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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)

Primary Purpose

Coronary Artery Disease, Coronary Heart Disease, Dyslipidemia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

ABT-335

Placebo

Atorvastatin

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ABT-335 + Atorvastatin

Placebo + Atorvastatin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT00616772

First Posted

February 5, 2008

Last Updated

June 1, 2018

Sponsor

AbbVie (prior sponsor, Abbott)

1. Study Identification

Unique Protocol Identification Number

NCT00616772

Brief Title

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

Acronym

FIRST

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease, Coronary Heart Disease, Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

682 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ABT-335 + Atorvastatin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo + Atorvastatin

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ABT-335

Other Intervention Name(s)

Choline fenofibrate, Fenofibric acid

Intervention Description

Capsule

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsule

Intervention Type

Other

Intervention Name(s)

Atorvastatin

Intervention Description

Capsule

Primary Outcome Measure Information:

Title

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

Description

Time Frame