NCT00758303

A Study to Evaluate the Lipid Regulating Effects of TRIA-662

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multi-Center Study to Evaluate the Lipid Regulating Effects of TRIA-662

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Cortria Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness and safety of TRIA-662 (also known as 1-MNA) in treating elevated triglyceride levels in patients not receiving lipid lowering treatment. This study will determine the effects of TRIA-662 on commonly measured blood fats that are known to be important in the prevention of vascular disease.

Detailed description

This is a randomized, double-blind, placebo-controlled, dose-ranging, multi-center study. Following a 6-8 week placebo and dietary-controlled baseline period, approximately 195 men and women with either hypertriglyceridemia or mixed hyperlipidemia with serum triglycerides (TG) \> 200 mg/dl (2.26 mmol/l) will be randomized to receive either placebo, 30 mg TRIA-662 or 90 mg TRIA-662 three times daily for twelve weeks. Lipid and ancillary exploratory parameters will be evaluated at screening, during the baseline period, upon randomisation and throughout the 12-week active treatment period.

Conditions

• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Low Dose TRIA-662	One Capsule 3 times a day
DRUG	High Dose TRIA-662	3 Capsules 3 times daily
DRUG	Placebo for TRIA-662	Matching Placebo for TRIA-662 taken 3 times a day

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-09-25
• Last updated: 2013-09-13