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
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Atorvastatin; Atorvastatin Calcium; Choline; Fenofibrate; Fenofibric acid

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