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

  Show 29 Study Locations
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 23, 2014