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

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ClinicalTrials.gov Identifier: NCT01972178
Recruitment Status : Terminated
First Posted : October 30, 2013
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Pronova BioPharma

Brief Summary:

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 or disease Intervention/treatment Phase
Dyslipidemia Drug: PRC-4016 Drug: Placebo Drug: Statins Phase 2

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRC-4016
PRC-4016, oral administration once daily, capsule
Drug: PRC-4016
Drug: Statins
Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc)

Placebo Comparator: Placebo
Placebo, oral administration once daily, capsule
Drug: Placebo
Drug: Statins
Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc)




Primary Outcome Measures :
  1. Percent change in Non-HDL-C from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]

Secondary Outcome Measures :
  1. Change in triglycerides from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  2. Change in HDL-C from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  3. Change in LDL-C from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  4. Change in VLDL-C from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  5. Change in total cholesterol from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  6. Change in ApoA1 from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  7. Change in ApoB from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  8. Change in insulin from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  9. Change in fasting plasma glucose from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  10. Change in HbA1c from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  11. Change in Lp-PLA2 from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  12. Change in hsCRP from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  13. Change in red blood cell content of EPA and DHA from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  14. Change in Insulin Resistance (HOMA) from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972178


  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, California
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
National Research Institute - Wilshire
Los Angeles, California, United States, 90057
Research Across America - Santa Ana
Santa Ana, California, United States, 92705
Encompass Clinical Research
Spring Valley, California, United States, 91978
United States, Florida
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, North Carolina
Peters Medical Research
High Point, North Carolina, United States, 27262
PMG Research of Raleigh, LLC
Raleigh, North Carolina, United States, 27609
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
PSB Research/P. S. Bains, M.S., D.O.
Marion, Ohio, United States, 43302
RAS Health Ltd
Marion, Ohio, United States, 43302
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, Texas
Padre Coast Clinical Research
Corpus Christi, Texas, United States, 78404
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

Responsible Party: Pronova BioPharma
ClinicalTrials.gov Identifier: NCT01972178     History of Changes
Other Study ID Numbers: CTN 4016 13202
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents