NCT00973271

Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides

A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Study Assessing the Efficacy, Safety and Tolerability of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects Without Diabetes Mellitus Having Very High Fasting Triglyceride Levels, With Double-Blind Active-Controlled Extension Assessing Safety and Tolerability

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Essentialis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis of this study is that DCCR is effective as both monotherapy and in combination with a statin in lowering triglycerides in subjects with very high triglycerides

Detailed description

Very high triglyceride is a risk for pancreatitis. Studies have shown Diazoxide Choline has the potential to effectively lower triglycerides in patients with very high triglycerides.

Conditions

• Hypertriglyceridemia

Interventions

Type	Name	Description
DRUG	290 mg DCCR	290 mg diazoxide choline
DRUG	435 mg DCCR	435 mg diazoxide choline
DRUG	135 mg fenofibric acid	135 mg fenofibric acid
DRUG	Placebo	Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
DRUG	atorvastatin	20 mg atorvastatin

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2009-09-09
• Last updated: 2016-09-01