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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 (FIRST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00616772
First received: February 5, 2008
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Coronary Heart Disease
Dyslipidemia
Drug: ABT-335
Drug: Placebo
Other: Atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Rate of Change in Mean Posterior-wall Carotid Intima-media Thickness (cIMT) [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Rate of Change in Mean of Maximal Posterior-wall Carotid Intima-media Thickness (cIMT) [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    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.

  • Rate of Change in Composite of Mean of the Mean Posterior-wall Intima-media Thickness (IMT) [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    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.

  • Rate of Change in Composite of Mean of Maximal Posterior-wall Intima-media Thickness (IMT) [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    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.

  • Rate of Change in Composite of Mean of Maximal Posterior-wall and Anterior-wall Intima-media Thickness (IMT) [ Time Frame: Baseline, 6 months, 12 months, 18 months, and 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 682
Study Start Date: February 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-335 + Atorvastatin
ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
Drug: ABT-335
Capsule
Other Names:
  • Choline fenofibrate
  • Fenofibric acid
Other: Atorvastatin
Capsule
Placebo Comparator: Placebo + Atorvastatin
Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
Drug: Placebo
Capsule
Other: Atorvastatin
Capsule

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with mixed dyslipidemia
  • Qualifying cIMT thickness

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616772

  Show 124 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Maureen Kelly, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00616772     History of Changes
Other Study ID Numbers: M10-158
Study First Received: February 5, 2008
Results First Received: September 13, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Dyslipidemias
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Atorvastatin
Fenofibrate
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014