Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects With Primary Hyperlipidemia or Mixed Dyslipidemia At Risk Of Cardiovascular Events



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:8/2/2018
Start Date:October 28, 2014
End Date:July 10, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A 52 Week Phase 3 Double-blind, Randomized, Placebo-controlled, Parallel-group Study To Assess The Efficacy, Safety And Tolerability Of Pf-04950615 In Subjects With Primary Hyperlipidemia Or Mixed Dyslipidemia At Risk Of Cardiovascular Events

This study is a multicenter, double-blind, randomized study to access the efficacy, safety
and tolerability of Bococizumab (PF-04950615; RN316) in subjects with hyperlipidemia
receiving background statin therapy.


Inclusion Criteria:

- Treated with a statin

- Fasting LDL-C >=100 mg/dL and triglyceride <= 400 mg/dL

- High or very high risk of incurring a cardiovascular event

Exclusion Criteria:

- Pregnant or breastfeeding females

- Cardiovascular or cerebrovascular event or procedure within 90 days

- Congestive heart failure NYHA class IV

- Poorly controlled hypertension
We found this trial at
107
sites
University of Colorado Hospital
12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Accord Clinical Research
3635 S. Clyde Morris Blvd
Port Orange, Florida 32129
386-760-3862
About Us Accord Clinical Research is a privately owned research facility, founded in Port Orange,...
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Millennium Clinical Trials, L.L.C.
3801 N. Fairfax Drive
Arlington, Virginia 22203
703-527-8100
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Millennium Clinical Trials, L.L.C.
3801 N. Fairfax Drive
Arlington, Virginia 22203
703-527-8100
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Renstar Medical Research
104 SE 1st Avenue
Ocala, Florida 34471
352-629-5800
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Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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Clinical Trials of Texas, Inc.
7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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Spartanburg Medical Research
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
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Castlerock Clinical Research Consultants, LLC
6804 South Canton
Tulsa, Oklahoma 74136
918-524-5205
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Heartland Research Associates, LLC
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Heartland Research Associates, LLC
1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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Albuquerque Clinical Trials
Albuquerque, New Mexico
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Advanced Cardiovascular, LLC Research
Alexander City, Alabama 35010
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Advanced Cardiovascular, LLC, Research
Auburn, Alabama 36830
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Heartland Research Associates, LLC
Augusta, Kansas 67010
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American Health Network Of Indiana Llc
Avon, Indiana 46123
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Bethesda Health Research
Bethesda, Maryland 20817
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BRCR Medical Center, Inc.
Boca Raton, Florida 33432
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Boca Raton Clinical Research Associates
Boca Raton, Florida 33432
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Northwest Clinical Trials
Boise, Idaho 83704
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Meridien Research
Brooksville, Florida
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LMC Clinical Research Inc. (Calgary)
Calgary, Alberta
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Punzi Medical Center
Carrollton, Texas 75006
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Medical Research South
Charleston, South Carolina 29407
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Clinical Research Advantage, Inc. / Colorado Springs Family Practice
Colorado Springs, Colorado 80909
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Ellipsis Research Group, LLC
Columbia, South Carolina 29201
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Linfritz Research Institute Inc.
Coral Gables, Florida 33134
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Primed Clinical Research
Dayton, Ohio 45419
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Creekside Endocrine Associates PC
Denver, Colorado 80209
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Centennial Medical Group
Elkridge, Maryland
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McLaren Flint
Flint, Michigan 48532
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Florida Health Center
Fort Lauderdale, Florida 33312
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Clinical Research Advantage, Inc./Prairie Fields Family Medicine, PC
Fremont, Nebraska 68025
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Stern Cardiovascular Foundation
Germantown, Tennessee 38138
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Physician's East
Greenville, North Carolina 27834
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Physician's East
Greenville, North Carolina 27834
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Physician's East Endocrinology
Greenville, North Carolina 27834
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Harleysville Medical Associates
Harleysville, Pennsylvania 19438
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Health Care Family Rehab & Research Center
Hialeah, Florida 33012
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Indago Research & Health Center, Inc.
Hialeah, Florida 33012
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Clinical Trials of America Inc
Hickory, North Carolina 28601
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PMG Research of Hickory, LLC
Hickory, North Carolina 28602
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Catawba Valley Medical Group, Inc.
Hickory, North Carolina 28601
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Gulf Coast Medical Research, LLC
Houston, Texas 77025
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Office of Michelle Zaniewski MD., PA.
Houston, Texas 77090
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Juno Research
Houston, Texas 77074
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Apex Cardiology
Jackson, Tennessee 38301
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Research Associates of Jackson
Jackson, Tennessee 38301
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Juno Research, LLC
Katy, Texas 77450
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Clinical Investigation Specialists
Kenosha, Wisconsin 53142
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PMG Research Inc. d/b/a PMG Research of Knoxville
Knoxville, Tennessee 37912
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Imperial Health, LLP
Lake Charles, Louisiana 70601
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Lynn Institute of the Ozarks
Little Rock, Arkansas 72205
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The Office of Larry Watkins, MD
Little Rock, Arkansas 72205
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The American Institute of Research
Los Angeles, California 90017
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IMD Medical Group
Los Angeles, California 90020
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lntermed Group
Los Angeles, California 90017
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HFM Heart and Vascular Center/Holy Family Memorial, Inc
Manitowoc, Wisconsin 54220
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Crescent City Clinical Research Center
Metairie, Louisiana 70006
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Sunrise Research Institute, Inc
Miami, Florida 33130
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Prestige Clinical Research Center Inc.
Miami, Florida 33125
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Elite Clinical Research
Miami, Florida 33144
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Columbus Clinical Services, LLC
Miami, Florida 33174
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The Research Specialists of Florida, Inc.
Miami, Florida 33162
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Advanced Clinical Research of Miami
Miami, Florida 33155
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Suncoast Research Group, LLD
2128 West Flagler Street
Miami, Florida 33135
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NewPhase Clinical Trials, Corp.
Miami Beach, Florida 33140
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Panax Clinical Research
Miami Lakes, Florida 33014
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Precision Research Organization
Miami Lakes, Florida 33016
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First Quality
Miramar, Florida 33025
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Gulf Coast Medical Research,LLC
Missouri City, Texas 77459
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Clinical Trials of America LA, LLC
Monroe, Louisiana 71203
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National Clinical Research - Norfolk, Inc.
Norfolk, Virginia 23502
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The Office of Lucita M. Cruz, M.D., Inc.
Norwalk, California 90650
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American Family Medical
Ocala, Florida 34471
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South Oklahoma Heart Research
Oklahoma City, Oklahoma 73135
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Aspen Clinical Research, LLC
Orem, Utah 84058
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Pines Care Research Center, LLC
Pembroke Pines, Florida 33026
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DBC Research USA
Pembroke Pines, Florida 33029
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Andres Patron, D.O.P.A.
10796 Pines Boulevard
Pembroke Pines, Florida 33026
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The Office of Daniel G. Williams, MD
Perrysburg, Ohio 43551
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Clinical Research Advantage, Inc./ Family Practice Specialists, Ltd.
Phoenix, Arizona 85018
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Riser Medical Research
Picayune, Mississippi 39466
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Clinical Research Advantage, Inc./ Plano Internal Medicine Associates
Plano, Texas 75093
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Progressive Medical Research
Port Orange, Florida 32127
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Sound Health Care Center
Port Orchard, Washington 98366
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Sound Medical Research
Port Orchard, Washington 98366
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ActivMed Practices & Research, Inc.
Portsmouth, New Hampshire 03801
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Wake Internal Medicine Consultants, Inc.
Raleigh, North Carolina 27612
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Wake Research Associates, LLC
3100 Duraleigh Rd
Raleigh, North Carolina 27612
(919) 781-2514
Wake Research Associates, LLC Wake Research is an Organization of Unified Investigational Sites working closely...
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Superior Research LLC
Sacramento, California 95825
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East Coast Institute for RSCH, St. Augustine Cardiology Associates, Research
Saint Augustine, Florida 32086
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East Coast Institute for Research, LLC/ Baker-Gilmour Cardiovascular Institute
Saint Augustine, Florida 32086
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CentraCare Heart & Vascular Center @ St. Cloud Hospital
1406 6th Avenue North
Saint Cloud, Minnesota 56303
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Washington University Center for Advanced Medicine
4921 Parkview Place
Saint Louis, Missouri 63110
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Washington University School of Medicine
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Meridien Research
Saint Petersburg, Florida 33709
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Radiant Research
Santa Rosa, California 95405
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Cardiovascular Center of Sarasota
Sarasota, Florida 34239
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Gulf Coast Medical Research, LLC
2225 Williams Trace Boulevard
Sugar Land, Texas 77478
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Meridien Research
Tampa, Florida
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