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

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

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.

Study Overview

• Status: Completed
• Conditions: Dyslipidemias; Coronary Heart Disease; Mixed Dyslipidemia; Combined (Atherogenic) Dyslipidemia
• Intervention / Treatment: Drug: ABT-335; Drug: atorvastatin; Drug: ezetimibe; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 543
• Phase: Phase 3

Contacts and Locations

Study 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
  • Arizona
    • Sierra Vista, Arizona, United States, 85635
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
  • 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
  • Colorado
    • Colorado Springs, Colorado, United States, 80904
    • Denver, Colorado, United States, 80206
  • 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, 32216
    • Jacksonville, Florida, United States, 32259
    • 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
  • 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
  • Idaho
    • Boise, Idaho, United States, 83704
  • Illinois
    • Chicago, Illinois, United States, 60610
    • Chicago, Illinois, United States, 60607
    • Peoria, Illinois, United States, 61602
  • Indiana
    • Evansville, Indiana, United States, 47713
    • Evansville, Indiana, United States, 47714
    • Indianapolis, Indiana, United States, 46260
  • Iowa
    • Iowa City, Iowa, United States, 52242
  • Kansas
    • Arkansas City, Kansas, United States, 67005
    • Overland Park, Kansas, United States, 66202
    • Wichita, Kansas, United States, 67207
  • Kentucky
    • Louisville, Kentucky, United States, 40213
    • Mt. Sterling, Kentucky, United States, 40353
  • Louisiana
    • Slidell, Louisiana, United States, 70458
  • Maryland
    • Baltimore, Maryland, United States, 21209
    • Oxon Hill, Maryland, United States, 20745
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
  • Minnesota
    • Edina, Minnesota, United States, 55435
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
  • 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
  • Montana
    • Billings, Montana, United States, 59101
  • Nevada
    • Las Vegas, Nevada, United States, 89123
  • 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
  • New York
    • Johnson City, New York, United States, 13790
  • 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
  • Ohio
    • Cincinnati, Ohio, United States, 45219
    • Mason, Ohio, United States, 45040
    • Mogadore, Ohio, United States, 44260
    • Warren, Ohio, United States, 44483
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
  • Oregon
    • Hillsboro, Oregon, United States, 97123
  • 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, 19152
    • Philadelphia, Pennsylvania, United States, 19114
    • Pittsburgh, Pennsylvania, United States, 15216
    • Sellersville, Pennsylvania, United States, 18960
    • Tipton, Pennsylvania, United States, 16684
    • Warminster, Pennsylvania, United States, 18974
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
  • 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
  • Tennessee
    • Nashville, Tennessee, United States, 37205
  • Texas
    • Dallas, Texas, United States, 75230
    • Fort Worth, Texas, United States, 76104
    • Houston, Texas, United States, 77030
    • San Antonio, Texas, United States, 78229
  • 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
  • Virginia
    • Norfolk, Virginia, United States, 23502
    • Richmond, Virginia, United States, 23294
    • Roanoke, Virginia, United States, 24014
    • Virginia Beach, Virginia, United States, 23455
  • Washington
    • Spokane, Washington, United States, 99216
  • Wisconsin
    • Madison, Wisconsin, United States, 53719

Participation Criteria

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Lipitor; Drug: ezetimibe; 10 mg capsule, daily, 12 weeks; Other Names: Zetia; Ezetrol; Ezemibe
PLACEBO_COMPARATOR: Placebo + atorvastatin + ezetimibe	Drug: atorvastatin; 40 mg, tablet, daily, 12 weeks; Other Names: Lipitor; Drug: ezetimibe; 10 mg capsule, daily, 12 weeks; Other Names: Zetia; Ezetrol; Ezemibe; Drug: placebo; placebo capsule, daily, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Percent Change in Triglycerides From Baseline to Final Visit	[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100	Baseline to 12 Weeks (Final Visit)
Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit	[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100	Baseline to 12 weeks (Final Visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit	[(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100	Baseline to 12 weeks (Final Visit)
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit	[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100	Baseline to 12 weeks (final visit)
Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit	[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100	Baseline to 12 weeks (Final Visit)
Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit	[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100	Baseline to 12 weeks (Final Visit)
Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit	[(Week 12 apoB minus baseline apoB)/baseline apoB] x 100	Baseline to 12 weeks (Final Visit)
Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit	[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100	Baseline to 12 weeks (Final Visit)

Collaborators and Investigators

• Sponsor: Abbott

Publications and helpful links

General Publications

• Jones PH, Goldberg AC, Knapp HR, Kelly MT, Setze CM, Stolzenbach JC, Sleep DJ. Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia. Am Heart J. 2010 Oct;160(4):759-66. doi: 10.1016/j.ahj.2010.06.045.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (ACTUAL): October 1, 2008

Study Registration Dates

• First Submitted: March 14, 2008
• First Submitted That Met QC Criteria: March 14, 2008
• First Posted (ESTIMATE): March 20, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 13, 2011
• Last Update Submitted That Met QC Criteria: June 9, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Gastrointestinal Agents; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Nootropic Agents; Lipotropic Agents; Atorvastatin; Choline; Fenofibric acid; Fenofibrate; Ezetimibe
• Other Study ID Numbers: M10-275