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

September 27, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

474

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A - ABT-143 capsules 5/135 mg
ABT-143 capsules 5/135 mg - ABT-143 (rosuvastatin 5 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Drug: ABT-143
Once daily for 8 weeks
Experimental: B - ABT-143 capsules 10/135 mg
ABT-143 capsules 10/135 mg - ABT-143 (rosuvastatin 10 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Drug: ABT-143
Once daily for 8 weeks
Experimental: C - ABT-143 capsules 20/135 mg
ABT-143 capsules 20/135 mg - ABT-143 (rosuvastatin 20 mg in combination with fenofibric acid 135 mg) once daily for 8 weeks
Drug: ABT-143
Once daily for 8 weeks
Active Comparator: D - Simvastatin capsules 40 mg
Simvastatin capsules 40 mg daily for 8 weeks
Drug: simvastatin
Once daily for 8 weeks simvastatin capsules 40 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set)
Time Frame: 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.
Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: 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.
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)
Time Frame: 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.
Baseline to 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Percent Change in Triglycerides From Baseline to the Final Visit (Full Analysis Set)
Time Frame: Baseline to 8 weeks
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
Mean Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline to the Final Visit (Full Analysis Set)
Time Frame: Baseline to 8 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Torbjörn Lundström, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 18, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

September 27, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-667

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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