The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pronova BioPharma
ClinicalTrials.gov Identifier:
NCT01893515
First received: June 28, 2013
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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

Condition Intervention Phase
Dyslipidemia
Drug: PRC-4016
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pronova BioPharma:

Primary Outcome Measures:
  • Percent change in triglycerides from baseline to week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HDL-C from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in non-HDL-C from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in LDL-C from baseline to Week 12 [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ]
  • Change in VLDL-C from baseline to Week 12 [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ]
  • Change in total cholesterol from baseline to Week 12 [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ]
  • Change in ApoA1 from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in Apo B from baseline to Week 12 [ Time Frame: from baseline to week 12 ] [ Designated as safety issue: No ]
  • Change in insulin from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in HbA1c from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in insulin resistance (HOMA) from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in Lp-PLA2 from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in hsCRP from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in red blood cell content of EPA and DHA from baseline to Week 12; [ Time Frame: from baseline to Week 12; ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: July 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRC-4016
PRC-4016, oral administration once daily, capsule
Drug: PRC-4016
Placebo Comparator: Placebo
Placebo, oral administration once daily, capsule
Drug: PRC-4016

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893515

  Hide Study Locations
Locations
United States, Alabama
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
Terence Hart, MD
Muscle Shoals, Alabama, United States, 35662
United States, Arizona
Central Phoenix Medical Clinic
Phoenix, Arizona, United States, 85020
United States, California
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
National Research Institute - Wilshire
Los Angeles, California, United States, 90057
National Research Institute - East 118
Los Angeles, California, United States, 90059
Research Across America - Santa Ana
Santa Ana, California, United States, 92705
Encompass Clinical Research
Spring Valley, California, United States, 91978
United States, Colorado
Colorado Springs Health Partners
Colorado Springs, Colorado, United States, 80920
United States, Florida
Clinical Research of South Florida
Coral Gables, Florida, United States, 33134
Jacksonville Impotence Treatment Center
Jacksonville, Florida, United States, 32223
Compass Research East, LLC
Oviedo, Florida, United States, 32765
Progressive Medical Research
Port Orange, Florida, United States, 32127
Meridien Research
St. Petersburg, Florida, United States, 33709
Meridien Research- Tampa
Tampa, Florida, United States, 33606
United States, Illinois
Evanston Premier Healthcare Research LLC
Evanston, Illinois, United States, 60201
United States, Indiana
Medisphere Medical Research Center
Evansville, Indiana, United States, 47714
United States, Kansas
Heartland Research Assoc., LLC
Newton, Kansas, United States, 67114
United States, Kentucky
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, United States, 40213
United States, Michigan
Troy Internal Medicine, P.C.
Troy, Michigan, United States, 48098
United States, Minnesota
Radiant Research - Edina
Edina, Minnesota, United States, 55435
United States, Montana
Mercury Street Medical
Butte, Montana, United States, 59701
United States, North Carolina
Peters Medical Research
High Point, North Carolina, United States, 27262
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States, 27609
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Sterling Research Group, Ltd. - Auburn
Cincinnati, Ohio, United States, 45219
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States, 45227
Columbus Clinical Research, Inc.
Columbus, Ohio, United States, 43213
RAS Health Ltd
Marion, Ohio, United States, 43302
PSB Research/P. S. Bains, M.S., D.O.
Marion, Ohio, United States, 43302
United States, Oklahoma
Lynn Health Science Institute - Oklahoma City
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Willamette Valley Clinical Studies
Eugene, Oregon, United States, 97404
United States, Pennsylvania
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, United States, 19446
United States, South Carolina
UnitedResearch - Orangeburg, LLC
Orangeburg, South Carolina, United States, 29118
United States, Texas
Padre Coast Clinical Research
Corpus Christi, Texas, United States, 78404
United States, Utah
Advanced Clinical Research
West Jordan, Utah, United States, 84088
United States, Virginia
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States, 23502
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Pronova BioPharma
Investigators
Study Director: Pål Nord, MD, MPH Pronova BioPharma
Principal Investigator: Traci A. Turner, MD, MT Metabolic and Atherosclerosis Research Center
  More Information

No publications provided

Responsible Party: Pronova BioPharma
ClinicalTrials.gov Identifier: NCT01893515     History of Changes
Other Study ID Numbers: CTN 4016 13201
Study First Received: June 28, 2013
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014