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

  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
  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 September 30, 2014