A Study in People With Abnormal Fat Levels in the Blood
NCT ID: NCT00116519
Last Updated: 2007-01-26
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
300 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-07-31
Study Completion Date
2006-10-31
Brief Summary
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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.
* 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.
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Detailed Description
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Conditions
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Dyslipidemia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Interventions
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PPAR alpha
Intervention Type
DRUG
placebo
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Men and women between 18 and 80 years of age
* People with abnormal fat levels in the blood (low HDL, high TG)
* People with abnormal fat levels in the blood (low HDL, high TG)
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday - Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Hoover, Alabama, United States
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Fayetteville, Arkansas, United States
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San Diego, California, United States
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Vista, California, United States
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Golden, Colorado, United States
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Highlands Ranch, Colorado, United States
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Littleton, Colorado, United States
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Brandon, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Longwood, Florida, United States
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Oviedo, Florida, United States
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Chicago, Illinois, United States
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Jeffersonville, Indiana, United States
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West Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Auburn, Maine, United States
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Rockville, Maryland, United States
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Benzonia, Michigan, United States
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Cadillac, Michigan, United States
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Flint, Michigan, United States
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Interlochen, Michigan, United States
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Ypsilanti, Michigan, United States
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Tupelo, Mississippi, United States
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Excelsior Springs, Missouri, United States
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Las Vegas, Nevada, United States
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West Seneca, New York, United States
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Westfield, New York, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Grand Forks, North Dakota, United States
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Cleveland, Ohio, United States
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East Cleveland, Ohio, United States
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Bend, Oregon, United States
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Portland, Oregon, United States
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Danville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Red Lion, Pennsylvania, United States
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Stoneboro, Pennsylvania, United States
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Columbia, South Carolina, United States
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Greer, South Carolina, United States
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Simpsonville, South Carolina, United States
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Bristol, Tennessee, United States
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Kingsport, Tennessee, United States
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Houston, Texas, United States
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Spokane, Washington, United States
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Wenatchee, Washington, United States
Site Status
Countries
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United States
References
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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.
Reference Type
DERIVED
Other Identifiers
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H8D-MC-EMBB
Identifier Type: -
Identifier Source: secondary_id
5750
Identifier Type: -
Identifier Source: org_study_id
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