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 (FIRST)

June 1, 2018 updated by: AbbVie (prior sponsor, Abbott)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

682

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Site Reference ID/Investigator# 6747
      • Gilbert, Arizona, United States, 85295
        • Site Reference ID/Investigator# 7089
      • Mesa, Arizona, United States, 85206
        • Site Reference ID/Investigator# 7097
      • Phoenix, Arizona, United States, 85032
        • Site Reference ID/Investigator# 26394
      • Scottsdale, Arizona, United States, 85251
        • Site Reference ID/Investigator# 6848
      • Tempe, Arizona, United States, 85282
        • Site Reference ID/Investigator# 7059
      • Tempe, Arizona, United States, 85282
        • Site Reference ID/Investigator# 7094
      • Tempe, Arizona, United States, 85282
        • Site Reference ID/Investigator# 7098
    • California
      • Anaheim, California, United States, 92804
        • Site Reference ID/Investigator# 25082
      • Corona, California, United States, 92879-3109
        • Site Reference ID/Investigator# 21347
      • Garden Grove, California, United States, 92843
        • Site Reference ID/Investigator# 21483
      • Huntington Beach, California, United States, 92648
        • Site Reference ID/Investigator# 21351
      • Laguna Hills, California, United States, 92653
        • Site Reference ID/Investigator# 21346
      • Long Beach, California, United States, 90806
        • Site Reference ID/Investigator# 21341
      • Norwalk, California, United States, 90650
        • Site Reference ID/Investigator# 21342
      • Santa Ana, California, United States, 92705
        • Site Reference ID/Investigator# 21321
      • Tustin, California, United States, 92780
        • Site Reference ID/Investigator# 26242
    • Colorado
      • Arvada, Colorado, United States, 80005-3927
        • Site Reference ID/Investigator# 15283
      • Aurora, Colorado, United States, 80012
        • Site Reference ID/Investigator# 7085
      • Denver, Colorado, United States, 80239
        • Site Reference ID/Investigator# 6749
      • Denver, Colorado, United States, 80246
        • Site Reference ID/Investigator# 7077
      • Golden, Colorado, United States, 80401
        • Site Reference ID/Investigator# 7092
      • Littleton, Colorado, United States, 80122
        • Site Reference ID/Investigator# 7722
      • Littleton, Colorado, United States, 80127
        • Site Reference ID/Investigator# 7721
    • Florida
      • Aventura, Florida, United States, 33180
        • Site Reference ID/Investigator# 11925
      • Boynton Beach, Florida, United States, 33472
        • Site Reference ID/Investigator# 15861
      • Deerfield Beach, Florida, United States, 33442
        • Site Reference ID/Investigator# 14422
      • Delray Beach, Florida, United States, 33445
        • Site Reference ID/Investigator# 19281
      • Hollywood, Florida, United States, 33021
        • Site Reference ID/Investigator# 20881
      • Kissimmee, Florida, United States, 34741
        • Site Reference ID/Investigator# 20882
      • Melbourne, Florida, United States, 32901
        • Site Reference ID/Investigator# 19321
      • Melbourne, Florida, United States, 32901
        • Site Reference ID/Investigator# 21353
      • Melbourne, Florida, United States, 32935
        • Site Reference ID/Investigator# 18503
      • Vero Beach, Florida, United States, 32960
        • Site Reference ID/Investigator# 18841
      • Vero Beach, Florida, United States, 32960
        • Site Reference ID/Investigator# 19961
      • West Palm Beach, Florida, United States, 33401
        • Site Reference ID/Investigator# 7166
      • West Palm Beach, Florida, United States, 33407
        • Site Reference ID/Investigator# 6744
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Site Reference ID/Investigator# 19301
      • Atlanta, Georgia, United States, 30342-1524
        • Site Reference ID/Investigator# 7051
      • Atlanta, Georgia, United States, 30342
        • Site Reference ID/Investigator# 7109
      • Dawsonville, Georgia, United States, 30534
        • Site Reference ID/Investigator# 7326
      • Decatur, Georgia, United States, 30033
        • Site Reference ID/Investigator# 7325
      • Dunwoody, Georgia, United States, 30338
        • Site Reference ID/Investigator# 7057
      • Dunwoody, Georgia, United States, 30338
        • Site Reference ID/Investigator# 7101
      • Roswell, Georgia, United States, 30076
        • Site Reference ID/Investigator# 11324
      • Roswell, Georgia, United States, 30076
        • Site Reference ID/Investigator# 6741
      • Suwanee, Georgia, United States, 30024
        • Site Reference ID/Investigator# 7103
    • Illinois
      • Addison, Illinois, United States, 60101
        • Site Reference ID/Investigator# 10761
      • Aurora, Illinois, United States, 60504
        • Site Reference ID/Investigator# 6748
      • Aurora, Illinois, United States, 60506
        • Site Reference ID/Investigator# 6742
      • Belleville, Illinois, United States, 62220-1986
        • Site Reference ID/Investigator# 7128
      • Chicago, Illinois, United States, 60607
        • Site Reference ID/Investigator# 7069
      • Chicago, Illinois, United States, 60612-9985
        • Site Reference ID/Investigator# 6849
      • Chicago, Illinois, United States, 60612
        • Site Reference ID/Investigator# 6867
      • Chicago, Illinois, United States, 60616
        • Site Reference ID/Investigator# 6751
      • Chicago, Illinois, United States, 60631
        • Site Reference ID/Investigator# 6847
      • Chicago, Illinois, United States, 60654
        • Site Reference ID/Investigator# 7049
      • Gurnee, Illinois, United States, 60031
        • Site Reference ID/Investigator# 7093
      • Hazel Crest, Illinois, United States, 60429
        • Site Reference ID/Investigator# 6746
      • Melrose Park, Illinois, United States, 60160
        • Site Reference ID/Investigator# 6743
      • Naperville, Illinois, United States, 60564
        • Site Reference ID/Investigator# 7090
      • Oak Brook, Illinois, United States, 60523
        • Site Reference ID/Investigator# 6750
      • Oak Park, Illinois, United States, 60304
        • Site Reference ID/Investigator# 6788
      • Vernon Hills, Illinois, United States, 60061
        • Site Reference ID/Investigator# 6927
    • Kentucky
      • Erlanger, Kentucky, United States, 41018
        • Site Reference ID/Investigator# 7076
    • Minnesota
      • Bloomington, Minnesota, United States, 55420
        • Site Reference ID/Investigator# 8103
      • Brooklyn Center, Minnesota, United States, 55430
        • Site Reference ID/Investigator# 15121
      • Edina, Minnesota, United States, 55435
        • Site Reference ID/Investigator# 7050
      • Edina, Minnesota, United States, 55435
        • Site Reference ID/Investigator# 7084
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Site Reference ID/Investigator# 6860
      • Saint Louis, Missouri, United States, 63117
        • Site Reference ID/Investigator# 13182
      • Saint Louis, Missouri, United States, 63128
        • Site Reference ID/Investigator# 14423
      • Saint Louis, Missouri, United States, 63141-6399
        • Site Reference ID/Investigator# 14541
      • Saint Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 6740
      • Saint Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 7053
      • Saint Peters, Missouri, United States, 63376
        • Site Reference ID/Investigator# 6784
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Site Reference ID/Investigator# 7063
      • Henderson, Nevada, United States, 89052
        • Site Reference ID/Investigator# 7070
      • Las Vegas, Nevada, United States, 89104
        • Site Reference ID/Investigator# 7106
      • Las Vegas, Nevada, United States, 89106
        • Site Reference ID/Investigator# 7518
      • Las Vegas, Nevada, United States, 89146
        • Site Reference ID/Investigator# 7119
      • Las Vegas, Nevada, United States, 89148
        • Site Reference ID/Investigator# 7129
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Site Reference ID/Investigator# 7071
      • Cincinnati, Ohio, United States, 45219
        • Site Reference ID/Investigator# 7100
      • Cincinnati, Ohio, United States, 45224
        • Site Reference ID/Investigator# 14321
      • Cincinnati, Ohio, United States, 45245
        • Site Reference ID/Investigator# 21355
      • Cincinnati, Ohio, United States, 45246
        • Site Reference ID/Investigator# 7074
      • Cincinnati, Ohio, United States, 45249
        • Site Reference ID/Investigator# 7065
      • Dayton, Ohio, United States, 45439
        • Site Reference ID/Investigator# 7075
      • Kettering, Ohio, United States, 45429
        • Site Reference ID/Investigator# 24802
      • Mason, Ohio, United States, 45040
        • Site Reference ID/Investigator# 7068
    • Texas
      • Bellaire, Texas, United States, 77401
        • Site Reference ID/Investigator# 7104
      • Carrollton, Texas, United States, 75006-5810
        • Site Reference ID/Investigator# 7060
      • Dallas, Texas, United States, 75230
        • Site Reference ID/Investigator# 15282
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 6745
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 7083
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 7127
      • Dallas, Texas, United States, 75251
        • Site Reference ID/Investigator# 7110
      • Deer Park, Texas, United States, 77536
        • Site Reference ID/Investigator# 21356
      • Fort Worth, Texas, United States, 76116
        • Site Reference ID/Investigator# 11923
      • Houston, Texas, United States, 77002
        • Site Reference ID/Investigator# 7321
      • Houston, Texas, United States, 77024
        • Site Reference ID/Investigator# 21354
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 21358
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 26482
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 7079
      • Houston, Texas, United States, 77030
        • Site Reference ID/Investigator# 7096
      • Houston, Texas, United States, 77036
        • Site Reference ID/Investigator# 7126
      • Houston, Texas, United States, 77036
        • Site Reference ID/Investigator# 8186
      • Houston, Texas, United States, 77074
        • Site Reference ID/Investigator# 11323
      • Houston, Texas, United States, 77081
        • Site Reference ID/Investigator# 7130
      • Irving, Texas, United States, 75039
        • Site Reference ID/Investigator# 11924
      • Irving, Texas, United States, 75061
        • Site Reference ID/Investigator# 13863
      • McKinney, Texas, United States, 75069
        • Site Reference ID/Investigator# 7099
      • New Braunfels, Texas, United States, 78130
        • Site Reference ID/Investigator# 19121
      • Pearland, Texas, United States, 77584
        • Site Reference ID/Investigator# 26244
      • Plano, Texas, United States, 75024
        • Site Reference ID/Investigator# 7105
      • San Antonio, Texas, United States, 78205
        • Site Reference ID/Investigator# 7061
      • San Antonio, Texas, United States, 78215
        • Site Reference ID/Investigator# 7320
      • San Antonio, Texas, United States, 78218
        • Site Reference ID/Investigator# 7914
      • San Antonio, Texas, United States, 78229-4801
        • Site Reference ID/Investigator# 7058
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 18402
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 7052
      • San Antonio, Texas, United States, 78229
        • Site Reference ID/Investigator# 7062
      • San Antonio, Texas, United States, 78238-1434
        • Site Reference ID/Investigator# 22947

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABT-335 + Atorvastatin
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
Drug: ABT-335
Capsule
Other Names:
  • Fenofibric acid
  • Choline fenofibrate
Other: Atorvastatin
Capsule
Placebo Comparator: Placebo + Atorvastatin
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
Drug: Placebo
Capsule
Other: Atorvastatin
Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)
Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)
Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in mean of maximal posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)
Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in composite of mean of the mean posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)
Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)
Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall and anterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.
Baseline, 6 months, 12 months, 18 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Maureen Kelly, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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