Clinical trial NCT00616772: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Coronary Heart Disease
Dyslipidemia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 682
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
Secondary outcomes:
measure: Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
measure: Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)
timeFrame: Baseline, 6 months, 12 months, 18 months, and 24 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Site Reference ID/Investigator# 6747
state: Arizona
city: Gilbert
country: United States
facility: Site Reference ID/Investigator# 7089
state: Arizona
city: Mesa
country: United States
facility: Site Reference ID/Investigator# 7097
state: Arizona
city: Phoenix
country: United States
facility: Site Reference ID/Investigator# 26394
state: Arizona
city: Scottsdale
country: United States
facility: Site Reference ID/Investigator# 6848
state: Arizona
city: Tempe
country: United States
facility: Site Reference ID/Investigator# 7059
state: Arizona
city: Tempe
country: United States
facility: Site Reference ID/Investigator# 7094
state: Arizona
city: Tempe
country: United States
facility: Site Reference ID/Investigator# 7098
state: Arizona
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 25082
state: California
city: Corona
country: United States
facility: Site Reference ID/Investigator# 21347
state: California
city: Garden Grove
country: United States
facility: Site Reference ID/Investigator# 21483
state: California
city: Huntington Beach
country: United States
facility: Site Reference ID/Investigator# 21351
state: California
city: Laguna Hills
country: United States
facility: Site Reference ID/Investigator# 21346
state: California
city: Long Beach
country: United States
facility: Site Reference ID/Investigator# 21341
state: California
city: Norwalk
country: United States
facility: Site Reference ID/Investigator# 21342
state: California
city: Santa Ana
country: United States
facility: Site Reference ID/Investigator# 21321
state: California
city: Tustin
country: United States
facility: Site Reference ID/Investigator# 26242
state: California
city: Arvada
country: United States
facility: Site Reference ID/Investigator# 15283
state: Colorado
city: Aurora
country: United States
facility: Site Reference ID/Investigator# 7085
state: Colorado
city: Denver
country: United States
facility: Site Reference ID/Investigator# 6749
state: Colorado
city: Denver
country: United States
facility: Site Reference ID/Investigator# 7077
state: Colorado
city: Golden
country: United States
facility: Site Reference ID/Investigator# 7092
state: Colorado
city: Littleton
country: United States
facility: Site Reference ID/Investigator# 7722
state: Colorado
city: Littleton
country: United States
facility: Site Reference ID/Investigator# 7721
state: Colorado
city: Aventura
country: United States
facility: Site Reference ID/Investigator# 11925
state: Florida
city: Boynton Beach
country: United States
facility: Site Reference ID/Investigator# 15861
state: Florida
city: Deerfield Beach
country: United States
facility: Site Reference ID/Investigator# 14422
state: Florida
city: Delray Beach
country: United States
facility: Site Reference ID/Investigator# 19281
state: Florida
city: Hollywood
country: United States
facility: Site Reference ID/Investigator# 20881
state: Florida
city: Kissimmee
country: United States
facility: Site Reference ID/Investigator# 20882
state: Florida
city: Melbourne
country: United States
facility: Site Reference ID/Investigator# 19321
state: Florida
city: Melbourne
country: United States
facility: Site Reference ID/Investigator# 21353
state: Florida
city: Melbourne
country: United States
facility: Site Reference ID/Investigator# 18503
state: Florida
city: Vero Beach
country: United States
facility: Site Reference ID/Investigator# 18841
state: Florida
city: Vero Beach
country: United States
facility: Site Reference ID/Investigator# 19961
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 7166
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 6744
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 19301
state: Georgia
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 7051
state: Georgia
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 7109
state: Georgia
city: Dawsonville
country: United States
facility: Site Reference ID/Investigator# 7326
state: Georgia
city: Decatur
country: United States
facility: Site Reference ID/Investigator# 7325
state: Georgia
city: Dunwoody
country: United States
facility: Site Reference ID/Investigator# 7057
state: Georgia
city: Dunwoody
country: United States
facility: Site Reference ID/Investigator# 7101
state: Georgia
city: Roswell
country: United States
facility: Site Reference ID/Investigator# 11324
state: Georgia
city: Roswell
country: United States
facility: Site Reference ID/Investigator# 6741
state: Georgia
city: Suwanee
country: United States
facility: Site Reference ID/Investigator# 7103
state: Georgia
city: Addison
country: United States
facility: Site Reference ID/Investigator# 10761
state: Illinois
city: Aurora
country: United States
facility: Site Reference ID/Investigator# 6748
state: Illinois
city: Aurora
country: United States
facility: Site Reference ID/Investigator# 6742
state: Illinois
city: Belleville
country: United States
facility: Site Reference ID/Investigator# 7128
state: Illinois
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 7069
state: Illinois
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 6849
state: Illinois
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 6867
state: Illinois
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 6751
state: Illinois
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 6847
state: Illinois
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 7049
state: Illinois
city: Gurnee
country: United States
facility: Site Reference ID/Investigator# 7093
state: Illinois
city: Hazel Crest
country: United States
facility: Site Reference ID/Investigator# 6746
state: Illinois
city: Melrose Park
country: United States
facility: Site Reference ID/Investigator# 6743
state: Illinois
city: Naperville
country: United States
facility: Site Reference ID/Investigator# 7090
state: Illinois
city: Oak Brook
country: United States
facility: Site Reference ID/Investigator# 6750
state: Illinois
city: Oak Park
country: United States
facility: Site Reference ID/Investigator# 6788
state: Illinois
city: Vernon Hills
country: United States
facility: Site Reference ID/Investigator# 6927
state: Illinois
city: Erlanger
country: United States
facility: Site Reference ID/Investigator# 7076
state: Kentucky
city: Bloomington
country: United States
facility: Site Reference ID/Investigator# 8103
state: Minnesota
city: Brooklyn Center
country: United States
facility: Site Reference ID/Investigator# 15121
state: Minnesota
city: Edina
country: United States
facility: Site Reference ID/Investigator# 7050
state: Minnesota
city: Edina
country: United States
facility: Site Reference ID/Investigator# 7084
state: Minnesota
city: Saint Louis
country: United States
facility: Site Reference ID/Investigator# 6860
state: Missouri
city: Saint Louis
country: United States
facility: Site Reference ID/Investigator# 13182
state: Missouri
city: Saint Louis
country: United States
facility: Site Reference ID/Investigator# 14423
state: Missouri
city: Saint Louis
country: United States
facility: Site Reference ID/Investigator# 14541
state: Missouri
city: Saint Louis
country: United States
facility: Site Reference ID/Investigator# 6740
state: Missouri
city: Saint Louis
country: United States
facility: Site Reference ID/Investigator# 7053
state: Missouri
city: Saint Peters
country: United States
facility: Site Reference ID/Investigator# 6784
state: Missouri
city: Henderson
country: United States
facility: Site Reference ID/Investigator# 7063
state: Nevada
city: Henderson
country: United States
facility: Site Reference ID/Investigator# 7070
state: Nevada
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 7106
state: Nevada
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 7518
state: Nevada
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 7119
state: Nevada
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 7129
state: Nevada
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 7071
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 7100
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 14321
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 21355
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 7074
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 7065
state: Ohio
city: Dayton
country: United States
facility: Site Reference ID/Investigator# 7075
state: Ohio
city: Kettering
country: United States
facility: Site Reference ID/Investigator# 24802
state: Ohio
city: Mason
country: United States
facility: Site Reference ID/Investigator# 7068
state: Ohio
city: Bellaire
country: United States
facility: Site Reference ID/Investigator# 7104
state: Texas
city: Carrollton
country: United States
facility: Site Reference ID/Investigator# 7060
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 15282
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 6745
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 7083
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 7127
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 7110
state: Texas
city: Deer Park
country: United States
facility: Site Reference ID/Investigator# 21356
state: Texas
city: Fort Worth
country: United States
facility: Site Reference ID/Investigator# 11923
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 7321
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 21354
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 21358
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 26482
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 7079
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 7096
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 7126
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 8186
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 11323
state: Texas
city: Houston
country: United States
facility: Site Reference ID/Investigator# 7130
state: Texas
city: Irving
country: United States
facility: Site Reference ID/Investigator# 11924
state: Texas
city: Irving
country: United States
facility: Site Reference ID/Investigator# 13863
state: Texas
city: McKinney
country: United States
facility: Site Reference ID/Investigator# 7099
state: Texas
city: New Braunfels
country: United States
facility: Site Reference ID/Investigator# 19121
state: Texas
city: Pearland
country: United States
facility: Site Reference ID/Investigator# 26244
state: Texas
city: Plano
country: United States
facility: Site Reference ID/Investigator# 7105
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 7061
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 7320
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 7914
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 7058
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 18402
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 7052
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 7062
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 22947
state: Texas
Study officials:
affiliation: AbbVie
name: Maureen Kelly, MD
role: STUDY_DIRECTOR
References:
citation: Davidson M, Rosenson RS, Maki KC, Nicholls SJ, Ballantyne CM, Setze C, Carlson DM, Stolzenbach J. Study design, rationale, and baseline characteristics: evaluation of fenofibric acid on carotid intima-media thickness in patients with type IIb dyslipidemia with residual risk in addition to atorvastatin therapy (FIRST) trial. Cardiovasc Drugs Ther. 2012 Aug;26(4):349-58. doi: 10.1007/s10557-012-6395-z.