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The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

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ClinicalTrials.gov Identifier: NCT01893515
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):
Pronova BioPharma

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

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2013
Primary Completion Date : July 2014
Study Completion Date : July 2014

Arm Intervention/treatment
Experimental: PRC-4016
PRC-4016, oral administration once daily, capsule
Drug: PRC-4016
Placebo Comparator: Placebo
Placebo, oral administration once daily, capsule
Drug: Placebo



Primary Outcome Measures :
  1. Percent change in triglycerides from baseline to week 12 [ Time Frame: from baseline to Week 12 ]

Secondary Outcome Measures :
  1. Change in HDL-C from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  2. Change in non-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 Apo B 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 insulin resistance (HOMA) from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  12. Change in Lp-PLA2 from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  13. Change in hsCRP from baseline to Week 12 [ Time Frame: from baseline to Week 12 ]
  14. Change in red blood cell content of EPA and DHA from baseline to Week 12; [ Time Frame: from baseline to Week 12; ]

Other Outcome Measures:
  1. 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 ]


Information from the National Library of Medicine

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

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): NCT01893515


  Show 39 Study Locations
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pronova BioPharma
ClinicalTrials.gov Identifier: NCT01893515     History of Changes
Other Study ID Numbers: CTN 4016 13201
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases