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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 July 22, 2014