The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects
NCT ID: NCT01893515
Last Updated: 2015-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2013-07-31
2014-07-31
Brief Summary
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* To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameters from baseline after 12 weeks of treatment.
* To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PRC-4016
PRC-4016, oral administration once daily, capsule
PRC-4016
Placebo
Placebo, oral administration once daily, capsule
Placebo
Interventions
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PRC-4016
Placebo
Eligibility Criteria
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Inclusion Criteria
* Not on other lipid altering therapy, OR on stable lipid altering therapy
Exclusion Criteria
* 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
18 Years
79 Years
ALL
No
Sponsors
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Pronova BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Pål Nord, MD, MPH
Role: STUDY_DIRECTOR
Pronova BioPharma
Traci A. Turner, MD, MT
Role: PRINCIPAL_INVESTIGATOR
Metabolic and Atherosclerosis Research Center
Locations
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Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Terence Hart, MD
Muscle Shoals, Alabama, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
National Research Institute - Wilshire
Los Angeles, California, United States
National Research Institute - East 118
Los Angeles, California, United States
Research Across America - Santa Ana
Santa Ana, California, United States
Encompass Clinical Research
Spring Valley, California, United States
Colorado Springs Health Partners
Colorado Springs, Colorado, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Jacksonville Impotence Treatment Center
Jacksonville, Florida, United States
Compass Research East, LLC
Oviedo, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Meridien Research- Tampa
Tampa, Florida, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, United States
Medisphere Medical Research Center
Evansville, Indiana, United States
Heartland Research Assoc., LLC
Newton, Kansas, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, United States
Troy Internal Medicine, P.C.
Troy, Michigan, United States
Radiant Research - Edina
Edina, Minnesota, United States
Mercury Street Medical
Butte, Montana, United States
Peters Medical Research
High Point, North Carolina, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Sterling Research Group, Ltd. - Auburn
Cincinnati, Ohio, United States
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, United States
PSB Research/P. S. Bains, M.S., D.O.
Marion, Ohio, United States
RAS Health Ltd
Marion, Ohio, United States
Lynn Health Science Institute - Oklahoma City
Oklahoma City, Oklahoma, United States
Willamette Valley Clinical Studies
Eugene, Oregon, United States
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, United States
UnitedResearch - Orangeburg, LLC
Orangeburg, South Carolina, United States
Padre Coast Clinical Research
Corpus Christi, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States
Countries
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References
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Bays HE, Hallen J, Vige R, Fraser D, Zhou R, Hustvedt SO, Orloff DG, Kastelein JJ. Icosabutate for the treatment of very high triglycerides: A placebo-controlled, randomized, double-blind, 12-week clinical trial. J Clin Lipidol. 2016 Jan-Feb;10(1):181-91.e1-2. doi: 10.1016/j.jacl.2015.10.012. Epub 2015 Nov 14.
Other Identifiers
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CTN 4016 13201
Identifier Type: -
Identifier Source: org_study_id