Efficacy and Safety of PRC-4016 in Subjects With Mixed Dyslipidemia

Phase 2

Terminated

• Conditions: Dyslipidemia
• Interventions: Drug: PRC-4016; Drug: Placebo; Drug: Statins

• Registration Number: NCT01972178
• Lead Sponsor: Pronova BioPharma

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-30
• Study Start: 2013-11
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Disposition First Submitted: 2015-09-21
• Status Verified: 2015-10
• Disposition First Submitted QC: 2015-10-07
• Last Update Submitted: 2015-10-07
• Disposition First Posted: 2015-10-30
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRC-4016	PRC-4016	PRC-4016, oral administration once daily, capsule
PRC-4016	Statins	PRC-4016, oral administration once daily, capsule
Placebo	Placebo	Placebo, oral administration once daily, capsule
Placebo	Statins	Placebo, oral administration once daily, capsule

Primary Outcome Measures

Name	Time	Method
Percent change in Non-HDL-C from baseline to Week 12	from baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline to Week 12	from baseline to Week 12
Change in Lp-PLA2 from baseline to Week 12	from baseline to Week 12
Change in ApoB from baseline to Week 12	from baseline to Week 12
Change in triglycerides from baseline to Week 12	from baseline to Week 12
Change in VLDL-C from baseline to Week 12	from baseline to Week 12
Change in total cholesterol from baseline to Week 12	from baseline to Week 12
Change in ApoA1 from baseline to Week 12	from baseline to Week 12
Change in HDL-C from baseline to Week 12	from baseline to Week 12
Change in LDL-C from baseline to Week 12	from baseline to Week 12
Change in fasting plasma glucose from baseline to Week 12	from baseline to Week 12
Change in insulin from baseline to Week 12	from baseline to Week 12
Change in hsCRP from baseline to Week 12	from baseline to Week 12
Change in red blood cell content of EPA and DHA from baseline to Week 12	from baseline to Week 12
Change in Insulin Resistance (HOMA) from baseline to Week 12	from baseline to Week 12

Trial Locations

Locations (29)

Medical Affiliated Research Center, Inc.; 🇺🇸 Huntsville, Alabama, United States

Terence Hart, MD; 🇺🇸 Muscle Shoals, Alabama, United States

Pacific Oaks Medical Group; 🇺🇸 Beverly Hills, California, United States

National Research Institute - Wilshire; 🇺🇸 Los Angeles, California, United States

Research Across America - Santa Ana; 🇺🇸 Santa Ana, California, United States

Encompass Clinical Research; 🇺🇸 Spring Valley, California, United States

Jacksonville Impotence Treatment Center; 🇺🇸 Jacksonville, Florida, United States

Compass Research East, LLC; 🇺🇸 Oviedo, Florida, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

Meridien Research; 🇺🇸 St. Petersburg, Florida, United States

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