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A Study in People With Abnormal Fat Levels in the Blood

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ClinicalTrials.gov Identifier: NCT00116519
Recruitment Status : Completed
First Posted : June 30, 2005
Last Update Posted : January 26, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: PPAR alpha Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: PPAR Alpha: A Phase 2 Dose-Finding and Safety Study for Atherogenic Dyslipidemia by Eli Lilly
Study Start Date : July 2005
Study Completion Date : October 2006
Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Effects on HDL-C and Triglycerides after 12 weeks
  2. Safety after 12 weeks

Secondary Outcome Measures :
  1. Effects on LDL-C after 12 weeks
  2. Effects on biomarkers of atherosclerosis after 12 weeks
  3. Effects on factors of metabolic syndrome after 12 weeks

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: June 30, 2005    Key Record Dates
Last Update Posted: January 26, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases