A Study in People With High Cholesterol

NCT ID: NCT00133380

Last Updated: 2007-04-06

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

2006-09-30

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 high levels of "bad" cholesterol (low-density lipoprotein-cholesterol \[LDL-C\]), alone or in combination with additional study medication

Detailed Description

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Conditions

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Hypercholesterolemia

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

atorvastatin

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 cholesterol levels

Exclusion Criteria

* People with diabetes
* People whose blood pressure \>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 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Fayetteville, Arkansas, United States

Site Status

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.

Stockton, California, United States

Site Status

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Highlands Ranch, Colorado, United States

Site Status

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Brandon, Florida, United States

Site Status

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Kissimmee, Florida, United States

Site Status

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Longwood, Florida, United States

Site Status

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Oviedo, Florida, United States

Site Status

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Chicago, Illinois, United States

Site Status

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Kansas City, Kansas, United States

Site Status

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Wichita, Kansas, United States

Site Status

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Lexington, Kentucky, United States

Site Status

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Auburn, Maine, United States

Site Status

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Rockville, Maryland, United States

Site Status

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Benzonia, Michigan, United States

Site Status

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Cadillac, Michigan, United States

Site Status

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Interlochen, Michigan, United States

Site Status

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Excelsior Springs, Missouri, United States

Site Status

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Charlotte, North Carolina, United States

Site Status

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Greensboro, North Carolina, United States

Site Status

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Raleigh, North Carolina, United States

Site Status

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Wilmington, North Carolina, United States

Site Status

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Winston-Salem, North Carolina, United States

Site Status

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Mansfield, Ohio, United States

Site Status

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Portland, Oregon, United States

Site Status

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Philadelphia, Pennsylvania, United States

Site Status

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Stoneboro, Pennsylvania, United States

Site Status

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Bristol, Tennessee, United States

Site Status

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Kingsport, Tennessee, 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
PMID: 17384435 (View on PubMed)

Other Identifiers

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H8D-MC-EMBF

Identifier Type: -

Identifier Source: secondary_id

9591

Identifier Type: -

Identifier Source: org_study_id