Clinical trial NCT01893515: The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Pronova BioPharma
Sponsor class: INDUSTRY
First posted: 2013-07-09
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Main Inclusion Criteria:

* Fasting triglycerides 500-1500 mg/dl
* Not on other lipid altering therapy, OR on stable lipid altering therapy

Main 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

Primary outcomes:
measure: Percent change in triglycerides from baseline to week 12
timeFrame: from baseline to Week 12
Secondary outcomes:
measure: Change in HDL-C from baseline to Week 12
timeFrame: from baseline to Week 12
measure: Change in non-HDL-C from baseline to Week 12
timeFrame: from baseline to Week 12
measure: Change in LDL-C from baseline to Week 12
timeFrame: from baseline to week 12
measure: Change in VLDL-C from baseline to Week 12
timeFrame: from baseline to week 12
measure: Change in total cholesterol from baseline to Week 12
timeFrame: from baseline to week 12
measure: Change in ApoA1 from baseline to Week 12
timeFrame: from baseline to Week 12
measure: Change in Apo B from baseline to Week 12
timeFrame: from baseline to week 12
measure: Change in insulin from baseline to Week 12
timeFrame: from baseline to Week 12
measure: Change in fasting plasma glucose from baseline to Week 12
timeFrame: from baseline to Week 12
measure: Change in HbA1c from baseline to Week 12
timeFrame: from baseline to Week 12
measure: Change in insulin resistance (HOMA) from baseline to Week 12
timeFrame: from baseline to Week 12
measure: Change in Lp-PLA2 from baseline to Week 12
timeFrame: from baseline to Week 12
measure: Change in hsCRP from baseline to Week 12
timeFrame: from baseline to Week 12
measure: Change in red blood cell content of EPA and DHA from baseline to Week 12;
timeFrame: from baseline to Week 12;
Other outcomes:
measure: Safety assessments will include adverse events, clinical laboratory measurements (chemistry, hematology, and urinalysis), 12-lead ECGs, blood pressure, and physical examinations.
timeFrame: Up to 12 weeks
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc.
state: Alabama
city: Muscle Shoals
country: United States
facility: Terence Hart, MD
state: Alabama
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
state: Arizona
city: Beverly Hills
country: United States
facility: Pacific Oaks Medical Group
state: California
city: Los Angeles
country: United States
facility: National Research Institute - Wilshire
state: California
city: Los Angeles
country: United States
facility: National Research Institute - East 118
state: California
city: Santa Ana
country: United States
facility: Research Across America - Santa Ana
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Health Partners
state: Colorado
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Impotence Treatment Center
state: Florida
city: Oviedo
country: United States
facility: Compass Research East, LLC
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Meridien Research- Tampa
state: Florida
city: Evanston
country: United States
facility: Evanston Premier Healthcare Research LLC
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center
state: Indiana
city: Newton
country: United States
facility: Heartland Research Assoc., LLC
state: Kansas
city: Louisville
country: United States
facility: Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
state: Kentucky
city: Troy
country: United States
facility: Troy Internal Medicine, P.C.
state: Michigan
city: Edina
country: United States
facility: Radiant Research - Edina
state: Minnesota
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
country: United States
facility: PMG Research of Raleigh, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd. - Auburn
state: Ohio
city: Cincinnati
country: United States
facility: Metabolic and Atherosclerosis Research Center
state: Ohio
city: Columbus
country: United States
facility: Columbus Clinical Research, Inc.
state: Ohio
city: Marion
country: United States
facility: PSB Research/P. S. Bains, M.S., D.O.
state: Ohio
city: Marion
country: United States
facility: RAS Health Ltd
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute - Oklahoma City
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Clinical Studies
state: Oregon
city: Lansdale
country: United States
facility: Green and Seidner Family Practice Associates
state: Pennsylvania
city: Orangeburg
country: United States
facility: UnitedResearch - Orangeburg, LLC
state: South Carolina
city: Corpus Christi
country: United States
facility: Padre Coast Clinical Research
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research - Richmond, Inc.
state: Virginia
Study officials:
affiliation: Pronova BioPharma
name: Pål Nord, MD, MPH
role: STUDY_DIRECTOR
affiliation: Metabolic and Atherosclerosis Research Center
name: Traci A. Turner, MD, MT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.