Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia Clinical Trial
Official title:
An 8-Week, Multicenter, Randomized, Double-blind, Four-arm, Parallel-group Study Comparing the Safety and Efficacy of ABT-143 to Simvastatin in Subjects With Hypercholesterolemia
| Verified date | September 2012 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 474 |
| Est. completion date | June 2009 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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)): - Triglycerides level greater than or equal to 150 milligrams/deciliter (mg/dL) and less than 400 milligrams/deciliter, and - Low-density lipoprotein cholesterol greater than or equal to 160 milligrams/deciliter and less than or equal to 240 milligrams/deciliter. Exclusion Criteria - Participants with certain chronic or unstable medical conditions. - Participants receiving coumarin anticoagulants, systemic cyclosporins, or certain other medications. - Pregnant or lactating women, or women intending to become pregnant. - Participants with diabetes mellitus that is poorly controlled. - Participant was of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Site Reference ID/Investigator# 12614 | Akron | Ohio |
| United States | Site Reference ID/Investigator# 12506 | Albuquerque | New Mexico |
| United States | Site Reference ID/Investigator# 12489 | Anaheim | California |
| United States | Site Reference ID/Investigator# 12676 | Arkansas City | Kansas |
| United States | Site Reference ID/Investigator# 12675 | Augusta | Georgia |
| United States | Site Reference ID/Investigator# 12586 | Baltimore | Maryland |
| United States | Site Reference ID/Investigator# 12610 | Beaver | Pennsylvania |
| United States | Site Reference ID/Investigator# 12554 | Berlin | New Jersey |
| United States | Site Reference ID/Investigator# 12480 | Bethesda | Maryland |
| United States | Site Reference ID/Investigator# 12592 | Billings | Montana |
| United States | Site Reference ID/Investigator# 12654 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 12609 | Brooklyn Center | Minnesota |
| United States | Site Reference ID/Investigator# 12495 | Carmichael | California |
| United States | Site Reference ID/Investigator# 17503 | Cary | North Carolina |
| United States | Site Reference ID/Investigator# 12673 | Chandler | Arizona |
| United States | Site Reference ID/Investigator# 12504 | Charlotte | North Carolina |
| United States | Site Reference ID/Investigator# 12558 | Charlotte | North Carolina |
| United States | Site Reference ID/Investigator# 12650 | Charlotte | North Carolina |
| United States | Site Reference ID/Investigator# 12671 | Charlotte | North Carolina |
| United States | Site Reference ID/Investigator# 12514 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 12467 | Chula Vista | California |
| United States | Site Reference ID/Investigator# 12545 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 12662 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 12598 | Clearwater | Florida |
| United States | Site Reference ID/Investigator# 12461 | Colorado Springs | Colorado |
| United States | Site Reference ID/Investigator# 12600 | Colorado Springs | Colorado |
| United States | Site Reference ID/Investigator# 12634 | Columbiana | Alabama |
| United States | Site Reference ID/Investigator# 15542 | Coral Gables | Florida |
| United States | Site Reference ID/Investigator# 12470 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 12492 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 16081 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 12477 | Daytona Beach | Florida |
| United States | Site Reference ID/Investigator# 12668 | Delray Beach | Florida |
| United States | Site Reference ID/Investigator# 12589 | Duncansville | Pennsylvania |
| United States | Site Reference ID/Investigator# 12620 | Dunwoody | Georgia |
| United States | Site Reference ID/Investigator# 16622 | Edina | Minnesota |
| United States | Site Reference ID/Investigator# 12637 | Elizabeth | New Jersey |
| United States | Site Reference ID/Investigator# 12529 | Evansville | Indiana |
| United States | Site Reference ID/Investigator# 15483 | Fort Lauderdale | Florida |
| United States | Site Reference ID/Investigator# 12645 | Fort Myers | Florida |
| United States | Site Reference ID/Investigator# 12464 | Fort Worth | Texas |
| United States | Site Reference ID/Investigator# 15642 | Germantown | Tennessee |
| United States | Site Reference ID/Investigator# 12607 | Harleysville | Pennsylvania |
| United States | Site Reference ID/Investigator# 12527 | Hickory | North Carolina |
| United States | Site Reference ID/Investigator# 12463 | Hillsborough | New Jersey |
| United States | Site Reference ID/Investigator# 12672 | Hollywood | Florida |
| United States | Site Reference ID/Investigator# 12559 | Huntsville | Alabama |
| United States | Site Reference ID/Investigator# 12688 | Indianapolis | Indiana |
| United States | Site Reference ID/Investigator# 12625 | Jackson | Mississippi |
| United States | Site Reference ID/Investigator# 12643 | Jackson | Tennessee |
| United States | Site Reference ID/Investigator# 12781 | Jacksonville | Florida |
| United States | Site Reference ID/Investigator# 17504 | Jacksonville | Florida |
| United States | Site Reference ID/Investigator# 12641 | Jersey Shore | Pennsylvania |
| United States | Site Reference ID/Investigator# 12539 | Johnson City | New York |
| United States | Site Reference ID/Investigator# 12665 | Jupiter | Florida |
| United States | Site Reference ID/Investigator# 12663 | Kalamazoo | Michigan |
| United States | Site Reference ID/Investigator# 12640 | Kettering | Ohio |
| United States | Site Reference ID/Investigator# 12587 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 12657 | Little Rock | Arkansas |
| United States | Site Reference ID/Investigator# 12498 | Long Beach | California |
| United States | Site Reference ID/Investigator# 12682 | Longwood | Florida |
| United States | Site Reference ID/Investigator# 12602 | Los Angeles | California |
| United States | Site Reference ID/Investigator# 12472 | Louisville | Kentucky |
| United States | Site Reference ID/Investigator# 12476 | Madison | Wisconsin |
| United States | Site Reference ID/Investigator# 12786 | Mason | Ohio |
| United States | Site Reference ID/Investigator# 12585 | Medford | Oregon |
| United States | Site Reference ID/Investigator# 15486 | Melbourne | Florida |
| United States | Site Reference ID/Investigator# 12507 | Melrose Park | Pennsylvania |
| United States | Site Reference ID/Investigator# 12608 | Morehead City | North Carolina |
| United States | Site Reference ID/Investigator# 12623 | Mount Pleasant | South Carolina |
| United States | Site Reference ID/Investigator# 12681 | Mount Pleasant | South Carolina |
| United States | Site Reference ID/Investigator# 12658 | Mount Sterling | Kentucky |
| United States | Site Reference ID/Investigator# 12502 | New Port Richey | Florida |
| United States | Site Reference ID/Investigator# 12538 | Norfolk | Virginia |
| United States | Site Reference ID/Investigator# 12510 | Norwalk | California |
| United States | Site Reference ID/Investigator# 12647 | Ocala | Florida |
| United States | Site Reference ID/Investigator# 12551 | Oklahoma City | Oklahoma |
| United States | Site Reference ID/Investigator# 12560 | Olive Branch | Mississippi |
| United States | Site Reference ID/Investigator# 12655 | Omaha | Nebraska |
| United States | Site Reference ID/Investigator# 12520 | Orlando | Florida |
| United States | Site Reference ID/Investigator# 12687 | Ormond Beach | Florida |
| United States | Site Reference ID/Investigator# 12638 | Oxon Hill | Maryland |
| United States | Site Reference ID/Investigator# 12499 | Ozark | Alabama |
| United States | Site Reference ID/Investigator# 12550 | Palm Desert | California |
| United States | Site Reference ID/Investigator# 12487 | Peoria | Illinois |
| United States | Site Reference ID/Investigator# 12627 | Peoria | Illinois |
| United States | Site Reference ID/Investigator# 12624 | Perkasie | Pennsylvania |
| United States | Site Reference ID/Investigator# 12669 | Philadelphia | Pennsylvania |
| United States | Site Reference ID/Investigator# 12788 | Philadelphia | Pennsylvania |
| United States | Site Reference ID/Investigator# 12525 | Pittsburgh | Pennsylvania |
| United States | Site Reference ID/Investigator# 12616 | Richmond | Virginia |
| United States | Site Reference ID/Investigator# 16503 | Roseville | California |
| United States | Site Reference ID/Investigator# 12653 | Roswell | Georgia |
| United States | Site Reference ID/Investigator# 12678 | Sacramento | California |
| United States | Site Reference ID/Investigator# 14241 | Sacramento | California |
| United States | Site Reference ID/Investigator# 12535 | Salisbury | North Carolina |
| United States | Site Reference ID/Investigator# 12466 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 12540 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 12622 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 12646 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 16601 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 12473 | San Diego | California |
| United States | Site Reference ID/Investigator# 12583 | Sarasota | Florida |
| United States | Site Reference ID/Investigator# 17282 | Scottsdale | Arizona |
| United States | Site Reference ID/Investigator# 12485 | Simpsonville | South Carolina |
| United States | Site Reference ID/Investigator# 15485 | South Bend | Indiana |
| United States | Site Reference ID/Investigator# 12513 | Springfield | Massachusetts |
| United States | Site Reference ID/Investigator# 12677 | St. Louis | Missouri |
| United States | Site Reference ID/Investigator# 12534 | St. Peters | Missouri |
| United States | Site Reference ID/Investigator# 12656 | Statesville | North Carolina |
| United States | Site Reference ID/Investigator# 12639 | Summerville | South Carolina |
| United States | Site Reference ID/Investigator# 12555 | Suwanee | Georgia |
| United States | Site Reference ID/Investigator# 12631 | Syracuse | New York |
| United States | Site Reference ID/Investigator# 12652 | Tampa | Florida |
| United States | Site Reference ID/Investigator# 12601 | Tipton | Pennsylvania |
| United States | Site Reference ID/Investigator# 12660 | Trenton | New Jersey |
| United States | Site Reference ID/Investigator# 12611 | Tulsa | Oklahoma |
| United States | Site Reference ID/Investigator# 12497 | Walnut Creek | California |
| United States | Site Reference ID/Investigator# 12686 | Warminster | Pennsylvania |
| United States | Site Reference ID/Investigator# 12630 | Warren | Ohio |
| United States | Site Reference ID/Investigator# 12679 | Waterbury | Connecticut |
| United States | Site Reference ID/Investigator# 12680 | West Hills | California |
| United States | Site Reference ID/Investigator# 12557 | West Palm Beach | Florida |
| United States | Site Reference ID/Investigator# 12597 | Wichita | Kansas |
| United States | Site Reference ID/Investigator# 17641 | Wilmington | North Carolina |
| United States | Site Reference ID/Investigator# 12606 | Winston-Salem | North Carolina |
| United States | Site Reference ID/Investigator# 12621 | Winter Haven | Florida |
| United States | Site Reference ID/Investigator# 16505 | Winter Park | Florida |
| United States | Site Reference ID/Investigator# 12787 | Woodstock | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | No |
| Other | 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 | No |
| 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. |
Baseline to 8 weeks | No |
| 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. | Baseline to 8 weeks | No |
| 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. | Baseline to 8 weeks | No |