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Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease; Coronary Heart Disease; Dyslipidemia

Intervention: ABT-335 (Drug); Placebo (Drug); Atorvastatin (Other)

Phase: Phase 3

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Maureen Kelly, MD, Study Director, Affiliation: AbbVie

Summary

The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.

Clinical Details

Official title: Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects With Type IIb Dyslipidemia With Residual Risk in Addition to Atorvastatin Therapy (FIRST) Trial

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)

Secondary outcome:

Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)

Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)

Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)

Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with mixed dyslipidemia

- Qualifying cIMT thickness

Exclusion Criteria:

- Patients with certain chronic or unstable medical conditions.

- Patients with unstable dose of medications or receiving coumadin, cyclosporine, or

certain other medications

- Pregnant or lactating women or women intending to become pregnant

- Patients with diabetes mellitus that is poorly controlled

Locations and Contacts

Site Reference ID/Investigator# 6747, Chandler, Arizona 85225, United States

Site Reference ID/Investigator# 7089, Gilbert, Arizona 85295, United States

Site Reference ID/Investigator# 7097, Mesa, Arizona 85206, United States

Site Reference ID/Investigator# 26394, Phoenix, Arizona 85032, United States

Site Reference ID/Investigator# 6848, Scottsdale, Arizona 85251, United States

Site Reference ID/Investigator# 7059, Tempe, Arizona 85282, United States

Site Reference ID/Investigator# 7094, Tempe, Arizona 85282, United States

Site Reference ID/Investigator# 7098, Tempe, Arizona 85282, United States

Site Reference ID/Investigator# 25082, Anaheim, California 92804, United States

Site Reference ID/Investigator# 21347, Corona, California 92879-3109, United States

Site Reference ID/Investigator# 21483, Garden Grove, California 92843, United States

Site Reference ID/Investigator# 21351, Huntington Beach, California 92648, United States

Site Reference ID/Investigator# 21346, Laguna Hills, California 92653, United States

Site Reference ID/Investigator# 21341, Long Beach, California 90806, United States

Site Reference ID/Investigator# 21342, Norwalk, California 90650, United States

Site Reference ID/Investigator# 21321, Santa Ana, California 92705, United States

Site Reference ID/Investigator# 26242, Tustin, California 92780, United States

Site Reference ID/Investigator# 15283, Arvada, Colorado 80005-3927, United States

Site Reference ID/Investigator# 7085, Aurora, Colorado 80012, United States

Site Reference ID/Investigator# 6749, Denver, Colorado 80239, United States

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Site Reference ID/Investigator# 15861, Boynton Beach, Florida 33472, United States

Site Reference ID/Investigator# 14422, Deerfield Beach, Florida 33442, United States

Site Reference ID/Investigator# 19281, Delray Beach, Florida 33445, United States

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Site Reference ID/Investigator# 7166, West Palm Beach, Florida 33401, United States

Site Reference ID/Investigator# 19301, Atlanta, Georgia 30308, United States

Site Reference ID/Investigator# 7051, Atlanta, Georgia 30342-1524, United States

Site Reference ID/Investigator# 7109, Atlanta, Georgia 30342, United States

Site Reference ID/Investigator# 7326, Dawsonville, Georgia 30534, United States

Site Reference ID/Investigator# 7325, Decatur, Georgia 30033, United States

Site Reference ID/Investigator# 7057, Dunwoody, Georgia 30338, United States

Site Reference ID/Investigator# 7101, Dunwoody, Georgia 30338, United States

Site Reference ID/Investigator# 11324, Roswell, Georgia 30076, United States

Site Reference ID/Investigator# 6741, Roswell, Georgia 30076, United States

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Site Reference ID/Investigator# 10761, Addison, Illinois 60101, United States

Site Reference ID/Investigator# 6742, Aurora, Illinois 60506, United States

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Site Reference ID/Investigator# 7128, Belleville, Illinois 62220-1986, United States

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Site Reference ID/Investigator# 6847, Chicago, Illinois 60631, United States

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Site Reference ID/Investigator# 6743, Melrose Park, Illinois 60160, United States

Site Reference ID/Investigator# 7090, Naperville, Illinois 60564, United States

Site Reference ID/Investigator# 6750, Oak Brook, Illinois 60523, United States

Site Reference ID/Investigator# 6788, Oak Park, Illinois 60304, United States

Site Reference ID/Investigator# 6927, Vernon Hills, Illinois 60061, United States

Site Reference ID/Investigator# 7076, Erlanger, Kentucky 41018, United States

Site Reference ID/Investigator# 8103, Bloomington, Minnesota 55420, United States

Site Reference ID/Investigator# 15121, Brooklyn Center, Minnesota 55430, United States

Site Reference ID/Investigator# 7050, Edina, Minnesota 55435, United States

Site Reference ID/Investigator# 7084, Edina, Minnesota 55435, United States

Site Reference ID/Investigator# 13182, St. Louis, Missouri 63117, United States

Site Reference ID/Investigator# 14423, St. Louis, Missouri 63128, United States

Site Reference ID/Investigator# 14541, St. Louis, Missouri 63141-6399, United States

Site Reference ID/Investigator# 6740, St. Louis, Missouri 63141, United States

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Site Reference ID/Investigator# 7053, St. Louis, Missouri 63141, United States

Site Reference ID/Investigator# 6784, St. Peters, Missouri 63376, United States

Site Reference ID/Investigator# 7063, Henderson, Nevada 89014, United States

Site Reference ID/Investigator# 7070, Henderson, Nevada 89052, United States

Site Reference ID/Investigator# 7106, Las Vegas, Nevada 89104, United States

Site Reference ID/Investigator# 7119, Las Vegas, Nevada 89146, United States

Site Reference ID/Investigator# 7129, Las Vegas, Nevada 89148, United States

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Site Reference ID/Investigator# 14321, Cincinnati, Ohio 45224, United States

Site Reference ID/Investigator# 21355, Cincinnati, Ohio 45245, United States

Site Reference ID/Investigator# 7065, Cincinnati, Ohio 45249, United States

Site Reference ID/Investigator# 7071, Cincinnati, Ohio 45212, United States

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Site Reference ID/Investigator# 7100, Cincinnati, Ohio 45219, United States

Site Reference ID/Investigator# 7075, Dayton, Ohio 45439, United States

Site Reference ID/Investigator# 24802, Kettering, Ohio 45429, United States

Site Reference ID/Investigator# 7068, Mason, Ohio 45040, United States

Site Reference ID/Investigator# 7104, Bellaire, Texas 77401, United States

Site Reference ID/Investigator# 7060, Carrollton, Texas 75006-5810, United States

Site Reference ID/Investigator# 15282, Dallas, Texas 75230, United States

Site Reference ID/Investigator# 6745, Dallas, Texas 75231, United States

Site Reference ID/Investigator# 7083, Dallas, Texas 75231, United States

Site Reference ID/Investigator# 7110, Dallas, Texas 75251, United States

Site Reference ID/Investigator# 7127, Dallas, Texas 75231, United States

Site Reference ID/Investigator# 21356, Deer Park, Texas 77536, United States

Site Reference ID/Investigator# 11923, Fort Worth, Texas 76116, United States

Site Reference ID/Investigator# 11323, Houston, Texas 77074, United States

Site Reference ID/Investigator# 21354, Houston, Texas 77024, United States

Site Reference ID/Investigator# 21358, Houston, Texas 77030, United States

Site Reference ID/Investigator# 26482, Houston, Texas 77030, United States

Site Reference ID/Investigator# 7079, Houston, Texas 77030, United States

Site Reference ID/Investigator# 7096, Houston, Texas 77030, United States

Site Reference ID/Investigator# 7126, Houston, Texas 77036, United States

Site Reference ID/Investigator# 7130, Houston, Texas 77081, United States

Site Reference ID/Investigator# 7321, Houston, Texas 77002, United States

Site Reference ID/Investigator# 8186, Houston, Texas 77036, United States

Site Reference ID/Investigator# 11924, Irving, Texas 75039, United States

Site Reference ID/Investigator# 13863, Irving, Texas 75061, United States

Site Reference ID/Investigator# 7099, McKinney, Texas 75069, United States

Site Reference ID/Investigator# 19121, New Braunfels, Texas 78130, United States

Site Reference ID/Investigator# 26244, Pearland, Texas 77584, United States

Site Reference ID/Investigator# 7105, Plano, Texas 75024, United States

Site Reference ID/Investigator# 18402, San Antonio, Texas 78229, United States

Site Reference ID/Investigator# 22947, San Antonio, Texas 78238-1434, United States

Site Reference ID/Investigator# 7052, San Antonio, Texas 78229, United States

Site Reference ID/Investigator# 7058, San Antonio, Texas 78229-4801, United States

Site Reference ID/Investigator# 7061, San Antonio, Texas 78205, United States

Site Reference ID/Investigator# 7062, San Antonio, Texas 78229, United States

Site Reference ID/Investigator# 7320, San Antonio, Texas 78215, United States

Site Reference ID/Investigator# 7914, San Antonio, Texas 78218, United States

Additional Information

Starting date: February 2008
Last updated: December 3, 2013

Page last updated: August 23, 2015

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