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
  Purpose

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 Intervention Phase
Hypertriglyceridemia
Drug: 290 mg DCCR
Drug: 435 mg DCCR
Drug: 135 mg fenofibric acid
Drug: Placebo
Drug: atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Essentialis, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 750
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 290 mg DCCR Drug: 290 mg DCCR
290 mg diazoxide choline
Other Name: 290 mg DCCR
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: 435 mg DCCR Drug: 435 mg DCCR
435 mg diazoxide choline
Other Name: 435 mg DCCR
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
Active Comparator: 135 mg fenobric acid 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
Placebo Comparator: Placebo 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973271

Contacts
Contact: Gloria C Lin, PhD 858-964-5013 gloria.lin@essentialistherapeutics.com
Contact: Neil M Cowen, PhD 858-964-5008 nmcowen@essentialistherapeutics.com

Sponsors and Collaborators
Essentialis, Inc.
  More Information

No publications provided

Responsible Party: Neil M. Cowen, PhD, Chief Scientific Officer, Essentialis, Inc.
ClinicalTrials.gov Identifier: NCT00973271     History of Changes
Other Study ID Numbers: PV011
Study First Received: September 5, 2009
Last Updated: November 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Essentialis, Inc.:
hypertriglyceridemia

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Choline
Fenofibric acid
Fenofibrate
Atorvastatin
Diazoxide
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents
Antihypertensive Agents
Cardiovascular Agents
Vasodilator Agents
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014