Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
| Status: | Archived |
|---|---|
| Conditions: | High Cholesterol, Metabolic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | October 2010 |
| End Date: | August 2011 |
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
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.
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).
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