NCT01972178

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Pronova BioPharma · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	PRC-4016
DRUG	Placebo
DRUG	Statins	Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc)

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2013-10-30
• Last updated: 2015-10-30

Locations

29 sites across 1 country: United States