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

NCT00639158 | Completed Phase 3 Results

• 1 other identifier: M10-275
• Study Type: interventional
• Target: 543
• Locations: 1 country
• Sites: 118

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.

Conditions

Dyslipidemias; Coronary Heart Disease; Combined (Atherogenic) Dyslipidemia; Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit

  Baseline to 12 weeks (Final Visit)

• Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit

  Baseline to 12 weeks (final visit)

• Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit

  Baseline to 12 weeks (Final Visit)

• Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit

  Baseline to 12 weeks (Final Visit)

• Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit

  Baseline to 12 weeks (Final Visit)

Study Arms (2)

ABT-335 + atorvastatin + ezetimibe

ACTIVE COMPARATOR

Drug: ABT-335; Drug: atorvastatin; Drug: ezetimibe

Placebo + atorvastatin + ezetimibe

PLACEBO COMPARATOR

Drug: placebo; Drug: atorvastatin; Drug: ezetimibe

Interventions

ABT-335 DRUG

135 mg capsule, daily, 12 weeks

Also known as: TriLipix, Fenofibric acid, Choline Fenofibrate

ABT-335 + atorvastatin + ezetimibe

placebo DRUG

placebo capsule, daily, 12 weeks

Placebo + atorvastatin + ezetimibe

atorvastatin DRUG

40 mg, tablet, daily, 12 weeks

Also known as: Lipitor

ABT-335 + atorvastatin + ezetimibe; Placebo + atorvastatin + ezetimibe

ezetimibe DRUG

10 mg capsule, daily, 12 weeks

Also known as: Ezetrol, Zetia, Ezemibe

ABT-335 + atorvastatin + ezetimibe; Placebo + atorvastatin + ezetimibe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott: lead

Study Sites (118)

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Birmingham, Alabama, 35209, United States

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Columbiana, Alabama, 35051, United States

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Hueytown, Alabama, 35023, United States

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Ozark, Alabama, 36360, United States

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Tuscaloosa, Alabama, 35406, United States

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Sierra Vista, Arizona, 85635, United States

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Hot Springs, Arkansas, 71913, United States

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Carmichael, California, 95608, United States

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Concord, California, 94520, United States

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Long Beach, California, 90806, United States

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Long Beach, California, 90822, United States

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Los Angeles, California, 90057, United States

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Norwalk, California, 90650, United States

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Roseville, California, 95661, United States

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Sacramento, California, 95825, United States

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Santa Ana, California, 92701, United States

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Tustin, California, 92780, United States

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West Hills, California, 91307, United States

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Colorado Springs, Colorado, 80904, United States

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Denver, Colorado, 80206, United States

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Clearwater, Florida, 33756, United States

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Delray Beach, Florida, 33484, United States

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Fort Myers, Florida, 33907, United States

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Holly Hill, Florida, 32117, United States

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Jacksonville, Florida, 32216, United States

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Jacksonville, Florida, 32259, United States

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Kissimmee, Florida, 34741, United States

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Longwood, Florida, 32750, United States

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Miami, Florida, 33173, United States

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New Port Richey, Florida, 34652, United States

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New Smyrna Beach, Florida, 32168, United States

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Ocala, Florida, 34471, United States

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Ormond Beach, Florida, 32174, United States

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Pembroke Pines, Florida, 33002, United States

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Sarasota, Florida, 34233, United States

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Tampa, Florida, 33607, United States

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Winter Haven, Florida, 33880, United States

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Atlanta, Georgia, 30342, United States

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Augusta, Georgia, 30904, United States

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Roswell, Georgia, 30076, United States

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Suwanee, Georgia, 30024, United States

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Woodstock, Georgia, 30189, United States

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Boise, Idaho, 83704, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60610, United States

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Peoria, Illinois, 61602, United States

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Evansville, Indiana, 47713, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46260, United States

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Iowa City, Iowa, 52242, United States

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Arkansas City, Kansas, 67005, United States

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Overland Park, Kansas, 66202, United States

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Wichita, Kansas, 67207, United States

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Louisville, Kentucky, 40213, United States

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Mount Sterling, Kentucky, 40353, United States

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Slidell, Louisiana, 70458, United States

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Baltimore, Maryland, 21209, United States

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Oxon Hill, Maryland, 20745, United States

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Brockton, Massachusetts, 02301, United States

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Edina, Minnesota, 55435, United States

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Olive Branch, Mississippi, 38654, United States

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City of Saint Peters, Missouri, 63376, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59101, United States

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Las Vegas, Nevada, 89123, United States

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Berlin, New Jersey, 08009, United States

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Elizabeth, New Jersey, 07202, United States

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Hillsborough, New Jersey, 08844, United States

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Trenton, New Jersey, 08611, United States

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Johnson City, New York, 13790, United States

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Charlotte, North Carolina, 28209, United States

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Hickory, North Carolina, 28601, United States

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Morehead City, North Carolina, 28557, United States

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Raleigh, North Carolina, 27609, United States

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Salisbury, North Carolina, 28144, United States

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Statesville, North Carolina, 25677, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45219, United States

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Mason, Ohio, 45040, United States

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Mogadore, Ohio, 44260, United States

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Warren, Ohio, 44483, United States

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Tulsa, Oklahoma, 74136, United States

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Hillsboro, Oregon, 97123, United States

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Duncansville, Pennsylvania, 16635, United States

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Harleysville, Pennsylvania, 19438, United States

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Jersey Shore, Pennsylvania, 17740, United States

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Lansdale, Pennsylvania, 19446, United States

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Melrose Park, Pennsylvania, 19027, United States

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Newtown, Pennsylvania, 18940, United States

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Perkasie, Pennsylvania, 18944, United States

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Philadelphia, Pennsylvania, 19114, United States

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Philadelphia, Pennsylvania, 19152, United States

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Pittsburgh, Pennsylvania, 15216, United States

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Sellersville, Pennsylvania, 18960, United States

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Tipton, Pennsylvania, 16684, United States

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Warminster, Pennsylvania, 18974, United States

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Cumberland, Rhode Island, 02864, United States

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Anderson, South Carolina, 29621, United States

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Greenville, South Carolina, 29615, United States

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Greer, South Carolina, 29651, United States

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Simpsonville, South Carolina, 29681, United States

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Summerville, South Carolina, 29485, United States

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Nashville, Tennessee, 37205, United States

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Dallas, Texas, 75230, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84102, United States

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Salt Lake City, Utah, 84103, United States

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Salt Lake City, Utah, 84107, United States

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West Jordan, Utah, 84088, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23294, United States

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Roanoke, Virginia, 24014, United States

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Virginia Beach, Virginia, 23455, United States

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Spokane, Washington, 99216, United States

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Madison, Wisconsin, 53719, United States

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Related Publications (1)

• 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.

  PMID: 20934572 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Coronary Disease

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid; Fenofibrate; fenofibric acid; Atorvastatin; Ezetimibe

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Azetidines; Azetines

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Last Updated: June 13, 2011
• Results First Posted: November 5, 2009

Record last verified: 2011-06

Locations

US (118)