The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893515
• Other study ID #: CTN 4016 13201
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2013
• Last updated: October 7, 2015
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: October 2015
• Source: Pronova BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• PRC-4016

• Placebo

Locations

Country	Name	City	State
United States	Pacific Oaks Medical Group	Beverly Hills	California
United States	Mercury Street Medical	Butte	Montana
United States	Metabolic and Atherosclerosis Research Center	Cincinnati	Ohio
United States	Sterling Research Group, Ltd. - Auburn	Cincinnati	Ohio
United States	Colorado Springs Health Partners	Colorado Springs	Colorado
United States	Columbus Clinical Research, Inc.	Columbus	Ohio
United States	Clinical Research of South Florida	Coral Gables	Florida
United States	Padre Coast Clinical Research	Corpus Christi	Texas
United States	Radiant Research - Edina	Edina	Minnesota
United States	Willamette Valley Clinical Studies	Eugene	Oregon
United States	Evanston Premier Healthcare Research LLC	Evanston	Illinois
United States	Medisphere Medical Research Center	Evansville	Indiana
United States	Peters Medical Research	High Point	North Carolina
United States	Medical Affiliated Research Center, Inc.	Huntsville	Alabama
United States	Jacksonville Impotence Treatment Center	Jacksonville	Florida
United States	Green and Seidner Family Practice Associates	Lansdale	Pennsylvania
United States	National Research Institute - East 118	Los Angeles	California
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Louisville Metabolic and Atherosclerosis Research Center (L-MARC)	Louisville	Kentucky
United States	PSB Research/P. S. Bains, M.S., D.O.	Marion	Ohio
United States	RAS Health Ltd	Marion	Ohio
United States	Terence Hart, MD	Muscle Shoals	Alabama
United States	Heartland Research Assoc., LLC	Newton	Kansas
United States	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia
United States	Lynn Health Science Institute - Oklahoma City	Oklahoma City	Oklahoma
United States	UnitedResearch - Orangeburg, LLC	Orangeburg	South Carolina
United States	Compass Research East, LLC	Oviedo	Florida
United States	Central Phoenix Medical Clinic	Phoenix	Arizona
United States	Progressive Medical Research	Port Orange	Florida
United States	PMG Research of Raleigh, LLC	Raleigh	North Carolina
United States	National Clinical Research - Richmond, Inc.	Richmond	Virginia
United States	Research Across America - Santa Ana	Santa Ana	California
United States	Encompass Clinical Research	Spring Valley	California
United States	Meridien Research	St. Petersburg	Florida
United States	Meridien Research- Tampa	Tampa	Florida
United States	Troy Internal Medicine, P.C.	Troy	Michigan
United States	Advanced Clinical Research	West Jordan	Utah
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina
United States	PMG Research of Winston-Salem, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pronova BioPharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety assessments will include adverse events, clinical laboratory measurements (chemistry, hematology, and urinalysis), 12-lead ECGs, blood pressure, and physical examinations.		Up to 12 weeks	No
Primary	Percent change in triglycerides from baseline to week 12		from baseline to Week 12	No
Secondary	Change in HDL-C from baseline to Week 12		from baseline to Week 12	No
Secondary	Change in non-HDL-C from baseline to Week 12		from baseline to Week 12	No
Secondary	Change in LDL-C from baseline to Week 12		from baseline to week 12	No
Secondary	Change in VLDL-C from baseline to Week 12		from baseline to week 12	No
Secondary	Change in total cholesterol from baseline to Week 12		from baseline to week 12	No
Secondary	Change in ApoA1 from baseline to Week 12		from baseline to Week 12	No
Secondary	Change in Apo B from baseline to Week 12		from baseline to week 12	No
Secondary	Change in insulin from baseline to Week 12		from baseline to Week 12	No
Secondary	Change in fasting plasma glucose from baseline to Week 12		from baseline to Week 12	No
Secondary	Change in HbA1c from baseline to Week 12		from baseline to Week 12	No
Secondary	Change in insulin resistance (HOMA) from baseline to Week 12		from baseline to Week 12	No
Secondary	Change in Lp-PLA2 from baseline to Week 12		from baseline to Week 12	No
Secondary	Change in hsCRP from baseline to Week 12		from baseline to Week 12	No
Secondary	Change in red blood cell content of EPA and DHA from baseline to Week 12;		from baseline to Week 12;	No