Efficacy and Safety of PRC-4016 in Subjects With Mixed Dyslipidemia

This study is currently recruiting participants.
Verified January 2014 by Pronova BioPharma
Sponsor:
Information provided by (Responsible Party):
Pronova BioPharma
ClinicalTrials.gov Identifier:
NCT01972178
First received: October 24, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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

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, Investigator)
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 600 mg Once Daily Versus Placebo in Statin-Stable Subjects With Mixed Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Pronova BioPharma:

Primary Outcome Measures:
  • Percent change in Non-HDL-C from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in triglycerides from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
  • Change in 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 ApoB 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 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 ]
  • Change in Insulin Resistance (HOMA) from baseline to Week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: November 2013
Estimated Primary Completion Date: September 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

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 200-499 mg/dl
  • Non-HDL-C > 130 mg/dl
  • Stable statin treatment

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01972178

Contacts
Contact: Pål Nord, MD, MPH +47 95748933 pal.nord@pronova.com
Contact: Runar Vige, M.Sc., MBA +47 99168298 runar.vige@pronova.com

  Hide Study Locations
Locations
United States, Alabama
Medical Affiliated Research Center, Inc. Recruiting
Huntsville, Alabama, United States, 35801
Contact: Michael Carter, MD    256-564-7264    mcarter@marc-research.com   
Principal Investigator: Michael Carter, MD         
Terence Hart, MD Recruiting
Muscle Shoals, Alabama, United States, 35662
Contact: Terence Hart, MD    256-386-1105    terhart@hiwaay.net   
Principal Investigator: Terence Hart, MD         
United States, California
Pacific Oaks Medical Group Recruiting
Beverly Hills, California, United States, 90211
Contact: Anthony John Scarsella, MD    310-967-3662    ascarsellaresearch@pacificoaks.com   
Principal Investigator: Anthony John Scarsella, MD         
National Research Institute - Wilshire Recruiting
Los Angeles, California, United States, 90057
Contact: Andrew Lewin, MD    213-413-2500    docL@clinical-studies.com   
Principal Investigator: Andrew Lewin, MD         
Research Across America - Santa Ana Recruiting
Santa Ana, California, United States, 92705
Contact: N. Charle Morcos, MD    714-542-3008 ext 315    NCMorcosMD@gmail.com   
Principal Investigator: N. Charle Morcos, MD         
Encompass Clinical Research Recruiting
Spring Valley, California, United States, 91978
Contact: Robert Lipetz    619-660-9068    rlipetz@ecrstudies.com   
Principal Investigator: Robert Lipetz         
United States, Florida
Jacksonville Impotence Treatment Center Recruiting
Jacksonville, Florida, United States, 32223
Contact: Roger Miller, MD    904-260-8552    jagmanrm@aol.com   
Principal Investigator: Roger Miller, MD         
Compass Research East, LLC Recruiting
Oviedo, Florida, United States, 32765
Contact: Bradley Block, MD    407-977-2705    compasseast.block@gmail.co   
Principal Investigator: Bradley Block, MD         
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
Contact: Alexander White, MD    386-304-7070    dralexwhite@progressivemedicalresearch.com   
Principal Investigator: Alexander White, MD         
Meridien Research Recruiting
St. Petersburg, Florida, United States, 33709
Contact: Gigi Lefebvre, MD    727-347-8839    glefebvre@meridienresearch.net   
Principal Investigator: Gigi Lefebvre, MD         
Meridien Research- Tampa Recruiting
Tampa, Florida, United States, 33606
Contact: Cynthia Huffman, MD    813-877-8839    chuffman@meridienresearch.net   
Principal Investigator: Cynthia Huffman, MD         
United States, Illinois
Evanston Premier Healthcare Research LLC Recruiting
Evanston, Illinois, United States, 60201
Contact: Jeffrey Geohas, MD    847-869-1191    jgeohas.ephr@gmail.com   
Principal Investigator: Jeffrey Geohas, MD         
United States, Indiana
Medisphere Medical Research Center Recruiting
Evansville, Indiana, United States, 47714
Contact: Hubert Reyes, MD    812-471-4110    hreyes@medisphereresearch.com   
Principal Investigator: Hubert Reyes, MD         
United States, Kansas
Heartland Research Assoc., LLC Recruiting
Newton, Kansas, United States, 67114
Contact: Robyn Hartvickson, MD    316-283-0828    rhartvickson@heartlandresearch.com   
Principal Investigator: Robyn Hartvickson, MD         
United States, Kentucky
Louisville Metabolic and Atherosclerosis Research Center (L-MARC) Recruiting
Louisville, Kentucky, United States, 40213
Contact: Harold Bays, MD    502-515-5672    hbaysmd@aol.com   
Principal Investigator: Harold Bays, MD         
United States, Michigan
Troy Internal Medicine, P.C. Recruiting
Troy, Michigan, United States, 48098
Contact: Neil Fraser, MD    248-312-0025    nfraser@troyinternalmedicine.com   
Principal Investigator: Neil Fraser, MD         
United States, Minnesota
Radiant Research - Edina Recruiting
Edina, Minnesota, United States, 55435
Contact: Larry Kotek, MD    952-922-7000 ext 4600    larrykotek@radiantresearch.com   
Sub-Investigator: Tami Helmer         
Principal Investigator: Larry Kotek, MD         
United States, North Carolina
Peters Medical Research Recruiting
High Point, North Carolina, United States, 27262
Contact: Thomas Jarrett    336-883-9773    thomasj@petersmedicalresearch.com   
Principal Investigator: Thomas Jarrett         
PMG Research of Raleigh, LLC Recruiting
Raleigh, North Carolina, United States, 27609
Contact: John Rubino, MD    919-783-4895    jrubino@pmg-research.com   
Principal Investigator: John Rubino, MD         
United States, Ohio
Sterling Research Group, Ltd. - Auburn Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Matthew D Wenker, MD    513-381-4100    mwenker@sterlingresearch.org   
Principal Investigator: Matthew D Wenker, MD         
Metabolic and Atherosclerosis Research Center Recruiting
Cincinnati, Ohio, United States, 45227
Contact: Traci A. Turner, MD, MT         
Principal Investigator: Traci A. Turner, MD, MT         
Columbus Clinical Research, Inc. Recruiting
Columbus, Ohio, United States, 43213
Contact: Samir Arora, MD    614-501-6164    sarora@columbusclinical.com   
Principal Investigator: Samir Arora, MD         
PSB Research/P. S. Bains, M.S., D.O. Recruiting
Marion, Ohio, United States, 43302
Contact: Paramvir Bains, DO    614-537-0499    Bains000@yahoo.com   
Principal Investigator: Paramvir Bains, DO         
RAS Health Ltd Recruiting
Marion, Ohio, United States, 43302
Contact: Chander Arora, MD    740-341-9943    chandera@aol.com   
Principal Investigator: Arora Chander, MD         
United States, Oregon
Willamette Valley Clinical Studies Recruiting
Eugene, Oregon, United States, 97404
Contact: Patricia Buchanan, MD    541-461-0132    drpatb@aol.com   
Principal Investigator: Patricia Buchanan, MD         
United States, Pennsylvania
Green and Seidner Family Practice Associates Recruiting
Lansdale, Pennsylvania, United States, 19446
Contact: Michael Seidner, MD    215-361-7164    mrseidner@gmail.com   
Principal Investigator: Michael Seidner, MD         
United States, Texas
Padre Coast Clinical Research Recruiting
Corpus Christi, Texas, United States, 78404
Contact: Jaime Sandoval, MD    361-881-9300    padrecoast@yahoo.com   
Principal Investigator: Jaime Sandoval, MD         
United States, Virginia
National Clinical Research - Norfolk, Inc. Recruiting
Norfolk, Virginia, United States, 23502
Contact: Lubin Barry, MD    757-461-3633    blubin@ncrinc.net   
Principal Investigator: Barry Lubin, MD         
National Clinical Research - Richmond, Inc. Recruiting
Richmond, Virginia, United States, 23294
Contact: James McKenney, PharmD    804-672-2133 ext 12    jmckenney@ncrinc.net   
Principal Investigator: James McKenney, PharmD         
Sponsors and Collaborators
Pronova BioPharma
Investigators
Study Director: Pål Nord, MD, MPH Pronova BioPharma
  More Information

No publications provided

Responsible Party: Pronova BioPharma
ClinicalTrials.gov Identifier: NCT01972178     History of Changes
Other Study ID Numbers: CTN 4016 13202
Study First Received: October 24, 2013
Last Updated: January 13, 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 April 17, 2014