A Study in People With Abnormal Fat Levels in the Blood
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00116519 |
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Recruitment Status :
Completed
First Posted : June 30, 2005
Last Update Posted : January 26, 2007
|
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |
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
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, Older Adult) |
| 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
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 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| 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 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Cleveland, Ohio, United States, 44195 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| East Cleveland, Ohio, United States, 44112 | |
| United States, Oregon | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Bend, Oregon, United States, 97701 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Danville, Pennsylvania, United States, 17822 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| 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 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Columbia, South Carolina, United States, 29201 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Greer, South Carolina, United States, 29651 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Simpsonville, South Carolina, United States, 29681 | |
| United States, Tennessee | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Bristol, Tennessee, United States, 37620 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Kingsport, Tennessee, United States, 37660 | |
| United States, Texas | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Houston, Texas, United States, 77024 | |
| United States, Washington | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| Spokane, Washington, United States, 99204 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test | |
| 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 |
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 |