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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00639158
First received: March 14, 2008
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Median Percent Change in Triglycerides From Baseline to Final Visit [ Time Frame: Baseline to 12 Weeks (Final Visit) ] [ Designated as safety issue: No ]
    [(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100

  • Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
    [(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100


Secondary Outcome Measures:
  • Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
    [(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100

  • Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (final visit) ] [ Designated as safety issue: No ]
    [(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100

  • Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
    [(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100

  • 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) ] [ Designated as safety issue: No ]
    [(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100

  • Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
    [(Week 12 apoB minus baseline apoB)/baseline apoB] x 100

  • Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit [ Time Frame: Baseline to 12 weeks (Final Visit) ] [ Designated as safety issue: No ]
    [(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100


Enrollment: 543
Study Start Date: February 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ABT-335 + atorvastatin + ezetimibe Drug: ABT-335
135 mg capsule, daily, 12 weeks
Other Names:
  • ABT-335
  • TriLipix
  • Fenofibric acid
  • Choline Fenofibrate
Drug: atorvastatin
40 mg, tablet, daily, 12 weeks
Other Names:
  • atorvastatin
  • Lipitor
Drug: ezetimibe
10 mg capsule, daily, 12 weeks
Other Names:
  • ezetimibe
  • Ezetrol
  • Zetia
  • Ezemibe
Placebo Comparator: Placebo + atorvastatin + ezetimibe Drug: placebo
placebo capsule, daily, 12 weeks
Other Name: placebo
Drug: atorvastatin
40 mg, tablet, daily, 12 weeks
Other Names:
  • atorvastatin
  • Lipitor
Drug: ezetimibe
10 mg capsule, daily, 12 weeks
Other Names:
  • ezetimibe
  • Ezetrol
  • Zetia
  • Ezemibe

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639158

  Hide Study Locations
Locations
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
United States, Arizona
Sierra Vista, Arizona, United States, 85635
United States, Arkansas
Hot Springs, Arkansas, United States, 71913
United States, California
Carmichael, California, United States, 95608
Concord, California, United States, 94520
Long Beach, California, United States, 90806
Long Beach, California, United States, 90822
Los Angeles, California, United States, 90057
Norwalk, California, United States, 90650
Roseville, California, United States, 95661
Sacramento, California, United States, 95825
Santa Ana, California, United States, 92701
Tustin, California, United States, 92780
West Hills, California, United States, 91307
United States, Colorado
Colorado Springs, Colorado, United States, 80904
Denver, Colorado, United States, 80206
United States, Florida
Clearwater, Florida, United States, 33756
Delray Beach, Florida, United States, 33484
Fort Myers, Florida, United States, 33907
Holly Hill, Florida, United States, 32117
Jacksonville, Florida, United States, 32259
Jacksonville, Florida, United States, 32216
Kissimmee, Florida, United States, 34741
Longwood, Florida, United States, 32750
Miami, Florida, United States, 33173
New Port Richey, Florida, United States, 34652
New Smyrna Beach, Florida, United States, 32168
Ocala, Florida, United States, 34471
Ormond Beach, Florida, United States, 32174
Pembroke Pines, Florida, United States, 33002
Sarasota, Florida, United States, 34233
Tampa, Florida, United States, 33607
Winter Haven, Florida, United States, 33880
United States, Georgia
Atlanta, Georgia, United States, 30342
Augusta, Georgia, United States, 30904
Roswell, Georgia, United States, 30076
Suwanee, Georgia, United States, 30024
Woodstock, Georgia, United States, 30189
United States, Idaho
Boise, Idaho, United States, 83704
United States, Illinois
Chicago, Illinois, United States, 60610
Chicago, Illinois, United States, 60607
Peoria, Illinois, United States, 61602
United States, Indiana
Evansville, Indiana, United States, 47714
Evansville, Indiana, United States, 47713
Indianapolis, Indiana, United States, 46260
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Arkansas City, Kansas, United States, 67005
Overland Park, Kansas, United States, 66202
Wichita, Kansas, United States, 67207
United States, Kentucky
Louisville, Kentucky, United States, 40213
Mt. Sterling, Kentucky, United States, 40353
United States, Louisiana
Slidell, Louisiana, United States, 70458
United States, Maryland
Baltimore, Maryland, United States, 21209
Oxon Hill, Maryland, United States, 20745
United States, Massachusetts
Brockton, Massachusetts, United States, 02301
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, Mississippi
Olive Branch, Mississippi, United States, 38654
United States, Missouri
St Louis, Missouri, United States, 63110
St Louis, Missouri, United States, 63141
St. Louis, Missouri, United States, 63141
St. Peters, Missouri, United States, 63376
United States, Montana
Billings, Montana, United States, 59101
United States, Nevada
Las Vegas, Nevada, United States, 89123
United States, New Jersey
Berlin, New Jersey, United States, 08009
Elizabeth, New Jersey, United States, 07202
Hillsborough, New Jersey, United States, 08844
Trenton, New Jersey, United States, 08611
United States, New York
Johnson City, New York, United States, 13790
United States, North Carolina
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
Salisbury, North Carolina, United States, 28144
Statesville, North Carolina, United States, 25677
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Cincinnati, Ohio, United States, 45219
Mason, Ohio, United States, 45040
Mogadore, Ohio, United States, 44260
Warren, Ohio, United States, 44483
United States, Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Hillsboro, Oregon, United States, 97123
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
Harleysville, Pennsylvania, United States, 19438
Jersey Shore, Pennsylvania, United States, 17740
Lansdale, Pennsylvania, United States, 19446
Melrose Park, Pennsylvania, United States, 19027
Newtown, Pennsylvania, United States, 18940
Perkasie, Pennsylvania, United States, 18944
Philadelphia, Pennsylvania, United States, 19114
Philadelphia, Pennsylvania, United States, 19152
Pittsburgh, Pennsylvania, United States, 15216
Sellersville, Pennsylvania, United States, 18960
Tipton, Pennsylvania, United States, 16684
Warminster, Pennsylvania, United States, 18974
United States, Rhode Island
Cumberland, Rhode Island, United States, 02864
United States, South Carolina
Anderson, South Carolina, United States, 29621
Greenville, South Carolina, United States, 29615
Greer, South Carolina, United States, 29651
Simpsonville, South Carolina, United States, 29681
Summerville, South Carolina, United States, 29485
United States, Tennessee
Nashville, Tennessee, United States, 37205
United States, Texas
Dallas, Texas, United States, 75230
Fort Worth, Texas, United States, 76104
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
United States, Utah
Salt Lake City, Utah, United States, 84107
Salt Lake City, Utah, United States, 84102
Salt Lake City, Utah, United States, 84103
West Jordan, Utah, United States, 84088
United States, Virginia
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
Abbott
  More Information

No publications provided by Abbott

Additional 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
Study First Received: March 14, 2008
Results First Received: October 2, 2009
Last Updated: June 9, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014