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

• Status: Terminated
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pronova BioPharma
• Treatments: Hydroxymethylglutaryl-CoA Reductase Inhibitors

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