Clinical trial NCT00812955: Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
Keywords: Dyslipidemia
Hypercholesterolemia
Hypertriglyceridemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-12-22
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
timeFrame: Baseline to 8 weeks
Secondary outcomes:
measure: 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)
timeFrame: Baseline to 8 weeks
measure: 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)
timeFrame: Baseline to 8 weeks
Other outcomes:
measure: Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set)
timeFrame: Baseline to 8 weeks
measure: Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set)
timeFrame: Baseline to 8 weeks
Locations:
city: Birmingham
country: United States
facility: Site Reference ID/Investigator# 12654
state: Alabama
city: Columbiana
country: United States
facility: Site Reference ID/Investigator# 12634
state: Alabama
city: Huntsville
country: United States
facility: Site Reference ID/Investigator# 12559
state: Alabama
city: Ozark
country: United States
facility: Site Reference ID/Investigator# 12499
state: Alabama
city: Chandler
country: United States
facility: Site Reference ID/Investigator# 12673
state: Arizona
city: Scottsdale
country: United States
facility: Site Reference ID/Investigator# 17282
state: Arizona
city: Little Rock
country: United States
facility: Site Reference ID/Investigator# 12657
state: Arkansas
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 12489
state: California
city: Carmichael
country: United States
facility: Site Reference ID/Investigator# 12495
state: California
city: Chula Vista
country: United States
facility: Site Reference ID/Investigator# 12467
state: California
city: Long Beach
country: United States
facility: Site Reference ID/Investigator# 12498
state: California
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 12602
state: California
city: Norwalk
country: United States
facility: Site Reference ID/Investigator# 12510
state: California
city: Palm Desert
country: United States
facility: Site Reference ID/Investigator# 12550
state: California
city: Roseville
country: United States
facility: Site Reference ID/Investigator# 16503
state: California
city: Sacramento
country: United States
facility: Site Reference ID/Investigator# 12678
state: California
city: Sacramento
country: United States
facility: Site Reference ID/Investigator# 14241
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 12473
state: California
city: Walnut Creek
country: United States
facility: Site Reference ID/Investigator# 12497
state: California
city: West Hills
country: United States
facility: Site Reference ID/Investigator# 12680
state: California
city: Colorado Springs
country: United States
facility: Site Reference ID/Investigator# 12461
state: Colorado
city: Colorado Springs
country: United States
facility: Site Reference ID/Investigator# 12600
state: Colorado
city: Waterbury
country: United States
facility: Site Reference ID/Investigator# 12679
state: Connecticut
city: Clearwater
country: United States
facility: Site Reference ID/Investigator# 12598
state: Florida
city: Coral Gables
country: United States
facility: Site Reference ID/Investigator# 15542
state: Florida
city: Daytona Beach
country: United States
facility: Site Reference ID/Investigator# 12477
state: Florida
city: Delray Beach
country: United States
facility: Site Reference ID/Investigator# 12668
state: Florida
city: Fort Lauderdale
country: United States
facility: Site Reference ID/Investigator# 15483
state: Florida
city: Fort Myers
country: United States
facility: Site Reference ID/Investigator# 12645
state: Florida
city: Hollywood
country: United States
facility: Site Reference ID/Investigator# 12672
state: Florida
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 17504
state: Florida
city: Jacksonville
country: United States
facility: Site Reference ID/Investigator# 12781
state: Florida
city: Jupiter
country: United States
facility: Site Reference ID/Investigator# 12665
state: Florida
city: Longwood
country: United States
facility: Site Reference ID/Investigator# 12682
state: Florida
city: Melbourne
country: United States
facility: Site Reference ID/Investigator# 15486
state: Florida
city: New Port Richey
country: United States
facility: Site Reference ID/Investigator# 12502
state: Florida
city: Ocala
country: United States
facility: Site Reference ID/Investigator# 12647
state: Florida
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 12520
state: Florida
city: Ormond Beach
country: United States
facility: Site Reference ID/Investigator# 12687
state: Florida
city: Sarasota
country: United States
facility: Site Reference ID/Investigator# 12583
state: Florida
city: Tampa
country: United States
facility: Site Reference ID/Investigator# 12652
state: Florida
city: West Palm Beach
country: United States
facility: Site Reference ID/Investigator# 12557
state: Florida
city: Winter Haven
country: United States
facility: Site Reference ID/Investigator# 12621
state: Florida
city: Winter Park
country: United States
facility: Site Reference ID/Investigator# 16505
state: Florida
city: Augusta
country: United States
facility: Site Reference ID/Investigator# 12675
state: Georgia
city: Dunwoody
country: United States
facility: Site Reference ID/Investigator# 12620
state: Georgia
city: Roswell
country: United States
facility: Site Reference ID/Investigator# 12653
state: Georgia
city: Suwanee
country: United States
facility: Site Reference ID/Investigator# 12555
state: Georgia
city: Woodstock
country: United States
facility: Site Reference ID/Investigator# 12787
state: Georgia
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 12514
state: Illinois
city: Peoria
country: United States
facility: Site Reference ID/Investigator# 12487
state: Illinois
city: Peoria
country: United States
facility: Site Reference ID/Investigator# 12627
state: Illinois
city: Evansville
country: United States
facility: Site Reference ID/Investigator# 12529
state: Indiana
city: Indianapolis
country: United States
facility: Site Reference ID/Investigator# 12688
state: Indiana
city: South Bend
country: United States
facility: Site Reference ID/Investigator# 15485
state: Indiana
city: Arkansas City
country: United States
facility: Site Reference ID/Investigator# 12676
state: Kansas
city: Wichita
country: United States
facility: Site Reference ID/Investigator# 12597
state: Kansas
city: Louisville
country: United States
facility: Site Reference ID/Investigator# 12472
state: Kentucky
city: Mount Sterling
country: United States
facility: Site Reference ID/Investigator# 12658
state: Kentucky
city: Baltimore
country: United States
facility: Site Reference ID/Investigator# 12586
state: Maryland
city: Bethesda
country: United States
facility: Site Reference ID/Investigator# 12480
state: Maryland
city: Oxon Hill
country: United States
facility: Site Reference ID/Investigator# 12638
state: Maryland
city: Springfield
country: United States
facility: Site Reference ID/Investigator# 12513
state: Massachusetts
city: Kalamazoo
country: United States
facility: Site Reference ID/Investigator# 12663
state: Michigan
city: Brooklyn Center
country: United States
facility: Site Reference ID/Investigator# 12609
state: Minnesota
city: Edina
country: United States
facility: Site Reference ID/Investigator# 16622
state: Minnesota
city: Jackson
country: United States
facility: Site Reference ID/Investigator# 12625
state: Mississippi
city: Olive Branch
country: United States
facility: Site Reference ID/Investigator# 12560
state: Mississippi
city: St. Louis
country: United States
facility: Site Reference ID/Investigator# 12677
state: Missouri
city: St. Peters
country: United States
facility: Site Reference ID/Investigator# 12534
state: Missouri
city: Billings
country: United States
facility: Site Reference ID/Investigator# 12592
state: Montana
city: Omaha
country: United States
facility: Site Reference ID/Investigator# 12655
state: Nebraska
city: Las Vegas
country: United States
facility: Site Reference ID/Investigator# 12587
state: Nevada
city: Berlin
country: United States
facility: Site Reference ID/Investigator# 12554
state: New Jersey
city: Elizabeth
country: United States
facility: Site Reference ID/Investigator# 12637
state: New Jersey
city: Hillsborough
country: United States
facility: Site Reference ID/Investigator# 12463
state: New Jersey
city: Trenton
country: United States
facility: Site Reference ID/Investigator# 12660
state: New Jersey
city: Albuquerque
country: United States
facility: Site Reference ID/Investigator# 12506
state: New Mexico
city: Johnson City
country: United States
facility: Site Reference ID/Investigator# 12539
state: New York
city: Syracuse
country: United States
facility: Site Reference ID/Investigator# 12631
state: New York
city: Cary
country: United States
facility: Site Reference ID/Investigator# 17503
state: North Carolina
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 12650
state: North Carolina
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 12504
state: North Carolina
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 12558
state: North Carolina
city: Charlotte
country: United States
facility: Site Reference ID/Investigator# 12671
state: North Carolina
city: Hickory
country: United States
facility: Site Reference ID/Investigator# 12527
state: North Carolina
city: Morehead City
country: United States
facility: Site Reference ID/Investigator# 12608
state: North Carolina
city: Salisbury
country: United States
facility: Site Reference ID/Investigator# 12535
state: North Carolina
city: Statesville
country: United States
facility: Site Reference ID/Investigator# 12656
state: North Carolina
city: Wilmington
country: United States
facility: Site Reference ID/Investigator# 17641
state: North Carolina
city: Winston-Salem
country: United States
facility: Site Reference ID/Investigator# 12606
state: North Carolina
city: Akron
country: United States
facility: Site Reference ID/Investigator# 12614
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 12662
state: Ohio
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 12545
state: Ohio
city: Kettering
country: United States
facility: Site Reference ID/Investigator# 12640
state: Ohio
city: Mason
country: United States
facility: Site Reference ID/Investigator# 12786
state: Ohio
city: Warren
country: United States
facility: Site Reference ID/Investigator# 12630
state: Ohio
city: Oklahoma City
country: United States
facility: Site Reference ID/Investigator# 12551
state: Oklahoma
city: Tulsa
country: United States
facility: Site Reference ID/Investigator# 12611
state: Oklahoma
city: Medford
country: United States
facility: Site Reference ID/Investigator# 12585
state: Oregon
city: Beaver
country: United States
facility: Site Reference ID/Investigator# 12610
state: Pennsylvania
city: Duncansville
country: United States
facility: Site Reference ID/Investigator# 12589
state: Pennsylvania
city: Harleysville
country: United States
facility: Site Reference ID/Investigator# 12607
state: Pennsylvania
city: Jersey Shore
country: United States
facility: Site Reference ID/Investigator# 12641
state: Pennsylvania
city: Melrose Park
country: United States
facility: Site Reference ID/Investigator# 12507
state: Pennsylvania
city: Perkasie
country: United States
facility: Site Reference ID/Investigator# 12624
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 12669
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site Reference ID/Investigator# 12788
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site Reference ID/Investigator# 12525
state: Pennsylvania
city: Tipton
country: United States
facility: Site Reference ID/Investigator# 12601
state: Pennsylvania
city: Warminster
country: United States
facility: Site Reference ID/Investigator# 12686
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Site Reference ID/Investigator# 12623
state: South Carolina
city: Mount Pleasant
country: United States
facility: Site Reference ID/Investigator# 12681
state: South Carolina
city: Simpsonville
country: United States
facility: Site Reference ID/Investigator# 12485
state: South Carolina
city: Summerville
country: United States
facility: Site Reference ID/Investigator# 12639
state: South Carolina
city: Germantown
country: United States
facility: Site Reference ID/Investigator# 15642
state: Tennessee
city: Jackson
country: United States
facility: Site Reference ID/Investigator# 12643
state: Tennessee
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 12470
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 16081
state: Texas
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 12492
state: Texas
city: Fort Worth
country: United States
facility: Site Reference ID/Investigator# 12464
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 12646
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 16601
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 12540
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 12466
state: Texas
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 12622
state: Texas
city: Norfolk
country: United States
facility: Site Reference ID/Investigator# 12538
state: Virginia
city: Richmond
country: United States
facility: Site Reference ID/Investigator# 12616
state: Virginia
city: Madison
country: United States
facility: Site Reference ID/Investigator# 12476
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: Torbjörn Lundström, MD
role: STUDY_DIRECTOR
References:
citation: 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.