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

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 600 mg Once Daily Versus Placebo in Statin-Stable Subjects With Mixed Dyslipidemia

Clinical Trial 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

Clinical Trial Description

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

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01972178
Study type Interventional
Source Pronova BioPharma
Contact
Status Terminated
Phase Phase 2
Start date November 2013
Completion date August 2014
View Details
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