A Study in People With Abnormal Fat Levels in the Blood

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00116519

First received: June 29, 2005

Last updated: January 24, 2007

Last verified: January 2007

History of Changes

Purpose

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.

Condition	Intervention	Phase
Dyslipidemia	Drug: PPAR alpha Drug: placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	PPAR Alpha: A Phase 2 Dose-Finding and Safety Study for Atherogenic Dyslipidemia by Eli Lilly

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Sphingolipidosis

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Effects on HDL-C and Triglycerides after 12 weeks
Safety after 12 weeks

Secondary Outcome Measures:

Effects on LDL-C after 12 weeks
Effects on biomarkers of atherosclerosis after 12 weeks
Effects on factors of metabolic syndrome after 12 weeks


Estimated Enrollment:	300
Study Start Date:	July 2005
Estimated Study Completion Date:	October 2006

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women between 18 and 80 years of age
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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116519

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Locations


United States, Alabama
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Hoover, Alabama, United States, 35216
United States, Arkansas
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Fayetteville, Arkansas, United States, 72703
United States, California
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San Diego, California, United States, 92128
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Vista, California, United States, 92083
United States, Colorado
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Golden, Colorado, United States, 80401
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Highlands Ranch, Colorado, United States, 80130
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Littleton, Colorado, United States, 80120
United States, Florida
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Brandon, Florida, United States, 33511
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Jupiter, Florida, United States, 33458
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Kissimmee, Florida, United States, 34741
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Longwood, Florida, United States, 32779
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Oviedo, Florida, United States, 32765
United States, Illinois
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Chicago, Illinois, United States, 60607
United States, Indiana
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Jeffersonville, Indiana, United States, 47130
United States, Iowa
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West Des Moines, Iowa, United States, 50266
United States, Kansas
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Kansas City, Kansas, United States, 66160
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Wichita, Kansas, United States, 67208
United States, Kentucky
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Lexington, Kentucky, United States, 40504
United States, Maine
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Auburn, Maine, United States, 04210
United States, Maryland
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Baltimore, Maryland, United States, 21208
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Rockville, Maryland, United States, 20854
United States, Michigan
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Benzonia, Michigan, United States, 49616
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Cadillac, Michigan, United States, 49601
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Flint, Michigan, United States, 48532
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Interlochen, Michigan, United States, 49643
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Ypsilanti, Michigan, United States, 48197
United States, Mississippi
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Tupelo, Mississippi, United States, 38801
United States, Missouri
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Excelsior Springs, Missouri, United States, 64024
United States, Nevada
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Las Vegas, Nevada, United States, 89146
United States, New York
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West Seneca, New York, United States, 14224
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Westfield, New York, United States, 14787
United States, North Carolina
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Charlotte, North Carolina, United States, 28262
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Greensboro, North Carolina, United States, 27401
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High Point, North Carolina, United States, 27262
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Raleigh, North Carolina, United States, 27609
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Wilmington, North Carolina, United States, 28412
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Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
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Grand Forks, North Dakota, United States, 58201
United States, Ohio
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Cleveland, Ohio, United States, 44195
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East Cleveland, Ohio, United States, 44112
United States, Oregon
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Bend, Oregon, United States, 97701
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Portland, Oregon, United States, 97225
United States, Pennsylvania
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Danville, Pennsylvania, United States, 17822
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Philadelphia, Pennsylvania, United States, 19115
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Red Lion, Pennsylvania, United States, 17356
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Stoneboro, Pennsylvania, United States, 16153
United States, South Carolina
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Columbia, South Carolina, United States, 29201
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Greer, South Carolina, United States, 29651
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Simpsonville, South Carolina, United States, 29681
United States, Tennessee
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Bristol, Tennessee, United States, 37620
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Kingsport, Tennessee, United States, 37660
United States, Texas
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Houston, Texas, United States, 77024
United States, Washington
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Spokane, Washington, United States, 99204
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Wenatchee, Washington, United States, 98801

Sponsors and Collaborators

Eli Lilly and Company

Investigators


Study Director:	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

More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2007 Mar 25.


ClinicalTrials.gov Identifier:	NCT00116519 History of Changes
Other Study ID Numbers:	5750, H8D-MC-EMBB
Study First Received:	June 29, 2005
Last Updated:	January 24, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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