Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides
NCT ID: NCT00973271
Last Updated: 2016-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2011-03-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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290 mg DCCR
290 mg DCCR
290 mg diazoxide choline
Placebo
Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
atorvastatin
20 mg atorvastatin
435 mg DCCR
435 mg DCCR
435 mg diazoxide choline
Placebo
Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
atorvastatin
20 mg atorvastatin
135 mg fenobric acid
135 mg fenofibric acid
135 mg fenofibric acid
Placebo
Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
atorvastatin
20 mg atorvastatin
Placebo
Placebo
Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
atorvastatin
20 mg atorvastatin
Interventions
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290 mg DCCR
290 mg diazoxide choline
435 mg DCCR
435 mg diazoxide choline
135 mg fenofibric acid
135 mg fenofibric acid
Placebo
Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
atorvastatin
20 mg atorvastatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Essentialis, Inc.
INDUSTRY
Responsible Party
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Essentialis, Inc.
Other Identifiers
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PV011
Identifier Type: -
Identifier Source: org_study_id
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