NCT00422396

Completed

Effects of Micronized Fenofibrate on Fasting and Postprandia...

University of Michigan Source

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Other study identifiers

Sponsor study identifier

877-017

Study Type

interventional

Reported enrollment (type unavailable)

60

Locations

1 country

Sites

1

Timeline

Study Start

January 2001

Actual (reported)

Primary Completion

April 2002

Actual (reported)

Study Completion

April 2002

Actual (reported)

Brief Summary

This is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: April 2002
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2001
Actual (reported)
Primary Completion
April 2002
Actual (reported)
Study Completion
April 2002
Actual (reported)
First Submitted
January 12, 2007
Actual (reported)
First Posted
January 17, 2007
Actual (reported)

Last Updated: February 10, 2017
Status Verified: February 2017
Last Update Submitted: February 9, 2017

Conditions

Hypertriglyceridemia With the Metabolic Syndrome

Keywords

HypertrigliceridemiaMetabolic syndromeObesityFenofibrateLipoproteinsCytokines

Outcome Measures

Primary Outcomes (1)

1. lipids and lipoproteins

Interventions

Fenofibrate (drug)Drug

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

males and postmenopausal females 18 years of age with fasting triglycerides greater than or equal to 1.7 mmol/L and \<6.9 mmol/L
two or more of the following Adult Treatment Panel III (1) criteria of the metabolic syndrome: abdominal obesity (waist circumference \>89 cm in females and \>102 cm in males); low high-density lipoprotein cholesterol (HDL-C) (\<1.3 mmol/L in women and \<1.0 mmol/L in men); hypertension (systolic blood pressure \>130 or diastolic blood pressure \>85 mm Hg) or current drug therapy for hypertension; and impaired fasting glucose (between 6.1 mmol/L and 7.0 mmol/L).

Sponsors & Collaborators

Abbott
Industrycollaborator
University of Michigan
Otherlead

Study Sites (1)

Northwestern University preventive Cardiology Center

Chicago, Illinois, 60611, United States

MeSH Terms

Conditions

Metabolic SyndromeObesity

Interventions

FenofibratePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Study Officials

Robert S Rosenson, MD
University of Michigan
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 12, 2007

First Posted

January 17, 2007

Study Start

January 2001

Actual (reported)

Primary Completion

April 2002

Actual (reported)

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You may not qualify if:

included types 1 or 2 diabetes
Body mass index \>40 kg/m2
Use of lipid-lowering therapies
Oral hypoglycemic therapies
Insulin
Aspirin \>81 mg daily
Regular use of non-steroidal anti-inflammatory agents or cyclooxygenase-2 inhibitors, corticosteroids (oral and inhaled), anti-oxidants (including multivitamins), herbal or fiber supplements recent changes in type or formulation of hormone replacement therapy (in the last 6 months)
Alcohol intake \>3 drinks per day
Untreated hypothyroidism or recent change (within 2 months) of thyroid replacement therapy
Cigarette smoking (current or within the last 6 months)

Contact the study team to confirm eligibility.

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Completion

April 2002

Actual (reported)

Last Updated

February 10, 2017

Record last verified: 2017-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00422396
Data provider: ClinicalTrials.gov
Source updated: 2017-02-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:06 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations