NCT00973271

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2009

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 1, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

September 5, 2009

Last Update Submit

August 30, 2016

Conditions

Hypertriglyceridemia

Keywords

hypertriglyceridemia

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (4)

290 mg DCCR

EXPERIMENTAL
Drug: 290 mg DCCRDrug: PlaceboDrug: atorvastatin

435 mg DCCR

EXPERIMENTAL
Drug: 435 mg DCCRDrug: PlaceboDrug: atorvastatin

135 mg fenobric acid

ACTIVE COMPARATOR
Drug: 135 mg fenofibric acidDrug: PlaceboDrug: atorvastatin

Placebo

PLACEBO COMPARATOR
Drug: PlaceboDrug: atorvastatin

Interventions

290 mg DCCRDRUG

290 mg diazoxide choline

290 mg DCCR
435 mg DCCRDRUG

435 mg diazoxide choline

435 mg DCCR
135 mg fenofibric acidDRUG

135 mg fenofibric acid

Also known as: 135 mg fenobric acid
135 mg fenobric acid
PlaceboDRUG

Placebos matching each of 2 doses of DCCR and 135 mg fenofibric acid

Also known as: Placebos matching DCCR and fenofibric acid
135 mg fenobric acid290 mg DCCR435 mg DCCRPlacebo
atorvastatinDRUG

20 mg atorvastatin

Also known as: 20 mg atorvastatin
135 mg fenobric acid290 mg DCCR435 mg DCCRPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

fenofibric acidAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2009

First Posted

September 9, 2009

Study Start

March 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

September 1, 2016

Record last verified: 2016-08