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Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

Primary Purpose

Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABT-143
simvastatin
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia focused on measuring Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Site Reference ID/Investigator# 12654
  • Site Reference ID/Investigator# 12634
  • Site Reference ID/Investigator# 12559
  • Site Reference ID/Investigator# 12499
  • Site Reference ID/Investigator# 12673
  • Site Reference ID/Investigator# 17282
  • Site Reference ID/Investigator# 12657
  • Site Reference ID/Investigator# 12489
  • Site Reference ID/Investigator# 12495
  • Site Reference ID/Investigator# 12467
  • Site Reference ID/Investigator# 12498
  • Site Reference ID/Investigator# 12602
  • Site Reference ID/Investigator# 12510
  • Site Reference ID/Investigator# 12550
  • Site Reference ID/Investigator# 16503
  • Site Reference ID/Investigator# 12678
  • Site Reference ID/Investigator# 14241
  • Site Reference ID/Investigator# 12473
  • Site Reference ID/Investigator# 12497
  • Site Reference ID/Investigator# 12680
  • Site Reference ID/Investigator# 12461
  • Site Reference ID/Investigator# 12600
  • Site Reference ID/Investigator# 12679
  • Site Reference ID/Investigator# 12598
  • Site Reference ID/Investigator# 15542
  • Site Reference ID/Investigator# 12477
  • Site Reference ID/Investigator# 12668
  • Site Reference ID/Investigator# 15483
  • Site Reference ID/Investigator# 12645
  • Site Reference ID/Investigator# 12672
  • Site Reference ID/Investigator# 17504
  • Site Reference ID/Investigator# 12781
  • Site Reference ID/Investigator# 12665
  • Site Reference ID/Investigator# 12682
  • Site Reference ID/Investigator# 15486
  • Site Reference ID/Investigator# 12502
  • Site Reference ID/Investigator# 12647
  • Site Reference ID/Investigator# 12520
  • Site Reference ID/Investigator# 12687
  • Site Reference ID/Investigator# 12583
  • Site Reference ID/Investigator# 12652
  • Site Reference ID/Investigator# 12557
  • Site Reference ID/Investigator# 12621
  • Site Reference ID/Investigator# 16505
  • Site Reference ID/Investigator# 12675
  • Site Reference ID/Investigator# 12620
  • Site Reference ID/Investigator# 12653
  • Site Reference ID/Investigator# 12555
  • Site Reference ID/Investigator# 12787
  • Site Reference ID/Investigator# 12514
  • Site Reference ID/Investigator# 12487
  • Site Reference ID/Investigator# 12627
  • Site Reference ID/Investigator# 12529
  • Site Reference ID/Investigator# 12688
  • Site Reference ID/Investigator# 15485
  • Site Reference ID/Investigator# 12676
  • Site Reference ID/Investigator# 12597
  • Site Reference ID/Investigator# 12472
  • Site Reference ID/Investigator# 12658
  • Site Reference ID/Investigator# 12586
  • Site Reference ID/Investigator# 12480
  • Site Reference ID/Investigator# 12638
  • Site Reference ID/Investigator# 12513
  • Site Reference ID/Investigator# 12663
  • Site Reference ID/Investigator# 12609
  • Site Reference ID/Investigator# 16622
  • Site Reference ID/Investigator# 12625
  • Site Reference ID/Investigator# 12560
  • Site Reference ID/Investigator# 12677
  • Site Reference ID/Investigator# 12534
  • Site Reference ID/Investigator# 12592
  • Site Reference ID/Investigator# 12655
  • Site Reference ID/Investigator# 12587
  • Site Reference ID/Investigator# 12554
  • Site Reference ID/Investigator# 12637
  • Site Reference ID/Investigator# 12463
  • Site Reference ID/Investigator# 12660
  • Site Reference ID/Investigator# 12506
  • Site Reference ID/Investigator# 12539
  • Site Reference ID/Investigator# 12631
  • Site Reference ID/Investigator# 17503
  • Site Reference ID/Investigator# 12650
  • Site Reference ID/Investigator# 12504
  • Site Reference ID/Investigator# 12558
  • Site Reference ID/Investigator# 12671
  • Site Reference ID/Investigator# 12527
  • Site Reference ID/Investigator# 12608
  • Site Reference ID/Investigator# 12535
  • Site Reference ID/Investigator# 12656
  • Site Reference ID/Investigator# 17641
  • Site Reference ID/Investigator# 12606
  • Site Reference ID/Investigator# 12614
  • Site Reference ID/Investigator# 12662
  • Site Reference ID/Investigator# 12545
  • Site Reference ID/Investigator# 12640
  • Site Reference ID/Investigator# 12786
  • Site Reference ID/Investigator# 12630
  • Site Reference ID/Investigator# 12551
  • Site Reference ID/Investigator# 12611
  • Site Reference ID/Investigator# 12585
  • Site Reference ID/Investigator# 12610
  • Site Reference ID/Investigator# 12589
  • Site Reference ID/Investigator# 12607
  • Site Reference ID/Investigator# 12641
  • Site Reference ID/Investigator# 12507
  • Site Reference ID/Investigator# 12624
  • Site Reference ID/Investigator# 12669
  • Site Reference ID/Investigator# 12788
  • Site Reference ID/Investigator# 12525
  • Site Reference ID/Investigator# 12601
  • Site Reference ID/Investigator# 12686
  • Site Reference ID/Investigator# 12623
  • Site Reference ID/Investigator# 12681
  • Site Reference ID/Investigator# 12485
  • Site Reference ID/Investigator# 12639
  • Site Reference ID/Investigator# 15642
  • Site Reference ID/Investigator# 12643
  • Site Reference ID/Investigator# 12470
  • Site Reference ID/Investigator# 16081
  • Site Reference ID/Investigator# 12492
  • Site Reference ID/Investigator# 12464
  • Site Reference ID/Investigator# 12646
  • Site Reference ID/Investigator# 16601
  • Site Reference ID/Investigator# 12540
  • Site Reference ID/Investigator# 12466
  • Site Reference ID/Investigator# 12622
  • Site Reference ID/Investigator# 12538
  • Site Reference ID/Investigator# 12616
  • Site Reference ID/Investigator# 12476

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

A - ABT-143 capsules 5/135 mg

B - ABT-143 capsules 10/135 mg

C - ABT-143 capsules 20/135 mg

D - Simvastatin capsules 40 mg

Arm Description

ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks

ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks

ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks

Simvastatin capsules 40 mg daily for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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 Information

First Posted
December 18, 2008
Last Updated
September 27, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00812955
Brief Title
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

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia
Keywords
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
474 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A - ABT-143 capsules 5/135 mg
Arm Type
Experimental
Arm Description
ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Arm Title
B - ABT-143 capsules 10/135 mg
Arm Type
Experimental
Arm Description
ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Arm Title
C - ABT-143 capsules 20/135 mg
Arm Type
Experimental
Arm Description
ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Arm Title
D - Simvastatin capsules 40 mg
Arm Type
Active Comparator
Arm Description
Simvastatin capsules 40 mg daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
ABT-143
Intervention Description
Once daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
simvastatin
Intervention Description
Once daily for 8 weeks simvastatin capsules 40 mg
Primary Outcome Measure Information:
Title
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
Description
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.
Time Frame
Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Baseline to 8 weeks
Title
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)
Description
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.
Time Frame
Baseline to 8 weeks
Other Pre-specified Outcome Measures:
Title
Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set)
Description
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.
Time Frame
Baseline to 8 weeks
Title
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set)
Description
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.
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torbjörn Lundström, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 12654
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Site Reference ID/Investigator# 12634
City
Columbiana
State/Province
Alabama
ZIP/Postal Code
35051
Country
United States
Facility Name
Site Reference ID/Investigator# 12559
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Site Reference ID/Investigator# 12499
City
Ozark
State/Province
Alabama
ZIP/Postal Code
36360
Country
United States
Facility Name
Site Reference ID/Investigator# 12673
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Site Reference ID/Investigator# 17282
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Site Reference ID/Investigator# 12657
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
Site Reference ID/Investigator# 12489
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Site Reference ID/Investigator# 12495
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Site Reference ID/Investigator# 12467
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Site Reference ID/Investigator# 12498
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Site Reference ID/Investigator# 12602
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Site Reference ID/Investigator# 12510
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
Country
United States
Facility Name
Site Reference ID/Investigator# 12550
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Site Reference ID/Investigator# 16503
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Site Reference ID/Investigator# 12678
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Site Reference ID/Investigator# 14241
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Site Reference ID/Investigator# 12473
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site Reference ID/Investigator# 12497
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Site Reference ID/Investigator# 12680
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Site Reference ID/Investigator# 12461
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Site Reference ID/Investigator# 12600
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Site Reference ID/Investigator# 12679
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Site Reference ID/Investigator# 12598
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Site Reference ID/Investigator# 15542
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Site Reference ID/Investigator# 12477
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Site Reference ID/Investigator# 12668
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Site Reference ID/Investigator# 15483
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33306
Country
United States
Facility Name
Site Reference ID/Investigator# 12645
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
Site Reference ID/Investigator# 12672
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Facility Name
Site Reference ID/Investigator# 17504
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Site Reference ID/Investigator# 12781
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32259
Country
United States
Facility Name
Site Reference ID/Investigator# 12665
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458-7200
Country
United States
Facility Name
Site Reference ID/Investigator# 12682
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Site Reference ID/Investigator# 15486
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Site Reference ID/Investigator# 12502
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Site Reference ID/Investigator# 12647
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Site Reference ID/Investigator# 12520
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 12687
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Site Reference ID/Investigator# 12583
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Site Reference ID/Investigator# 12652
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Site Reference ID/Investigator# 12557
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Site Reference ID/Investigator# 12621
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Site Reference ID/Investigator# 16505
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Site Reference ID/Investigator# 12675
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Site Reference ID/Investigator# 12620
City
Dunwoody
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Site Reference ID/Investigator# 12653
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Site Reference ID/Investigator# 12555
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
Site Reference ID/Investigator# 12787
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Site Reference ID/Investigator# 12514
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Site Reference ID/Investigator# 12487
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Site Reference ID/Investigator# 12627
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Site Reference ID/Investigator# 12529
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Site Reference ID/Investigator# 12688
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Site Reference ID/Investigator# 15485
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Site Reference ID/Investigator# 12676
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
Facility Name
Site Reference ID/Investigator# 12597
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Site Reference ID/Investigator# 12472
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Site Reference ID/Investigator# 12658
City
Mount Sterling
State/Province
Kentucky
ZIP/Postal Code
40353
Country
United States
Facility Name
Site Reference ID/Investigator# 12586
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Site Reference ID/Investigator# 12480
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Site Reference ID/Investigator# 12638
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Site Reference ID/Investigator# 12513
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Site Reference ID/Investigator# 12663
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Site Reference ID/Investigator# 12609
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55430
Country
United States
Facility Name
Site Reference ID/Investigator# 16622
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Site Reference ID/Investigator# 12625
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Site Reference ID/Investigator# 12560
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Site Reference ID/Investigator# 12677
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Site Reference ID/Investigator# 12534
City
St. Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Site Reference ID/Investigator# 12592
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Site Reference ID/Investigator# 12655
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Site Reference ID/Investigator# 12587
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Site Reference ID/Investigator# 12554
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Site Reference ID/Investigator# 12637
City
Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
Country
United States
Facility Name
Site Reference ID/Investigator# 12463
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Site Reference ID/Investigator# 12660
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Site Reference ID/Investigator# 12506
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Site Reference ID/Investigator# 12539
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Site Reference ID/Investigator# 12631
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
Facility Name
Site Reference ID/Investigator# 17503
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Site Reference ID/Investigator# 12650
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Site Reference ID/Investigator# 12504
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Site Reference ID/Investigator# 12558
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Site Reference ID/Investigator# 12671
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Site Reference ID/Investigator# 12527
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Site Reference ID/Investigator# 12608
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Site Reference ID/Investigator# 12535
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Site Reference ID/Investigator# 12656
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Site Reference ID/Investigator# 17641
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Site Reference ID/Investigator# 12606
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site Reference ID/Investigator# 12614
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
Facility Name
Site Reference ID/Investigator# 12662
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Site Reference ID/Investigator# 12545
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Site Reference ID/Investigator# 12640
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Site Reference ID/Investigator# 12786
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Site Reference ID/Investigator# 12630
City
Warren
State/Province
Ohio
ZIP/Postal Code
44483
Country
United States
Facility Name
Site Reference ID/Investigator# 12551
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Site Reference ID/Investigator# 12611
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Site Reference ID/Investigator# 12585
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Site Reference ID/Investigator# 12610
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Site Reference ID/Investigator# 12589
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Site Reference ID/Investigator# 12607
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438-2513
Country
United States
Facility Name
Site Reference ID/Investigator# 12641
City
Jersey Shore
State/Province
Pennsylvania
ZIP/Postal Code
17740
Country
United States
Facility Name
Site Reference ID/Investigator# 12507
City
Melrose Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Facility Name
Site Reference ID/Investigator# 12624
City
Perkasie
State/Province
Pennsylvania
ZIP/Postal Code
18944
Country
United States
Facility Name
Site Reference ID/Investigator# 12669
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
Site Reference ID/Investigator# 12788
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Site Reference ID/Investigator# 12525
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15216
Country
United States
Facility Name
Site Reference ID/Investigator# 12601
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
Facility Name
Site Reference ID/Investigator# 12686
City
Warminster
State/Province
Pennsylvania
ZIP/Postal Code
18974
Country
United States
Facility Name
Site Reference ID/Investigator# 12623
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site Reference ID/Investigator# 12681
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Site Reference ID/Investigator# 12485
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Site Reference ID/Investigator# 12639
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Site Reference ID/Investigator# 15642
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Site Reference ID/Investigator# 12643
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Site Reference ID/Investigator# 12470
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Site Reference ID/Investigator# 16081
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Site Reference ID/Investigator# 12492
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Site Reference ID/Investigator# 12464
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Site Reference ID/Investigator# 12646
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
Facility Name
Site Reference ID/Investigator# 16601
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Site Reference ID/Investigator# 12540
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Site Reference ID/Investigator# 12466
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 12622
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 12538
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502-9921
Country
United States
Facility Name
Site Reference ID/Investigator# 12616
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Site Reference ID/Investigator# 12476
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20524719
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.
Results Reference
derived

Learn more about this trial

Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides

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