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

NCT00616772 | Completed Phase 3 Results DMC

• 1 other identifier: M10-158
• Study Type: interventional
• Target: 682
• Locations: 1 country
• Sites: 124

Brief 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.

Conditions

Coronary Artery Disease; Coronary Heart Disease; Dyslipidemia

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

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

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

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

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

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

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

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

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

Study Arms (2)

ABT-335 + Atorvastatin

EXPERIMENTAL

ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.

Drug: ABT-335; Other: Atorvastatin

Placebo + Atorvastatin

PLACEBO COMPARATOR

Placebo and atorvastatin (up to 40 mg) once daily for 2 years.

Drug: Placebo; Other: Atorvastatin

Interventions

ABT-335 DRUG

Capsule

Also known as: Choline fenofibrate, Fenofibric acid

ABT-335 + Atorvastatin

Placebo DRUG

Capsule

Placebo + Atorvastatin

Atorvastatin OTHER

Capsule

ABT-335 + Atorvastatin; Placebo + Atorvastatin

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mixed dyslipidemia
• Qualifying cIMT thickness

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (124)

Site Reference ID/Investigator# 6747

Chandler, Arizona, 85225, United States

Location

Site Reference ID/Investigator# 7089

Gilbert, Arizona, 85295, United States

Location

Site Reference ID/Investigator# 7097

Mesa, Arizona, 85206, United States

Location

Site Reference ID/Investigator# 26394

Phoenix, Arizona, 85032, United States

Location

Site Reference ID/Investigator# 6848

Scottsdale, Arizona, 85251, United States

Location

Site Reference ID/Investigator# 7059

Tempe, Arizona, 85282, United States

Location

Site Reference ID/Investigator# 7094

Tempe, Arizona, 85282, United States

Location

Site Reference ID/Investigator# 7098

Tempe, Arizona, 85282, United States

Location

Site Reference ID/Investigator# 25082

Anaheim, California, 92804, United States

Location

Site Reference ID/Investigator# 21347

Corona, California, 92879-3109, United States

Location

Site Reference ID/Investigator# 21483

Garden Grove, California, 92843, United States

Location

Site Reference ID/Investigator# 21351

Huntington Beach, California, 92648, United States

Location

Site Reference ID/Investigator# 21346

Laguna Hills, California, 92653, United States

Location

Site Reference ID/Investigator# 21341

Long Beach, California, 90806, United States

Location

Site Reference ID/Investigator# 21342

Norwalk, California, 90650, United States

Location

Site Reference ID/Investigator# 21321

Santa Ana, California, 92705, United States

Location

Site Reference ID/Investigator# 26242

Tustin, California, 92780, United States

Location

Site Reference ID/Investigator# 15283

Arvada, Colorado, 80005-3927, United States

Location

Site Reference ID/Investigator# 7085

Aurora, Colorado, 80012, United States

Location

Site Reference ID/Investigator# 6749

Denver, Colorado, 80239, United States

Location

Site Reference ID/Investigator# 7077

Denver, Colorado, 80246, United States

Location

Site Reference ID/Investigator# 7092

Golden, Colorado, 80401, United States

Location

Site Reference ID/Investigator# 7722

Littleton, Colorado, 80122, United States

Location

Site Reference ID/Investigator# 7721

Littleton, Colorado, 80127, United States

Location

Site Reference ID/Investigator# 11925

Aventura, Florida, 33180, United States

Location

Site Reference ID/Investigator# 15861

Boynton Beach, Florida, 33472, United States

Location

Site Reference ID/Investigator# 14422

Deerfield Beach, Florida, 33442, United States

Location

Site Reference ID/Investigator# 19281

Delray Beach, Florida, 33445, United States

Location

Site Reference ID/Investigator# 20881

Hollywood, Florida, 33021, United States

Location

Site Reference ID/Investigator# 20882

Kissimmee, Florida, 34741, United States

Location

Site Reference ID/Investigator# 19321

Melbourne, Florida, 32901, United States

Location

Site Reference ID/Investigator# 21353

Melbourne, Florida, 32901, United States

Location

Site Reference ID/Investigator# 18503

Melbourne, Florida, 32935, United States

Location

Site Reference ID/Investigator# 18841

Vero Beach, Florida, 32960, United States

Location

Site Reference ID/Investigator# 19961

Vero Beach, Florida, 32960, United States

Location

Site Reference ID/Investigator# 7166

West Palm Beach, Florida, 33401, United States

Location

Site Reference ID/Investigator# 6744

West Palm Beach, Florida, 33407, United States

Location

Site Reference ID/Investigator# 19301

Atlanta, Georgia, 30308, United States

Location

Site Reference ID/Investigator# 7051

Atlanta, Georgia, 30342-1524, United States

Location

Site Reference ID/Investigator# 7109

Atlanta, Georgia, 30342, United States

Location

Site Reference ID/Investigator# 7326

Dawsonville, Georgia, 30534, United States

Location

Site Reference ID/Investigator# 7325

Decatur, Georgia, 30033, United States

Location

Site Reference ID/Investigator# 7057

Dunwoody, Georgia, 30338, United States

Location

Site Reference ID/Investigator# 7101

Dunwoody, Georgia, 30338, United States

Location

Site Reference ID/Investigator# 11324

Roswell, Georgia, 30076, United States

Location

Site Reference ID/Investigator# 6741

Roswell, Georgia, 30076, United States

Location

Site Reference ID/Investigator# 7103

Suwanee, Georgia, 30024, United States

Location

Site Reference ID/Investigator# 10761

Addison, Illinois, 60101, United States

Location

Site Reference ID/Investigator# 6748

Aurora, Illinois, 60504, United States

Location

Site Reference ID/Investigator# 6742

Aurora, Illinois, 60506, United States

Location

Site Reference ID/Investigator# 7128

Belleville, Illinois, 62220-1986, United States

Location

Site Reference ID/Investigator# 7069

Chicago, Illinois, 60607, United States

Location

Site Reference ID/Investigator# 6849

Chicago, Illinois, 60612-9985, United States

Location

Site Reference ID/Investigator# 6867

Chicago, Illinois, 60612, United States

Location

Site Reference ID/Investigator# 6751

Chicago, Illinois, 60616, United States

Location

Site Reference ID/Investigator# 6847

Chicago, Illinois, 60631, United States

Location

Site Reference ID/Investigator# 7049

Chicago, Illinois, 60654, United States

Location

Site Reference ID/Investigator# 7093

Gurnee, Illinois, 60031, United States

Location

Site Reference ID/Investigator# 6746

Hazel Crest, Illinois, 60429, United States

Location

Site Reference ID/Investigator# 6743

Melrose Park, Illinois, 60160, United States

Location

Site Reference ID/Investigator# 7090

Naperville, Illinois, 60564, United States

Location

Site Reference ID/Investigator# 6750

Oak Brook, Illinois, 60523, United States

Location

Site Reference ID/Investigator# 6788

Oak Park, Illinois, 60304, United States

Location

Site Reference ID/Investigator# 6927

Vernon Hills, Illinois, 60061, United States

Location

Site Reference ID/Investigator# 7076

Erlanger, Kentucky, 41018, United States

Location

Site Reference ID/Investigator# 8103

Bloomington, Minnesota, 55420, United States

Location

Site Reference ID/Investigator# 15121

Brooklyn Center, Minnesota, 55430, United States

Location

Site Reference ID/Investigator# 7050

Edina, Minnesota, 55435, United States

Location

Site Reference ID/Investigator# 7084

Edina, Minnesota, 55435, United States

Location

Site Reference ID/Investigator# 6784

City of Saint Peters, Missouri, 63376, United States

Location

Site Reference ID/Investigator# 6860

St Louis, Missouri, 63110, United States

Location

Site Reference ID/Investigator# 13182

St Louis, Missouri, 63117, United States

Location

Site Reference ID/Investigator# 14423

St Louis, Missouri, 63128, United States

Location

Site Reference ID/Investigator# 14541

St Louis, Missouri, 63141-6399, United States

Location

Site Reference ID/Investigator# 6740

St Louis, Missouri, 63141, United States

Location

Site Reference ID/Investigator# 7053

St Louis, Missouri, 63141, United States

Location

Site Reference ID/Investigator# 7063

Henderson, Nevada, 89014, United States

Location

Site Reference ID/Investigator# 7070

Henderson, Nevada, 89052, United States

Location

Site Reference ID/Investigator# 7106

Las Vegas, Nevada, 89104, United States

Location

Site Reference ID/Investigator# 7518

Las Vegas, Nevada, 89106, United States

Location

Site Reference ID/Investigator# 7119

Las Vegas, Nevada, 89146, United States

Location

Site Reference ID/Investigator# 7129

Las Vegas, Nevada, 89148, United States

Location

Site Reference ID/Investigator# 7071

Cincinnati, Ohio, 45212, United States

Location

Site Reference ID/Investigator# 7100

Cincinnati, Ohio, 45219, United States

Location

Site Reference ID/Investigator# 14321

Cincinnati, Ohio, 45224, United States

Location

Site Reference ID/Investigator# 21355

Cincinnati, Ohio, 45245, United States

Location

Site Reference ID/Investigator# 7074

Cincinnati, Ohio, 45246, United States

Location

Site Reference ID/Investigator# 7065

Cincinnati, Ohio, 45249, United States

Location

Site Reference ID/Investigator# 7075

Dayton, Ohio, 45439, United States

Location

Site Reference ID/Investigator# 24802

Kettering, Ohio, 45429, United States

Location

Site Reference ID/Investigator# 7068

Mason, Ohio, 45040, United States

Location

Site Reference ID/Investigator# 7104

Bellaire, Texas, 77401, United States

Location

Site Reference ID/Investigator# 7060

Carrollton, Texas, 75006-5810, United States

Location

Site Reference ID/Investigator# 15282

Dallas, Texas, 75230, United States

Location

Site Reference ID/Investigator# 6745

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 7083

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 7127

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 7110

Dallas, Texas, 75251, United States

Location

Site Reference ID/Investigator# 21356

Deer Park, Texas, 77536, United States

Location

Site Reference ID/Investigator# 11923

Fort Worth, Texas, 76116, United States

Location

Site Reference ID/Investigator# 7321

Houston, Texas, 77002, United States

Location

Site Reference ID/Investigator# 21354

Houston, Texas, 77024, United States

Location

Site Reference ID/Investigator# 21358

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 26482

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 7079

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 7096

Houston, Texas, 77030, United States

Location

Site Reference ID/Investigator# 7126

Houston, Texas, 77036, United States

Location

Site Reference ID/Investigator# 8186

Houston, Texas, 77036, United States

Location

Site Reference ID/Investigator# 11323

Houston, Texas, 77074, United States

Location

Site Reference ID/Investigator# 7130

Houston, Texas, 77081, United States

Location

Site Reference ID/Investigator# 11924

Irving, Texas, 75039, United States

Location

Site Reference ID/Investigator# 13863

Irving, Texas, 75061, United States

Location

Site Reference ID/Investigator# 7099

McKinney, Texas, 75069, United States

Location

Site Reference ID/Investigator# 19121

New Braunfels, Texas, 78130, United States

Location

Site Reference ID/Investigator# 26244

Pearland, Texas, 77584, United States

Location

Site Reference ID/Investigator# 7105

Plano, Texas, 75024, United States

Location

Site Reference ID/Investigator# 7061

San Antonio, Texas, 78205, United States

Location

Site Reference ID/Investigator# 7320

San Antonio, Texas, 78215, United States

Location

Site Reference ID/Investigator# 7914

San Antonio, Texas, 78218, United States

Location

Site Reference ID/Investigator# 7058

San Antonio, Texas, 78229-4801, United States

Location

Site Reference ID/Investigator# 18402

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 7052

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 7062

San Antonio, Texas, 78229, United States

Location

Site Reference ID/Investigator# 22947

San Antonio, Texas, 78238-1434, United States

Location

Related Publications (1)

• 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.

  PMID: 22622962 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Dyslipidemias

Interventions

2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid; fenofibric acid; Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Maureen Kelly, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 15, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 2, 2018
• Results First Posted: January 20, 2014

Record last verified: 2013-12

Locations

US (124)