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Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides

Sponsor
Essentialis, Inc. (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00973271
Collaborator
(none)
0
Enrollment
4
Arms
9
Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: 290 mg DCCR
  • Drug: 435 mg DCCR
  • Drug: 135 mg fenofibric acid
  • Drug: Placebo
  • Drug: atorvastatin
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Study Assessing the Efficacy, Safety and Tolerability of Diazoxide Choline Controlled-Release Tablet (DCCR) in Subjects Without Diabetes Mellitus Having Very High Fasting Triglyceride Levels, With Double-Blind Active-Controlled Extension Assessing Safety and Tolerability
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 290 mg DCCR

Drug: 290 mg DCCR
290 mg diazoxide choline

Drug: Placebo
Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
Other Names:
  • Placebos matching DCCR and fenofibric acid

    • Drug: atorvastatin
    20 mg atorvastatin
    Other Names:
  • 20 mg atorvastatin

    		•
    Experimental: 435 mg DCCR

    Drug: 435 mg DCCR
    435 mg diazoxide choline

    Drug: Placebo
    Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
    Other Names:
  • Placebos matching DCCR and fenofibric acid

    • Drug: atorvastatin
    20 mg atorvastatin
    Other Names:
  • 20 mg atorvastatin

    		•
    Active Comparator: 135 mg fenobric acid

    Drug: 135 mg fenofibric acid
    135 mg fenofibric acid
    Other Names:
  • 135 mg fenobric acid

    • Drug: Placebo
    Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
    Other Names:
  • Placebos matching DCCR and fenofibric acid

    • Drug: atorvastatin
    20 mg atorvastatin
    Other Names:
  • 20 mg atorvastatin

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
    Other Names:
  • Placebos matching DCCR and fenofibric acid

    • Drug: atorvastatin
    20 mg atorvastatin
    Other Names:
  • 20 mg atorvastatin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days [84 days]

    Secondary Outcome Measures

    1. The effects of DCCR on Apo B and non-HDL in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days [84 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Essentialis, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00973271
    Other Study ID Numbers:
    • PV011
    First Posted:
    Sep 9, 2009
    Last Update Posted:
    Sep 1, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by , ,
    hypertriglyceridemia
    Additional relevant MeSH terms:
    Hypertriglyceridemia
    Atorvastatin
    Fenofibric acid
    Fenofibrate

    Study Results

    No Results Posted as of Sep 1, 2016