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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-335 + Atorvastatin | Experimental | ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years. |
|
| Placebo + Atorvastatin | Placebo Comparator | Placebo and atorvastatin (up to 40 mg) once daily for 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-335 | Drug | Capsule |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maureen Kelly, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 6747 | Chandler | Arizona | 85225 | United States | ||
| Site Reference ID/Investigator# 7089 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22622962 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABT-335 + Atorvastatin | ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years. |
| FG001 | Placebo + Atorvastatin | Placebo and atorvastatin (up to 40 mg) once daily for 2 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Capsule |
|
| Atorvastatin | Other | Capsule |
|
| 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) | 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) | 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) | 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 |
| 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 |
| Site Reference ID/Investigator# 7077 | Denver | Colorado | 80246 | United States |
| Site Reference ID/Investigator# 7092 | Golden | Colorado | 80401 | United States |
| Site Reference ID/Investigator# 7722 | Littleton | Colorado | 80122 | United States |
| Site Reference ID/Investigator# 7721 | Littleton | Colorado | 80127 | United States |
| Site Reference ID/Investigator# 11925 | Aventura | Florida | 33180 | United States |
| 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 |
| Site Reference ID/Investigator# 20881 | Hollywood | Florida | 33021 | United States |
| Site Reference ID/Investigator# 20882 | Kissimmee | Florida | 34741 | United States |
| Site Reference ID/Investigator# 19321 | Melbourne | Florida | 32901 | United States |
| Site Reference ID/Investigator# 21353 | Melbourne | Florida | 32901 | United States |
| Site Reference ID/Investigator# 18503 | Melbourne | Florida | 32935 | United States |
| Site Reference ID/Investigator# 18841 | Vero Beach | Florida | 32960 | United States |
| Site Reference ID/Investigator# 19961 | Vero Beach | Florida | 32960 | United States |
| Site Reference ID/Investigator# 7166 | West Palm Beach | Florida | 33401 | United States |
| Site Reference ID/Investigator# 6744 | West Palm Beach | Florida | 33407 | 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 |
| Site Reference ID/Investigator# 7103 | Suwanee | Georgia | 30024 | United States |
| Site Reference ID/Investigator# 10761 | Addison | Illinois | 60101 | United States |
| Site Reference ID/Investigator# 6748 | Aurora | Illinois | 60504 | United States |
| Site Reference ID/Investigator# 6742 | Aurora | Illinois | 60506 | United States |
| Site Reference ID/Investigator# 7128 | Belleville | Illinois | 62220-1986 | United States |
| Site Reference ID/Investigator# 7069 | Chicago | Illinois | 60607 | United States |
| Site Reference ID/Investigator# 6849 | Chicago | Illinois | 60612-9985 | United States |
| Site Reference ID/Investigator# 6867 | Chicago | Illinois | 60612 | United States |
| Site Reference ID/Investigator# 6751 | Chicago | Illinois | 60616 | United States |
| Site Reference ID/Investigator# 6847 | Chicago | Illinois | 60631 | United States |
| Site Reference ID/Investigator# 7049 | Chicago | Illinois | 60654 | United States |
| Site Reference ID/Investigator# 7093 | Gurnee | Illinois | 60031 | United States |
| Site Reference ID/Investigator# 6746 | Hazel Crest | Illinois | 60429 | United States |
| 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# 6784 | City of Saint Peters | Missouri | 63376 | United States |
| Site Reference ID/Investigator# 6860 | St Louis | Missouri | 63110 | 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 |
| Site Reference ID/Investigator# 7053 | St Louis | Missouri | 63141 | 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# 7518 | Las Vegas | Nevada | 89106 | United States |
| Site Reference ID/Investigator# 7119 | Las Vegas | Nevada | 89146 | United States |
| Site Reference ID/Investigator# 7129 | Las Vegas | Nevada | 89148 | United States |
| Site Reference ID/Investigator# 7071 | Cincinnati | Ohio | 45212 | United States |
| Site Reference ID/Investigator# 7100 | Cincinnati | Ohio | 45219 | United States |
| Site Reference ID/Investigator# 14321 | Cincinnati | Ohio | 45224 | United States |
| Site Reference ID/Investigator# 21355 | Cincinnati | Ohio | 45245 | United States |
| Site Reference ID/Investigator# 7074 | Cincinnati | Ohio | 45246 | United States |
| Site Reference ID/Investigator# 7065 | Cincinnati | Ohio | 45249 | 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# 7127 | Dallas | Texas | 75231 | United States |
| Site Reference ID/Investigator# 7110 | Dallas | Texas | 75251 | 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# 7321 | Houston | Texas | 77002 | 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# 8186 | Houston | Texas | 77036 | United States |
| Site Reference ID/Investigator# 11323 | Houston | Texas | 77074 | United States |
| Site Reference ID/Investigator# 7130 | Houston | Texas | 77081 | 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# 7061 | San Antonio | Texas | 78205 | United States |
| Site Reference ID/Investigator# 7320 | San Antonio | Texas | 78215 | United States |
| Site Reference ID/Investigator# 7914 | San Antonio | Texas | 78218 | United States |
| Site Reference ID/Investigator# 7058 | San Antonio | Texas | 78229-4801 | United States |
| Site Reference ID/Investigator# 18402 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 7052 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 7062 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 22947 | San Antonio | Texas | 78238-1434 | United States |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
All randomized participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | ABT-335 + Atorvastatin | ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years. |
| BG001 | Placebo + Atorvastatin | Placebo and atorvastatin (up to 40 mg) once daily for 2 years. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Low-density Lipoprotein Cholesterol (LDL-C) | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Triglycerides | Mean | Standard Deviation | mg/dL |
| |||||||||||||||
| Posterior-wall Carotid Intima-media (cIMT) Thickness | Mean | Standard Deviation | mm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized participants who had both a baseline value and at least 1 postbaseline value for that parameter. | Posted | Mean | Standard Error | mm/year | 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. | All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter. | Posted | Mean | Standard Error | mm/year | 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. | All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years. | Posted | Mean | Standard Error | mm/year | 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. | All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 3 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 3 or more segments matched the segments at baseline and at 2 years. | Posted | Mean | Standard Error | mm/year | 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. | All randomized subjects who had both a baseline value and at least 1 postbaseline value for that parameter, as well as 6 or more matching segments at baseline and the 2-year visit. Observations at the interim visits were included only if 6 or more segments matched the segments at baseline and at 2 years. | Posted | Mean | Standard Error | mm/year | Baseline, 6 months, 12 months, 18 months, and 24 months |
|
AEs that occurred on or after the first dose of study drug through 30 days after last dose of study drug (up to 25 months).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABT-335 + Atorvastatin | ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years. | 58 | 337 | 235 | 337 | ||
| EG001 | Placebo + Atorvastatin | Placebo and atorvastatin (up to 40 mg) once daily for 2 years. | 66 | 339 | 241 | 339 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COAGULOPATHY | Blood and lymphatic system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ACUTE CORONARY SYNDROME | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ANGINA UNSTABLE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ATRIOVENTRICULAR BLOCK COMPLETE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CARDIAC FAILURE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| DIASTOLIC DYSFUNCTION | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| EXTRASYSTOLES | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ISCHAEMIC CARDIOMYOPATHY | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| TACHYARRHYTHMIA | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| WOLFF-PARKINSON-WHITE SYNDROME | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| VESTIBULAR DISORDER | Ear and labyrinth disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| RETINAL HAEMORRHAGE | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ABDOMINAL HERNIA | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| COLITIS ISCHAEMIC | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| DIVERTICULUM INTESTINAL HAEMORRHAGIC | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| MEDICAL DEVICE COMPLICATION | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ABSCESS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| ARTHRITIS INFECTIVE | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| CLOSTRIDIAL INFECTION | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| PYELONEPHRITIS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| SIALOADENITIS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| JAW FRACTURE | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| MENISCUS LESION | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| MULTIPLE INJURIES | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| MUSCLE RUPTURE | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CERVICAL SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| JOINT INSTABILITY | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| BENIGN PANCREATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| BRAIN NEOPLASM BENIGN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| BREAST CANCER IN SITU | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| CARCINOID TUMOUR PULMONARY | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| ENDOMETRIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| LARGE CELL CARCINOMA OF THE RESPIRATORY TRACT STAGE UNSPECIFIED | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| METASTATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| NEUROENDOCRINE CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| NON-SMALL CELL LUNG CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| OESOPHAGEAL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| OVARIAN CANCER STAGE III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| PROSTATE CANCER STAGE II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| SARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 15.0 | Systematic Assessment |
| |
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CERVICOBRACHIAL SYNDROME | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| COMPLICATED MIGRAINE | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| DIABETIC NEUROPATHY | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| METABOLIC ENCEPHALOPATHY | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| RUPTURED CEREBRAL ANEURYSM | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| TRANSIENT ISCHAEMIC ATTACK | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| UNRESPONSIVE TO STIMULI | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| GENERALISED ANXIETY DISORDER | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| SUICIDAL IDEATION | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| NEPHROTIC SYNDROME | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| BENIGN PROSTATIC HYPERPLASIA | Reproductive system and breast disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| HYPOXIA | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| NASAL POLYPS | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| PULMONARY MASS | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ANGIOEDEMA | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ANEURYSM | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| AORTIC ANEURYSM | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| AORTIC STENOSIS | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| FEMORAL ARTERY OCCLUSION | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| PERIPHERAL VASCULAR DISORDER | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| SUBCLAVIAN ARTERY ANEURYSM | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| BLOOD CREATININE INCREASED | Investigations | MedDRA version 15.0 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA version 15.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533234 | 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid |
| C006012 | fenofibric acid |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
Not provided
Not provided
| Male |
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| Units | Counts |
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| Participants |
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