NCT01003847

Brief Summary

The investigators hypothesize that fenofibrate and fatty acid may have different metabolic effects in hypertriglyceridemic patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 10, 2011

Status Verified

October 1, 2010

Enrollment Period

10 months

First QC Date

October 28, 2009

Last Update Submit

May 9, 2011

Conditions

Hypertriglyceridemia

Keywords

Insulin resistance

Outcome Measures

Primary Outcomes (1)

  • flow-mediated dilation

    8 weeks of treatment

Secondary Outcomes (1)

  • insulin resistance

    8 weeks of treatment

Study Arms (3)

fenofibrate

ACTIVE COMPARATOR
Drug: fenofibrate, fatty acid, placebo

fatty acid

ACTIVE COMPARATOR

drug

Drug: fenofibrate, fatty acid, placebo

Placebo

ACTIVE COMPARATOR
Drug: fenofibrate, fatty acid, placebo

Interventions

fenofibrate, fatty acid, placeboDRUG

fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment

Placebofatty acidfenofibrate

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypertriglyceridemia

You may not qualify if:

  • Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gil Medical Center

Incheon, 405-760, South Korea

Location

MeSH Terms

Conditions

HypertriglyceridemiaInsulin Resistance

Interventions

FenofibrateFatty Acids

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetonesLipids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2009

First Posted

October 29, 2009

Study Start

November 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

May 10, 2011

Record last verified: 2010-10

Locations

KR(1)