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Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood

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ClinicalTrials.gov Identifier: NCT00639158
Recruitment Status : Completed
First Posted : March 20, 2008
Results First Posted : November 5, 2009
Last Update Posted : June 13, 2011
Information provided by:

Brief Summary:
The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.

Condition or disease Intervention/treatment Phase
Dyslipidemias Coronary Heart Disease Combined (Atherogenic) Dyslipidemia Mixed Dyslipidemia Drug: ABT-335 Drug: placebo Drug: atorvastatin Drug: ezetimibe Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of ABT-335 in Combination With Atorvastatin and Ezetimibe to Atorvastatin in Combination With Ezetimibe in Subjects With Combined (Atherogenic) Dyslipidemia
Study Start Date : February 2008
Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: ABT-335 + atorvastatin + ezetimibe Drug: ABT-335
135 mg capsule, daily, 12 weeks
Other Names:
  • TriLipix
  • Fenofibric acid
  • Choline Fenofibrate
Drug: atorvastatin
40 mg, tablet, daily, 12 weeks
Other Name: Lipitor
Drug: ezetimibe
10 mg capsule, daily, 12 weeks
Other Names:
  • Ezetrol
  • Zetia
  • Ezemibe
Placebo Comparator: Placebo + atorvastatin + ezetimibe Drug: placebo
placebo capsule, daily, 12 weeks
Drug: atorvastatin
40 mg, tablet, daily, 12 weeks
Other Name: Lipitor
Drug: ezetimibe
10 mg capsule, daily, 12 weeks
Other Names:
  • Ezetrol
  • Zetia
  • Ezemibe

Primary Outcome Measures :
  1. Median Percent Change in Triglycerides From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ]
    [(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100

  2. Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ]
    [(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100

Secondary Outcome Measures :
  1. Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ]
    [(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100

  2. Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (final visit) ]
    [(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100

  3. Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ]
    [(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100

  4. Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ]
    [(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100

  5. Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ]
    [(Week 12 apoB minus baseline apoB)/baseline apoB] x 100

  6. Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ]
    [(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with mixed dyslipidemia (trigylcerides, > or = to 150 mg/dL to < 400 mg/dL; HDL-C < 40 mg/dL for males, < 50 mg/dL for females; LDL-C, > or = to 130 mg/dL).
  • Subjects must agree to use adequate birth control methods and to adhere to the American Heart Association (AHA) Diet.

Exclusion Criteria:

  • Subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial.
  • Subjects with an unstable dose of medications or receiving Coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications.
  • Women who are pregnant or plan on becoming pregnant, or women who are lactating.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639158

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United States, Alabama
Birmingham, Alabama, United States, 35209
Columbiana, Alabama, United States, 35051
Hueytown, Alabama, United States, 35023
Ozark, Alabama, United States, 36360
Tuscaloosa, Alabama, United States, 35406
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Sierra Vista, Arizona, United States, 85635
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Hot Springs, Arkansas, United States, 71913
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Carmichael, California, United States, 95608
Concord, California, United States, 94520
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Clearwater, Florida, United States, 33756
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Baltimore, Maryland, United States, 21209
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Brockton, Massachusetts, United States, 02301
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Edina, Minnesota, United States, 55435
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Olive Branch, Mississippi, United States, 38654
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St Louis, Missouri, United States, 63110
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Billings, Montana, United States, 59101
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Las Vegas, Nevada, United States, 89123
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Berlin, New Jersey, United States, 08009
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Hillsborough, New Jersey, United States, 08844
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Johnson City, New York, United States, 13790
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Charlotte, North Carolina, United States, 28209
Hickory, North Carolina, United States, 28601
Morehead City, North Carolina, United States, 28557
Raleigh, North Carolina, United States, 27609
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Cincinnati, Ohio, United States, 45219
Mason, Ohio, United States, 45040
Mogadore, Ohio, United States, 44260
Warren, Ohio, United States, 44483
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Tulsa, Oklahoma, United States, 74136
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Hillsboro, Oregon, United States, 97123
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Duncansville, Pennsylvania, United States, 16635
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Pittsburgh, Pennsylvania, United States, 15216
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Tipton, Pennsylvania, United States, 16684
Warminster, Pennsylvania, United States, 18974
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Cumberland, Rhode Island, United States, 02864
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Anderson, South Carolina, United States, 29621
Greenville, South Carolina, United States, 29615
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Simpsonville, South Carolina, United States, 29681
Summerville, South Carolina, United States, 29485
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Nashville, Tennessee, United States, 37205
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Dallas, Texas, United States, 75230
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Salt Lake City, Utah, United States, 84102
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West Jordan, Utah, United States, 84088
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Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23294
Roanoke, Virginia, United States, 24014
Virginia Beach, Virginia, United States, 23455
United States, Washington
Spokane, Washington, United States, 99216
United States, Wisconsin
Madison, Wisconsin, United States, 53719
Sponsors and Collaborators

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maureen Kelly, MD, Abbott
ClinicalTrials.gov Identifier: NCT00639158     History of Changes
Other Study ID Numbers: M10-275
First Posted: March 20, 2008    Key Record Dates
Results First Posted: November 5, 2009
Last Update Posted: June 13, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arterial Occlusive Diseases
Atorvastatin Calcium
Fenofibric acid
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors