Site
Halen, Belgium, 3545
Research Site
Ham, Belgium, 3945
Research Site
Linkebeek, Belgium, 1630
Research Site
Retie, Belgium, 2470
Canada, Newfoundland and Labrador
Research Site
Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
Research Site
Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
Canada, Ontario
Research Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
Research Site
Granby, Quebec, Canada, J2G 8Z9
Denmark
Research Site
Aalborg, Denmark, 9000
Research Site
Ballerup, Denmark, 2750
Research Site
Vejle, Denmark, 7100

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided by Amgen

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

Koren MJ, Scott R, Kim JB, Knusel B, Liu T, Lei L, Bolognese M, Wasserman SM. Efficacy, safety, and tolerability of a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 as monotherapy in patients with hypercholesterolaemia (MENDEL): a randomised, double-blind, placebo-controlled, phase 2 study. Lancet. 2012 Dec 8;380(9858):1995-2006. doi: 10.1016/S0140-6736(12)61771-1. Epub 2012 Nov 6.

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT01375777 History of Changes
Other Study ID Numbers:	20101154
Study First Received:	June 16, 2011
Last Updated:	April 2, 2013
Health Authority:	Canada: Health Canada Denmark: Laegemiddelstyrelsen Germany: Paul_Ehrlich-Institut Bundesamt fur Sera und Impfstoffe South Africa: Medicines Control Council United States: Food and Drug Administration Australia: Therapeutic Goods Administration Belgium: Directorate-General for Medicinal Products

Keywords provided by Amgen:

High cholesterol
Treatment for high cholesterol
Lowering cholesterol
Lowering high cholesterol
Hypercholesterolemia

Additional relevant MeSH terms:

Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013

Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels (MENDEL)