NCT00116519

Brief Summary

The purposes of this study are to determine:

  • The safety of the study medication and any side effects that might be associated with it;
  • Whether the study medication can help patients with low levels of 'good' cholesterol (HDL-C) and high blood fats or triglycerides (TG);
  • How much of the study medication should be given to patients;
  • How the study medication compares to fenofibrate (Lofibra), a drug used for people with low levels of HDL-C and high levels of TG.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

54 active sites

Status
completed

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

June 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

January 26, 2007

Status Verified

January 1, 2007

First QC Date

June 29, 2005

Last Update Submit

January 24, 2007

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • Effects on HDL-C and Triglycerides after 12 weeks

  • Safety after 12 weeks

Secondary Outcomes (3)

  • Effects on LDL-C after 12 weeks

  • Effects on biomarkers of atherosclerosis after 12 weeks

  • Effects on factors of metabolic syndrome after 12 weeks

Interventions

PPAR alphaDRUG
placeboDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between 18 and 80 years of age
  • People with abnormal fat levels in the blood (low HDL, high TG)

You may not qualify if:

  • People with diabetes
  • People whose blood pressure is greater than 160/95 mm Hg, on or off blood pressure medicine
  • People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure, including stent placement, within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (54)

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Hoover, Alabama, 35216, United States

Location

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Fayetteville, Arkansas, 72703, United States

Location

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San Diego, California, 92128, United States

Location

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Vista, California, 92083, United States

Location

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Golden, Colorado, 80401, United States

Location

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Highlands Ranch, Colorado, 80130, United States

Location

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Littleton, Colorado, 80120, United States

Location

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Brandon, Florida, 33511, United States

Location

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Jupiter, Florida, 33458, United States

Location

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Kissimmee, Florida, 34741, United States

Location

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Longwood, Florida, 32779, United States

Location

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Oviedo, Florida, 32765, United States

Location

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Chicago, Illinois, 60607, United States

Location

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Jeffersonville, Indiana, 47130, United States

Location

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West Des Moines, Iowa, 50266, United States

Location

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Kansas City, Kansas, 66160, United States

Location

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Wichita, Kansas, 67208, United States

Location

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Lexington, Kentucky, 40504, United States

Location

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Auburn, Maine, 04210, United States

Location

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Baltimore, Maryland, 21208, United States

Location

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Rockville, Maryland, 20854, United States

Location

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Benzonia, Michigan, 49616, United States

Location

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Cadillac, Michigan, 49601, United States

Location

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Flint, Michigan, 48532, United States

Location

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Interlochen, Michigan, 49643, United States

Location

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Ypsilanti, Michigan, 48197, United States

Location

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Tupelo, Mississippi, 38801, United States

Location

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Excelsior Springs, Missouri, 64024, United States

Location

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Las Vegas, Nevada, 89146, United States

Location

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West Seneca, New York, 14224, United States

Location

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Westfield, New York, 14787, United States

Location

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Charlotte, North Carolina, 28262, United States

Location

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Greensboro, North Carolina, 27401, United States

Location

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High Point, North Carolina, 27262, United States

Location

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Raleigh, North Carolina, 27609, United States

Location

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Wilmington, North Carolina, 28412, United States

Location

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Winston-Salem, North Carolina, 27103, United States

Location

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Grand Forks, North Dakota, 58201, United States

Location

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Cleveland, Ohio, 44195, United States

Location

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East Cleveland, Ohio, 44112, United States

Location

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Bend, Oregon, 97701, United States

Location

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Portland, Oregon, 97225, United States

Location

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Danville, Pennsylvania, 17822, United States

Location

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Philadelphia, Pennsylvania, 19115, United States

Location

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Red Lion, Pennsylvania, 17356, United States

Location

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Stoneboro, Pennsylvania, 16153, United States

Location

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Columbia, South Carolina, 29201, United States

Location

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Greer, South Carolina, 29651, United States

Location

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Simpsonville, South Carolina, 29681, United States

Location

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Bristol, Tennessee, 37620, United States

Location

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Kingsport, Tennessee, 37660, United States

Location

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Houston, Texas, 77024, United States

Location

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Spokane, Washington, 99204, United States

Location

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Wenatchee, Washington, 98801, United States

Location

Related Publications (1)

  • Nissen SE, Nicholls SJ, Wolski K, Howey DC, McErlean E, Wang MD, Gomez EV, Russo JM. Effects of a potent and selective PPAR-alpha agonist in patients with atherogenic dyslipidemia or hypercholesterolemia: two randomized controlled trials. JAMA. 2007 Mar 28;297(12):1362-73. doi: 10.1001/jama.297.12.1362. Epub 2007 Mar 25.

    PMID: 17384435DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

PPAR alpha

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peroxisome Proliferator-Activated ReceptorsReceptors, Cytoplasmic and NuclearProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday - Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2005

First Posted

June 30, 2005

Study Start

July 1, 2005

Study Completion

October 1, 2006

Last Updated

January 26, 2007

Record last verified: 2007-01

Locations

US(54)