Efficacy and Safety of PRC-4016 in Subjects With Mixed Dyslipidemia



Status:Terminated
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 79
Updated:4/21/2016
Start Date:November 2013
End Date:August 2014

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Trial Summary
Trial Overview
Inclusion Criteria

A Multicenter, Randomized, Double-Blind, Placebo-Controlled 12-Week Phase II Proof of Concept Study to Evaluate the Efficacy and Safety of PRC-4016 600 mg Once Daily Versus Placebo in Statin-Stable Subjects With Mixed Dyslipidemia

The objective of this study is

- To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood
lipids and lipoprotein parameter from baseline after 12 weeks of treatment

- To evaluate the safety of PRC-4016 as assessed by adverse events and other safety
parameters

6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification

Main Inclusion Criteria:

- Fasting triglycerides 200-499 mg/dl

- Non-HDL-C > 130 mg/dl

- Stable statin treatment

Exclusion Criteria:

- Type I diabetes or uncontrolled type II diabetes

- Recent cardiovascular or coronary event

- History of pancreatitis

- History or evidence of major and clinically significant diseases that would interfere
with the conduct of the study or interpretation of data

- Uncontrolled hypertension
We found this trial at
29
sites
National Clinical Research - Richmond, Inc.
Richmond, Virginia 23294
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Richmond, VA
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Columbus Clinical Research
99 N. Brice Rd
Columbus, Ohio 43068
614-501-6164
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Columbus, OH
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Medical Affiliated Research Center, Inc.
303 Williams Ave
Huntsville, Alabama 35801
256-533-6603
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Huntsville, AL
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Jacksonville Impotence Treatment Center
2950 Halcyon Ln # 706
Jacksonville, Florida 32223
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Jacksonville, FL
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Pacific Oaks Medical Group
Beverly Hills, California 90211
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Beverly Hills, CA
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Sterling Research Group, Ltd. - Auburn
Cincinnati, Ohio 45219
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Cincinnati, OH
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Metabolic And Atherosclerosis Research Center
Cincinnati, Ohio 45212
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Cincinnati, OH
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Padre Coast Clinical Research
Corpus Christi, Texas 78404
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Corpus Christi, TX
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Radiant Research - Edina
Edina, Minnesota 55435
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Edina, MN
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Willamette Valley Clinical Studies
Eugene, Oregon 97404
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Eugene, OR
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Evanston Premier Healthcare Research LLC
Evanston, Illinois 60201
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Evanston, IL
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Medisphere Medical Research Center
Evansville, Indiana 47714
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Evansville, IN
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Peters Medical Research
HIgh Point, North Carolina 27262
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HIgh Point, NC
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Green and Seidner Family Practice Associates
Lansdale, Pennsylvania 19446
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Lansdale, PA
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National Research Institute - Wilshire
Los Angeles, California 90057
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Los Angeles, CA
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Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky 40213
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Louisville, KY
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PSB Research/P. S. Bains, M.S., D.O.
Marion, Ohio 43302
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Marion, OH
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RAS Health
Marion, Ohio 43302
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Marion, OH
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Terence Hart, MD
Muscle Shoals, Alabama 35662
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Muscle Shoals, AL
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Heartland Research Assoc., LLC
Newton, Kansas 67114
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Newton, KS
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National Clinical Research - Norfolk, Inc.
Norfolk, Virginia 23502
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Norfolk, VA
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Compass Research East, LLC
Oviedo, Florida 32765
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Oviedo, FL
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Progressive Medical Research
Port Orange, Florida 32127
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Port Orange, FL
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PMG Research of Raleigh, LLC
Raleigh, North Carolina 27609
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Raleigh, NC
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Research Across America - Santa Ana
Santa Ana, California 92705
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Santa Ana, CA
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Encompass Clinical Research
Spring Valley, California 91978
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Spring Valley, CA
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Meridien Research
St. Petersburg, Florida
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St. Petersburg, FL
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Meridien Research- Tampa
Tampa, Florida 33606
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Tampa, FL
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Troy Internal Medicine, PC
Troy, Michigan 48098
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Troy, MI
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