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The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PRC-4016
Placebo
Sponsored by
Pronova BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Affiliated Research Center, Inc.
  • Terence Hart, MD
  • Central Phoenix Medical Clinic
  • Pacific Oaks Medical Group
  • National Research Institute - Wilshire
  • National Research Institute - East 118
  • Research Across America - Santa Ana
  • Encompass Clinical Research
  • Colorado Springs Health Partners
  • Clinical Research of South Florida
  • Jacksonville Impotence Treatment Center
  • Compass Research East, LLC
  • Progressive Medical Research
  • Meridien Research
  • Meridien Research- Tampa
  • Evanston Premier Healthcare Research LLC
  • Medisphere Medical Research Center
  • Heartland Research Assoc., LLC
  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
  • Troy Internal Medicine, P.C.
  • Radiant Research - Edina
  • Mercury Street Medical
  • Peters Medical Research
  • PMG Research of Raleigh, LLC
  • PMG Research of Wilmington, LLC
  • PMG Research of Winston-Salem, LLC
  • Sterling Research Group, Ltd. - Auburn
  • Metabolic and Atherosclerosis Research Center
  • Columbus Clinical Research, Inc.
  • PSB Research/P. S. Bains, M.S., D.O.
  • RAS Health Ltd
  • Lynn Health Science Institute - Oklahoma City
  • Willamette Valley Clinical Studies
  • Green and Seidner Family Practice Associates
  • UnitedResearch - Orangeburg, LLC
  • Padre Coast Clinical Research
  • Advanced Clinical Research
  • National Clinical Research - Norfolk, Inc.
  • National Clinical Research - Richmond, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PRC-4016

Placebo

Arm Description

PRC-4016, oral administration once daily, capsule

Placebo, oral administration once daily, capsule

Outcomes

Primary Outcome Measures

Percent change in triglycerides from baseline to week 12

Secondary Outcome Measures

Change in HDL-C from baseline to Week 12
Change in non-HDL-C from baseline to Week 12
Change in LDL-C from baseline to Week 12
Change in VLDL-C from baseline to Week 12
Change in total cholesterol from baseline to Week 12
Change in ApoA1 from baseline to Week 12
Change in Apo B from baseline to Week 12
Change in insulin from baseline to Week 12
Change in fasting plasma glucose from baseline to Week 12
Change in HbA1c from baseline to Week 12
Change in insulin resistance (HOMA) from baseline to Week 12
Change in Lp-PLA2 from baseline to Week 12
Change in hsCRP from baseline to Week 12
Change in red blood cell content of EPA and DHA from baseline to Week 12;

Full Information

First Posted
June 28, 2013
Last Updated
October 7, 2015
Sponsor
Pronova BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT01893515
Brief Title
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pronova BioPharma

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PRC-4016
Arm Type
Experimental
Arm Description
PRC-4016, oral administration once daily, capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, oral administration once daily, capsule
Intervention Type
Drug
Intervention Name(s)
PRC-4016
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percent change in triglycerides from baseline to week 12
Time Frame
from baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in HDL-C from baseline to Week 12
Time Frame
from baseline to Week 12
Title
Change in non-HDL-C from baseline to Week 12
Time Frame
from baseline to Week 12
Title
Change in LDL-C from baseline to Week 12
Time Frame
from baseline to week 12
Title
Change in VLDL-C from baseline to Week 12
Time Frame
from baseline to week 12
Title
Change in total cholesterol from baseline to Week 12
Time Frame
from baseline to week 12
Title
Change in ApoA1 from baseline to Week 12
Time Frame
from baseline to Week 12
Title
Change in Apo B from baseline to Week 12
Time Frame
from baseline to week 12
Title
Change in insulin from baseline to Week 12
Time Frame
from baseline to Week 12
Title
Change in fasting plasma glucose from baseline to Week 12
Time Frame
from baseline to Week 12
Title
Change in HbA1c from baseline to Week 12
Time Frame
from baseline to Week 12
Title
Change in insulin resistance (HOMA) from baseline to Week 12
Time Frame
from baseline to Week 12
Title
Change in Lp-PLA2 from baseline to Week 12
Time Frame
from baseline to Week 12
Title
Change in hsCRP from baseline to Week 12
Time Frame
from baseline to Week 12
Title
Change in red blood cell content of EPA and DHA from baseline to Week 12;
Time Frame
from baseline to Week 12;
Other Pre-specified Outcome Measures:
Title
Safety assessments will include adverse events, clinical laboratory measurements (chemistry, hematology, and urinalysis), 12-lead ECGs, blood pressure, and physical examinations.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pål Nord, MD, MPH
Organizational Affiliation
Pronova BioPharma
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Traci A. Turner, MD, MT
Organizational Affiliation
Metabolic and Atherosclerosis Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Affiliated Research Center, Inc.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Terence Hart, MD
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35662
Country
United States
Facility Name
Central Phoenix Medical Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Pacific Oaks Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
National Research Institute - Wilshire
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
National Research Institute - East 118
City
Los Angeles
State/Province
California
ZIP/Postal Code
90059
Country
United States
Facility Name
Research Across America - Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Encompass Clinical Research
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Colorado Springs Health Partners
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80920
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Jacksonville Impotence Treatment Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32223
Country
United States
Facility Name
Compass Research East, LLC
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Meridien Research- Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Evanston Premier Healthcare Research LLC
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Medisphere Medical Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Heartland Research Assoc., LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Troy Internal Medicine, P.C.
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Radiant Research - Edina
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercury Street Medical
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Peters Medical Research
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
PMG Research of Raleigh, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
PMG Research of Winston-Salem, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sterling Research Group, Ltd. - Auburn
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Metabolic and Atherosclerosis Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Columbus Clinical Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
PSB Research/P. S. Bains, M.S., D.O.
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
RAS Health Ltd
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Lynn Health Science Institute - Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Willamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Green and Seidner Family Practice Associates
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
UnitedResearch - Orangeburg, LLC
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Padre Coast Clinical Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
National Clinical Research - Norfolk, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
National Clinical Research - Richmond, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26892135
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.
Results Reference
derived

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The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

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