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Coronary Artery DiseasePhase 3FIRSTNCT00616772

Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood

A Phase 3 study testing ABT-335 and Atorvastatin in people with Coronary Artery Disease and Coronary Heart Disease, run by AbbVie (prior sponsor, Abbott) at 124 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 test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin. Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
ABT-335 and Atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
682 participants
Where
124 sitesUnited States
Study dates
Feb 2008to Sep 2012
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with mixed dyslipidemia
  • Qualifying cIMT thickness

Who cannot join

  • Patients with certain chronic or unstable medical conditions.
  • Patients with unstable dose of medications or receiving coumadin, cyclosporine, or certain other medications
  • Pregnant or lactating women or women intending to become pregnant
  • Patients with diabetes mellitus that is poorly controlled

Trial locations and contacts

124 sites in 1 country.

124 sites in 1 country

United States124 sites

  • Site Reference ID/Investigator# 10761

    Addison, Illinois, 60101

  • Site Reference ID/Investigator# 25082

    Anaheim, California, 92804

  • Site Reference ID/Investigator# 15283

    Arvada, Colorado, 80005-3927

  • Site Reference ID/Investigator# 19301

    Atlanta, Georgia, 30308

  • Site Reference ID/Investigator# 7051

    Atlanta, Georgia, 30342-1524

  • Site Reference ID/Investigator# 7109

    Atlanta, Georgia, 30342

  • Site Reference ID/Investigator# 7085

    Aurora, Colorado, 80012

  • Site Reference ID/Investigator# 6748

    Aurora, Illinois, 60504

  • Site Reference ID/Investigator# 6742

    Aurora, Illinois, 60506

  • Site Reference ID/Investigator# 11925

    Aventura, Florida, 33180

  • Site Reference ID/Investigator# 7104

    Bellaire, Texas, 77401

  • Site Reference ID/Investigator# 7128

    Belleville, Illinois, 62220-1986

  • Site Reference ID/Investigator# 8103

    Bloomington, Minnesota, 55420

  • Site Reference ID/Investigator# 15861

    Boynton Beach, Florida, 33472

  • Site Reference ID/Investigator# 15121

    Brooklyn Center, Minnesota, 55430

  • Site Reference ID/Investigator# 7060

    Carrollton, Texas, 75006-5810

  • Site Reference ID/Investigator# 6747

    Chandler, Arizona, 85225

  • Site Reference ID/Investigator# 7069

    Chicago, Illinois, 60607

  • Site Reference ID/Investigator# 6849

    Chicago, Illinois, 60612-9985

  • Site Reference ID/Investigator# 6867

    Chicago, Illinois, 60612

  • Site Reference ID/Investigator# 6751

    Chicago, Illinois, 60616

  • Site Reference ID/Investigator# 6847

    Chicago, Illinois, 60631

  • Site Reference ID/Investigator# 7049

    Chicago, Illinois, 60654

  • Site Reference ID/Investigator# 7071

    Cincinnati, Ohio, 45212

  • Site Reference ID/Investigator# 7100

    Cincinnati, Ohio, 45219

  • Site Reference ID/Investigator# 14321

    Cincinnati, Ohio, 45224

  • Site Reference ID/Investigator# 21355

    Cincinnati, Ohio, 45245

  • Site Reference ID/Investigator# 7074

    Cincinnati, Ohio, 45246

  • Site Reference ID/Investigator# 7065

    Cincinnati, Ohio, 45249

  • Site Reference ID/Investigator# 6784

    City of Saint Peters, Missouri, 63376

  • Site Reference ID/Investigator# 21347

    Corona, California, 92879-3109

  • Site Reference ID/Investigator# 15282

    Dallas, Texas, 75230

  • Site Reference ID/Investigator# 6745

    Dallas, Texas, 75231

  • Site Reference ID/Investigator# 7083

    Dallas, Texas, 75231

  • Site Reference ID/Investigator# 7127

    Dallas, Texas, 75231

  • Site Reference ID/Investigator# 7110

    Dallas, Texas, 75251

  • Site Reference ID/Investigator# 7326

    Dawsonville, Georgia, 30534

  • Site Reference ID/Investigator# 7075

    Dayton, Ohio, 45439

  • Site Reference ID/Investigator# 7325

    Decatur, Georgia, 30033

  • Site Reference ID/Investigator# 21356

    Deer Park, Texas, 77536

  • Site Reference ID/Investigator# 14422

    Deerfield Beach, Florida, 33442

  • Site Reference ID/Investigator# 19281

    Delray Beach, Florida, 33445

  • Site Reference ID/Investigator# 6749

    Denver, Colorado, 80239

  • Site Reference ID/Investigator# 7077

    Denver, Colorado, 80246

  • Site Reference ID/Investigator# 7057

    Dunwoody, Georgia, 30338

  • Site Reference ID/Investigator# 7101

    Dunwoody, Georgia, 30338

  • Site Reference ID/Investigator# 7050

    Edina, Minnesota, 55435

  • Site Reference ID/Investigator# 7084

    Edina, Minnesota, 55435

  • Site Reference ID/Investigator# 7076

    Erlanger, Kentucky, 41018

  • Site Reference ID/Investigator# 11923

    Fort Worth, Texas, 76116

  • Site Reference ID/Investigator# 21483

    Garden Grove, California, 92843

  • Site Reference ID/Investigator# 7089

    Gilbert, Arizona, 85295

  • Site Reference ID/Investigator# 7092

    Golden, Colorado, 80401

  • Site Reference ID/Investigator# 7093

    Gurnee, Illinois, 60031

  • Site Reference ID/Investigator# 6746

    Hazel Crest, Illinois, 60429

  • Site Reference ID/Investigator# 7063

    Henderson, Nevada, 89014

  • Site Reference ID/Investigator# 7070

    Henderson, Nevada, 89052

  • Site Reference ID/Investigator# 20881

    Hollywood, Florida, 33021

  • Site Reference ID/Investigator# 7321

    Houston, Texas, 77002

  • Site Reference ID/Investigator# 21354

    Houston, Texas, 77024

  • Site Reference ID/Investigator# 21358

    Houston, Texas, 77030

  • Site Reference ID/Investigator# 26482

    Houston, Texas, 77030

  • Site Reference ID/Investigator# 7079

    Houston, Texas, 77030

  • Site Reference ID/Investigator# 7096

    Houston, Texas, 77030

  • Site Reference ID/Investigator# 7126

    Houston, Texas, 77036

  • Site Reference ID/Investigator# 8186

    Houston, Texas, 77036

  • Site Reference ID/Investigator# 11323

    Houston, Texas, 77074

  • Site Reference ID/Investigator# 7130

    Houston, Texas, 77081

  • Site Reference ID/Investigator# 21351

    Huntington Beach, California, 92648

  • Site Reference ID/Investigator# 11924

    Irving, Texas, 75039

  • Site Reference ID/Investigator# 13863

    Irving, Texas, 75061

  • Site Reference ID/Investigator# 24802

    Kettering, Ohio, 45429

  • Site Reference ID/Investigator# 20882

    Kissimmee, Florida, 34741

  • Site Reference ID/Investigator# 21346

    Laguna Hills, California, 92653

  • Site Reference ID/Investigator# 7106

    Las Vegas, Nevada, 89104

  • Site Reference ID/Investigator# 7518

    Las Vegas, Nevada, 89106

  • Site Reference ID/Investigator# 7119

    Las Vegas, Nevada, 89146

  • Site Reference ID/Investigator# 7129

    Las Vegas, Nevada, 89148

  • Site Reference ID/Investigator# 7722

    Littleton, Colorado, 80122

  • Site Reference ID/Investigator# 7721

    Littleton, Colorado, 80127

  • Site Reference ID/Investigator# 21341

    Long Beach, California, 90806

  • Site Reference ID/Investigator# 7068

    Mason, Ohio, 45040

  • Site Reference ID/Investigator# 7099

    McKinney, Texas, 75069

  • Site Reference ID/Investigator# 19321

    Melbourne, Florida, 32901

  • Site Reference ID/Investigator# 21353

    Melbourne, Florida, 32901

  • Site Reference ID/Investigator# 18503

    Melbourne, Florida, 32935

  • Site Reference ID/Investigator# 6743

    Melrose Park, Illinois, 60160

  • Site Reference ID/Investigator# 7097

    Mesa, Arizona, 85206

  • Site Reference ID/Investigator# 7090

    Naperville, Illinois, 60564

  • Site Reference ID/Investigator# 19121

    New Braunfels, Texas, 78130

  • Site Reference ID/Investigator# 21342

    Norwalk, California, 90650

  • Site Reference ID/Investigator# 6750

    Oak Brook, Illinois, 60523

  • Site Reference ID/Investigator# 6788

    Oak Park, Illinois, 60304

  • Site Reference ID/Investigator# 26244

    Pearland, Texas, 77584

  • Site Reference ID/Investigator# 26394

    Phoenix, Arizona, 85032

  • Site Reference ID/Investigator# 7105

    Plano, Texas, 75024

  • Site Reference ID/Investigator# 11324

    Roswell, Georgia, 30076

  • Site Reference ID/Investigator# 6741

    Roswell, Georgia, 30076

  • Site Reference ID/Investigator# 7061

    San Antonio, Texas, 78205

  • Site Reference ID/Investigator# 7320

    San Antonio, Texas, 78215

  • Site Reference ID/Investigator# 7914

    San Antonio, Texas, 78218

  • Site Reference ID/Investigator# 7058

    San Antonio, Texas, 78229-4801

  • Site Reference ID/Investigator# 18402

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 7052

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 7062

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 22947

    San Antonio, Texas, 78238-1434

  • Site Reference ID/Investigator# 21321

    Santa Ana, California, 92705

  • Site Reference ID/Investigator# 6848

    Scottsdale, Arizona, 85251

  • Site Reference ID/Investigator# 6860

    St Louis, Missouri, 63110

  • Site Reference ID/Investigator# 13182

    St Louis, Missouri, 63117

  • Site Reference ID/Investigator# 14423

    St Louis, Missouri, 63128

  • Site Reference ID/Investigator# 14541

    St Louis, Missouri, 63141-6399

  • Site Reference ID/Investigator# 6740

    St Louis, Missouri, 63141

  • Site Reference ID/Investigator# 7053

    St Louis, Missouri, 63141

  • Site Reference ID/Investigator# 7103

    Suwanee, Georgia, 30024

  • Site Reference ID/Investigator# 7059

    Tempe, Arizona, 85282

  • Site Reference ID/Investigator# 7094

    Tempe, Arizona, 85282

  • Site Reference ID/Investigator# 7098

    Tempe, Arizona, 85282

  • Site Reference ID/Investigator# 26242

    Tustin, California, 92780

  • Site Reference ID/Investigator# 6927

    Vernon Hills, Illinois, 60061

  • Site Reference ID/Investigator# 18841

    Vero Beach, Florida, 32960

  • Site Reference ID/Investigator# 19961

    Vero Beach, Florida, 32960

  • Site Reference ID/Investigator# 7166

    West Palm Beach, Florida, 33401

  • Site Reference ID/Investigator# 6744

    West Palm Beach, Florida, 33407

Other trials in United States

About this study

Official title: Evaluation of Choline Fenofibrate (ABT-335) on Carotid Intima-Media Thickness (cIMT) in Subjects With Type IIb Dyslipidemia With Residual Risk in Addition to Atorvastatin Therapy (FIRST) Trial

The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.

Being tested
ABT-335, Placebo, Atorvastatin
Medical subject headings
Coronary Artery Disease, Coronary Disease, Dyslipidemias

What participants receive

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

  • ABT-335Drug

    Also called Choline fenofibrate, Fenofibric acid

    Capsule

  • PlaceboDrug

    Capsule

  • AtorvastatinOther

    Capsule

Study groups in NCT00616772
Study groupRoleWhat they receive
ABT-335 + AtorvastatinExperimentalABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
Receives: Drug: ABT-335; Other: Atorvastatin
Placebo + AtorvastatinPlacebo comparatorPlacebo and atorvastatin (up to 40 mg) once daily for 2 years.
Receives: Drug: Placebo; Other: Atorvastatin

What is being measured

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

  1. Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT)

    Rate of change (mm/year) from baseline in mean of posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.

    Measured: Baseline, 6 months, 12 months, 18 months, and 24 months

Secondary outcomes (4)

  1. Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT)

    Rate of change (mm/year) from baseline in mean of maximal posterior-wall carotid intima-media thickness (cIMT) of the left and right common carotid artery. The statistical model used change from baseline as the dependent variable, with time of cIMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. cIMT was measured using non-invasive ultrasound.

    Measured: Baseline, 6 months, 12 months, 18 months, and 24 months

  2. Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT)

    Rate of change (mm/year) from baseline in composite of mean of the mean posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.

    Measured: Baseline, 6 months, 12 months, 18 months, and 24 months

  3. Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT)

    Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.

    Measured: Baseline, 6 months, 12 months, 18 months, and 24 months

  4. Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT)

    Rate of change (mm/year) from baseline in composite of mean of maximal posterior-wall and anterior-wall intima-media thickness (IMT) of the left and right common carotid artery, internal carotid artery, and carotid bifurcation. The statistical model used change from baseline as the dependent variable, with time of IMT assessment (in years) as one of the factors in the model. The between-group difference in the rate of change was based on the parameter coefficient for the time-by-treatment interaction. The within-group rate of change was obtained from estimate statements within the repeated measures analysis. IMT was measured using non-invasive ultrasound.

    Measured: Baseline, 6 months, 12 months, 18 months, and 24 months

Timeline

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

  1. First posted15 Feb 2008 (estimated)
  2. Study startFeb 2008
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

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
682 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00616772
Sponsor's protocol ID
M10-158
Acronym
FIRST
Status last verified
Dec 2013
First submitted
5 Feb 2008
Last updated
2 Jul 2018
Data monitoring committee
Yes

Publications

  • Davidson M, Rosenson RS, Maki KC, Nicholls SJ, Ballantyne CM, Setze C, Carlson DM, Stolzenbach J. Study design, rationale, and baseline characteristics: evaluation of fenofibric acid on carotid intima-media thickness in patients with type IIb dyslipidemia with residual risk in addition to atorvastatin therapy (FIRST) trial. Cardiovasc Drugs Ther. 2012 Aug;26(4):349-58. doi: 10.1007/s10557-012-6395-z.

    PubMed 22622962

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-335 and Atorvastatin in people with Coronary Artery Disease and Coronary Heart Disease, run by AbbVie (prior sponsor, Abbott) at 124 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 4 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 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 124 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 20 Jan 2014). 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?

Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT) (time frame: Baseline, 6 months, 12 months, 18 months, and 24 months). 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 NCT00616772, 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 2 Jul 2018.

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