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

Phase 3

Withdrawn

• Conditions: Hypertriglyceridemia
• Interventions: Drug: 290 mg DCCR; Drug: 435 mg DCCR; Drug: 135 mg fenofibric acid; Drug: Placebo; Drug: atorvastatin

• Registration Number: NCT00973271
• Lead Sponsor: Essentialis, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2009-09-05
• Study First Submitted QC: 2009-09-08
• Study First Posted: 2009-09-09
• Study Start: 2011-03
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
290 mg DCCR	290 mg DCCR	-
290 mg DCCR	Placebo	-
435 mg DCCR	435 mg DCCR	-
435 mg DCCR	Placebo	-
135 mg fenobric acid	Placebo	-
Placebo	Placebo	-
135 mg fenobric acid	135 mg fenofibric acid	-
290 mg DCCR	atorvastatin	-
435 mg DCCR	atorvastatin	-
135 mg fenobric acid	atorvastatin	-
Placebo	atorvastatin	-

Primary Outcome Measures

Name	Time	Method
The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days	84 days

Secondary Outcome Measures

Name	Time	Method
The effects of DCCR on Apo B and non-HDL in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days	84 days