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

June 9, 2011 updated by: Abbott

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
543

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Median Percent Change in Triglycerides From Baseline to Final Visit
Time Frame: Baseline to 12 Weeks (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
Time Frame: Baseline to 12 weeks (Final Visit)
[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C] x 100
Baseline to 12 weeks (Final Visit)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit
Time Frame: Baseline to 12 weeks (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
Time Frame: Baseline to 12 weeks (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
Time Frame: Baseline to 12 weeks (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
Time Frame: Baseline to 12 weeks (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
Time Frame: Baseline to 12 weeks (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
Time Frame: Baseline to 12 weeks (Final Visit)
[(Week 12 hsCRP minus baseline hsCRP)/baseline hSCRP] x 100
Baseline to 12 weeks (Final Visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M10-275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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