Status:
WITHDRAWN
Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides
Lead Sponsor:
Essentialis, Inc.
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Fasting triglycerides
- Difference between Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit) ≤ 60% (compared to the higher value of Visit 3 or Visit 4)
- Run-in Triglycerides\* ≥ 500 mg/dL and \< 1500 mg/dL \*Run-in Triglyceride is defined as the average fasting triglycerides for Visit 3 (7 days prior to Baseline Visit) and Visit 4 (3 days prior to Baseline Visit).
- Statin use
- Either Statin-naive
- \- Must not be on statin at Screening and remaining as such during the Run-in/Washout Period and throughout the study
- Or Statin-treated
- Must be receiving a stable and effective dose of statin for ≥ 3 months without significant side effects or intolerance prior to Screening
- Must be willing to switch to 20 mg atorvastatin at the start of the Run-in/Washout Period and continue throughout the study
- Medication washout
- All subjects must be willing to undergo washout of all other lipid-lowering medications
- Fasting LDL cholesterol
- ≤ l60 mg/dL at both Screening Visit and Visit 4
- Glycemic status
- Fasting glucose \< 126 mg/dL at Screening Visit
- HbA1c \< 6.5% at Screening Visit
- EXCLUSION CRITERIA:
- Medications: recent, current, anticipated
- Administration of investigational drugs within 1 month prior to Screening Visit
- Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)
- Thiazide diuretics within 2 weeks prior to Screening Visit
- Discontinuation of beta-blockers within 1 month prior to Screening Visit or planned discontinuation of beta-blocker therapy
- Anticipated requirement for use of prohibited concomitant medications
- History of allergic reaction or significant intolerance to:
- Diazoxide
- Thiazides
- Sulfonamides
- Fenofibrate or fenofibric acid derivatives
- Lifestyle changes
- • Subjects intending to change exercise habits, quit smoking and/or quit alcohol use during the initial 12-week Placebo-Controlled Treatment Period of the study
- Specific diagnoses, medical conditions and history
- Known type I or III hyperlipidemia
- Known type 1 DM
- Known type 2 DM
- Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the study medications, according to the Investigator
- Specific laboratory test results
- • Any relevant biochemical abnormality interfering with the assessments of the study medications
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00973271
Start Date
March 1 2011
End Date
December 1 2011
Last Update
September 1 2016
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