The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects
A Multicenter, Randomized, Double-Blind, Placebo-Controlled 12-Week Phase II Proof of Concept Study to Evaluate the Efficacy and Safety of PRC-4016 Once Daily Versus Placebo in Statin-Naïve or Statin-Stable Hypertriglyceridemic Subjects
1 other identifier
interventional
87
1 country
39
Brief Summary
The objectives of this study is
- 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2013
Shorter than P25 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedOctober 30, 2015
October 1, 2015
1 year
June 28, 2013
October 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in triglycerides from baseline to week 12
from baseline to Week 12
Secondary Outcomes (14)
Change in HDL-C from baseline to Week 12
from baseline to Week 12
Change in non-HDL-C from baseline to Week 12
from baseline to Week 12
Change in LDL-C from baseline to Week 12
from baseline to week 12
Change in VLDL-C from baseline to Week 12
from baseline to week 12
Change in total cholesterol from baseline to Week 12
from baseline to week 12
- +9 more secondary outcomes
Other Outcomes (1)
Safety assessments will include adverse events, clinical laboratory measurements (chemistry, hematology, and urinalysis), 12-lead ECGs, blood pressure, and physical examinations.
Up to 12 weeks
Study Arms (2)
PRC-4016
EXPERIMENTALPRC-4016, oral administration once daily, capsule
Placebo
PLACEBO COMPARATORPlacebo, oral administration once daily, capsule
Interventions
Eligibility Criteria
You may qualify if:
- Fasting triglycerides 500-1500 mg/dl
- Not on other lipid altering therapy, OR on stable lipid altering therapy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
Terence Hart, MD
Muscle Shoals, Alabama, 35662, United States
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020, United States
Pacific Oaks Medical Group
Beverly Hills, California, 90211, United States
National Research Institute - Wilshire
Los Angeles, California, 90057, United States
National Research Institute - East 118
Los Angeles, California, 90059, United States
Research Across America - Santa Ana
Santa Ana, California, 92705, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Colorado Springs Health Partners
Colorado Springs, Colorado, 80920, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
Jacksonville Impotence Treatment Center
Jacksonville, Florida, 32223, United States
Compass Research East, LLC
Oviedo, Florida, 32765, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Meridien Research- Tampa
Tampa, Florida, 33606, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, 60201, United States
Medisphere Medical Research Center
Evansville, Indiana, 47714, United States
Heartland Research Assoc., LLC
Newton, Kansas, 67114, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, 40213, United States
Troy Internal Medicine, P.C.
Troy, Michigan, 48098, United States
Radiant Research - Edina
Edina, Minnesota, 55435, United States
Mercury Street Medical
Butte, Montana, 59701, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, United States
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Sterling Research Group, Ltd. - Auburn
Cincinnati, Ohio, 45219, United States
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, 45227, United States
Columbus Clinical Research, Inc.
Columbus, Ohio, 43213, United States
PSB Research/P. S. Bains, M.S., D.O.
Marion, Ohio, 43302, United States
RAS Health Ltd
Marion, Ohio, 43302, United States
Lynn Health Science Institute - Oklahoma City
Oklahoma City, Oklahoma, 73112, United States
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, 19446, United States
UnitedResearch - Orangeburg, LLC
Orangeburg, South Carolina, 29118, United States
Padre Coast Clinical Research
Corpus Christi, Texas, 78404, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, 23294, United States
Related Publications (1)
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.
PMID: 26892135DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pål Nord, MD, MPH
Pronova BioPharma
- PRINCIPAL INVESTIGATOR
Traci A. Turner, MD, MT
Metabolic and Atherosclerosis Research Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2013
First Posted
July 9, 2013
Study Start
July 1, 2013
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
October 30, 2015
Record last verified: 2015-10