Clinical trial NCT00639158: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyslipidemias
Coronary Heart Disease
Combined (Atherogenic) Dyslipidemia
Mixed Dyslipidemia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Median Percent Change in Triglycerides From Baseline to Final Visit
timeFrame: Baseline to 12 Weeks (Final Visit)
measure: Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
timeFrame: Baseline to 12 weeks (Final Visit)
Secondary outcomes:
measure: Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit
timeFrame: Baseline to 12 weeks (Final Visit)
measure: Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
timeFrame: Baseline to 12 weeks (final visit)
measure: Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit
timeFrame: Baseline to 12 weeks (Final Visit)
measure: Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit
timeFrame: Baseline to 12 weeks (Final Visit)
measure: Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit
timeFrame: Baseline to 12 weeks (Final Visit)
measure: Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit
timeFrame: Baseline to 12 weeks (Final Visit)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Columbiana
country: United States
state: Alabama
city: Hueytown
country: United States
state: Alabama
city: Ozark
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Sierra Vista
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Carmichael
country: United States
state: California
city: Concord
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
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state: California
city: Norwalk
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state: California
city: Roseville
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state: California
city: Sacramento
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state: California
city: Santa Ana
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state: California
city: West Hills
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state: California
city: Colorado Springs
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state: Colorado
city: Denver
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state: Colorado
city: Clearwater
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state: Florida
city: Delray Beach
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state: Florida
city: Fort Myers
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state: Florida
city: Holly Hill
country: United States
state: Florida
city: Jacksonville
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state: Florida
city: Jacksonville
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state: Florida
city: Kissimmee
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city: Longwood
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city: Miami
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city: New Port Richey
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city: Pembroke Pines
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city: Mt. Sterling
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state: Missouri
city: St Louis
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state: Missouri
city: St. Louis
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city: St. Peters
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city: Billings
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city: Elizabeth
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city: Hillsborough
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city: Trenton
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city: Johnson City
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state: New York
city: Charlotte
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state: North Carolina
city: Hickory
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city: Morehead City
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state: North Carolina
city: Raleigh
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state: North Carolina
city: Salisbury
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city: Statesville
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state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
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state: Ohio
city: Mason
country: United States
state: Ohio
city: Mogadore
country: United States
state: Ohio
city: Warren
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Hillsboro
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state: Oregon
city: Duncansville
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state: Pennsylvania
city: Harleysville
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state: Pennsylvania
city: Jersey Shore
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state: Pennsylvania
city: Lansdale
country: United States
state: Pennsylvania
city: Melrose Park
country: United States
state: Pennsylvania
city: Newtown
country: United States
state: Pennsylvania
city: Perkasie
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Tipton
country: United States
state: Pennsylvania
city: Warminster
country: United States
state: Pennsylvania
city: Cumberland
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Greenville
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state: South Carolina
city: Greer
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state: South Carolina
city: Simpsonville
country: United States
state: South Carolina
city: Summerville
country: United States
state: South Carolina
city: Nashville
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state: Tennessee
city: Dallas
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state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
References:
citation: 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.