Efficacy and Safety of PRC-4016 in Subjects With Mixed Dyslipidemia
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
1 other identifier
interventional
113
1 country
29
Brief Summary
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
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 Nov 2013
Shorter than P25 for phase_2
29 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
October 24, 2013
CompletedFirst Posted
Study publicly available on registry
October 30, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedOctober 30, 2015
October 1, 2015
8 months
October 24, 2013
October 7, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in Non-HDL-C from baseline to Week 12
from baseline to Week 12
Secondary Outcomes (14)
Change in triglycerides from baseline to Week 12
from baseline to Week 12
Change in 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
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 200-499 mg/dl
- Non-HDL-C \> 130 mg/dl
- Stable statin treatment
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 (29)
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801, United States
Terence Hart, MD
Muscle Shoals, Alabama, 35662, United States
Pacific Oaks Medical Group
Beverly Hills, California, 90211, United States
National Research Institute - Wilshire
Los Angeles, California, 90057, United States
Research Across America - Santa Ana
Santa Ana, California, 92705, United States
Encompass Clinical Research
Spring Valley, California, 91978, 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
Peters Medical Research
High Point, North Carolina, 27262, United States
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609, 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
Willamette Valley Clinical Studies
Eugene, Oregon, 97404, United States
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, 19446, United States
Padre Coast Clinical Research
Corpus Christi, Texas, 78404, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pål Nord, MD, MPH
Pronova BioPharma
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2013
First Posted
October 30, 2013
Study Start
November 1, 2013
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
October 30, 2015
Record last verified: 2015-10