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NCT00696475 · ClinicalTrials.gov registry record · Phase 2
Diazoxide Choline in Hypertriglyceridemia
A Phase 2 study, sponsored by Essentialis.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00696475 is a Phase 2 study that has completed, run by Essentialis. The registered enrollment target is 80 participants.
The verdict
NCT00696475, a Phase 2 study, has completed, sponsored by Essentialis.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG Diazoxide choline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00696475
The ClinicalTrials.gov registry entry for NCT00696475 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Essentialis, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00696475 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00696475 about?
NCT00696475 is a clinical study titled "Diazoxide Choline in Hypertriglyceridemia". 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...
What is the current status of trial NCT00696475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2008-06. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00696475?
The interventions under investigation include: Placebo (DRUG), Diazoxide choline (DRUG).
Who is sponsoring clinical trial NCT00696475?
This trial is sponsored by Essentialis, which has 4 total clinical trials registered on ClinicalTrials.gov.
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