Clinical Trial: TRIal For Efficacy of Capre on hyperTriglyceridemiA

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Placebo-controlled, Double-blind, Dose-ranging, Multi-centered Trial to Evaluate the Safety and Efficacy of NKPL66 (CaPre™) in the Treatment of Mild-to-high H

Brief Summary: The purpose of this study is to determine whether CaPre(TM), given at doses 1.0g or 2.0g for 12 weeks, has an effect on fasting plasma triglycerides in patients with mild to high hypertriglyceridemia as compared to a placebo.

Detailed Summary:
Sponsor: Acasti Pharma Inc.

Current Primary Outcome: Percent (%) change in triglycerides between the baseline and the 12-week assessment visit. [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Absolute change in triglycerides between the baseline and the 12-week assessment visit. [ Time Frame: 12 weeks ]

Original Secondary Outcome: Same as current

Information By: Acasti Pharma Inc.

Dates:
Date Received: October 18, 2011
Date Started: September 2011
Date Completion:
Last Updated: August 21, 2014
Last Verified: August 2014