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



Status:Completed
Conditions:High Cholesterol, Peripheral Vascular Disease, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:45 - Any
Updated:7/4/2018
Start Date:February 2008
End Date:September 2012

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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.


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
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