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
- Conditions
- Coronary Heart DiseaseDyslipidemiaCoronary Artery Disease
- Interventions
- Registration Number
- NCT00616772
- Lead Sponsor
- AbbVie (prior sponsor, Abbott)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 682
- Patients with mixed dyslipidemia
- Qualifying cIMT thickness
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + Atorvastatin Atorvastatin Placebo and atorvastatin (up to 40 mg) once daily for 2 years. ABT-335 + Atorvastatin ABT-335 ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years. ABT-335 + Atorvastatin Atorvastatin ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years. Placebo + Atorvastatin Placebo Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
- Primary Outcome Measures
Name Time Method Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT) 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.
- Secondary Outcome Measures
Name Time Method Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT) 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.
Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT) 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.
Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT) 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.
Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT) 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.
Trial Locations
- Locations (124)
Site Reference ID/Investigator# 7098
🇺🇸Tempe, Arizona, United States
Site Reference ID/Investigator# 20882
🇺🇸Kissimmee, Florida, United States
Site Reference ID/Investigator# 19321
🇺🇸Melbourne, Florida, United States
Site Reference ID/Investigator# 19301
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 7069
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 6849
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 6748
🇺🇸Aurora, Illinois, United States
Site Reference ID/Investigator# 6742
🇺🇸Aurora, Illinois, United States
Site Reference ID/Investigator# 6751
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 6847
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 7083
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 14422
🇺🇸Deerfield Beach, Florida, United States
Site Reference ID/Investigator# 18503
🇺🇸Melbourne, Florida, United States
Site Reference ID/Investigator# 7051
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 7109
🇺🇸Atlanta, Georgia, United States
Site Reference ID/Investigator# 7722
🇺🇸Littleton, Colorado, United States
Site Reference ID/Investigator# 7325
🇺🇸Decatur, Georgia, United States
Site Reference ID/Investigator# 7721
🇺🇸Littleton, Colorado, United States
Site Reference ID/Investigator# 18841
🇺🇸Vero Beach, Florida, United States
Site Reference ID/Investigator# 19281
🇺🇸Delray Beach, Florida, United States
Site Reference ID/Investigator# 20881
🇺🇸Hollywood, Florida, United States
Site Reference ID/Investigator# 15861
🇺🇸Boynton Beach, Florida, United States
Site Reference ID/Investigator# 11925
🇺🇸Aventura, Florida, United States
Site Reference ID/Investigator# 7166
🇺🇸West Palm Beach, Florida, United States
Site Reference ID/Investigator# 6744
🇺🇸West Palm Beach, Florida, United States
Site Reference ID/Investigator# 7057
🇺🇸Dunwoody, Georgia, United States
Site Reference ID/Investigator# 7075
🇺🇸Dayton, Ohio, United States
Site Reference ID/Investigator# 7068
🇺🇸Mason, Ohio, United States
Site Reference ID/Investigator# 26244
🇺🇸Pearland, Texas, United States
Site Reference ID/Investigator# 21356
🇺🇸Deer Park, Texas, United States
Site Reference ID/Investigator# 13182
🇺🇸Saint Louis, Missouri, United States
Site Reference ID/Investigator# 7127
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 7326
🇺🇸Dawsonville, Georgia, United States
Site Reference ID/Investigator# 11324
🇺🇸Roswell, Georgia, United States
Site Reference ID/Investigator# 6741
🇺🇸Roswell, Georgia, United States
Site Reference ID/Investigator# 14423
🇺🇸Saint Louis, Missouri, United States
Site Reference ID/Investigator# 7053
🇺🇸Saint Louis, Missouri, United States
Site Reference ID/Investigator# 7110
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 14541
🇺🇸Saint Louis, Missouri, United States
Site Reference ID/Investigator# 7090
🇺🇸Naperville, Illinois, United States
Site Reference ID/Investigator# 7050
🇺🇸Edina, Minnesota, United States
Site Reference ID/Investigator# 6750
🇺🇸Oak Brook, Illinois, United States
Site Reference ID/Investigator# 15121
🇺🇸Brooklyn Center, Minnesota, United States
Site Reference ID/Investigator# 7104
🇺🇸Bellaire, Texas, United States
Site Reference ID/Investigator# 6860
🇺🇸Saint Louis, Missouri, United States
Site Reference ID/Investigator# 7084
🇺🇸Edina, Minnesota, United States
Site Reference ID/Investigator# 7049
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 6745
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 7093
🇺🇸Gurnee, Illinois, United States
Site Reference ID/Investigator# 7060
🇺🇸Carrollton, Texas, United States
Site Reference ID/Investigator# 6740
🇺🇸Saint Louis, Missouri, United States
Site Reference ID/Investigator# 15282
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 6784
🇺🇸Saint Peters, Missouri, United States
Site Reference ID/Investigator# 14321
🇺🇸Cincinnati, Ohio, United States
Site Reference ID/Investigator# 21355
🇺🇸Cincinnati, Ohio, United States
Site Reference ID/Investigator# 7106
🇺🇸Las Vegas, Nevada, United States
Site Reference ID/Investigator# 7100
🇺🇸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# 7065
🇺🇸Cincinnati, Ohio, United States
Site Reference ID/Investigator# 7321
🇺🇸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# 7096
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 8186
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 11323
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 7130
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 7092
🇺🇸Golden, Colorado, United States
Site Reference ID/Investigator# 26394
🇺🇸Phoenix, Arizona, United States
Site Reference ID/Investigator# 7914
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 7058
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 22947
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 7061
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 7320
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 7062
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 6749
🇺🇸Denver, Colorado, United States
Site Reference ID/Investigator# 7077
🇺🇸Denver, Colorado, United States
Site Reference ID/Investigator# 25082
🇺🇸Anaheim, California, United States
Site Reference ID/Investigator# 21347
🇺🇸Corona, California, United States
Site Reference ID/Investigator# 21483
🇺🇸Garden Grove, California, United States
Site Reference ID/Investigator# 21346
🇺🇸Laguna Hills, California, United States
Site Reference ID/Investigator# 21351
🇺🇸Huntington Beach, California, United States
Site Reference ID/Investigator# 21341
🇺🇸Long Beach, California, United States
Site Reference ID/Investigator# 21342
🇺🇸Norwalk, California, United States
Site Reference ID/Investigator# 21321
🇺🇸Santa Ana, California, United States
Site Reference ID/Investigator# 26242
🇺🇸Tustin, California, United States
Site Reference ID/Investigator# 15283
🇺🇸Arvada, Colorado, United States
Site Reference ID/Investigator# 6927
🇺🇸Vernon Hills, Illinois, United States
Site Reference ID/Investigator# 7076
🇺🇸Erlanger, Kentucky, United States
Site Reference ID/Investigator# 8103
🇺🇸Bloomington, Minnesota, United States
Site Reference ID/Investigator# 24802
🇺🇸Kettering, Ohio, United States
Site Reference ID/Investigator# 18402
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 6747
🇺🇸Chandler, Arizona, United States
Site Reference ID/Investigator# 7089
🇺🇸Gilbert, Arizona, United States
Site Reference ID/Investigator# 7059
🇺🇸Tempe, Arizona, United States
Site Reference ID/Investigator# 6848
🇺🇸Scottsdale, Arizona, United States
Site Reference ID/Investigator# 7094
🇺🇸Tempe, Arizona, United States
Site Reference ID/Investigator# 7097
🇺🇸Mesa, Arizona, United States
Site Reference ID/Investigator# 7070
🇺🇸Henderson, Nevada, United States
Site Reference ID/Investigator# 7063
🇺🇸Henderson, Nevada, United States
Site Reference ID/Investigator# 7518
🇺🇸Las Vegas, Nevada, United States
Site Reference ID/Investigator# 7129
🇺🇸Las Vegas, Nevada, United States
Site Reference ID/Investigator# 7119
🇺🇸Las Vegas, Nevada, United States
Site Reference ID/Investigator# 21353
🇺🇸Melbourne, Florida, United States
Site Reference ID/Investigator# 7101
🇺🇸Dunwoody, Georgia, United States
Site Reference ID/Investigator# 7103
🇺🇸Suwanee, Georgia, United States
Site Reference ID/Investigator# 10761
🇺🇸Addison, Illinois, United States
Site Reference ID/Investigator# 7128
🇺🇸Belleville, Illinois, United States
Site Reference ID/Investigator# 6743
🇺🇸Melrose Park, Illinois, United States
Site Reference ID/Investigator# 6746
🇺🇸Hazel Crest, Illinois, United States
Site Reference ID/Investigator# 6788
🇺🇸Oak Park, Illinois, United States
Site Reference ID/Investigator# 7079
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 7126
🇺🇸Houston, Texas, United States
Site Reference ID/Investigator# 11923
🇺🇸Fort Worth, Texas, United States
Site Reference ID/Investigator# 11924
🇺🇸Irving, Texas, United States
Site Reference ID/Investigator# 7105
🇺🇸Plano, Texas, United States
Site Reference ID/Investigator# 13863
🇺🇸Irving, Texas, United States
Site Reference ID/Investigator# 7099
🇺🇸McKinney, Texas, United States
Site Reference ID/Investigator# 19121
🇺🇸New Braunfels, Texas, United States
Site Reference ID/Investigator# 7052
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 6867
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 19961
🇺🇸Vero Beach, Florida, United States
Site Reference ID/Investigator# 7085
🇺🇸Aurora, Colorado, United States