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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Essentialis, Inc..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Essentialis, Inc.
ClinicalTrials.gov Identifier:
NCT00973271
First received: September 5, 2009
Last updated: November 4, 2010
Last verified: November 2010

September 5, 2009
November 4, 2010
March 2011
August 2012   (final data collection date for primary outcome measure)
The effect of DCCR on triglycerides in subjects without diabetes mellitus who have very high triglycerides over a period of 84 days [ Time Frame: 84 days ] [ Designated as safety issue: No ]
to assess the effect of DCCR on fasting triglyceride levels over a period of 84 days in subjects without diabetes mellitus who have very high fasting triglyceride levels [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00973271 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 84 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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Diazoxide Choline Controlled-Release Tablet (DCCR) for Very High Triglycerides
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

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypertriglyceridemia
  • Drug: 290 mg DCCR
    290 mg diazoxide choline
    Other Name: 290 mg DCCR
  • Drug: 435 mg DCCR
    435 mg diazoxide choline
    Other Name: 435 mg DCCR
  • Drug: 135 mg fenofibric acid
    135 mg fenofibric acid
    Other Name: 135 mg fenobric acid
  • Drug: Placebo
    Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid
    Other Name: Placebos matching DCCR and fenofibric acid
  • Drug: atorvastatin
    20 mg atorvastatin
    Other Name: 20 mg atorvastatin
  • Experimental: 290 mg DCCR
    Interventions:
    • Drug: 290 mg DCCR
    • Drug: Placebo
    • Drug: atorvastatin
  • Experimental: 435 mg DCCR
    Interventions:
    • Drug: 435 mg DCCR
    • Drug: Placebo
    • Drug: atorvastatin
  • Active Comparator: 135 mg fenobric acid
    Interventions:
    • Drug: 135 mg fenofibric acid
    • Drug: Placebo
    • Drug: atorvastatin
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Drug: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
750
December 2012
August 2012   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Gloria C Lin, PhD 858-964-5013 gloria.lin@essentialistherapeutics.com
Contact: Neil M Cowen, PhD 858-964-5008 nmcowen@essentialistherapeutics.com
Not Provided
 
NCT00973271
PV011
Yes
Neil M. Cowen, PhD, Chief Scientific Officer, Essentialis, Inc.
Essentialis, Inc.
Not Provided
Not Provided
Essentialis, Inc.
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP