DyslipidemiasPhase 3NCT00639158

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 Phase 3 study testing ABT-335, atorvastatin and ezetimibe in people with Dyslipidemias and Coronary Heart Disease, run by Abbott at 118 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dyslipidemias, Coronary Heart Disease, Combined (Atherogenic) Dyslipidemia
What is being tested?: ABT-335, atorvastatin and ezetimibe
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 543 participants
Where: 118 sitesUnited States
Study dates: Feb 2008to Oct 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

118 sites in 1 country.

City, postcode or hospital

118 sites in 1 country

United States118 sites

Study site
Anderson, South Carolina, 29621
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Arkansas City, Kansas, 67005
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Atlanta, Georgia, 30342
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Augusta, Georgia, 30904
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Baltimore, Maryland, 21209
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Berlin, New Jersey, 08009
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Billings, Montana, 59101
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Birmingham, Alabama, 35209
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Boise, Idaho, 83704
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Brockton, Massachusetts, 02301
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Carmichael, California, 95608
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Charlotte, North Carolina, 28209
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Chicago, Illinois, 60607
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Chicago, Illinois, 60610
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Cincinnati, Ohio, 45219
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City of Saint Peters, Missouri, 63376
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Clearwater, Florida, 33756
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Colorado Springs, Colorado, 80904
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Columbiana, Alabama, 35051
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Concord, California, 94520
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Cumberland, Rhode Island, 02864
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Dallas, Texas, 75230
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Delray Beach, Florida, 33484
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Denver, Colorado, 80206
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Duncansville, Pennsylvania, 16635
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Edina, Minnesota, 55435
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Elizabeth, New Jersey, 07202
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Evansville, Indiana, 47713
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Evansville, Indiana, 47714
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Fort Myers, Florida, 33907
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Fort Worth, Texas, 76104
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Greenville, South Carolina, 29615
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Greer, South Carolina, 29651
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Harleysville, Pennsylvania, 19438
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Hickory, North Carolina, 28601
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Hillsboro, Oregon, 97123
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Hillsborough, New Jersey, 08844
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Holly Hill, Florida, 32117
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77030
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Hueytown, Alabama, 35023
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Indianapolis, Indiana, 46260
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Iowa City, Iowa, 52242
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Jacksonville, Florida, 32216
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Jacksonville, Florida, 32259
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Jersey Shore, Pennsylvania, 17740
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Johnson City, New York, 13790
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Kissimmee, Florida, 34741
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Lansdale, Pennsylvania, 19446
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Las Vegas, Nevada, 89123
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Long Beach, California, 90806
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Long Beach, California, 90822
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Longwood, Florida, 32750
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Los Angeles, California, 90057
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Louisville, Kentucky, 40213
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Madison, Wisconsin, 53719
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Mason, Ohio, 45040
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Melrose Park, Pennsylvania, 19027
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Miami, Florida, 33173
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Mogadore, Ohio, 44260
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Morehead City, North Carolina, 28557
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Mount Sterling, Kentucky, 40353
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Nashville, Tennessee, 37205
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New Port Richey, Florida, 34652
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New Smyrna Beach, Florida, 32168
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Newtown, Pennsylvania, 18940
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Norfolk, Virginia, 23502
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Norwalk, California, 90650
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Ocala, Florida, 34471
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Olive Branch, Mississippi, 38654
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Ormond Beach, Florida, 32174
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Overland Park, Kansas, 66202
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Oxon Hill, Maryland, 20745
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Ozark, Alabama, 36360
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Pembroke Pines, Florida, 33002
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Peoria, Illinois, 61602
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Perkasie, Pennsylvania, 18944
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Philadelphia, Pennsylvania, 19114
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Philadelphia, Pennsylvania, 19152
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Pittsburgh, Pennsylvania, 15216
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Raleigh, North Carolina, 27609
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Richmond, Virginia, 23294
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Roanoke, Virginia, 24014
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Roseville, California, 95661
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Roswell, Georgia, 30076
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Sacramento, California, 95825
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Salisbury, North Carolina, 28144
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Salt Lake City, Utah, 84102
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Salt Lake City, Utah, 84103
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Salt Lake City, Utah, 84107
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San Antonio, Texas, 78229
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Santa Ana, California, 92701
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Sarasota, Florida, 34233
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Sellersville, Pennsylvania, 18960
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Sierra Vista, Arizona, 85635
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Simpsonville, South Carolina, 29681
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Slidell, Louisiana, 70458
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Spokane, Washington, 99216
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St Louis, Missouri, 63110
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St Louis, Missouri, 63141
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Statesville, North Carolina, 25677
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Summerville, South Carolina, 29485
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Suwanee, Georgia, 30024
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Tampa, Florida, 33607
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Tipton, Pennsylvania, 16684
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Trenton, New Jersey, 08611
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Tulsa, Oklahoma, 74136
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Tuscaloosa, Alabama, 35406
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Tustin, California, 92780
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Virginia Beach, Virginia, 23455
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Warminster, Pennsylvania, 18974
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Warren, Ohio, 44483
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West Hills, California, 91307
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West Jordan, Utah, 84088
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Wichita, Kansas, 67207
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Winston-Salem, North Carolina, 27103
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Winter Haven, Florida, 33880
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Woodstock, Georgia, 30189

Other trials in United States

About this study

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

Conditions: Dyslipidemias, Coronary Heart Disease, Combined (Atherogenic) Dyslipidemia, Mixed Dyslipidemia
Being tested: ABT-335, placebo, atorvastatin, ezetimibe
Medical subject headings: Dyslipidemias, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ABT-335Drug
Also called TriLipix, Fenofibric acid, Choline Fenofibrate
135 mg capsule, daily, 12 weeks
placeboDrug
placebo capsule, daily, 12 weeks
atorvastatinDrug
Also called Lipitor
40 mg, tablet, daily, 12 weeks
ezetimibeDrug
Also called Ezetrol, Zetia, Ezemibe
10 mg capsule, daily, 12 weeks

Study groups in NCT00639158
Study group	Role	What they receive
ABT-335 + atorvastatin + ezetimibe	Active comparator	Not described Receives: Drug: ABT-335; Drug: atorvastatin; Drug: ezetimibe
Placebo + atorvastatin + ezetimibe	Placebo comparator	Not described Receives: Drug: placebo; Drug: atorvastatin; Drug: ezetimibe

What is being measured

The primary outcome is the main question the study is designed to answer.

Median Percent Change in Triglycerides From Baseline to Final Visit
[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides] x 100
Measured: 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
Measured: Baseline to 12 weeks (Final Visit)

Secondary outcomes (6)

Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit
[(Week 12 apoAI minus baseline apoAI)/baseline apoAI] x 100
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 12 weeks (Final Visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Oct 2008

First posted20 Mar 2008 (estimated)
Study startFeb 2008
Primary completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DyslipidemiasStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 543 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00639158
Sponsor's protocol ID: M10-275
Status last verified: Jun 2011
First submitted: 14 Mar 2008
Last updated: 13 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 20934572

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dyslipidemias trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00639158
Acronym / sponsor ID: M10-275
Conditions: Dyslipidemias, Coronary Heart Disease, Combined (Atherogenic) Dyslipidemia, Mixed Dyslipidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 543 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Oct 2008 (actual)
First posted: 20 Mar 2008 (estimated)
Results: Posted 5 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ABT-335 + atorvastatin + ezetimibe	Active comparator	Drug: ABT-335, Drug: atorvastatin, Drug: ezetimibe
Placebo + atorvastatin + ezetimibe	Placebo comparator	Drug: placebo, Drug: atorvastatin, Drug: ezetimibe

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ABT-335Also: TriLipix, Fenofibric acid, Choline Fenofibrate135 mg capsule, daily, 12 weeks	Drug	ABT-335 + atorvastatin + ezetimibe
placeboplacebo capsule, daily, 12 weeks	Drug	Placebo + atorvastatin + ezetimibe
atorvastatinAlso: Lipitor40 mg, tablet, daily, 12 weeks	Drug	ABT-335 + atorvastatin + ezetimibe, Placebo + atorvastatin + ezetimibe
ezetimibeAlso: Ezetrol, Zetia, Ezemibe10 mg capsule, daily, 12 weeks	Drug	ABT-335 + atorvastatin + ezetimibe, Placebo + atorvastatin + ezetimibe

Primary outcome

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
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

6 secondary outcomes

Mean Percent Change in Apolipoprotein AI (apoAI) From Baseline to Final Visit
Time frame: 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)
Mean Percent Change in Apolipoprotein CIII (apoCIII) From Baseline to Final Visit
Time frame: 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)
Mean Percent Change in Apolipoprotein B (apoB) From Baseline to Final Visit
Time frame: 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)

Results and safety

Results posted to the registry on 5 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe	272	246
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe	270	240

Primary outcome: Median Percent Change in Triglycerides From Baseline to Final Visit

Time frame: Baseline to 12 Weeks (Final Visit). Median (Inter-Quartile Range). Unit: Percent change

Measure	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe n = 262	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe n = 262
Value	-57.3 (22.32)	-39.7 (29.44)

ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe vs Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe: p < 0.001, Wilcoxon (Mann-Whitney)

Population analysed: All randomized subjects with a baseline triglyceride value and at least 1 postbaseline triglyceride value, last observation carried forward.

Primary outcome: Mean Percent Change in High-Density Lipoprotein Cholesterol (HDL-C) From Baseline to Final Visit

Time frame: Baseline to 12 weeks (Final Visit). Mean (Standard Error). Unit: Percent change

Measure	ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe n = 262	Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe n = 262
Value	13.0 (0.95)	4.2 (0.95)

ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe vs Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe: p < 0.001, ANCOVA

Population analysed: All randomized subjects with a baseline high density lipoprotein cholesterol (HDL-C) value and at least 1 postbaseline HDL-C value, last observation carried forward.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ABT-335 + 40 mg Atorvastatin + 10 mg Ezetimibe	3 of 272 (1.1%)	41 of 272 (15.1%)	Not reported
Placebo + 40 mg Atorvastatin + 10 mg Ezetimibe	5 of 270 (1.9%)	51 of 270 (18.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20934572Jones 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.

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Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
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Active, not recruitingObservational study
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

118 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-335, atorvastatin and ezetimibe in people with Dyslipidemias and Coronary Heart Disease, run by Abbott at 118 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Percent Change in Triglycerides From Baseline to Final Visit (time frame: Baseline to 12 Weeks (Final Visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00639158, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2011.