Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to test the effect and safety of three different doses of ABT-143 compared to simvastatin in subjects with elevated levels of low density lipoprotein cholesterol ("bad cholesterol") and triglycerides.
There are 4 treatment groups in the study: ABT-143 capsules 20/135 mg, ABT-143 capsules 10/135 mg, ABT-143 5/135 mg, and simvastatin capsules 40 mg. The primary outcome measure only compares 2 of these groups: ABT-143 capsules 20/135 mg and the simvastatin capsules 40 mg groups, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure . Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 10/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 10/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. Secondary outcome measure (mean percent change in LDL-C comparing ABT-143 capsules 5/135 mg to simvastatin capsules 40 mg) only compares these 2 groups: ABT-143 capsules 5/135 mg and simvastatin capsules 40 mg, therefore there are only results for these 2 groups and not all 4 groups for this outcome measure. For the other pre-specified outcome measures, median percent change in triglycerides from baseline to the final visit and mean percent change in HDL-C from baseline to the final visit for the full analysis sets, all 3 ABT-143 capsules 20/135 mg, 10/135 mg, and 5/135 mg groups were compared to the simvastatin capsules 40 mg group, therefore there are results for all 4 treatment groups for these outcome measures.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - ABT-143 capsules 5/135 mg | Experimental | ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks |
|
| B - ABT-143 capsules 10/135 mg | Experimental | ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks |
|
| C - ABT-143 capsules 20/135 mg | Experimental | ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks |
|
| D - Simvastatin capsules 40 mg | Active Comparator | Simvastatin capsules 40 mg daily for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-143 | Drug | Once daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups: ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set. | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set. |
| Measure | Description | Time Frame |
|---|---|---|
| Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set) | The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set. | Baseline to 8 weeks |
Inclusion Criteria
Participants with hypercholesterolemia and hypertriglyceridemia.
Participants had the following fasting lipid results following a greater than or equal to 12 hour fasting period (measured at the Screening Visit(s)):
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Torbjörn Lundström, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 12654 | Birmingham | Alabama | 35235 | United States | ||
| Site Reference ID/Investigator# 12634 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20524719 | Derived | Roth EM, McKenney JM, Kelly MT, Setze CM, Carlson DM, Gold A, Stolzenbach JC, Williams LA, Jones PH. Efficacy and safety of rosuvastatin and fenofibric acid combination therapy versus simvastatin monotherapy in patients with hypercholesterolemia and hypertriglyceridemia: a randomized, double-blind study. Am J Cardiovasc Drugs. 2010;10(3):175-86. doi: 10.2165/11533430-000000000-00000. |
Not provided
Not provided
Not provided
474 subjects were randomized and treated at 111 sites in the United States between 29 December 2008 and 14 May 2009.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Simvastatin Capsules 40 mg | Simvastatin capsules 40 mg once daily for 8 weeks |
| FG001 | ABT-143 Capsules 5/135 mg | ABT-143 capsules 5/135 mg once daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| simvastatin | Drug | Once daily for 8 weeks simvastatin capsules 40 mg |
|
| Baseline to 8 weeks |
| Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set. | Baseline to 8 weeks |
| Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set) | The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set. | Baseline to 8 weeks |
| Columbiana |
| Alabama |
| 35051 |
| United States |
| Site Reference ID/Investigator# 12559 | Huntsville | Alabama | 35801 | United States |
| Site Reference ID/Investigator# 12499 | Ozark | Alabama | 36360 | United States |
| Site Reference ID/Investigator# 12673 | Chandler | Arizona | 85225 | United States |
| Site Reference ID/Investigator# 17282 | Scottsdale | Arizona | 85251 | United States |
| Site Reference ID/Investigator# 12657 | Little Rock | Arkansas | 72204 | United States |
| Site Reference ID/Investigator# 12489 | Anaheim | California | 92804 | United States |
| Site Reference ID/Investigator# 12495 | Carmichael | California | 95608 | United States |
| Site Reference ID/Investigator# 12467 | Chula Vista | California | 91911 | United States |
| Site Reference ID/Investigator# 12498 | Long Beach | California | 90806 | United States |
| Site Reference ID/Investigator# 12602 | Los Angeles | California | 90057 | United States |
| Site Reference ID/Investigator# 12510 | Norwalk | California | 90650 | United States |
| Site Reference ID/Investigator# 12550 | Palm Desert | California | 92260 | United States |
| Site Reference ID/Investigator# 16503 | Roseville | California | 95661 | United States |
| Site Reference ID/Investigator# 12678 | Sacramento | California | 95825 | United States |
| Site Reference ID/Investigator# 14241 | Sacramento | California | 95825 | United States |
| Site Reference ID/Investigator# 12473 | San Diego | California | 92123 | United States |
| Site Reference ID/Investigator# 12497 | Walnut Creek | California | 94598 | United States |
| Site Reference ID/Investigator# 12680 | West Hills | California | 91307 | United States |
| Site Reference ID/Investigator# 12461 | Colorado Springs | Colorado | 80904 | United States |
| Site Reference ID/Investigator# 12600 | Colorado Springs | Colorado | 80909 | United States |
| Site Reference ID/Investigator# 12679 | Waterbury | Connecticut | 06708 | United States |
| Site Reference ID/Investigator# 12598 | Clearwater | Florida | 33756 | United States |
| Site Reference ID/Investigator# 15542 | Coral Gables | Florida | 33134 | United States |
| Site Reference ID/Investigator# 12477 | Daytona Beach | Florida | 32117 | United States |
| Site Reference ID/Investigator# 12668 | Delray Beach | Florida | 33484 | United States |
| Site Reference ID/Investigator# 15483 | Fort Lauderdale | Florida | 33306 | United States |
| Site Reference ID/Investigator# 12645 | Fort Myers | Florida | 33907 | United States |
| Site Reference ID/Investigator# 12672 | Hollywood | Florida | 33023 | United States |
| Site Reference ID/Investigator# 17504 | Jacksonville | Florida | 32205 | United States |
| Site Reference ID/Investigator# 12781 | Jacksonville | Florida | 32259 | United States |
| Site Reference ID/Investigator# 12665 | Jupiter | Florida | 33458-7200 | United States |
| Site Reference ID/Investigator# 12682 | Longwood | Florida | 32779 | United States |
| Site Reference ID/Investigator# 15486 | Melbourne | Florida | 32935 | United States |
| Site Reference ID/Investigator# 12502 | New Port Richey | Florida | 34652 | United States |
| Site Reference ID/Investigator# 12647 | Ocala | Florida | 34471 | United States |
| Site Reference ID/Investigator# 12520 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 12687 | Ormond Beach | Florida | 32174 | United States |
| Site Reference ID/Investigator# 12583 | Sarasota | Florida | 34233 | United States |
| Site Reference ID/Investigator# 12652 | Tampa | Florida | 33607 | United States |
| Site Reference ID/Investigator# 12557 | West Palm Beach | Florida | 33401 | United States |
| Site Reference ID/Investigator# 12621 | Winter Haven | Florida | 33880 | United States |
| Site Reference ID/Investigator# 16505 | Winter Park | Florida | 32792 | United States |
| Site Reference ID/Investigator# 12675 | Augusta | Georgia | 30909 | United States |
| Site Reference ID/Investigator# 12620 | Dunwoody | Georgia | 30338 | United States |
| Site Reference ID/Investigator# 12653 | Roswell | Georgia | 30076 | United States |
| Site Reference ID/Investigator# 12555 | Suwanee | Georgia | 30024 | United States |
| Site Reference ID/Investigator# 12787 | Woodstock | Georgia | 30189 | United States |
| Site Reference ID/Investigator# 12514 | Chicago | Illinois | 60654 | United States |
| Site Reference ID/Investigator# 12487 | Peoria | Illinois | 61602 | United States |
| Site Reference ID/Investigator# 12627 | Peoria | Illinois | 61614 | United States |
| Site Reference ID/Investigator# 12529 | Evansville | Indiana | 47714 | United States |
| Site Reference ID/Investigator# 12688 | Indianapolis | Indiana | 46260 | United States |
| Site Reference ID/Investigator# 15485 | South Bend | Indiana | 46601 | United States |
| Site Reference ID/Investigator# 12676 | Arkansas City | Kansas | 67005 | United States |
| Site Reference ID/Investigator# 12597 | Wichita | Kansas | 67203 | United States |
| Site Reference ID/Investigator# 12472 | Louisville | Kentucky | 40213 | United States |
| Site Reference ID/Investigator# 12658 | Mount Sterling | Kentucky | 40353 | United States |
| Site Reference ID/Investigator# 12586 | Baltimore | Maryland | 21209 | United States |
| Site Reference ID/Investigator# 12480 | Bethesda | Maryland | 20817 | United States |
| Site Reference ID/Investigator# 12638 | Oxon Hill | Maryland | 20745 | United States |
| Site Reference ID/Investigator# 12513 | Springfield | Massachusetts | 01103 | United States |
| Site Reference ID/Investigator# 12663 | Kalamazoo | Michigan | 49009 | United States |
| Site Reference ID/Investigator# 12609 | Brooklyn Center | Minnesota | 55430 | United States |
| Site Reference ID/Investigator# 16622 | Edina | Minnesota | 55435 | United States |
| Site Reference ID/Investigator# 12625 | Jackson | Mississippi | 39202 | United States |
| Site Reference ID/Investigator# 12560 | Olive Branch | Mississippi | 38654 | United States |
| Site Reference ID/Investigator# 12534 | City of Saint Peters | Missouri | 63376 | United States |
| Site Reference ID/Investigator# 12677 | St Louis | Missouri | 63141 | United States |
| Site Reference ID/Investigator# 12592 | Billings | Montana | 59101 | United States |
| Site Reference ID/Investigator# 12655 | Omaha | Nebraska | 68131 | United States |
| Site Reference ID/Investigator# 12587 | Las Vegas | Nevada | 89123 | United States |
| Site Reference ID/Investigator# 12554 | Berlin | New Jersey | 08009 | United States |
| Site Reference ID/Investigator# 12637 | Elizabeth | New Jersey | 07202 | United States |
| Site Reference ID/Investigator# 12463 | Hillsborough | New Jersey | 08844 | United States |
| Site Reference ID/Investigator# 12660 | Trenton | New Jersey | 08611 | United States |
| Site Reference ID/Investigator# 12506 | Albuquerque | New Mexico | 87108 | United States |
| Site Reference ID/Investigator# 12539 | Johnson City | New York | 13790 | United States |
| Site Reference ID/Investigator# 12631 | Syracuse | New York | 13202 | United States |
| Site Reference ID/Investigator# 17503 | Cary | North Carolina | 27518 | United States |
| Site Reference ID/Investigator# 12650 | Charlotte | North Carolina | 28209 | United States |
| Site Reference ID/Investigator# 12504 | Charlotte | North Carolina | 28211 | United States |
| Site Reference ID/Investigator# 12558 | Charlotte | North Carolina | 28262 | United States |
| Site Reference ID/Investigator# 12671 | Charlotte | North Carolina | 28277 | United States |
| Site Reference ID/Investigator# 12527 | Hickory | North Carolina | 28601 | United States |
| Site Reference ID/Investigator# 12608 | Morehead City | North Carolina | 28557 | United States |
| Site Reference ID/Investigator# 12535 | Salisbury | North Carolina | 28144 | United States |
| Site Reference ID/Investigator# 12656 | Statesville | North Carolina | 28677 | United States |
| Site Reference ID/Investigator# 17641 | Wilmington | North Carolina | 28401 | United States |
| Site Reference ID/Investigator# 12606 | Winston-Salem | North Carolina | 27103 | United States |
| Site Reference ID/Investigator# 12614 | Akron | Ohio | 44311 | United States |
| Site Reference ID/Investigator# 12662 | Cincinnati | Ohio | 45219 | United States |
| Site Reference ID/Investigator# 12545 | Cincinnati | Ohio | 45242 | United States |
| Site Reference ID/Investigator# 12640 | Kettering | Ohio | 45429 | United States |
| Site Reference ID/Investigator# 12786 | Mason | Ohio | 45040 | United States |
| Site Reference ID/Investigator# 12630 | Warren | Ohio | 44483 | United States |
| Site Reference ID/Investigator# 12551 | Oklahoma City | Oklahoma | 73112 | United States |
| Site Reference ID/Investigator# 12611 | Tulsa | Oklahoma | 74136 | United States |
| Site Reference ID/Investigator# 12585 | Medford | Oregon | 97504 | United States |
| Site Reference ID/Investigator# 12610 | Beaver | Pennsylvania | 15009 | United States |
| Site Reference ID/Investigator# 12589 | Duncansville | Pennsylvania | 16635 | United States |
| Site Reference ID/Investigator# 12607 | Harleysville | Pennsylvania | 19438-2513 | United States |
| Site Reference ID/Investigator# 12641 | Jersey Shore | Pennsylvania | 17740 | United States |
| Site Reference ID/Investigator# 12507 | Melrose Park | Pennsylvania | 19027 | United States |
| Site Reference ID/Investigator# 12624 | Perkasie | Pennsylvania | 18944 | United States |
| Site Reference ID/Investigator# 12669 | Philadelphia | Pennsylvania | 19114 | United States |
| Site Reference ID/Investigator# 12788 | Philadelphia | Pennsylvania | 19152 | United States |
| Site Reference ID/Investigator# 12525 | Pittsburgh | Pennsylvania | 15216 | United States |
| Site Reference ID/Investigator# 12601 | Tipton | Pennsylvania | 16684 | United States |
| Site Reference ID/Investigator# 12686 | Warminster | Pennsylvania | 18974 | United States |
| Site Reference ID/Investigator# 12623 | Mt. Pleasant | South Carolina | 29464 | United States |
| Site Reference ID/Investigator# 12681 | Mt. Pleasant | South Carolina | 29464 | United States |
| Site Reference ID/Investigator# 12485 | Simpsonville | South Carolina | 29681 | United States |
| Site Reference ID/Investigator# 12639 | Summerville | South Carolina | 29485 | United States |
| Site Reference ID/Investigator# 15642 | Germantown | Tennessee | 38138 | United States |
| Site Reference ID/Investigator# 12643 | Jackson | Tennessee | 38305 | United States |
| Site Reference ID/Investigator# 12470 | Dallas | Texas | 75230 | United States |
| Site Reference ID/Investigator# 16081 | Dallas | Texas | 75234 | United States |
| Site Reference ID/Investigator# 12492 | Dallas | Texas | 75251 | United States |
| Site Reference ID/Investigator# 12464 | Fort Worth | Texas | 76104 | United States |
| Site Reference ID/Investigator# 12646 | San Antonio | Texas | 78205 | United States |
| Site Reference ID/Investigator# 16601 | San Antonio | Texas | 78215 | United States |
| Site Reference ID/Investigator# 12540 | San Antonio | Texas | 78224 | United States |
| Site Reference ID/Investigator# 12466 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 12622 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 12538 | Norfolk | Virginia | 23502-9921 | United States |
| Site Reference ID/Investigator# 12616 | Richmond | Virginia | 23294 | United States |
| Site Reference ID/Investigator# 12476 | Madison | Wisconsin | 53719 | United States |
| FG002 | ABT-143 Capsules 10/135 mg | ABT-143 capsules 10/135 mg once daily for 8 weeks |
| FG003 | ABT-143 Capsules 20/135 mg | ABT-143 capsules 20/135 mg once daily for 8 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Simvastatin Capsules 40 mg | Simvastatin capsules 40 mg once daily for 8 weeks |
| BG001 | ABT-143 Capsules 5/135 mg | ABT-143 capsules 5/135 mg once daily for 8 weeks |
| BG002 | ABT-143 Capsules 10/135 mg | ABT-143 capsules 10/135 mg once daily for 8 weeks |
| BG003 | ABT-143 Capsules 20/135 mg | ABT-143 capsules 20/135 mg once daily for 8 weeks |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following two treatment groups: ABT-143 capsules 20/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set. | Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 8 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 10/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 10/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set. | Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 8 weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C), With ABT-143 Capsules 5/135 Milligrams Versus Simvastatin Capsules 40 Milligrams (Full Analysis Set) | The mean percent change from Baseline to the Final Visit in low-density lipoprotein cholesterol, comparing the following treatment groups, ABT-143 capsules 5/135 milligrams versus simvastatin capsules 40 milligrams for the full analysis set. | Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for LDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 8 weeks |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set) | The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for median percent change in triglycerides from Baseline to the Final Visit for the full analysis set. | Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Median | Inter-Quartile Range | percent change | Baseline to 8 weeks |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set) | The ABT-143 capsules 20/135 milligram, ABT-143 capsules 10/135 milligram, and ABT-143 capsules 5/135 milligram groups were compared to the simvastatin capsules 40 milligram group for mean percent change in high-density lipoprotein cholesterol from Baseline to the Final Visit for the full analysis set. | Full Analysis Set was used and defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 8 weeks |
|
18 weeks
Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Serious adverse events were collected from the time the participant signed the informed consent until 30 calendar days following discontinuation of study drug.
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 | Simvastatin Capsules 40 mg | Simvastatin capsules 40 mg once daily for 8 weeks | 0 | 119 | 10 | 119 | ||
| EG001 | ABT-143 Capsules 5/135 mg | ABT-143 capsules 5/135 mg once daily for 8 weeks | 4 | 118 | 13 | 118 | ||
| EG002 | ABT-143 Capsules 10/135 mg | ABT-143 capsules 10/135 mg once daily for 8 weeks | 1 | 119 | 6 | 119 | ||
| EG003 | ABT-143 Capsules 20/135 mg | ABT-143 capsules 20/135 mg once daily for 8 weeks | 3 | 118 | 17 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 11.1 |
| ||
| Myocardial Infarction | Cardiac disorders | MedDRA 11.1 |
| ||
| Tachycardia | Cardiac disorders | MedDRA 11.1 |
| ||
| Abdominal Hernia | Gastrointestinal disorders | MedDRA 11.1 |
| ||
| Chest Pain | General disorders | MedDRA 11.1 |
| ||
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA 11.1 |
| ||
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 |
| ||
| Syncope | Nervous system disorders | MedDRA 11.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.1 |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 |
| ||
| Headache | Nervous system disorders | MedDRA 11.1 |
|
Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 1509 645 895 | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006949 | Hyperlipidemias |
Not provided
Not provided
| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
|
| ABT-143 Capsules 20/135 mg |
ABT-143 capsules 20/135 mg once daily for 8 weeks |
|
|
| ABT-143 Capsules 20/135 mg |
ABT-143 capsules 20/135 mg once daily for 8 weeks |
|
|