Diazoxide Choline in Hypertriglyceridemia
Public ClinicalTrials.gov record NCT00696475. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Diazoxide Choline in Non-Diabetic Hypertriglyceridemic Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Hypertriglyceridemia affects 30% of the population in the US. Very high level of triglycerides is a known risk factor for pancreatitis. In addition, studies have shown that hypertriglyceridemia is an independent risk factor for cardiovascular disease. Diazoxide is a KATP channel opener. It has been approved by the FDA as an oral suspension for the treatment of hyperinsulinemic hypoglycemic conditions and as an IV solution for malignant hypertension. Preclinical and clinical studies suggest that diazoxide can be a potential therapeutic agent for hypertriglyceridemia. Diazoxide choline is a novel, highly crystalline proprietary salt of diazoxide, which has been formulated as a controlled-release tablet suitable for once per day dosing. This current study is designed to assess the effect of diazoxide choline on triglycerides in subjects with baseline hypertriglyceridemia. In addition, the effects on other lipid parameters, glucose and insulin, body weight as well as the safety and tolerability of diazoxide choline will be assessed.
Study identification
- NCT ID
- NCT00696475
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2008
- Primary completion
- Dec 31, 2008
- Completion
- Feb 28, 2009
- Last update posted
- Nov 7, 2010
2008 – 2009
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Research Institute | Los Angeles | California | 90057 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Allied Research International/Cetero Research | Miami Gardens | Florida | 33169 | — |
| Meridien Research | Tampa | Florida | 33606 | — |
| Midwest Institute for Clinical Research | Indianapolis | Indiana | 46260 | — |
| L-MARC Research Center | Louisville | Kentucky | 40213 | — |
| St. Luke's Lipid and Diabetes Research Center | Kansas City | Missouri | 64111 | — |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | — |
| Metabolic and Atherosclerosis Research Center (MARC) | Cincinnati | Ohio | 45212 | — |
| Sterling Research Group, Ltd | Cincinnati | Ohio | 45219 | — |
| Frederick C. Smith Clinic | Marion | Ohio | 43302 | — |
| TriCities Medical Research | Bristol | Tennessee | 37620 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00696475, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 7, 2010 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00696475 live on ClinicalTrials.gov.