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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

Primary Purpose

Dyslipidemias, Coronary Heart Disease, Combined (Atherogenic) Dyslipidemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABT-335
placebo
atorvastatin
ezetimibe
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemias

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ABT-335 + atorvastatin + ezetimibe

Placebo + atorvastatin + ezetimibe

Arm Description

Outcomes

Primary Outcome Measures

Median Percent Change in Triglycerides From Baseline to Final Visit
[(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
[(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
[(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
[(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
[(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
[(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
[(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
[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100

Full Information

First Posted
March 14, 2008
Last Updated
June 9, 2011
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00639158
Brief Title
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

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Coronary Heart Disease, Combined (Atherogenic) Dyslipidemia, Mixed Dyslipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
543 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-335 + atorvastatin + ezetimibe
Arm Type
Active Comparator
Arm Title
Placebo + atorvastatin + ezetimibe
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ABT-335
Other Intervention Name(s)
TriLipix, Fenofibric acid, Choline Fenofibrate
Intervention Description
135 mg capsule, daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo capsule, daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
40 mg, tablet, daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
ezetimibe
Other Intervention Name(s)
Ezetrol, Zetia, Ezemibe
Intervention Description
10 mg capsule, daily, 12 weeks
Primary Outcome Measure Information:
Title
Median Percent Change in Triglycerides From Baseline to Final Visit
Description
[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100
Time Frame
Baseline to 12 Weeks (Final Visit)
Title
Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit
Description
[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100
Time Frame
Baseline to 12 weeks (Final Visit)
Secondary Outcome Measure Information:
Title
Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit
Description
[(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100
Time Frame
Baseline to 12 weeks (Final Visit)
Title
Mean Percent Change in Very Low-Density Lipoprotein Cholesterol (VLDL-C) From Baseline to Final Visit
Description
[(Week 12 VLDL-C minus baseline VLDL-C)/baseline VLDL-C] x 100
Time Frame
Baseline to 12 weeks (final visit)
Title
Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit
Description
[(Week 12 apoCIII minus baseline apoCIII)/baseline apoCIII] x 100
Time Frame
Baseline to 12 weeks (Final Visit)
Title
Mean Percent Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Final Visit
Description
[(Week 12 non-HDL-C minus baseline non-HDL-C)/baseline non-HDL-C] x 100
Time Frame
Baseline to 12 weeks (Final Visit)
Title
Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit
Description
[(Week 12 apoB minus baseline apoB)/baseline apoB] x 100
Time Frame
Baseline to 12 weeks (Final Visit)
Title
Median Percent Change in High-Sensitivity C-Reactive Protein (hsCRP) From Baseline to Final Visit
Description
[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100
Time Frame
Baseline to 12 weeks (Final Visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Columbiana
State/Province
Alabama
ZIP/Postal Code
35051
Country
United States
City
Hueytown
State/Province
Alabama
ZIP/Postal Code
35023
Country
United States
City
Ozark
State/Province
Alabama
ZIP/Postal Code
36360
Country
United States
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
City
Sierra Vista
State/Province
Arizona
ZIP/Postal Code
85635
Country
United States
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
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United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
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United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
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United States
City
Norwalk
State/Province
California
ZIP/Postal Code
90650
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United States
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Roseville
State/Province
California
ZIP/Postal Code
95661
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United States
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Sacramento
State/Province
California
ZIP/Postal Code
95825
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United States
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Santa Ana
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California
ZIP/Postal Code
92701
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United States
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Tustin
State/Province
California
ZIP/Postal Code
92780
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United States
City
West Hills
State/Province
California
ZIP/Postal Code
91307
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United States
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Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
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United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
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United States
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Clearwater
State/Province
Florida
ZIP/Postal Code
33756
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United States
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Delray Beach
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Florida
ZIP/Postal Code
33484
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United States
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Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
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United States
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Holly Hill
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Florida
ZIP/Postal Code
32117
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United States
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Jacksonville
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Florida
ZIP/Postal Code
32216
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Jacksonville
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Florida
ZIP/Postal Code
32259
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Kissimmee
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Florida
ZIP/Postal Code
34741
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Longwood
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Florida
ZIP/Postal Code
32750
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Miami
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Florida
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33173
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United States
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New Port Richey
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Florida
ZIP/Postal Code
34652
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United States
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New Smyrna Beach
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Florida
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32168
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United States
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Ocala
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Florida
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34471
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United States
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Ormond Beach
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Florida
ZIP/Postal Code
32174
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United States
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Pembroke Pines
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Florida
ZIP/Postal Code
33002
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United States
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Sarasota
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Florida
ZIP/Postal Code
34233
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United States
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Tampa
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Florida
ZIP/Postal Code
33607
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United States
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Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
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United States
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Atlanta
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Georgia
ZIP/Postal Code
30342
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United States
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Augusta
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Georgia
ZIP/Postal Code
30904
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United States
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Roswell
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Georgia
ZIP/Postal Code
30076
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United States
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Suwanee
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Georgia
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30024
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Woodstock
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Georgia
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30189
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Boise
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83704
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Chicago
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Illinois
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60607
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Chicago
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60610
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Peoria
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ZIP/Postal Code
61602
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Evansville
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Indiana
ZIP/Postal Code
47713
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Evansville
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Indiana
ZIP/Postal Code
47714
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Indianapolis
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Indiana
ZIP/Postal Code
46260
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Iowa City
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Iowa
ZIP/Postal Code
52242
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Arkansas City
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Kansas
ZIP/Postal Code
67005
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United States
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Overland Park
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Kansas
ZIP/Postal Code
66202
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United States
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Wichita
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Kansas
ZIP/Postal Code
67207
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United States
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Louisville
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Kentucky
ZIP/Postal Code
40213
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United States
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Mt. Sterling
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Kentucky
ZIP/Postal Code
40353
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United States
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Slidell
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Louisiana
ZIP/Postal Code
70458
Country
United States
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Baltimore
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Maryland
ZIP/Postal Code
21209
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United States
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Oxon Hill
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Maryland
ZIP/Postal Code
20745
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United States
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Brockton
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Massachusetts
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02301
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Edina
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55435
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Olive Branch
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38654
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St Louis
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63110
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United States
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St Louis
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Missouri
ZIP/Postal Code
63141
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United States
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St. Louis
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Missouri
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63141
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St. Peters
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Missouri
ZIP/Postal Code
63376
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United States
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Billings
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Montana
ZIP/Postal Code
59101
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Las Vegas
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Nevada
ZIP/Postal Code
89123
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United States
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Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
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United States
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Elizabeth
State/Province
New Jersey
ZIP/Postal Code
07202
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United States
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Hillsborough
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New Jersey
ZIP/Postal Code
08844
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United States
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Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
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United States
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Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
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Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
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Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
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Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
25677
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
City
Warren
State/Province
Ohio
ZIP/Postal Code
44483
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
City
Hillsboro
State/Province
Oregon
ZIP/Postal Code
97123
Country
United States
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Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Harleysville
State/Province
Pennsylvania
ZIP/Postal Code
19438
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United States
City
Jersey Shore
State/Province
Pennsylvania
ZIP/Postal Code
17740
Country
United States
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
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United States
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Melrose Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
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United States
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Newtown
State/Province
Pennsylvania
ZIP/Postal Code
18940
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United States
City
Perkasie
State/Province
Pennsylvania
ZIP/Postal Code
18944
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United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15216
Country
United States
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Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
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United States
City
Tipton
State/Province
Pennsylvania
ZIP/Postal Code
16684
Country
United States
City
Warminster
State/Province
Pennsylvania
ZIP/Postal Code
18974
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United States
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23455
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20934572
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.
Results Reference
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Learn more about this trial

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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