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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

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   (Adult, Senior)
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

  Hide Study Locations
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

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

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 September 23, 2016