Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
- Conditions
- Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
- Interventions
- Drug: ABT-143
- Registration Number
- NCT00812955
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 474
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A - ABT-143 capsules 5/135 mg ABT-143 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 ABT-143 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 ABT-143 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 simvastatin Simvastatin capsules 40 mg daily for 8 weeks
- Primary Outcome Measures
Name Time Method Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) Baseline to 8 weeks 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.
- Secondary Outcome Measures
Name Time Method 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) Baseline to 8 weeks 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.
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) Baseline to 8 weeks 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.
Trial Locations
- Locations (129)
Site Reference ID/Investigator# 12495
🇺🇸Carmichael, California, United States
Site Reference ID/Investigator# 12668
🇺🇸Delray Beach, Florida, United States
Site Reference ID/Investigator# 12554
🇺🇸Berlin, New Jersey, United States
Site Reference ID/Investigator# 17503
🇺🇸Cary, North Carolina, 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# 12470
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 16081
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 12662
🇺🇸Cincinnati, Ohio, United States
Site Reference ID/Investigator# 12545
🇺🇸Cincinnati, Ohio, United States
Site Reference ID/Investigator# 12646
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 12540
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 12676
🇺🇸Arkansas City, Kansas, United States
Site Reference ID/Investigator# 12597
🇺🇸Wichita, Kansas, United States
Site Reference ID/Investigator# 12498
🇺🇸Long Beach, California, United States
Site Reference ID/Investigator# 12602
🇺🇸Los Angeles, California, United States
Site Reference ID/Investigator# 12510
🇺🇸Norwalk, California, United States
Site Reference ID/Investigator# 12550
🇺🇸Palm Desert, California, United States
Site Reference ID/Investigator# 12473
🇺🇸San Diego, California, United States
Site Reference ID/Investigator# 12598
🇺🇸Clearwater, Florida, United States
Site Reference ID/Investigator# 12467
🇺🇸Chula Vista, California, United States
Site Reference ID/Investigator# 12634
🇺🇸Columbiana, Alabama, United States
Site Reference ID/Investigator# 12499
🇺🇸Ozark, Alabama, United States
Site Reference ID/Investigator# 12638
🇺🇸Oxon Hill, Maryland, United States
Site Reference ID/Investigator# 12600
🇺🇸Colorado Springs, Colorado, United States
Site Reference ID/Investigator# 12583
🇺🇸Sarasota, Florida, United States
Site Reference ID/Investigator# 17504
🇺🇸Jacksonville, Florida, United States
Site Reference ID/Investigator# 15483
🇺🇸Fort Lauderdale, Florida, United States
Site Reference ID/Investigator# 15486
🇺🇸Melbourne, Florida, United States
Site Reference ID/Investigator# 16505
🇺🇸Winter Park, Florida, United States
Site Reference ID/Investigator# 12688
🇺🇸Indianapolis, Indiana, United States
Site Reference ID/Investigator# 12477
🇺🇸Daytona Beach, Florida, United States
Site Reference ID/Investigator# 12647
🇺🇸Ocala, Florida, United States
Site Reference ID/Investigator# 12682
🇺🇸Longwood, Florida, United States
Site Reference ID/Investigator# 12555
🇺🇸Suwanee, Georgia, United States
Site Reference ID/Investigator# 12529
🇺🇸Evansville, Indiana, United States
Site Reference ID/Investigator# 12658
🇺🇸Mount Sterling, Kentucky, United States
Site Reference ID/Investigator# 12586
🇺🇸Baltimore, Maryland, United States
Site Reference ID/Investigator# 12534
🇺🇸St. Peters, Missouri, United States
Site Reference ID/Investigator# 12631
🇺🇸Syracuse, New York, United States
Site Reference ID/Investigator# 12527
🇺🇸Hickory, North Carolina, United States
Site Reference ID/Investigator# 12609
🇺🇸Brooklyn Center, Minnesota, United States
Site Reference ID/Investigator# 12506
🇺🇸Albuquerque, New Mexico, United States
Site Reference ID/Investigator# 12504
🇺🇸Charlotte, North Carolina, United States
Site Reference ID/Investigator# 12466
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 12476
🇺🇸Madison, Wisconsin, United States
Site Reference ID/Investigator# 12535
🇺🇸Salisbury, North Carolina, United States
Site Reference ID/Investigator# 12786
🇺🇸Mason, Ohio, United States
Site Reference ID/Investigator# 17641
🇺🇸Wilmington, North Carolina, United States
Site Reference ID/Investigator# 16601
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 12671
🇺🇸Charlotte, North Carolina, United States
Site Reference ID/Investigator# 12608
🇺🇸Morehead City, North Carolina, United States
Site Reference ID/Investigator# 12654
🇺🇸Birmingham, Alabama, United States
Site Reference ID/Investigator# 12551
🇺🇸Oklahoma City, Oklahoma, United States
Site Reference ID/Investigator# 17282
🇺🇸Scottsdale, Arizona, United States
Site Reference ID/Investigator# 12559
🇺🇸Huntsville, Alabama, United States
Site Reference ID/Investigator# 16503
🇺🇸Roseville, California, United States
Site Reference ID/Investigator# 12665
🇺🇸Jupiter, Florida, United States
Site Reference ID/Investigator# 12652
🇺🇸Tampa, Florida, United States
Site Reference ID/Investigator# 12502
🇺🇸New Port Richey, Florida, United States
Site Reference ID/Investigator# 12620
🇺🇸Dunwoody, Georgia, United States
Site Reference ID/Investigator# 12653
🇺🇸Roswell, Georgia, United States
Site Reference ID/Investigator# 12675
🇺🇸Augusta, Georgia, United States
Site Reference ID/Investigator# 12487
🇺🇸Peoria, Illinois, United States
Site Reference ID/Investigator# 15485
🇺🇸South Bend, Indiana, United States
Site Reference ID/Investigator# 12627
🇺🇸Peoria, Illinois, United States
Site Reference ID/Investigator# 12513
🇺🇸Springfield, Massachusetts, United States
Site Reference ID/Investigator# 12650
🇺🇸Charlotte, North Carolina, United States
Site Reference ID/Investigator# 12616
🇺🇸Richmond, Virginia, United States
Site Reference ID/Investigator# 12622
🇺🇸San Antonio, Texas, United States
Site Reference ID/Investigator# 15542
🇺🇸Coral Gables, Florida, United States
Site Reference ID/Investigator# 12538
🇺🇸Norfolk, Virginia, United States
Site Reference ID/Investigator# 12489
🇺🇸Anaheim, California, United States
Site Reference ID/Investigator# 12497
🇺🇸Walnut Creek, California, United States
Site Reference ID/Investigator# 12679
🇺🇸Waterbury, Connecticut, United States
Site Reference ID/Investigator# 12461
🇺🇸Colorado Springs, Colorado, United States
Site Reference ID/Investigator# 12781
🇺🇸Jacksonville, Florida, United States
Site Reference ID/Investigator# 12672
🇺🇸Hollywood, Florida, United States
Site Reference ID/Investigator# 12645
🇺🇸Fort Myers, Florida, United States
Site Reference ID/Investigator# 12621
🇺🇸Winter Haven, Florida, United States
Site Reference ID/Investigator# 12557
🇺🇸West Palm Beach, Florida, United States
Site Reference ID/Investigator# 12687
🇺🇸Ormond Beach, Florida, United States
Site Reference ID/Investigator# 12787
🇺🇸Woodstock, Georgia, United States
Site Reference ID/Investigator# 12514
🇺🇸Chicago, Illinois, United States
Site Reference ID/Investigator# 12480
🇺🇸Bethesda, Maryland, United States
Site Reference ID/Investigator# 16622
🇺🇸Edina, Minnesota, United States
Site Reference ID/Investigator# 12663
🇺🇸Kalamazoo, Michigan, United States
Site Reference ID/Investigator# 12625
🇺🇸Jackson, Mississippi, United States
Site Reference ID/Investigator# 12677
🇺🇸St. Louis, Missouri, United States
Site Reference ID/Investigator# 12560
🇺🇸Olive Branch, Mississippi, United States
Site Reference ID/Investigator# 12592
🇺🇸Billings, Montana, United States
Site Reference ID/Investigator# 12558
🇺🇸Charlotte, North Carolina, United States
Site Reference ID/Investigator# 12539
🇺🇸Johnson City, New York, United States
Site Reference ID/Investigator# 12614
🇺🇸Akron, Ohio, United States
Site Reference ID/Investigator# 12656
🇺🇸Statesville, North Carolina, United States
Site Reference ID/Investigator# 12640
🇺🇸Kettering, Ohio, United States
Site Reference ID/Investigator# 12630
🇺🇸Warren, Ohio, United States
Site Reference ID/Investigator# 12611
🇺🇸Tulsa, Oklahoma, United States
Site Reference ID/Investigator# 12610
🇺🇸Beaver, Pennsylvania, United States
Site Reference ID/Investigator# 12585
🇺🇸Medford, Oregon, United States
Site Reference ID/Investigator# 12589
🇺🇸Duncansville, Pennsylvania, United States
Site Reference ID/Investigator# 12607
🇺🇸Harleysville, Pennsylvania, United States
Site Reference ID/Investigator# 12641
🇺🇸Jersey Shore, Pennsylvania, United States
Site Reference ID/Investigator# 12624
🇺🇸Perkasie, Pennsylvania, United States
Site Reference ID/Investigator# 12507
🇺🇸Melrose Park, Pennsylvania, United States
Site Reference ID/Investigator# 12681
🇺🇸Mount Pleasant, South Carolina, United States
Site Reference ID/Investigator# 12686
🇺🇸Warminster, Pennsylvania, United States
Site Reference ID/Investigator# 12623
🇺🇸Mount Pleasant, South Carolina, United States
Site Reference ID/Investigator# 12601
🇺🇸Tipton, Pennsylvania, United States
Site Reference ID/Investigator# 12492
🇺🇸Dallas, Texas, United States
Site Reference ID/Investigator# 12464
🇺🇸Fort Worth, Texas, United States
Site Reference ID/Investigator# 12673
🇺🇸Chandler, Arizona, United States
Site Reference ID/Investigator# 12660
🇺🇸Trenton, New Jersey, United States
Site Reference ID/Investigator# 12657
🇺🇸Little Rock, Arkansas, United States
Site Reference ID/Investigator# 12639
🇺🇸Summerville, South Carolina, United States
Site Reference ID/Investigator# 12587
🇺🇸Las Vegas, Nevada, United States
Site Reference ID/Investigator# 15642
🇺🇸Germantown, Tennessee, United States
Site Reference ID/Investigator# 12637
🇺🇸Elizabeth, New Jersey, United States
Site Reference ID/Investigator# 12463
🇺🇸Hillsborough, New Jersey, United States
Site Reference ID/Investigator# 12485
🇺🇸Simpsonville, South Carolina, United States
Site Reference ID/Investigator# 12655
🇺🇸Omaha, Nebraska, United States
Site Reference ID/Investigator# 12643
🇺🇸Jackson, Tennessee, United States
Site Reference ID/Investigator# 12678
🇺🇸Sacramento, California, United States
Site Reference ID/Investigator# 14241
🇺🇸Sacramento, California, United States
Site Reference ID/Investigator# 12520
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 12472
🇺🇸Louisville, Kentucky, United States
Site Reference ID/Investigator# 12606
🇺🇸Winston-Salem, North Carolina, United States
Site Reference ID/Investigator# 12680
🇺🇸West Hills, California, United States