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

June 28, 2013
August 6, 2014
July 2013
July 2014   (final data collection date for primary outcome measure)
Percent change in triglycerides from baseline to week 12 [ Time Frame: from baseline to Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01893515 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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 ]
Same as current
 
The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects
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

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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dyslipidemia
Drug: PRC-4016
  • Experimental: PRC-4016
    PRC-4016, oral administration once daily, capsule
    Intervention: Drug: PRC-4016
  • Placebo Comparator: Placebo
    Placebo, oral administration once daily, capsule
    Intervention: Drug: PRC-4016
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01893515
CTN 4016 13201
Yes
Pronova BioPharma
Pronova BioPharma
Not Provided
Study Director: Pål Nord, MD, MPH Pronova BioPharma
Principal Investigator: Traci A. Turner, MD, MT Metabolic and Atherosclerosis Research Center
Pronova BioPharma
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP