NCT01229566

Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Study to Assess Efficacy and Safety of AKR-963 Therapy in Subjects With Severe Hypertriglyceridemia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Trygg Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine the efficacy of AKR963 compared to placebo and active comparator in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 1500 mg/dL.

Detailed description

Increases in triglyceride concentrations have been correlated with increased risk for pancreatitis as well as for coronary heart disease (Ginsberg 2001, 2002). The incidence rates for major coronary events in the Munster Heart Study increased from 4.4% among Subjects with baseline TG concentrations under 200 mg/dL to 9.3% among Subjects with TG concentrations in the 200-399 mg/dL range, and up to 13.2% in Subjects with TG levels ranging from 400-799 mg/dL (Assmann 1996).

Conditions

• Severe Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	AKR-963	3600mg/day in capsules of AKR-963, Placebo, or Active Comparator

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-10-27
• Last updated: 2011-11-24

Locations

1 site across 1 country: United States