NCT00133380

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

April 6, 2007

Status Verified

April 1, 2007

First QC Date

August 19, 2005

Last Update Submit

April 4, 2007

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Effects on "bad" cholesterol, LDL-C, after 12 weeks

Secondary Outcomes (3)

  • Evaluate safety after 12 weeks

  • Effects on other lipids and biomarkers associated with atherosclerosis after 12 weeks

  • Evaluate interaction of the 2 different study medications

Interventions

PPAR alphaDRUG
atorvastatinDRUG
placeboDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between 18 and 80 years of age
  • People with abnormal cholesterol levels

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

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, 72703, United States

Location

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, 95204, United States

Location

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Highlands Ranch, Colorado, 80130, United States

Location

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Brandon, Florida, 33511, United States

Location

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Kissimmee, Florida, 34741, United States

Location

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Longwood, Florida, 32779, United States

Location

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Oviedo, Florida, 32765, United States

Location

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Chicago, Illinois, 60607, United States

Location

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.

Kansas City, Kansas, 66160, United States

Location

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Wichita, Kansas, 67208, United States

Location

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Lexington, Kentucky, 40504, United States

Location

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Auburn, Maine, 04210, United States

Location

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Rockville, Maryland, 20854, United States

Location

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Benzonia, Michigan, 49616, United States

Location

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Cadillac, Michigan, 49601, United States

Location

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Interlochen, Michigan, 49643, United States

Location

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Excelsior Springs, Missouri, 64024, United States

Location

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Charlotte, North Carolina, 28262, United States

Location

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Greensboro, North Carolina, 27401, United States

Location

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Raleigh, North Carolina, 27609, United States

Location

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.

Wilmington, North Carolina, 28412, United States

Location

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.

Winston-Salem, North Carolina, 27103, United States

Location

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.

Mansfield, Ohio, 44903, United States

Location

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.

Portland, Oregon, 97225, United States

Location

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.

Philadelphia, Pennsylvania, 19115, United States

Location

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.

Stoneboro, Pennsylvania, 16153, United States

Location

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.

Bristol, Tennessee, 37620, United States

Location

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.

Kingsport, Tennessee, 37660, United States

Location

Related Publications (1)

  • 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.

    PMID: 17384435DERIVED

Related Links

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

PPAR alphaAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peroxisome Proliferator-Activated ReceptorsReceptors, Cytoplasmic and NuclearProteinsAmino Acids, Peptides, and ProteinsPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 23, 2005

Study Start

July 1, 2005

Study Completion

September 1, 2006

Last Updated

April 6, 2007

Record last verified: 2007-04

Locations

US(28)