Coronary Artery Disease Clinical Trial
— FIRSTOfficial 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
| Verified date | December 2013 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 682 |
| Est. completion date | September 2012 |
| Est. primary completion date | September 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 45 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Site Reference ID/Investigator# 10761 | Addison | Illinois |
| United States | Site Reference ID/Investigator# 25082 | Anaheim | California |
| United States | Site Reference ID/Investigator# 15283 | Arvada | Colorado |
| United States | Site Reference ID/Investigator# 19301 | Atlanta | Georgia |
| United States | Site Reference ID/Investigator# 7051 | Atlanta | Georgia |
| United States | Site Reference ID/Investigator# 7109 | Atlanta | Georgia |
| United States | Site Reference ID/Investigator# 6742 | Aurora | Illinois |
| United States | Site Reference ID/Investigator# 6748 | Aurora | Illinois |
| United States | Site Reference ID/Investigator# 7085 | Aurora | Colorado |
| United States | Site Reference ID/Investigator# 11925 | Aventura | Florida |
| United States | Site Reference ID/Investigator# 7104 | Bellaire | Texas |
| United States | Site Reference ID/Investigator# 7128 | Belleville | Illinois |
| United States | Site Reference ID/Investigator# 8103 | Bloomington | Minnesota |
| United States | Site Reference ID/Investigator# 15861 | Boynton Beach | Florida |
| United States | Site Reference ID/Investigator# 15121 | Brooklyn Center | Minnesota |
| United States | Site Reference ID/Investigator# 7060 | Carrollton | Texas |
| United States | Site Reference ID/Investigator# 6747 | Chandler | Arizona |
| United States | Site Reference ID/Investigator# 6751 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 6847 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 6849 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 6867 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 7049 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 7069 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 14321 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 21355 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 7065 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 7071 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 7074 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 7100 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 21347 | Corona | California |
| United States | Site Reference ID/Investigator# 15282 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 6745 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 7083 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 7110 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 7127 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 7326 | Dawsonville | Georgia |
| United States | Site Reference ID/Investigator# 7075 | Dayton | Ohio |
| United States | Site Reference ID/Investigator# 7325 | Decatur | Georgia |
| United States | Site Reference ID/Investigator# 21356 | Deer Park | Texas |
| United States | Site Reference ID/Investigator# 14422 | Deerfield Beach | Florida |
| United States | Site Reference ID/Investigator# 19281 | Delray Beach | Florida |
| United States | Site Reference ID/Investigator# 6749 | Denver | Colorado |
| United States | Site Reference ID/Investigator# 7077 | Denver | Colorado |
| United States | Site Reference ID/Investigator# 7057 | Dunwoody | Georgia |
| United States | Site Reference ID/Investigator# 7101 | Dunwoody | Georgia |
| United States | Site Reference ID/Investigator# 7050 | Edina | Minnesota |
| United States | Site Reference ID/Investigator# 7084 | Edina | Minnesota |
| United States | Site Reference ID/Investigator# 7076 | Erlanger | Kentucky |
| United States | Site Reference ID/Investigator# 11923 | Fort Worth | Texas |
| United States | Site Reference ID/Investigator# 21483 | Garden Grove | California |
| United States | Site Reference ID/Investigator# 7089 | Gilbert | Arizona |
| United States | Site Reference ID/Investigator# 7092 | Golden | Colorado |
| United States | Site Reference ID/Investigator# 7093 | Gurnee | Illinois |
| United States | Site Reference ID/Investigator# 6746 | Hazel Crest | Illinois |
| United States | Site Reference ID/Investigator# 7063 | Henderson | Nevada |
| United States | Site Reference ID/Investigator# 7070 | Henderson | Nevada |
| United States | Site Reference ID/Investigator# 20881 | Hollywood | Florida |
| United States | Site Reference ID/Investigator# 11323 | Houston | Texas |
| United States | Site Reference ID/Investigator# 21354 | Houston | Texas |
| United States | Site Reference ID/Investigator# 21358 | Houston | Texas |
| United States | Site Reference ID/Investigator# 26482 | Houston | Texas |
| United States | Site Reference ID/Investigator# 7079 | Houston | Texas |
| United States | Site Reference ID/Investigator# 7096 | Houston | Texas |
| United States | Site Reference ID/Investigator# 7126 | Houston | Texas |
| United States | Site Reference ID/Investigator# 7130 | Houston | Texas |
| United States | Site Reference ID/Investigator# 7321 | Houston | Texas |
| United States | Site Reference ID/Investigator# 8186 | Houston | Texas |
| United States | Site Reference ID/Investigator# 21351 | Huntington Beach | California |
| United States | Site Reference ID/Investigator# 11924 | Irving | Texas |
| United States | Site Reference ID/Investigator# 13863 | Irving | Texas |
| United States | Site Reference ID/Investigator# 24802 | Kettering | Ohio |
| United States | Site Reference ID/Investigator# 20882 | Kissimmee | Florida |
| United States | Site Reference ID/Investigator# 21346 | Laguna Hills | California |
| United States | Site Reference ID/Investigator# 7106 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 7119 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 7129 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 7518 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 7721 | Littleton | Colorado |
| United States | Site Reference ID/Investigator# 7722 | Littleton | Colorado |
| United States | Site Reference ID/Investigator# 21341 | Long Beach | California |
| United States | Site Reference ID/Investigator# 7068 | Mason | Ohio |
| United States | Site Reference ID/Investigator# 7099 | McKinney | Texas |
| United States | Site Reference ID/Investigator# 18503 | Melbourne | Florida |
| United States | Site Reference ID/Investigator# 19321 | Melbourne | Florida |
| United States | Site Reference ID/Investigator# 21353 | Melbourne | Florida |
| United States | Site Reference ID/Investigator# 6743 | Melrose Park | Illinois |
| United States | Site Reference ID/Investigator# 7097 | Mesa | Arizona |
| United States | Site Reference ID/Investigator# 7090 | Naperville | Illinois |
| United States | Site Reference ID/Investigator# 19121 | New Braunfels | Texas |
| United States | Site Reference ID/Investigator# 21342 | Norwalk | California |
| United States | Site Reference ID/Investigator# 6750 | Oak Brook | Illinois |
| United States | Site Reference ID/Investigator# 6788 | Oak Park | Illinois |
| United States | Site Reference ID/Investigator# 26244 | Pearland | Texas |
| United States | Site Reference ID/Investigator# 26394 | Phoenix | Arizona |
| United States | Site Reference ID/Investigator# 7105 | Plano | Texas |
| United States | Site Reference ID/Investigator# 11324 | Roswell | Georgia |
| United States | Site Reference ID/Investigator# 6741 | Roswell | Georgia |
| United States | Site Reference ID/Investigator# 13182 | Saint Louis | Missouri |
| United States | Site Reference ID/Investigator# 14423 | Saint Louis | Missouri |
| United States | Site Reference ID/Investigator# 14541 | Saint Louis | Missouri |
| United States | Site Reference ID/Investigator# 6740 | Saint Louis | Missouri |
| United States | Site Reference ID/Investigator# 6860 | Saint Louis | Missouri |
| United States | Site Reference ID/Investigator# 7053 | Saint Louis | Missouri |
| United States | Site Reference ID/Investigator# 6784 | Saint Peters | Missouri |
| United States | Site Reference ID/Investigator# 18402 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 22947 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 7052 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 7058 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 7061 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 7062 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 7320 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 7914 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 21321 | Santa Ana | California |
| United States | Site Reference ID/Investigator# 6848 | Scottsdale | Arizona |
| United States | Site Reference ID/Investigator# 7103 | Suwanee | Georgia |
| United States | Site Reference ID/Investigator# 7059 | Tempe | Arizona |
| United States | Site Reference ID/Investigator# 7094 | Tempe | Arizona |
| United States | Site Reference ID/Investigator# 7098 | Tempe | Arizona |
| United States | Site Reference ID/Investigator# 26242 | Tustin | California |
| United States | Site Reference ID/Investigator# 6927 | Vernon Hills | Illinois |
| United States | Site Reference ID/Investigator# 18841 | Vero Beach | Florida |
| United States | Site Reference ID/Investigator# 19961 | Vero Beach | Florida |
| United States | Site Reference ID/Investigator# 6744 | West Palm Beach | Florida |
| United States | Site Reference ID/Investigator# 7166 | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) |
United States,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT) | 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 | Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT) | 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 | |
| Secondary | Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT) | 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 | |
| Secondary | Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT) | 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 | |
| Secondary | Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT) | 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 |
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