Status:
COMPLETED
Diazoxide Choline in Hypertriglyceridemia
Lead Sponsor:
Essentialis, Inc.
Collaborating Sponsors:
Medpace, Inc.
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- triglycerides ≥ 250 mg/dL and \< 600 mg/dL
- BMI between 18.5 and 45
- Signed informed consent form
Exclusion
- Fasting glucose ≥ 126 mg/dL
- Glycosylated hemoglobin (HbA1c) \> 6.5%
- LDL cholesterol \> 190 mg/dL
- Known history of type I and II DM
- Known history of type I and III hyperlipidemia
- Weight change \> 3 kg between screening and baseline visits
- Pregnancy or intention to become pregnant
- Presence of significant underlying conditions that may interfere with the assessments of the study drug
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00696475
Start Date
June 1 2008
End Date
March 1 2009
Last Update
November 8 2010
Active Locations (12)
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1
National Research Institute
Los Angeles, California, United States, 90057
2
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
3
Allied Research International/Cetero Research
Miami Gardens, Florida, United States, 33169
4
Meridien Research
Tampa, Florida, United States, 33606